chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pityriasis rosea, Sleep disorder, Streptococcus test negative, Vaccination site pain, Viral infection
Clinical narrative: Within 24 hours of injection patient experienced body aches, local vaccine site pain and "vivid dreams' That disturbed sleep. She also had a very sore throat - these symptoms persisted for 5 days and she came in to be seen 11/14/17 - her strep test was negative. I viral illness combined with post-vaccine discomfort was suspected. Patient returned 11/30/17 with a rash consistent with pityriasis rosea, and again with the sore throat - she had been feeling weak tired and achey since 11/10/17. I told the mother I would submit a VAERS form however I personally felt the events all signified a viral illness.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Mass, Mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Golf ball size lump within 2 hours, no treatment at that time with achy. Now unable to move arm, weak, throbs like a toothache. Pain has increased and almost unbearable. Apt 12/13 with Dr.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Pain, limited range of motion (inability to lift arm in motion to take shirt off over head, or move arm to the right).
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 14-year-old male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain (serious criteria disability). On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be possibly related to BEXSERO. Additional details were provided as follows: This case was reported by an office manager who was married to a physician and was reporting this case as a patient's parent. The age at vaccination was not reported. The limited information was provided by the sales representative from the office manager.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, Vomiting, Diarrhea symptoms began day after 3 pill, no symptoms with pill 1 or 2.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Flatulence, Vomiting
Clinical narrative: Gas & severe abdominal pain for 1.5 hours with chills (about 10 hours after getting vaccine), then vomiting (1x), stomach pain lasted at least another 1 hour (then fell asleep). No treatment. Woke up next day fine.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Patient was given two of the same vaccine in error. First dose was given 10/31/17, second dose given 12/11/17. The patient is pregnant with an EDD of 01/22/2018.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Mobility decreased, Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: On 10/6/17 woke up from nap and could not rise. Had worse case of vertigo. World was spinning. Called Doctor. Ambulance took me to Hospital.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Chest discomfort, Lip swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of lip swelling in a adult female patient who received ENGERIX B adult (batch number B39CM, expiry date 3rd February 2020). Previously administered products included DTP vaccine with an associated reaction of lip swelling (refer case US2017GSK190455). On 1st December 2017, the patient received ENGERIX B adult (intramuscular) 1 ml. In December 2017, 6 hrs after receiving ENGERIX B adult, the patient experienced lip swelling (serious criteria life threatening), anxiety (serious criteria life threatening) and chest tightness (serious criteria life threatening). The patient was treated with prednisone and BENADRYL. In December 2017, the outcome of the lip swelling, anxiety and chest tightness were recovered/resolved. It was unknown if the reporter considered the lip swelling, anxiety and chest tightness to be related to ENGERIX B adult. Additional details were provided as follows: The patient received DTP vaccination as a child and had similar reactions, specifics unknown by reporter. The patient required urgent care visit for the events. The reporter stated that the reactions were attributed to the pertussis portion of the vaccine. The brand name was unknown for the DTP vaccine.
Age: 78.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Patient received Prevnar 13 in her right shoulder on 12/4/17. On 12/11/17 patient came to the pharmacy and stated that for the last 2 days he right shoulder had started to become tender and swollen. She presented with a light red circle roughly 3 inches in diameter around her injection site. It was noted that her shoulder felt warm to the touch and that the red area did appear to be somewhat swollen. There was no additional bruising or bleeding evident. The patient reported no other adverse effects of any kind. The pharmacist instructed the patient to seek medical attention if she noted a fever, worsening/spreading of the red mark on her shoulder or any difficulty breathing. Her primary care physician was notified via fax. The patient was asked to keep the pharmacy apprised of the situation in case anything changed in the coming days.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Pyrexia, Urticaria
Clinical narrative: Patient broke out in noticeable hives on his forehead, behind his left ear and on his left arm around 4pm on 12/9/17. There were no other symptoms other than the hives. We reached out to the nurse advice line to inquire whether we should give him BENADRYL or take him in for evaluation. They told us to give BENADRYL and re-evaluate in 30 minutes. The hives were still present, but there were no other symptoms other than a mild fever. We gave him a second dose of BENADRYL around 10pm and he went to bed. He woke around 8am the next morning and the hives resolved. No other symptoms have been noted other than some soreness at the injection site.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Abdominal discomfort, Chills, Erythema, Pain, Peripheral swelling
Clinical narrative: Patient's right arm became red and swollen 3.5 inches by 5 inches. Patient also reported fever of 102 F, body aches, chills, and upset stomach.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient's right arm became red and swollen 3.5 inches by 5 inches. Patient also reported fever of 102 F, body aches, chills, and upset stomach.
