chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On 07-FEB-2019, the patient was vaccinated with VARIVAX (strength, dose, anatomical location, and route of administration were not reported) lot # R019237 with expiration date of 04-JUL-2020, indicated for prophylaxis; which was reconstituted with sterile diluent (MERCK) properly stored. Administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F°) to 14 degrees Fahrenheit (F°) (9.9 (F°)) for 5 minutes on unspecified date, which was recorded with a data logger. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA003926.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On 07-FEB-2019, the patient was vaccinated with VARIVAX (strength, dose, anatomical location, and route of administration were not reported) lot # N026073 with expiration date of 20-SEP-2019, indicated for prophylaxis; which was reconstituted with sterile diluent (MERCK) properly stored. Administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F°) to 14 degrees Fahrenheit (F°) (9.9 (F°)) for 5 minutes on unspecified date which was recorded with a data logger. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA003793: Original Case: 1902USA003793.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist, concerning an male patient on his seventy's. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unspecified date in January 2019 (reported as "a couple weeks ago"), the patient was vaccinated with PNEUMOVAX 23 1 injection for prophylaxis, route of administration reported as injection (strength, frequency, lot number and expiration date were not reported). On an unspecified date in January 2019, the patient experienced more injection-site swelling than usually sees for patients receiving that vaccine. At the time of reporting, the outcome of injection-site swelling was unknown. The causal relationship between the vaccination with PNEUMOVAX 23 and the event was not provided by the reporting pharmacist. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1901USA012214.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist, concerning an male patient on his seventy's. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unspecified date in January 2019 (reported as "a couple weeks ago"), the patient was vaccinated with PNEUMOVAX 23 1 injection for prophylaxis, route of administration reported as injection (strength, frequency, lot number and expiration date were not reported). On an unspecified date in January 2019, the patient experienced more injection-site swelling than usually sees for patients receiving that vaccine. At the time of reporting, the outcome of injection-site swelling was unknown. The causal relationship between the vaccination with PNEUMOVAX 23 and the event was not provided by the reporting pharmacist. This is one of three reports received from the same reporter. Sender's Comments: 01087630.
Sex: U
Vaccine: VARZOS
Symptoms: Taste disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of taste altered in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced taste altered. On an unknown date, the outcome of the taste altered was unknown. It was unknown if the reporter considered the taste altered to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Food or drinks taste bad day after SHINGRIX shot. The patient wanted to know was this side effect of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Helicobacter infection, Helicobacter test
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of helicobacter pylori infection in a female patient who received SHINGRIX for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a year after receiving SHINGRIX, the patient experienced helicobacter pylori infection (serious criteria GSK medically significant). The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the helicobacter pylori infection was unknown. It was unknown if the reporter considered the helicobacter pylori infection to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who was a retired nurse. The age at vaccination was not reported. The patient paid for the 2nd dose of SHINGRIX at the time of receiving the 1st dose. The patient was diagnosed with H Pylori (helicobacter pylori infection) and already took the first round of antibiotics. The patient just took a breath test to see if she was over the H Pylori. The patient read that, it was mildly radioactive and did not want it to compromise with the SHINGRIX. The patient wanted to know if one would play against the other, because she wanted the SHINGRIX to work perfectly. It was lemon flavored medicine in water to drink. The patient did not called about H Pylori in relation to receiving SHINGRIX, but she mentioned the H Pylori started in December 2018, adverse event filed conservatively. Lab Comments: On an unknown date, the patient just took a breath test to see if she was over the H Pylori. She read that it is mildy radioactive and does not want it to compromise with the SHINGRIX.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 85-year-old female patient who received SHINGRIX (batch number T4952, expiry date 18th June 2021) for prophylaxis. Previously administered products included SHINGRIX (on an unknown date received 1st dose). On 3rd February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, skin warm and pruritus. On an unknown date, the outcome of the erythema of extremities and skin warm were unknown and the outcome of the pruritus was not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, skin warm and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm. The patient experienced redness and warmth to touch which was spreading down to her elbow. The patient was also experiencing itching. No further details were provided. This case has been linked to the case US2019021292, reported by the same reporter.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves unknown demographic patient who experienced allergies to tetanus toxoid fluid, while he/she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number, Exp. Date, dose, route and administration site not reported. On an unknown date, the patient developed non-serious allergy to tetanus toxoid fluid following the administration of TETANUS TOXOID. Details of lab data not provided. Final diagnosis was allergy to tetanus toxoid fluid. It was not reported if the patient received any corrective treatment. The event outcome was not reported. List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: 6VAX-F
Symptoms: Injection site haemorrhage, Injection site mass, Injection site pruritus, Middle insomnia
Clinical narrative: Lump developed in thigh at injection site about the size of a pea or maybe a little bigger. It itches and sometimes it flares up and is worse than at other times. My daughter scratches it until it bleeds and sometimes it wakes her up at night. She started getting the lump pretty much right after she was injected and she still has the lump now, over a year later. She has two bumps with the same symptoms in her other two injection sites on both hips. I'll report those two separately. Her doctor has been notified several times and advised us to report the adverse reaction. Dr stated could possibly be ARTHUS reaction.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Pt was given HAVRIX 1 on 2/5/19 and the next day, 2/6/19 woke up with red rash on face that was itchy and swollen. Rash goes away after 30-60 mins and then will reappear usually after patient has been sleeping. Advised to give zyrtec  liquid 1/2 tsp twice daily.
