chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Middle insomnia, Pain in extremity, Paraesthesia
Clinical narrative: Woke up in middle of night w numbness in right arm. Thought it might be a stroke. Following days and nights with tingling in hands and feet, an extreme and persistent pain bottom of right forearm similar to a bad bruise and continuing intermittent numbness in both arms during night while sleeping. No reaction at injection site. I am healthy and this vaccine was the only change in my health history..  Symptoms continued for weeks so I made an Appt for 2-16-2019 for 5 health screenings--Carotid Artery Disease, Atrial Fib,, Abdominal Aortic Aneurysm, Peripheral Arterial Disease and numerous other tests ruling out heart/stroke risks.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Began with pain around injection site for first twelve hours, progressed to more severe pain throughout injection site arm and then to other arm and legs. Also experienced low grade fever for which she took tylenol. Took about 3-4 days total to resolve.
Age: 67.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Tied, cant do anything, weak.
Age: 67.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Tied, cant do anything, weak.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Parents of patient reported there was an 8-10cm swelling at the site of injection. This was noted "soon after" the injection was given. The parents deny noting fevers or other symptoms. The patient was not seen by any providers for this reaction.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy abnormal, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 22-year-old female patient. The patient's concurrent conditions included asthma and homosexuality. It was also reported that the patient previously had heterosexual relationships. The patient's concomitant therapies included SINGULAIR, ASMANEX and albuterol. No information regarding the patient's drug reactions or allergies was provided. On unknown dates, the patient was vaccinated with 3 doses of GARDASIL (strength, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in August 2018, the patient had abnormal Papanicolaou (PAP) test and colposcopy which demonstrated cervical intra-epithelial neoplasia 2 (CIN2) so the patient was recommended for loop electrosurgical procedure (LEEP). On an unknown date, the patient had a follow up colposcopy and was not recommended for LEEP surgery. On unknown date in December 2018, she had a follow up PAP smear which was negative. It was reported that the patient did not have LEEP surgery. The relatedness between the events and GARDASIL was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-FEB-2019, the patient was vaccinated with an improperly stored doses of VARIVAX lot R018933, expiration date 02-JUL-2020 and lot R017641, expiration date 20-JUN-2020 subcutaneously (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of - 6 degrees Celsius for 2 hours. Sterile diluent used was properly stored. Data logger was involved. There were no previous excursions reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles.  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at a hospital emergency room for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a 16-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, 14 days after receiving BEXSERO, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the swelling arm to be related to BEXSERO. Additional information was provided as follows: The age at vaccination was not reported. But, it could be 15 or 16 years. The patient's arm was swollen for 2 after weeks of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received SHINGRIX for prophylaxis. On 21st February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, arm discomfort and mobility decreased. On 22nd February 2019, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm, arm discomfort, mobility decreased and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the pain in arm, arm discomfort and mobility decreased to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient received SHINGRIX the day before the reporting day, injected by a person in the pharmacy of an urgent care facility. The patient had constant pain as the patient felt the needle hit my bone in the upper arm, which led to vaccine administered at inappropriate site. The patient thought the injection site was high, but whateve, only to be hardly able to lift that arm halfway up. The patient wanted to know what should take for the pain, and whether he/she quit raising it to not further irritate that bone in the socket. The patient said that not all pharmacists, this one man being young, was good at giving shots the patient guess.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 16th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient had developed a rash. The rash moved to different locations on the patient's body each day. Caller did not have any additional details at the time of the call. Emergency room visit required.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Mobility decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX. On 26th February 2019, less than a day after receiving SHINGRIX, the patient experienced shoulder pain, headache, neck pain, mobility decreased and pain. On an unknown date, the outcome of the shoulder pain, headache, neck pain, mobility decreased and pain were not recovered/not resolved. It was unknown if the reporter considered the shoulder pain, headache, neck pain, mobility decreased and pain to be related to SHINGRIX. Additional details were provided as follows: At the day of reporting, the patient received the dose of SHINGRIX and experienced pain in the shoulder, at the top of her head and neck. The patient could not lift her arm because of the pain. The reporter did not consent to follow-up.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Tremor, Walking aid user
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor limb in a 87-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included back disorder and neuropathy (affecting feet and legs). On 26th February 2019, the patient received SHINGRIX (intramuscular). In February 2019, 9 hrs after receiving SHINGRIX, the patient experienced tremor limb and unsteadiness. On an unknown date, the outcome of the tremor limb and unsteadiness were recovering/resolving. It was unknown if the reporter considered the tremor limb and unsteadiness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 27th February 2019, the patient experienced arms quivering, legs shaking, and he was not steady on his feet. He did use a walker and his wife had to hold him steady. Till the reporting time, the patient was improving. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: HEP, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Nurse inadvertently gave client MenB (BEXSERO) rather then Meningococcal. Physician contacted for recommendation. As client was 15 years and 10 month at time of injection - physician believes that MenB will be effective. Client contacted and has been scheduled to receive Meningococcal vaccine as schedule suggests - received 03/05/2019. No adverse events experienced.