Age: 47.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Abdominal discomfort, Blister, Diarrhoea, Wound
Clinical narrative: Symptoms started 2 days after getting the vaccines with diarrhea, upset stomach. Next day he developed blisters in the left hand. Two of the blisters popped and are now open sores.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood creatine phosphokinase normal, C-reactive protein increased, Musculoskeletal pain, Neck pain
Clinical narrative: Classic symptoms of polymyalgia rheumatic; neck, shoulder hip pain, elevated ESR and qCRP; responded to prednisone,
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Classic symptoms of polymyalgia rheumatic; neck, shoulder hip pain, elevated ESR and qCRP; responded to prednisone,
Sex: U
Vaccine: PNC13
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: This is a spontaneous report from a contactable pharmacist based on information received by Pfizer from Merck & Co., Inc, manufacturer control number 00670303. A patient of unspecified age, ethnicity, and gender received PREVNAR 13 (Pfizer; Lot Number: N05077; Expiration Date: 01Sep2017), via an unspecified route of administration on 12Oct2016 at a single dose for immunisation and polysorbate 20 (POLYSORBATE), via an unspecified route of administration on 12Oct2016 at a single dose as an adjuvant. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient who was allergic to polysorbate was administered the vaccine. No adverse effect was reported. The action taken in response to the event for the vaccine and polysorbate 20 was not applicable. The clinical outcome for the event was unknown. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Cyanosis, Erythema, Injection site discolouration, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable pharmacist and physician via a Pfizer sales representative. A female patient (66; Unit: Unknown) of unspecified ethnicity received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) via unspecified route of administration on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. Pharmacist stated that the patient experienced extreme redness and discoloration at the injection site in the days after her injections. She said there was bruising and blue/red/yellow coloration on her skin. The events took place on 11Oct2017, and were confirmed to experience after the vaccination. Outcome of the events was unknown. The information about batch/lot number has been requested through follow-up activities.
Sex: F
Vaccine: PNC13
Symptoms: Skin discolouration
Clinical narrative: This is a spontaneous report from a contactable pharmacist and physician via a Pfizer sales representative. A female patient (66; Unit: Unknown) of unspecified ethnicity received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) via unspecified route of administration on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. Pharmacist stated that the patient experienced extreme redness and discoloration at the injection site in the days after her injections. She said there was bruising and blue/red/yellow coloration on her skin. The events took place on 11Oct2017, and were confirmed to experience after the vaccination. Outcome of the events was unknown. The information about batch/lot number has been requested through follow-up activities.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Pain, Peripheral swelling, Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received the first dose of PREVNAR 13 (Lot number: T08483 and Expiration date: Sep2019, NDC number: 00005197102), intramuscular in left deltoid on 11Nov2017 at 0.5 ml, single for routine vaccination. The patient received the vaccine in a Pharmacy/drug store. Patient medical history, family medical history relevant to adverse events and relevant tests were none. The patient was on other medications (unspecified; the reporter does not think that these were relevant to the adverse events). The patient previously received flu vaccine (but it was not within the 4 week time frame). The patient was having red and swollen arm, the patient also experienced headache, body ache, and runny nose on unspecified date after receiving the vaccine. The events required a visit on physician office. The patient's doctor treated the events. The reporting pharmacist assessed the events as non-serious. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling ranges from shoulder all the way to the elbow on an unspecified date. It was reported that the patient had the vaccination five days ago on an unspecified date and she still had a really big swelling that was not subsiding. Outcome of the event was not recovered. The reporter's opinion of causality between the event and the suspect drug was related.