Age: 0.92
Sex: F
Vaccine: 6VAX-F
Symptoms: Immediate post-injection reaction, Induration, Mass, Pain, Pruritus
Clinical narrative: Small lump developed under the skin immediately following injection, feels very hard like pebble and itches. Continues to itch and cause pain as of this reporting date. Same reaction as the last injection. This one in the left or right hip. Doctor states it could be ARTHUS reaction.
Age: 1.17
Sex: F
Vaccine: 6VAX-F
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Small lump in hip at injection site that itches and is red and painful. Lump not going away and is the same reaction as the last two doses of the same type of vaccination. All three have been reported.  Patient's doctor says it could be ARTHUS reaction and that I should report and find out what else it could be.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Fatigue, nausea and fever of 100.3.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Erythema, Petechiae, Rosacea
Clinical narrative: Child was quite behind on vaccinations after missing several appointments with our office. Came in with mom, VIS statements given and screening checklist completed. Mom denied any illness, client was noted to have rosy cheeks, appearance similar to rosacea, he has fair skin and mom reports as sensitive skin. Child received vaccinations, he did cry pretty hard during the process as one would expect. He was consoled quickly after the injections were complete. Several minutes after the injections checked on client, he was drinking a bottle and interacting appropriately, normal behavior. At that time it was noted he had small petechiae on his face. Noted on forehead, eye lids and cheeks. None noted anywhere else on his body. We questioned if this was related to the crying during the procedure. We watched the child for the full 15 minutes and maybe a bit longer, no change in rash, no signs of other reaction. Mom was instructed to keep an eye on him and to bring to ED if any changes. Once the child had left we discussed case with each other and decided it would be best to let the Immunization program chief and the child's PCP know about the event in case it was a reaction to one of the vaccines. Mother was made aware we would be contacting the PCP, at the time of this call she reports child is behaving normally and no change or worsening of rash. PCP called and he did decide to order bloodwork, CBC. When called mother to let her know about the order she was resistant to bring the child in for bloodwork that night. She was encouraged by this nurse to call the PCP to discuss risk versus benefits of that decision. PCP also called by this nurse and made aware of mother's response, at that point transfer of care to PCP.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 25-year-old (discrepant information also reported as "23") male patient. Information about medical history, drug reactions, allergies or concomitant medications were not provided. On 26-JAN-2019, the patient was vaccinated with VARIVAX 0.5 mL, by intramuscular route, in the left arm, for prophylaxis, lot # R011809 and expiration date 23-APR-2020. The patient had not reported any other issues.