Age: 38.0
Sex: F
Vaccine: FLU4, HEP, HEPA
Symptoms: Exposure during pregnancy, No adverse event, Vaccination error
Clinical narrative: Client is 12.5 weeks gestation, with current EDD 09/13/2019. Client was inadvertently given Hepatitis A and Hepatitis B vaccines during this visit. Client did not complain of any signs or symptoms due to the vaccinations.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, TDAP, HEPA, HPV9, TDAP
Symptoms: Blood glucose normal, Loss of consciousness, Tremor
Clinical narrative: Patient was shaking for about 30 seconds and appeared to lose consciousness for about 30 seconds.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, TDAP, HEPA, HPV9, TDAP
Symptoms: Blood glucose normal, Crying, Headache, Loss of consciousness, Seizure like phenomena
Clinical narrative: Patient was shaking for about 30 seconds and appeared to lose consciousness for about 30 seconds.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, TDAP, HEPA, HPV9, TDAP
Symptoms: Tension, Tremor
Clinical narrative: Patient was shaking for about 30 seconds and appeared to lose consciousness for about 30 seconds.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Nausea, Palpitations
Clinical narrative: Woke up from deep sleep with heart pounding. Pulse rate 110-120, then followed by intense nausea, generalized abdominal discomfort (slight) lasting about 2 - 2 1/2 hrs. After about 30 min of onset of  symptoms  I took Benadryl 50mg. After about 2 hrs I fell back to sleep & woke up with  symptoms resolved.
Age: 20.0
Sex: F
Vaccine: HPV9, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm was red, warm and the site was elevated. Patient was unable to perform full range of motion.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Swollen tongue
Clinical narrative: At 1620 patient complains of tongue swelling sensation. BENADRYL 25 mg PO given to patient right away. At 1630 patient complains of tongue swelling is getting worse. EPIPEN 0.3 mg IM given to patient in his right leg. Patient is monitored closely x 40 min. Vitals are checked repeatedly and remain stable. Symptoms completely resolve. Patient is released into the care of his wife.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability
Clinical narrative: Baby was fussy.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vaccine error - patient was given an adult Hep A instead of a ped/adol Hep A, no adverse reactions reported by patient.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: General symptom
Clinical narrative: Patient received the influenza vaccine a few months prior to event in December. Patient recently recovered from bronchitis. One day after the first SHINGRIX dose, symptoms began.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: The adverse events was a reaction that began 5-6 days after the vaccine in the site of vaccination. There was a red indurated stripe of inflammatory swelling extending from the upper deltoid at the site of vaccine to the mid upper arm. It was itchy and tender.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pseudocyst
Clinical narrative: The adverse events was a reaction that began 5-6 days after the vaccine in the site of vaccination. There was a red indurated stripe of inflammatory swelling extending from the upper deltoid at the site of vaccine to the mid upper arm. It was itchy and tender.