Sex: M
Vaccine: DTAP
Symptoms: Autism spectrum disorder
Clinical narrative: Initial unsolicited case received from a consumer (patient parent) on 28 Nov 2017. This case involves three-year-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP VACCINE) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient medical history was not reported. It was reported as prior to vaccinations patient had been starting to talk. Patient family history was reported as his siblings also had cerebral palsy and who are also autistic but thought may not be related to vaccinations. Concomitant medications were not reported. On an unknown date, following the vaccination, patient developed autism. Relevant lab tests and corrective treatment were not reported. Outcome of the event was unknown. Upon internal review the company decided to consider the case as serious, due to important medical event: autism. List of documents held by sender: none.; Sender's Comments: This is poorly documented case as patient had Autism following DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. Time of onset is unknown, further information on patient's medical history, concomitant medications, any recent infection, birth history, previous immunization and its tolerance are needed further assess this case.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Abscess
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of abscess in a patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, 14 days after receiving PEDIARIX, the patient experienced abscess. On an unknown date, the outcome of the abscess was unknown. It was unknown if the reporter considered the abscess to be related to PEDIARIX. Additional details were reported as follows: The health care professional reported that the patient experienced an abscess 2 to 3 weeks after receiving PEDIARIX. The patient did come back into the office for a follow up visit. At the time of reporting, no further information was available.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt called two days after injection (12/6/17), regarding concerns. Call placed to patient on 12/7/17 to discuss concerns. Pt returned call on 12/11/17 stating pt had localized redness and swelling at injection site, but at this time it had resolved. Pt describes no other symptoms. Discussed with provider, no actions taken.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Both MMR and Varicella were given subcutaneously with a 25g 5/8" syringe in the abdomen. The MMR was given in the right subcutaneous abdomen with a 25g 5/8" syringe. The Varicella was given in the left subcutaneous abdomen with a 25g 5/8" syringe. No adverse reactions were reported or observed.
Age: 10.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Abdominal discomfort, Cough, Decreased appetite, Headache, Malaise
Clinical narrative: Monday, 10/23/2017-- patient's mom called HD reporting that patient had received flu shot and started oral typhoid pills on Thursday 10/19/2017 and has not been feeling well since. He started with a low grade fever which spiked on Saturday to 103 F and a persistent cough, headache, and stomach upset (he has not had nausea or vomiting but has not really had an appetite). Patient has taken 2 oral typhoid pills, one on Thurs 10/19/17 and one on Sat 10/21/17, she was wondering if he should continue and take 3rd pill today. She states that patient does not have a fever today but still isn't feeling great. They are leaving on their trip on 11/17/2017 and will be there 8 days. I consulted with one other person and PaxVax Medical - they recommended that oral typhoid not be taken during acute febrile illness. Explained this to mom, told her that if patient is feeling better tomorrow he can take 3rd pill and finish oral typhoid series or if not recommended that he stop and start all over with oral typhoid or receive injectable typhoid when he is feeling better. Gave mom my direct phone number and she said she will call and let me know what they end up deciding.  10/26/2017--Called to f/u with mom, she states that patient has still not been feeling well and fever has persisted so he didn't take 3rd pill and mom is just waiting. I reiterated recommendation that he start oral typhoid series or receive injectable typhoid when he is feeling better so that he will have full protection for trip. Mom verbalized understanding and I asked if I could f/u with her next week, she told me 'no' I will call you. Decided to call mom back again to recommend that patient be seen by his primary doctor if he hasn't been since his symptoms haven't resolved, spoke to dad who states that mom is not available. Recommended to him that patient be seen by primary doctor if he hasn't been. He states that he does not think that they will have patient revaccinated with typhoid, I explained recommendation that he be revaccinated when he is feeling better to have the best protection for the trip. They will call back if they have any additional questions. 12/11/2017--As of today client/client's parents have not called or returned to HD to receive additional doses of oral typhoid pills or for client to receive injectable typhoid to ensure full protection.