Age: 14.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 14-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 20-DEC-2018, the patient was inadvertently vaccinated with MMR II, (recombinant Human albumin (rHA)), lot# M049212, expiration date 16-12-2018, (dose and route of administration were not reported) for prophylaxis, which was expired. No adverse effects were reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Emphysema, Influenza like illness, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a 66-year-old female patient who refers to herself. The patient had no pertinent medical history, drug reactions and allergies. Concomitant therapies included progesterone and MENEST. On an unknown day in May 2018, the patient was vaccinated with 1 dose of PNEUMOVAX 23 0.5 milliliter, intramuscularly (lot # and expiration date were not reported) for prevention of Pneumonia. On an unknown day in May 2018, the patient experienced soreness and mild swelling in her arm. On the same day, the patient experienced severe reaction with flu like symptoms, she reported that she felt like she was going to need to go to the intensive care unit (ICU) at the hospital. The patient reported that that she contacted her pharmacist. The patient reported that the flu like symptoms passed by on an unknown day in 2018 (reported as the next day). On an unknown day in November 2018, the patient experienced respiratory problems and chest discomfort. On an unknown date, the patient was diagnosed with mild to moderate emphysema. It was reported that the patient received treatment for the events. No lab diagnostics and studies performed. The outcome of respiratory disorder, chest discomfort, emphysema, injection site swelling and injection site pain was unknown. The relatedness between the events and PNEUMOVAX 23 was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory disorder
Clinical narrative: This spontaneous report as received from a 66-year-old female patient who refers to herself. The patient had no pertinent medical history, drug reactions and allergies. Concomitant therapies included progesterone and MENEST. On an unknown day in May 2018, the patient was vaccinated with 1 dose of PNEUMOVAX 23 0.5 milliliter, intramuscularly (lot # and expiration date were not reported) for prevention of Pneumonia. On an unknown day in May 2018, the patient experienced soreness and mild swelling in her arm. On the same day, the patient experienced severe reaction with flu like symptoms, she reported that she felt like she was going to need to go to the intensive care unit (ICU) at the hospital. The patient reported that that she contacted her pharmacist. The patient reported that the flu like symptoms passed by on an unknown day in 2018 (reported as the next day). On an unknown day in November 2018, the patient experienced respiratory problems and chest discomfort. On an unknown date, the patient was diagnosed with mild to moderate emphysema. It was reported that the patient received treatment for the events. No lab diagnostics and studies performed. The outcome of respiratory disorder, chest discomfort, emphysema, injection site swelling and injection site pain was unknown. The relatedness between the events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling, Rash
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative, referring to a female patient of unknown age. There was no information reported regarding the patient's medical history, concomitant medication, concurrent conditions and drug reactions/allergies. In December 2018 (reported as: "2 months ago"), the patient received her first dose of GARDASIL 9 route reported as: "on the deltoid of the arm") (strength, lot number and expiration date not provided) to avoid HPV (prophylaxis). In December 2018 (reported as: "The same day as vaccination"), the patient got an unspecified rash and her arm was swollen for two days. It was reported that the events "went away" without treatment and that she did not seek medical attention. No lab diagnostics/studies were performed. At the time of reporting the patient had recovered from the events, on an unknown date. The clinician declined to administer the second dose of GARDASIL 9. There was no causality assessment provided between the events and GARDASIL 9.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-FEB-2019, the patient was inadvertently administered a dose of ROTATEQ, orally, lot# N010707, expiration date 03-DEC-2018, (exact dose was not reported), that was expired. No adverse effect was reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of worn out in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (In August 2018). On 30th January 2019 09:00, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced worn out, injection site pain, injection site erythema and injection site lump. On 30th January 2019, the patient experienced shivering and general body pain. On 30th January 2019 16:00, the patient experienced cramps calf. On 31st January 2019, the patient experienced muscle pain. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the worn out, injection site pain, cramps calf, shivering, general body pain and injection site erythema were unknown and the outcome of the injection site lump was not recovered/not resolved and the outcome of the muscle pain was recovered/resolved. It was unknown if the reporter considered the worn out, injection site pain, cramps calf, shivering, general body pain, injection site erythema, injection site lump and muscle pain to be related to SHINGRIX. Rerun. Additional details were reported as follows: The patient received SHINGRIX on left arm early the previous week before the day of reporting and was in bed for 2 to 3 days feeling wiped out and a very sore injection site on her arm. The patient stated she had mentioned her reaction to the SHINGRIX received on Wednesday. The patient had shingles in August and wanted to know if this could be why she had the reactions to SHINGRIX. At 4:00 pm 7 hours after vaccination, she started to experience a cramp in her left calf that went up through her back to her neck. The patient went to bed after dinner and began shivering from inside herself and her body started to hurt. The patient took one TYLENOL and one ibuprofen which seemed to calm down her shivers after a couple of hours. The patient experienced body and muscle aches the entire next day and was not able to go to work. These symptoms were better by Friday morning but it felt as if someone punched her in her left arm and she had a large red lump at the site of the injection. By Sunday, the lump was larger than a half dollar coin, still red and a little tender. This continued to improve but she could still feel a small lump at the site of the injection on the day of reporting.