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Injection site discharge, Injection site inflammation, Pain
Clinical narrative: Patient is a 50-year-old male who is seen in consultation for Dr for evaluation of left arm injection site reaction. Patient states he had left arm vaccination injection on 10/3/18. States the injection site became inflamed following vaccination. States the area drained on its own. Reports that the drainage was a yellow/white/bloody fluid. Denies fever, sweats, chills. Rates pain as 1/10. States the area has decreased in size over time. Follow-up PRN.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Flu like symptoms; achy, soreness, low grade fever; sore arm at injection site. My arm was red for about 4-5 inches around the injection site with notable puffiness swelling about 5 inches below the injection site similar to an allergic reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Flu like symptoms; achy, soreness, low grade fever; sore arm at injection site. My arm was red for about 4-5 inches around the injection site with notable puffiness swelling about 5 inches below the injection site similar to an allergic reaction.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient recieved a properly reconstituted 0.5mm dose of Yellow Fever subcutaniously on 04Mar19. Within 24hrs of recieving vaccine he began having symptoms of mild erythmea, swelling and pruritis roughly 2-3cm around the injection site. Patient reported to medical on 06Mar19 to have it checked out. Patient reports no other symptoms. Medical staff advised patient to return to normal activity but to report any worsening of symptoms to medical immediately.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Two days of symptoms, starting with sore arm 30 minutes after injection & lasting  3 days. A few hours after injection, malaise, loss of appetite, fever & chills, lasting approximately 1 1/2 days. When I had the second dose (03/04/2019), symptoms of similar duration, but not quite as severe.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an adult patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On unknown date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacy manager via Pfizer pharmacy representative (manufacturer control number 2018405472) refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient experienced injection site pain. The outcome of injection site pain was unknown. The causality assessment was not provided.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2010, at approximately 73 years of age, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his ZOSTAVAX use: Ocular shingles. The outcome of the ocular shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Upon internal review, ocular shingles was determined to be medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 66 years of age, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 57 or 58 years old. The patient reported a sore arm after the SHINGRIX injection. This case was linked with US2019035161, reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a 58-year-old female patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on an unknown date, see case US2019GSK040681). On 19th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced headache, fever, muscle pain and pain. The patient was treated with fluticasone propionate, ADVAIR and TYLENOL. On an unknown date, the outcome of the headache, fever, muscle pain and pain were recovering/resolving. It was unknown if the reporter considered the headache, fever, muscle pain and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX in the left deltoid. The healthcare professional reported that the patient contacted their office reporting that after the dose of SHINGRIX. The patient experienced a headache, low grade fever of 107 degree F, muscle aches and soreness. The healthcare professional followed up with the patient the following day and she reported that she was feeling much better after taking TYLENOL and ADVAIR alternately. The healthcare professional consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes mellitus and rheumatoid arthritis. On 1st October 2018, the patient received the 1st dose of SHINGRIX. On 2nd October 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms and weakness. On an unknown date, the outcome of the influenza-like symptoms and weakness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and weakness to be related to SHINGRIX. Additional details were provided as follows: The reporter reported the case for his wife, who caller reported his wife experienced flu like symptoms and weakness the day after receiving her first dose of SHINGRIX. The symptoms resolved after 3 days. She did not report it to her physician. The reporter asked Health care professional was asked but declined at the time of reporting.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 29th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the left arm and experienced an ache or hurting at the injection site on his left arm after the injection which resolved after a day or so. It has been unable to secure the second dose because of the backorder.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site abscess, Injection site discharge, Injection site mass
Clinical narrative: Abscess at injection site. Lump with no cellulitis or pain. Site drained and prescribed Cephalexin 250mg/5ml Two milliliters three times daily for ten days.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Agitation, Dyspnoea, Lethargy, Malaise, Neck pain