Age: 10.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Pyrexia
Clinical narrative: Monday, 10/23/2017-- patient's mom called HD reporting that patient had received flu shot and started oral typhoid pills on Thursday 10/19/2017 and has not been feeling well since. He started with a low grade fever which spiked on Saturday to 103 F and a persistent cough, headache, and stomach upset (he has not had nausea or vomiting but has not really had an appetite). Patient has taken 2 oral typhoid pills, one on Thurs 10/19/17 and one on Sat 10/21/17, she was wondering if he should continue and take 3rd pill today. She states that patient does not have a fever today but still isn't feeling great. They are leaving on their trip on 11/17/2017 and will be there 8 days. I consulted with one other person and PaxVax Medical - they recommended that oral typhoid not be taken during acute febrile illness. Explained this to mom, told her that if patient is feeling better tomorrow he can take 3rd pill and finish oral typhoid series or if not recommended that he stop and start all over with oral typhoid or receive injectable typhoid when he is feeling better. Gave mom my direct phone number and she said she will call and let me know what they end up deciding.  10/26/2017--Called to f/u with mom, she states that patient has still not been feeling well and fever has persisted so he didn't take 3rd pill and mom is just waiting. I reiterated recommendation that he start oral typhoid series or receive injectable typhoid when he is feeling better so that he will have full protection for trip. Mom verbalized understanding and I asked if I could f/u with her next week, she told me 'no' I will call you. Decided to call mom back again to recommend that patient be seen by his primary doctor if he hasn't been since his symptoms haven't resolved, spoke to dad who states that mom is not available. Recommended to him that patient be seen by primary doctor if he hasn't been. He states that he does not think that they will have patient revaccinated with typhoid, I explained recommendation that he be revaccinated when he is feeling better to have the best protection for the trip. They will call back if they have any additional questions. 12/11/2017--As of today client/client's parents have not called or returned to HD to receive additional doses of oral typhoid pills or for client to receive injectable typhoid to ensure full protection.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Blindness unilateral, Eye pain, Eye swelling
Clinical narrative: Lost vision in left eye which was swollen and painful for an extended period.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, HPV9, MNQ
Symptoms: Injection site erythema
Clinical narrative: Local redness at injection site.
Sex: F
Vaccine: DTAPIPV
Symptoms: Accidental exposure to product, Exposure via skin contact, Immediate post-injection reaction, Injury associated with device, Skin abrasion
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of skin abrasion in a adult female patient who intended to vaccinate a patient with KINRIX. On 1st December 2017, the patient received KINRIX .5 ml. On 1st December 2017, immediately after receiving KINRIX, the patient experienced skin abrasion, needle injury, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the skin abrasion, needle injury, inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the skin abrasion and needle injury to be related to KINRIX. Additional details were provided as follows: This case was reported by a medical assistant (MA), who reported the case for herself. The age at vaccination was not reported. The child jerked and the KINRIX needle grazed the nurse's knuckle, which led to inadvertent exposure to vaccine and exposure via skin contact. No adverse event reported necessary for child, since the event occurred prior to injection. The dose wasted due to contamination and a new KINRIX dose was used for vaccination to the intended patient (vaccine).
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia
Clinical narrative: Patient called stating she has had severe joint pain in the arm she received her flu vaccine in. She states it's lasted for several weeks.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Product quality issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a child patient who received KINRIX (batch number 74G79, expiry date 16th August 2019). On an unknown date, the patient received KINRIX. On an unknown date, unknown after receiving KINRIX, the patient experienced injection site reaction and pharmaceutical product complaint. On an unknown date, the outcome of the injection site reaction and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient had a severe local injection site reaction. This physician believed that there is a quality issue with this lot because. A related product quality complaint was being registered. The physician retained the product for return to GSK for investigation and was requested that GSK put a hold on this lot until investigation is completed. The physician was requesting investigation results. No credit was arranged. The physician refused to provide details and will fax the adverse event information to the Safety Department. She would also email photos to the Quality Department. The physician already reported the AE details to VAERS. This is 3rd of 3 cases reported by the same reporter. Follow up information received on 28th November 2017 from the QA department. GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Seizure episodes one day after the vaccination, similar to his regular seizures episodes. Pt noted to have 1-2 baseline seizures from his underlying chronic medical conditions.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Several hours after vaccine administration patient reported shortness of breath that has lasted several days. This effect has not been accompanied by any other signs or symptoms pe r the patient's report.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Chest X-ray abnormal, Chest discomfort, Chest pain, Chills