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of worn out in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (In August 2018). On 30th January 2019 09:00, the patient received the 1st dose of SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced worn out, injection site pain, injection site erythema and injection site lump. On 30th January 2019, the patient experienced shivering and general body pain. On 30th January 2019 16:00, the patient experienced cramps calf. On 31st January 2019, the patient experienced muscle pain. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the worn out, injection site pain, cramps calf, shivering, general body pain and injection site erythema were unknown and the outcome of the injection site lump was not recovered/not resolved and the outcome of the muscle pain was recovered/resolved. It was unknown if the reporter considered the worn out, injection site pain, cramps calf, shivering, general body pain, injection site erythema, injection site lump and muscle pain to be related to SHINGRIX. Rerun. Additional details were reported as follows: The patient received SHINGRIX on left arm early the previous week before the day of reporting and was in bed for 2 to 3 days feeling wiped out and a very sore injection site on her arm. The patient stated she had mentioned her reaction to the SHINGRIX received on Wednesday. The patient had shingles in August and wanted to know if this could be why she had the reactions to SHINGRIX. At 4:00 pm 7 hours after vaccination, she started to experience a cramp in her left calf that went up through her back to her neck. The patient went to bed after dinner and began shivering from inside herself and her body started to hurt. The patient took one TYLENOL and one ibuprofen which seemed to calm down her shivers after a couple of hours. The patient experienced body and muscle aches the entire next day and was not able to go to work. These symptoms were better by Friday morning but it felt as if someone punched her in her left arm and she had a large red lump at the site of the injection. By Sunday, the lump was larger than a half dollar coin, still red and a little tender. This continued to improve but she could still feel a small lump at the site of the injection on the day of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got shingles after a second dose of SHINGRIX. The patient's demographics were declined. No other details were known. This case was considered as suspected vaccination failure cases as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting. The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 7th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 8th January 2019, the patient experienced atrial fibrillation (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the atrial fibrillation and injection site pain were unknown. It was unknown if the reporter considered the atrial fibrillation and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced soreness at injection site and that next day she felt her heartbeat and went to emergency room and was admitted to hospital overnight and diagnosed with atrial fibrillation. The patient was discharged the next day. The patient consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling jittery, Headache, Nausea, Peripheral coldness
Clinical narrative: Night chills, icy feet, nausea and vomiting, restlessness (jittery), headache: all symptoms except the icy feet abated within 24 hours. Icy feet:  symptom persisted for 4 days, especially in the toes with particular icy feeling in both big toes.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness, Vomiting
Clinical narrative: Night chills, icy feet, nausea and vomiting, restlessness (jittery), headache: all symptoms except the icy feet abated within 24 hours. Icy feet:  symptom persisted for 4 days, especially in the toes with particular icy feeling in both big toes.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Injection site erythema, Injection site pain, Pain
Clinical narrative: Pain at injection site that migrated to back and underside of arm. Pain increased when lifting arm up. 3" red area around injection site. Extreme tiredness night of vaccination. Severe Body aches day after injection that would have prevented going to work had TYLENOL not eased the body aches. Ice helps with injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Injection site pain, Pyrexia, Rash pruritic
Clinical narrative: Initially, just slight fever and pain at site. But, began with an intense and itchy rash a few days later that have persisted for the past five months. I've seen my GP and two dermatologists, an urgent care PA. Treated for scabies which it was tested for later and found not to be. I CANNOT PROVE THAT THE SHINGRIX VACCINE CAUSED ALL THESE SYMPTOMS BUT I AM SUSPICIOUS SINCE THEY OCCURRED AND PERSIST WITHIN DAYS OF RECEIVING SECOND SHINGRIX VACCINE.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cyanosis, Dyskinesia, Eye movement disorder, Immediate post-injection reaction, Neurological examination normal
Clinical narrative: Immediately after vaccination patient climbed off the exam table, laid herself down on the floor and then had 2-3 seconds of the left side of her body jerking-including her head tilting to the left side. Her eyes rolled back at onset and her lips appeared blue and she appeared unresponsive during the short episode. When the jerking stopped she immediately became responsive and alert and color returned.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Posture abnormal, Unresponsive to stimuli
Clinical narrative: Immediately after vaccination patient climbed off the exam table, laid herself down on the floor and then had 2-3 seconds of the left side of her body jerking-including her head tilting to the left side. Her eyes rolled back at onset and her lips appeared blue and she appeared unresponsive during the short episode. When the jerking stopped she immediately became responsive and alert and color returned.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Burning sensation, Discomfort
Clinical narrative: Client received HPV (R) arm on 1-15-19. Return to clinic 2-11-19 stating right arm "burning" and discomfort for approximately 2 weeks.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Injection site pain, Malaise