Clinical narrative: 5 minutes after MMR given employee complained of pain all along left arm, up into her neck and left fingers tingling. Had her sit to observe her. 5 minutes later stated she "did not feel well", and started retching. She then became more agitating stating "I can't breathe". Told bystander to call 911, RNs administered .5cc epinephrine, 25 mg po benadryl. Employee became lethargic, had her lie on the floor until ambulance personnel arrived. Sent via ambulance to ED. ED monitored her and discharged her to home. ED Physician stated "probable vasovagal reaction" versus anaphylaxis.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Paraesthesia, Presyncope, Retching
Clinical narrative: 5 minutes after MMR given employee complained of pain all along left arm, up into her neck and left fingers tingling. Had her sit to observe her. 5 minutes later stated she "did not feel well", and started retching. She then became more agitating stating "I can't breathe". Told bystander to call 911, RNs administered .5cc epinephrine, 25 mg po benadryl. Employee became lethargic, had her lie on the floor until ambulance personnel arrived. Sent via ambulance to ED. ED monitored her and discharged her to home. ED Physician stated "probable vasovagal reaction" versus anaphylaxis.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Dyskinesia, Loss of consciousness, Seizure like phenomena, Trismus, Tunnel vision
Clinical narrative: Individual receiving vaccine reported Seizure like event approx. 18 hours after MMR vaccine was given. Stated she had her jaw lock up, very tight and was unable to close her mouth. This was followed by tunnel vision with loss of consciousness for an undetermined amount of time with slight urinary incontinence.  Could not give exact time of how long the symptoms lasted but does not report any residual effects of the event at the time it was reported to me. I strongly advised her to follow up with her Health Care Provider/Neurology for diagnostic examination and future management.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Urinary incontinence
Clinical narrative: Individual receiving vaccine reported Seizure like event approx. 18 hours after MMR vaccine was given. Stated she had her jaw lock up, very tight and was unable to close her mouth. This was followed by tunnel vision with loss of consciousness for an undetermined amount of time with slight urinary incontinence.  Could not give exact time of how long the symptoms lasted but does not report any residual effects of the event at the time it was reported to me. I strongly advised her to follow up with her Health Care Provider/Neurology for diagnostic examination and future management.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin irritation
Clinical narrative: Patient had a large red patch of irritated skin from her shoulder to her elbow. It went away on its own after a few days. She told her primary care but did not seek any medical attention.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Body temperature, Computerised tomogram head, Dizziness, Dysgeusia
Clinical narrative: Had a metallic taste in mouth and started getting nasueas. As the day progressed started swelling in hands and feet. Got a rash and had a low grade temp. Also by morning started vomitting and having syncope spells. was incoherent most of the day. Started getting flashers in my eyes that would come and go. Had a severe headache. As time progressed the headaches got worse and I was dizzy a lot.  About 2 weeks later I started noticing  body spasms which in turn put me in the hospital. I was unable to walk without assistance. Seen neurology and was given a diagnosis of myoclonus.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Gait inability, Headache, Incoherent, Muscle spasms, Myoclonus
Clinical narrative: Had a metallic taste in mouth and started getting nasueas. As the day progressed started swelling in hands and feet. Got a rash and had a low grade temp. Also by morning started vomitting and having syncope spells. was incoherent most of the day. Started getting flashers in my eyes that would come and go. Had a severe headache. As time progressed the headaches got worse and I was dizzy a lot.  About 2 weeks later I started noticing  body spasms which in turn put me in the hospital. I was unable to walk without assistance. Seen neurology and was given a diagnosis of myoclonus.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Nuclear magnetic resonance imaging, Peripheral swelling, Photopsia, Rash
Clinical narrative: Had a metallic taste in mouth and started getting nasueas. As the day progressed started swelling in hands and feet. Got a rash and had a low grade temp. Also by morning started vomitting and having syncope spells. was incoherent most of the day. Started getting flashers in my eyes that would come and go. Had a severe headache. As time progressed the headaches got worse and I was dizzy a lot.  About 2 weeks later I started noticing  body spasms which in turn put me in the hospital. I was unable to walk without assistance. Seen neurology and was given a diagnosis of myoclonus.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vomiting, Walking aid user
Clinical narrative: Had a metallic taste in mouth and started getting nasueas. As the day progressed started swelling in hands and feet. Got a rash and had a low grade temp. Also by morning started vomitting and having syncope spells. was incoherent most of the day. Started getting flashers in my eyes that would come and go. Had a severe headache. As time progressed the headaches got worse and I was dizzy a lot.  About 2 weeks later I started noticing  body spasms which in turn put me in the hospital. I was unable to walk without assistance. Seen neurology and was given a diagnosis of myoclonus.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Reddened, swollen area at site, extending down under her axilla and into her breast area.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Hypersensitivity, Malaise