Clinical narrative: I suffered from high fever of 103, early 12/02/17, By midday 12/02 chills, body aches, pounding headache, nasal burning, hacking cough (worst at night) but consistent, my joints and muscles were stiff, weakness, and trouble breathing all through 12/06. Low grade fever on 12/06/17, cough worsened, hard time breathing and chest tightness, diarrhea, my chest hurt really bad.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Contraindication to vaccination, Cough, Diarrhoea, Dyspnoea, Electrocardiogram
Clinical narrative: I suffered from high fever of 103, early 12/02/17, By midday 12/02 chills, body aches, pounding headache, nasal burning, hacking cough (worst at night) but consistent, my joints and muscles were stiff, weakness, and trouble breathing all through 12/06. Low grade fever on 12/06/17, cough worsened, hard time breathing and chest tightness, diarrhea, my chest hurt really bad.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Joint stiffness, Musculoskeletal stiffness, Nasal discomfort, Pain
Clinical narrative: I suffered from high fever of 103, early 12/02/17, By midday 12/02 chills, body aches, pounding headache, nasal burning, hacking cough (worst at night) but consistent, my joints and muscles were stiff, weakness, and trouble breathing all through 12/06. Low grade fever on 12/06/17, cough worsened, hard time breathing and chest tightness, diarrhea, my chest hurt really bad.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Pneumonia, Pyrexia
Clinical narrative: I suffered from high fever of 103, early 12/02/17, By midday 12/02 chills, body aches, pounding headache, nasal burning, hacking cough (worst at night) but consistent, my joints and muscles were stiff, weakness, and trouble breathing all through 12/06. Low grade fever on 12/06/17, cough worsened, hard time breathing and chest tightness, diarrhea, my chest hurt really bad.
Age: 29.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Underdose
Clinical narrative: All vaccines administered without issue on 12/5/2017. However, after patient left clinic, it was realized that the Hepatitis B dose was incorrect. A child's (0.5 mL) dose was given to the patient instead of the full adult dose (1.0 mL). The patient came back on 12/7/2017 for the other half of the adult dose. After the patient left, it was realized that the correct dosing should have been to give a full 1.0 mL instead of the second half as has been done in the past. Upon review with the hospital pharmacy and review of CDC information (noting no risk for overdose with Hepatitis B or other risks) - the patient is scheduled to return on 12/11 to receive the correct full 1.0 mL adult dose.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Bed rest, Hyperhidrosis, Pallor, Vision blurred
Clinical narrative: Diaphoretic - blurred vision - pale - did not become syncopal happened within one minute of vaccine administration.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site reaction, Pain, Rash macular, Skin warm
Clinical narrative: Patient's upper left arm showed red, blotchy spots on the outer arm near the injection site and then showed a large red spot (3-4 inches in length) on the inner side of the upper left arm below the lymph node area. Patient started noticing pain and swelling the night she received the vaccinations (about 6-8 hours after injections). The arm is warm to the touch.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: Patient's upper left arm showed red, blotchy spots on the outer arm near the injection site and then showed a large red spot (3-4 inches in length) on the inner side of the upper left arm below the lymph node area. Patient started noticing pain and swelling the night she received the vaccinations (about 6-8 hours after injections). The arm is warm to the touch.
Age: 1.58
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Cellulitis, pain, redness and swelling R upper arm.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 6 month old male patient. The patient had no known pre-existing physician-diagnosed allergies, birth defects, nor medical conditions. On 15-NOV-2017, the patient was vaccinated with improperly stored doses of ROTATEQ orally, dose 3, for prophylaxis (lot # M039061, expiry date: 28-APR-2018, dose not reported); and LIQUID PEDVAXHIB, intramuscular in the left thigh, dose 3, for prophylaxis (lot#N012119, expiry date: 06-FEB-2020, dose not reported). Other vaccines administered on the same date included: PEDIARIX, intramuscular in the right thigh; and PREVNAR 13 intramuscular in the left thigh. No adverse effects were reported and the patient did not have any illness at time of vaccination. The doses of the vaccines were exposed to a temperature of 9°C to 25°C (15.2°C) for a time frame of 1 hour and 48 minutes. There was no previous temperature excursion. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an approximately 5-week-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-NOV-2017, which was one day shy of the patient's 6 week recommended first dose schedule, the patient was vaccinated with a dose of ROTATEQ, orally, lot # N005618, expiration date 04-OCT-2018, for prophylaxis. No adverse effects were reported. The reporter stated that ROTATEQ did not undergo a temperature excursion.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions, allergies or concomitant medications was reported. On 30-NOV-2017, the patient was vaccinated an expired dose of with PNEUMOVAX 23 injection, intramuscularly (dose, dose number and anatomical location were not reported; lot # M018766 with expiration date 25-OCT-2017). No adverse effects reported.