Clinical narrative: Initially fever, chills, myalasia, headache, injection site pain at night: could not sleep well.   Followed by severe watery diarrhea and vomiting starting the morning after the shot and lasting for about 24 hours. Felt back to normal but still weak, two days after the shot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pyrexia, Vomiting
Clinical narrative: Initially fever, chills, myalasia, headache, injection site pain at night: could not sleep well.   Followed by severe watery diarrhea and vomiting starting the morning after the shot and lasting for about 24 hours. Felt back to normal but still weak, two days after the shot.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: There was swelling, itching, redness, and hardness about the size of my palm around the injection site for five days, I experienced fatigue, headache and swollen lymph nodes for three days. I applied cortisone topical cream at the site for relief.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: There was swelling, itching, redness, and hardness about the size of my palm around the injection site for five days, I experienced fatigue, headache and swollen lymph nodes for three days. I applied cortisone topical cream at the site for relief.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Blood test, Chest pain, Dizziness, Dysarthria
Clinical narrative: Lost feeling and numbness and tingle to both arms and legs, trouble walking, slurred speech, twitching, nausea, dizziness, weakness and fatigue, chest pain.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Electrocardiogram, Fatigue, Gait disturbance, Hypoaesthesia, Muscle twitching
Clinical narrative: Lost feeling and numbness and tingle to both arms and legs, trouble walking, slurred speech, twitching, nausea, dizziness, weakness and fatigue, chest pain.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Sensory loss
Clinical narrative: Lost feeling and numbness and tingle to both arms and legs, trouble walking, slurred speech, twitching, nausea, dizziness, weakness and fatigue, chest pain.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: There were none.
Age: 9.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Drooling, Dyskinesia, Tremor
Clinical narrative: Patient's mother reports that he went to sleep about 5 minutes after vaccines were given. When he woke up she noticed that his drooling has increased and that he now has "jerks" and "shaking all over". Reports he has done this 1-2 times a day since receiving vaccines on 1-29-2019.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain, Toothache
Clinical narrative: Pt (Who is also a physician @ practice)  reports moderate body aches starting around noon the following day lasting for approximately 48 hours. He reports moderate left arm discomfort at rest and to touch. Pt states " even my teeth hurt to chew food". Symptoms completely resolved after several days. Pt reports he had no symptoms after 1st vaccine dose.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches, fever.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Skin warm, Swelling face, Urticaria
Clinical narrative: This spontaneous report was received from a nurse via Pfizer (2017481808) refers to a 60 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dosing details, strength, route, frequency and indication were unknown). The co suspect medication included PREVNAR 13. On an unknown date, after receiving the vaccine the patient started breaking out in a rash, more or less hives, to her upper body and upper chest. Her face was red, swollen and warm to the touch. The patient did not mention the time or length of the event (urticaria, drug hypersensitivity, feeling hot, swelling face and erythema). The outcome of urticaria, drug hypersensitivity, feeling hot, swelling face and erythema were unknown. The reporter considered drug hypersensitivity to be related to PNEUMOVAX 23.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse refers to a 21 week old patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the 4 month and 28 day old infant was vaccinated with first dose of ROTATEQ (dose, route and lot # were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse symptoms reported.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUN-2010, the patient was vaccinated with the first dose of GARDASIL, intramuscularly, (dose, lot#, expiration date were not reported). On 01-AUG-2010, the patient was vaccinated with the second dose of GARDASIL, intramuscularly, (dose, lot#, expiration date were not reported). On 22-OCT-2010, the patient was vaccinated with the third dose of GARDASIL, intramuscularly, (dose, lot#, expiration date were not reported), which was off schedule. No adverse effects was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in February 2019, the patient was subcutaneously vaccinated with a dose of M-M-R II lot # R013129, expiration date 03-FEB-2019, albumin status of rHA (recombinant human albumin) (exact dose was not reported) for prophylaxis. The dose of M-M-R II was after its labeled expiration date. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a female patient of unknown age. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date in 2017, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On 08-FEB-2019, the patient was back for the second dose. No adverse effects were reported from the first or second dose.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nausea
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 66-year-old female patient. Her concurrent conditions included elevated blood pressure, hypothyroid, allergy to ragweed, mold and pollen. Her medical history was not reported. The patient's concomitant therapies included unspecified medications for blood pressure and thyroid. On 07-FEB-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 lot #R002084, expiry date 26-OCT-2019 (exact dose, route and site of administration were not reported) for prophylaxis. Patient was due for vaccination because she received last dose in 2012. On 07-FEB-2019, the patient experienced muscle pain at injection site. On 08-FEB-2019, the patient experienced nausea. No treatment was given for the event. No lab tests were performed. The patient sought medical attention in doctor's office. The outcome of the events was reported as not recovered. The causality assessment was not reported.