Clinical narrative: After receiving the vaccine, I went home and took a nap. 2 hours later, I woke up and was very sick.I was experiencing pain rash all over body, soreness, swelling, headache, muscle aches,fatigue, nausea, stomach pain, I was hurting all over my body. Four days later, I went to the doctor, she told me that, I had a very severe reaction to shingles vaccine, and prescribed BENADRYL. I ended up in the emergency room, a week later, and needed more BENADRYL. I was back in the emergency room in 2 days, again I needed BENADRYL. I was not aware that my body and mind had been affected, so badly by vaccine injection. I saw my doctor and now I have to take BENADRYL and CLARITIN all the time.  I have a very hard time mentally, to remember anything, like I did before vaccine injection. I was lucky, I did not die from it! My body is so bad with allergies now, that I have to be tested to see, what medication I will have to be on, in the future.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Memory impairment, Myalgia, Nausea, Pain, Rash generalised
Clinical narrative: After receiving the vaccine, I went home and took a nap. 2 hours later, I woke up and was very sick.I was experiencing pain rash all over body, soreness, swelling, headache, muscle aches,fatigue, nausea, stomach pain, I was hurting all over my body. Four days later, I went to the doctor, she told me that, I had a very severe reaction to shingles vaccine, and prescribed BENADRYL. I ended up in the emergency room, a week later, and needed more BENADRYL. I was back in the emergency room in 2 days, again I needed BENADRYL. I was not aware that my body and mind had been affected, so badly by vaccine injection. I saw my doctor and now I have to take BENADRYL and CLARITIN all the time.  I have a very hard time mentally, to remember anything, like I did before vaccine injection. I was lucky, I did not die from it! My body is so bad with allergies now, that I have to be tested to see, what medication I will have to be on, in the future.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Vaccination complication
Clinical narrative: After receiving the vaccine, I went home and took a nap. 2 hours later, I woke up and was very sick.I was experiencing pain rash all over body, soreness, swelling, headache, muscle aches,fatigue, nausea, stomach pain, I was hurting all over my body. Four days later, I went to the doctor, she told me that, I had a very severe reaction to shingles vaccine, and prescribed BENADRYL. I ended up in the emergency room, a week later, and needed more BENADRYL. I was back in the emergency room in 2 days, again I needed BENADRYL. I was not aware that my body and mind had been affected, so badly by vaccine injection. I saw my doctor and now I have to take BENADRYL and CLARITIN all the time.  I have a very hard time mentally, to remember anything, like I did before vaccine injection. I was lucky, I did not die from it! My body is so bad with allergies now, that I have to be tested to see, what medication I will have to be on, in the future.
Age: 54.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Feeling hot, Pruritus
Clinical narrative: Patient called and stated "I am burning up all over and itching".
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Local injection site rash. No fever.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity, Pruritus
Clinical narrative: Soreness - unable to use the arm x 7 days. Improved, but persistent 2-3/10  pain on a numeric pain scale. Also complains of intermittent itchiness. States improves as time goes by. Pain does not radiate anywhere. She denies redness, swelling, fever, or hard lump at the injection site.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Full blood count, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: Appeared to be vasovagal response, pt appeared very pale, tried to vomit then lost consciousness, was diaphoretic, got patient to exam table when conscious (1-2 mins) and elevated feet. o2 sats were 96-98 thru out, b/p 90/60. CBC drawn and recovered rapidly with all VS normal.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Presyncope
Clinical narrative: Appeared to be vasovagal response, pt appeared very pale, tried to vomit then lost consciousness, was diaphoretic, got patient to exam table when conscious (1-2 mins) and elevated feet. o2 sats were 96-98 thru out, b/p 90/60. CBC drawn and recovered rapidly with all VS normal.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: 3-4-19: Itching, low grade fever, soreness 3-5-19: erythema, rash is hot to touch, 3-6-19: erythema expanded to about 6 inch diameter, still hot to touch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: 3-4-19: Itching, low grade fever, soreness 3-5-19: erythema, rash is hot to touch, 3-6-19: erythema expanded to about 6 inch diameter, still hot to touch.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Insomnia, Lethargy, Pyrexia
Clinical narrative: Fever greater than 101.5 degrees, runny nose, cough, lethargy, trouble breathing and sleeplessness. Runny nose and cough have lasted more than 2 weeks.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Rhinorrhoea
Clinical narrative: Fever greater than 101.5 degrees, runny nose, cough, lethargy, trouble breathing and sleeplessness. Runny nose and cough have lasted more than 2 weeks.