Sex: M
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Initial unsolicited report received from nurse on 25-Oct-2017. This case was linked to 2017SA210269 and 2017SA210270 (same reporter, same vaccine). This case involves a six-year-old male patient who was vaccinated with 0.5 ml dose once of FLUZONE (Batch number: U5896CA, expiration date, dose was not reported) via intramuscular route in right deltoid on 21 Oct 2017. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced softball size bump from deltoid to elbow and around to bicep. Lab data was not reported. The patient received corrective treatment with Tylenol. The patient was not recovered from event. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Initial unsolicited report received from nurse on 25-Oct-2017. This case was linked to 2017SA210257 and 2017SA210270 (same reporter, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with 0.5 ml dose once of FLUZONE QIV (Batch number: U5896CA, expiration date, dose was not reported) via intramuscular route in right deltoid on 21 Oct 2017. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced softball size bump in deltoid. Lab data was not reported. The patient received corrective treatment with Tylenol. The patient's event outcome was not reported. List of documents held by sender: none.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Initial unsolicited report received from a consumer on 03-Nov-2017 and additional information was received on 03-Nov-2017. This case involves 55-year-old male patient who was vaccinated with 0.5 ml single dose of FLUZONE QUADRIVALENT via intramuscular route in the left deltoid (batch number, expiry date, dose in series were not reported) on 01-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, 2 days after the vaccination, patient's left elbow started hurting and had not stopped hurting. Reportedly, patient will visit to doctor. Reporter stated he was not sure if the side effect he was experiencing was truly from Sanofi's product. Lab data and corrective treatment were not reported. The outcome of the event was not recovered at the time of reporting. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Rash erythematous
Clinical narrative: Initial unsolicited report received from a nurse on 28-Nov-2017. This case involves a male patient of unknown age, who was vaccinated with 0.5 ml dose of FLUZONE QIV (batch number: U589DA, expiry date, dose, dose in series, route, site of administration were not reported), on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following vaccination the patient developed large red rash. Laboratory tests and corrective treatment were not reported. The event's outcome was not reported. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Decreased appetite, Diarrhoea, Expired product administered
Clinical narrative: Initial unsolicited report received from a physician on 27-Nov-2017. This case involves a 02-month-old female patient who was vaccinated with a 0.5 mL dose of ACTHIB (single dose, batch number: UI726AA, expiry date: 19-Nov-2017, dose in series and site of the administration were not reported) intramuscularly on 22-Nov-2017. The patient's medical history was not reported. The patient received PEDIARIX, PCV13, and Rotavirus vaccine concomitantly. On 23-Nov-2017, one day (reported as next day) post vaccination, the mother reported that the infant's appetite was decreased by 2 ounces, she had some diarrhea and was less active initially. It was also a case of actual medication error due to expired vaccine used. Relevant lab details were not reported. It was not reported if the patient received any corrective treatment. Dr. stated she was seeing the infant in 2 days for a recheck. On 27-Nov-2017, her symptoms (decreased appetite) was resolved with the exception of some loose stools. The outcome of the event loose stools was recovering. It was reported that the physician was seeing the patient in 2 days for a recheck. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe pain and limited mobility in right arm. For months after pain improving but still limited mobility.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Pyrexia
Clinical narrative: 6 or 7 hrs after the shot, I felt feverish and flushed and these symptoms lasted 3 days. Took temp: no fever.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: About 8 hrs after this "flu shot", my wife began feeling feverish and had myalgia and arthralgia. Symptoms persisted for 2 days more.