Age: 57.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Shingrix (batch number D9P5X, expiry date 18th April 2021) for prophylaxis. On 4th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th February 2019, less than a day after receiving Shingrix, the patient experienced injection site pain (serious criteria hospitalization), fever (serious criteria hospitalization) and shivering (serious criteria hospitalization). The patient was treated with Tylenol. On an unknown date, the outcome of the injection site pain and fever were not recovered/not resolved and the outcome of the shivering was unknown. It was unknown if the reporter considered the injection site pain, fever and shivering to be related to Shingrix. Additional information was reported as follows: At 4 PM, the patient received Shingrix in an unknown deltoid. The patient developed fever (body temperature 102.6 degree F) and shivers. The patient took Tylenol and the fever subsided. The patient then underwent a repeat breast surgery which was not related to vaccination. After surgery, the patient experienced a re-occurrence of the 3rd degree fever. The physician stated that, the patient also experienced pain at the injection site. No additional details were reported.
Sex: M
Vaccine: MENB
Symptoms: Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable healthcare professional received from Pfizer Sponsored Program. A currently 49-year-old male patient of an unspecified ethnicity started to receive ZITHROMAX, allopurinol, codeine, colchicine, TRESIBA, HUMALOG, and MOBIC, all via unspecified routes of administration on unspecified dates at unknown doses for unspecified indications and TRUMENBA, via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced drug allergies to azithromycin, allopurinol, codeine, colchicine, insulin degludec, insulin lispro, meloxicam and TRUMENBA. The action taken in response to the event for azithromycin was unknown, allopurinol was unknown, codeine was unknown, colchicine was unknown, insulin degludec was unknown, insulin lispro was unknown, and meloxicam was unknown. The clinical outcome of the event, drug allergies, was unknown. The reporting health professional clarified that "drug allergies to azithromycin, allopurinol, codeine, colchicine, insulin degludec, insulin lispro, and meloxicam" were the patient's past adverse drug experience but the health professional is not aware of recent "drug allergies to azithromycin, allopurinol, codeine, colchicine, insulin degludec, insulin lispro, and meloxicam" experienced by the patient. Follow-up (03Aug2017): New information from the same contactable health professional includes: patient information (name). Follow-up (22Aug2017): New information received from the same contactable health professional includes: the physician was not aware of recent allergy experienced by the patient. Follow-up attempts are completed. No further information is expected. Follow-up (31Jan2019): This is a follow-up report combining information from duplicate reports 2017360611 and 2017336335. The current and all subsequent information will be reported under manufacturer report number 2017336335. New information includes: suspect drug (TRUMENBA was added).