Age: 74.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient describes bad pain in both arms that started in December after receiving the vaccines, and still hasn't resolved as of 3-6-2019. She squeezes her biceps and the place where the pain is located, not up on her deltoid muscle where the shots were given at.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction noted at this time. Pt received flu vaccine on 2/26 with another flu vaccine given again on 3/6.
Age: 53.0
Sex: M
Vaccine: FLUX, HEPA, PPV
Symptoms: Fungal test, Gram stain, Incisional drainage, Injection site discharge, Injection site infection
Clinical narrative: Patient is a 54-year-old male who is seen in consultation for Dr. evaluation of bilateral arm injection sites. She reports he had influenza vaccination injection in his proximal left upper extremity and hepatitis A and pneumonia vaccination injections in his proximal right upper extremity on 10/3/18. States he first noticed changes at the injection sites about 1 week following injections. States the areas is "festered up". States that 2 spots appeared on his proximal right upper extremity. States that 1 area drained on its own, and had the other lanced and packed at his PCP office about 2 months ago. Reports purulent drainage. Denies fever, chills, sweats. Patient states about 1 week ago he noticed one of the lesions filling up with clear fluid again. Reports only soreness of his proximal left upper extremity, which she states has improved over time. I&D, WTD BID, cultures obtained.
Age: 53.0
Sex: M
Vaccine: FLUX, HEPA, PPV
Symptoms: Injection site pain, Mycobacterium test, Purulent discharge, Smear test
Clinical narrative: Patient is a 54-year-old male who is seen in consultation for Dr. evaluation of bilateral arm injection sites. She reports he had influenza vaccination injection in his proximal left upper extremity and hepatitis A and pneumonia vaccination injections in his proximal right upper extremity on 10/3/18. States he first noticed changes at the injection sites about 1 week following injections. States the areas is "festered up". States that 2 spots appeared on his proximal right upper extremity. States that 1 area drained on its own, and had the other lanced and packed at his PCP office about 2 months ago. Reports purulent drainage. Denies fever, chills, sweats. Patient states about 1 week ago he noticed one of the lesions filling up with clear fluid again. Reports only soreness of his proximal left upper extremity, which she states has improved over time. I&D, WTD BID, cultures obtained.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from an unspecified reporter via Novartis company representative (manufacturer control # PHEH2018US022678_OS), concerning a 73-year-old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (strength, dose #, route, lot # and expiration date were unknown). Concomitant medications were not reported. On an unknown date, the patient experienced allergy to vaccine (reported as "drug allergy"). It the time of reporting, the outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This consumer reported for himself and his wife. This is the second of two reports. A male patient of an unspecified age received, on 18Feb2019, PREVNAR 13 at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On 18Feb2019, the patient experienced a little bit of pain at the injection site. The patient recovered from the event on an unspecified date, in 2019. The information on the lot number has been requested.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Erythema
Clinical narrative: This is a spontaneous report from a contactable physician. An 84-year-old female patient received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "allergies as of 18Feb2019: PREVNAR 13" and reactions: erythema on an unspecified date.  The outcome of the events was unknown. Information on the batch number has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient came in to the pharmacy complaining of a sore arm (she expected) but redness and swelling around the injection site. Patient showed me the area and it was pink and raised. She was advised to make sure the site didnt get any worse and to treat with ibuprofen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Skin warm, Swelling, Tenderness
Clinical narrative: Raised, tender area with approximately a 4 inch oblong red, inflamed area. Tender and warm to touch.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Influenza virus test, Metabolic function test normal, Mononucleosis heterophile test, Neck pain
Clinical narrative: Developed fever, neck pain and headache within hours of vaccination. Presented to ED where she was diagnosed with a viral illness vs vaccine reaction after CBC, influenza and mono testing were performed. She was given anti-emetics and antipyretics after NS bolus. She was seen in follow up 2 days later where a rapid strep test was positive. She was started on appropriate antibiotics and anti-pruritics for urticaria.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Neutrophil percentage increased, Platelet count normal, Pyrexia, Red blood cell count normal, Streptococcus test positive
Clinical narrative: Developed fever, neck pain and headache within hours of vaccination. Presented to ED where she was diagnosed with a viral illness vs vaccine reaction after CBC, influenza and mono testing were performed. She was given anti-emetics and antipyretics after NS bolus. She was seen in follow up 2 days later where a rapid strep test was positive. She was started on appropriate antibiotics and anti-pruritics for urticaria.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Urticaria, Viral infection, White blood cell count increased
Clinical narrative: Developed fever, neck pain and headache within hours of vaccination. Presented to ED where she was diagnosed with a viral illness vs vaccine reaction after CBC, influenza and mono testing were performed. She was given anti-emetics and antipyretics after NS bolus. She was seen in follow up 2 days later where a rapid strep test was positive. She was started on appropriate antibiotics and anti-pruritics for urticaria.