Age: 0.42
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a 5-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 14-NOV-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, lot # N014946 with expiration date on 01-FEB-2017 (dose was unspecified) for prophylaxis, instead of scheduled PREVNAR 13. The reporter confirmed that that was an human error, not a product quality issue. No adverse effects were reported.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Employee reported to this writer that after receiving the flu shot, her left arm became red, hot to the touch and tender. There was no shortness of breath, rash, no swelling of the eyes, lips or tongue; no drainage, denies pain. This continued for 24 hours after receiving this vaccine. Employee was instructed if symptoms worsened, to seek care at her primary physician.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Adverse event
Clinical narrative: On 11/30/17 patient received 3 immunizations intramuscular DTaP in left lateral thigh and influenza and HIB in right lateral thigh with no complications. Patient presented at urgent care on 12/2/17 for evaluation.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: One day after vaccine was administered mom called reporting redness and swelling to the vaccine site follow up with allergist was done immediately and symptoms were treated approximately - oral steroids were given (prednisolone). *No Anaphylaxis*.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Allergy test, Pain, Rash erythematous, Rash pruritic
Clinical narrative: 2 days after vaccine administration a few itchy red bumps appeared. Worsened to redness, some pain and itchiness. Oral BENADRYL administered and oral prednisolone. An allergist referral was provided.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Adverse event of vaccines and biological substances, init on 2017-10-23.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Arm swelling, tenderness.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Injection site erythema, Injection site oedema, Pain, Pruritus
Clinical narrative: Arm swelling, tenderness.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Localized erythema and edema (18 cm x 21 cm) surrounding injection site began on day of injection.  Pain and minimal pruritis. Seen in clinic on day following injection. Treated with ice, ibuprofen, and diphenhydramine.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Injection site erythema, Injection site oedema, Pain, Pruritus
Clinical narrative: Localized erythema and edema (18 cm x 21 cm) surrounding injection site began on day of injection.  Pain and minimal pruritis. Seen in clinic on day following injection. Treated with ice, ibuprofen, and diphenhydramine.
Age: 1.08
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Ataxia, Clumsiness, Febrile convulsion, Full blood count, Hemiparesis
Clinical narrative: 5 days after vaccination she had a fever. 7 days post vaccination she had a complex febrile seizure and developed ATAXIA, clumsiness, and weakness of left side. These symptoms are gradually improving.
Age: 1.08
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Lymphocyte percentage increased, Neutrophil count decreased, Pyrexia, White blood cell count normal
Clinical narrative: 5 days after vaccination she had a fever. 7 days post vaccination she had a complex febrile seizure and developed ATAXIA, clumsiness, and weakness of left side. These symptoms are gradually improving.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Blood glucose, Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Patient was walking to the check out counter after receiving the Hep A and MENACTRA vaccinations, where she has a syncopal episode. Patient states that she felt dizzy and then fell. Patient was unconscious for  about 30 seconds. Patient did hit head on the floor. Patient was then examined for head and neck injurys and was taken to the hospital via ambulance for further treatment and evaluation.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Neck injury, Syncope
Clinical narrative: Patient was walking to the check out counter after receiving the Hep A and MENACTRA vaccinations, where she has a syncopal episode. Patient states that she felt dizzy and then fell. Patient was unconscious for  about 30 seconds. Patient did hit head on the floor. Patient was then examined for head and neck injurys and was taken to the hospital via ambulance for further treatment and evaluation.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Antinuclear antibody, Blood creatine phosphokinase, Blood thyroid stimulating hormone, Diarrhoea
Clinical narrative: 2 days after the flu shot she experienced vomiting and diarrhea and abdominal pain later that day had leg pain by groin to knees but not knees, vomiting and diarrhea stopped, abdominal pain comes and goes, leg pain is still there and getting worse, worse on right side.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Epstein-Barr virus test, Full blood count, Metabolic function test, Pain in extremity, Thyroxine
Clinical narrative: 2 days after the flu shot she experienced vomiting and diarrhea and abdominal pain later that day had leg pain by groin to knees but not knees, vomiting and diarrhea stopped, abdominal pain comes and goes, leg pain is still there and getting worse, worse on right side.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: 2 days after the flu shot she experienced vomiting and diarrhea and abdominal pain later that day had leg pain by groin to knees but not knees, vomiting and diarrhea stopped, abdominal pain comes and goes, leg pain is still there and getting worse, worse on right side.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Right shoulder and tricep pain.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Nausea, Syncope, Vomiting