Sex: U
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported similar events for 2 patients. This is the 2nd of 2 reports.  A 20-year-old patient of an unspecified and gender started to receive TRUMENBA, 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. On an unspecified date, the patient experienced severe headache. The outcome of the event was unknown. Information on the lot number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019059786 Same reporter/drugs/events, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, (lot number and expiration date unknown), 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. On an unspecified date, the patient experienced redness, swelling at the site of injection. Outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a female patient of an unspecified age 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 immunization. The patient medical history and concomitant medications were not reported. The patient stated, "I need to talk to someone about the pain I'm feeling after the shot", on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information on the batch number cannot be requested. No further information is expected.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal discomfort, Abdominal pain, Arthralgia, Blood test, Decreased appetite
Clinical narrative: Different degrees of headaches, dizziness, chronic pain on arm/legs (mainly knees, wrists, ankles), excessive fatigue, lack of appetite, gastrointestinal discomfort, abdominal pain, nausea, etc. These symptoms were characterized by a fast onset short duration and spontaneous recovery after 2 years.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Epstein-Barr virus test positive, Fatigue, Headache, Nausea
Clinical narrative: Different degrees of headaches, dizziness, chronic pain on arm/legs (mainly knees, wrists, ankles), excessive fatigue, lack of appetite, gastrointestinal discomfort, abdominal pain, nausea, etc. These symptoms were characterized by a fast onset short duration and spontaneous recovery after 2 years.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Vitamin D decreased
Clinical narrative: Different degrees of headaches, dizziness, chronic pain on arm/legs (mainly knees, wrists, ankles), excessive fatigue, lack of appetite, gastrointestinal discomfort, abdominal pain, nausea, etc. These symptoms were characterized by a fast onset short duration and spontaneous recovery after 2 years.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Cardiac stress test normal, Chest pain, Chills, Echocardiogram normal
Clinical narrative: 1/17/19 - chills/shivering - fever 101.3, pain and swelling at site of injection - upper left arm muscle. Went to ER. 1/18/19 - pain in chest near left arm. 1/20 extreme rash and redness with drainage under chin forming crystals on skin if not covered w/gauze. The rash extended from under chin (with swelling) to right ear covering most of chest. Necessary to cover all of effected area w/gauze and secure as best I could w/1 hand. top of left hand and wrist also had severe rash; covering needed there also. Right arm had several spots at inside of elbow, 3 to be exact which also had severe red rash and coverage necessary. 1 small spot above L. eyebrow formed crystal and redness but did not need covering. 3 red spots on stomach did not drain - no covering needed. The redness on the chest was so bright red it resembled a piece of fresh steak being put on the grill. Took pictures to verify and remember for years to come. Blood work at the Emergency Room proved all O.K. The Echo of the heart and Stress test were fine, in fact, the cardiologist assured me I have a strong heart. They never did get to see the "red rash". My granddaughter has had the shingles 3 times on her face and my son has had them once on his face also, so this is what gave me the idea I needed protection. Last Spring I saw an interview with a doctor on TV news regarding the SHINGRIX shots - prompting me to take action. I received shot #1 on 7/17/18 and could not find the second shot until 1/17/19 - exactly 6 months later. I was confined to my home for 2 weeks except for the 3 doctor visits. Have only been out twice since then. No insurance coverage on these vaccines. My cost $332.14 total.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Pyrexia, Rash
Clinical narrative: 1/17/19 - chills/shivering - fever 101.3, pain and swelling at site of injection - upper left arm muscle. Went to ER. 1/18/19 - pain in chest near left arm. 1/20 extreme rash and redness with drainage under chin forming crystals on skin if not covered w/gauze. The rash extended from under chin (with swelling) to right ear covering most of chest. Necessary to cover all of effected area w/gauze and secure as best I could w/1 hand. top of left hand and wrist also had severe rash; covering needed there also. Right arm had several spots at inside of elbow, 3 to be exact which also had severe red rash and coverage necessary. 1 small spot above L. eyebrow formed crystal and redness but did not need covering. 3 red spots on stomach did not drain - no covering needed. The redness on the chest was so bright red it resembled a piece of fresh steak being put on the grill. Took pictures to verify and remember for years to come. Blood work at the Emergency Room proved all O.K. The Echo of the heart and Stress test were fine, in fact, the cardiologist assured me I have a strong heart. They never did get to see the "red rash". My granddaughter has had the shingles 3 times on her face and my son has had them once on his face also, so this is what gave me the idea I needed protection. Last Spring I saw an interview with a doctor on TV news regarding the SHINGRIX shots - prompting me to take action. I received shot #1 on 7/17/18 and could not find the second shot until 1/17/19 - exactly 6 months later. I was confined to my home for 2 weeks except for the 3 doctor visits. Have only been out twice since then. No insurance coverage on these vaccines. My cost $332.14 total.