Age: 17.0
Sex: U
Vaccine: FLU4, IPV, TD
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: PATIENT INTO CLINIC WITH MOTHER FOR VACCINES, PATIENT WAS ON A CATCH UP SCHEDULE.  PATIENT DUE FOR TD#3, POLIO#3 AND MOTHER CONSENTED TO INFLUENZA VACCINE.  VACCINES ADMINISTERED WITHOUT DIFFICULTY. IT WAS DISCOVERED AFTER PATIENT LEFT CLINIC THAT PATIENT RECEIVED HIGHER THAN RECOMMENDED DOSE OF POLIO VACCINE, PATIENT RECEIVED 1.5CC OF POLIO VACCINE INSTEAD OF 0.5CC  PHONE CALL TO SANOFI PASTEUR, OUR MEDICAL DIRECTOR AND PATIENT. PATIENT WAS SEEN BY OUR MEDICAL DIRECTOR, NO ADVERSE REACTIONS UPON PHYSICAL EXAM.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Pain in extremity, Skin discolouration
Clinical narrative: Pt state the he rec'd the vaccine during an office visit on 3/4/19. Pt states that on 3/5/19 his noted moderate RUE tenderness. On 3/6/19 RUE pain had worsened and pt noted reddened and blue skin discoloration on his right deltoid. Pt woke up today and report that the RUE pain was so severe that he cannot use his R arm at all and that the skin discoloration is spreading towards his chest.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Pt state the he rec'd the vaccine during an office visit on 3/4/19. Pt states that on 3/5/19 his noted moderate RUE tenderness. On 3/6/19 RUE pain had worsened and pt noted reddened and blue skin discoloration on his right deltoid. Pt woke up today and report that the RUE pain was so severe that he cannot use his R arm at all and that the skin discoloration is spreading towards his chest.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Medication had expired on 2/25/19.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had swelling, redness, hot to the touch and painful on his right arm where the injection was given. The reaction was noticed the morning after he got the vaccine.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Polymerase chain reaction, Pruritus generalised, Viral test negative
Clinical narrative: Associate reported that she started itching all over. No rash visible to inspection. Took OTC BENADRYL no relief. Associate went to ER (3/4/2019)and lab drawn for Mumps RT-PCR and Measles RT-PCR. Both have come back negative. Associate followed up with PCP(3/5/2019) and was told she had an allergic reaction but unsure to what.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: High fever, probably 103, Chills, strong headache. Nausea, inability to sleep, very sore arm. Fever dropped some by next day, but not completely, headache remained, tiredness, sore arm, nausea continues as I write.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: High fever, probably 103, Chills, strong headache. Nausea, inability to sleep, very sore arm. Fever dropped some by next day, but not completely, headache remained, tiredness, sore arm, nausea continues as I write.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia, Tremor
Clinical narrative: Shooting pain down arm after lifting a large object after vaccine and once home. Patient reported to us a couple days later and patient is still having issues with tremors, arm pain, and numbness/tinging throughout the vaccinated arm. Patient has stated that the symptoms are improving, but still significant at this time.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia, Tremor
Clinical narrative: Shooting pain down after vaccine and once home. Patient reported to us 2 days later and patient is still having issues with tremors, arm pain, and numbness/tinging throughout the vaccinated arm. Patient has stated that the symptoms are improving, but still significant.