Clinical narrative: Approximately 1 minute after the vaccination, the patient fainted. Shortly thereafter, the patient came back to and felt nauseous and vomited.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Discomfort, Joint crepitation, Mobility decreased, Musculoskeletal pain
Clinical narrative: On 11/16/17 pt reported the following:  States no pain at time of injection but by late afternoon she could barely lift her arm x4d. By end of the first week she could move the arm but felt like her shoulder was frozen. Had pain in the upper deltoid, 9/10 that radiated to the posterior shoulder blade. Describes throbbing pain at rest which became sharp & stabbing with movement. States shoulder would lock, "pop" when she attempted to raise. Was unable to lift 5 lb weight. Symptoms improved with warm weather, but worsened again with colder weather. Reports "jabbing" pain, 7/10. Had tried heating pad, ROM exercises, Advil 800 mg BID-TID x2 weeks which she had not taken for one week prior to presentation. States was not helpful. Denies previous injury to the shoulder or previous problems. Was given Naproxen 500 mg PO and instructed to take BID. Referred to Ortho for further evaluation.  On 12/4/17 follow up was made. Pt stated she did not go to Ortho as symptoms improved with Naproxen which she took x6d. Continues to feel some discomfort on occasions, but otherwise significantly improved. Instructed to f/u with Ortho if symptoms returned.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity, Periarthritis, Weight bearing difficulty
Clinical narrative: On 11/16/17 pt reported the following:  States no pain at time of injection but by late afternoon she could barely lift her arm x4d. By end of the first week she could move the arm but felt like her shoulder was frozen. Had pain in the upper deltoid, 9/10 that radiated to the posterior shoulder blade. Describes throbbing pain at rest which became sharp & stabbing with movement. States shoulder would lock, "pop" when she attempted to raise. Was unable to lift 5 lb weight. Symptoms improved with warm weather, but worsened again with colder weather. Reports "jabbing" pain, 7/10. Had tried heating pad, ROM exercises, Advil 800 mg BID-TID x2 weeks which she had not taken for one week prior to presentation. States was not helpful. Denies previous injury to the shoulder or previous problems. Was given Naproxen 500 mg PO and instructed to take BID. Referred to Ortho for further evaluation.  On 12/4/17 follow up was made. Pt stated she did not go to Ortho as symptoms improved with Naproxen which she took x6d. Continues to feel some discomfort on occasions, but otherwise significantly improved. Instructed to f/u with Ortho if symptoms returned.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Right shoulder pain.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Influenza virus test negative, Pain
Clinical narrative: Fatigue, feeling "run down" and body aches, negative flu swab in clinic, advised TYLENOL/MOTRIN and BENADRYL for symptoms and go to the ER if worsening.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain in left upper arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Redness over the left upper arm, pain and swelling that lasted 4 days (and counting). Though, swelling and redness are decreasing. Patient reported this same reaction when she receieved this same vaccine last year from a different facility.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Vomiting
Clinical narrative: Patient was throwing up in his sleep and continued to throw up multiple times over the course of 48 hours. He was NOT sick before receiving this shot.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccine was given, however had expired on November 18th 2017.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Crying, Cyanosis, Emotional disorder, Lethargy, Pyrexia
Clinical narrative: Severe screaming/crying upwards of 3.5 hours approximately 36 hours after vaccination. Child was turning blue the crying was so severe. Inconsolable and completely out of character. 99.9 fever. Lethargy/drowsiness for 4 days after vaccination (12/8-12/12).
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Screaming, Somnolence
Clinical narrative: Severe screaming/crying upwards of 3.5 hours approximately 36 hours after vaccination. Child was turning blue the crying was so severe. Inconsolable and completely out of character. 99.9 fever. Lethargy/drowsiness for 4 days after vaccination (12/8-12/12).
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apnoea, Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Child found apneic, unresponsive, brought to hospital by EMS with CPR in progress, child expired.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Blood urine present, Full blood count normal, Laboratory test normal
Clinical narrative: Patient started experiencing shin, back and joint pain 20 minutes after receiving the vaccination. The symptoms worsened over the next 2 days, then patient reported to ER for treatment. Pt noted to have tenderness to joints.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Urine analysis normal
Clinical narrative: Patient started experiencing shin, back and joint pain 20 minutes after receiving the vaccination. The symptoms worsened over the next 2 days, then patient reported to ER for treatment. Pt noted to have tenderness to joints.