chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 17th January 2023) for prophylaxis.   On 27th July 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Boostrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / on 3/18/2019  and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose, which led to  incomplete course of vaccination. No further information was reported. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1 dose / on 10/22/2020 / 1, 6-month doses were not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 42-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 22nd October 2020, batch number P4DJ5, expiry date 15th December 2022).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose, which led to incomplete course of vaccination. The vaccine administration facility details were reported for 1st dose. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164837:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received a dose of shingrix after they've completing the series; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional asked was there any implications if the patient accidentally received a dose of Shingrix after they had completed the series, which extra dose administered. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the shingrix vaccine dose #1 in October 2019 / wants to know if he can get dose #2 now; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient reported the case for himself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to know if he could get dose now or if he need to start the series again. The reporter consent to follow up.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: pediatric dose / was given to a 40 year old adult; pediatric dose / was given to a 40 year old adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number LM992, expiry date 13th December 2022) for prophylaxis.   On 30th July 2021, the patient received Engerix B pediatric 10 ug. On 30th July 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The adult patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: PATIENT RECEIVED MODERNA DOSE  AFTER JANSSEN VACCINE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination. On 29-JUL-2021, the subject experienced subject received moderna dose after janssen vaccine. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received moderna dose after janssen vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hypotension, Inappropriate schedule of product administration, Pain, Pain of skin
Clinical narrative: ADMINISTRATION ERROR 2ND SHOT GIVEN; ACHES; HAIR HURT (PHANTOM HAIR PAIN); RELATIVE HYPOTENSION; UNCONTROLLABLE RIGORS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced administration error 2nd shot given, aches, hair hurt (phantom hair pain), relative hypotension, uncontrollable rigors, and fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, aches, hair hurt (phantom hair pain), relative hypotension, and uncontrollable rigors, and the outcome of administration error 2nd shot given was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ADMINISTRATION ERROR 2ND SHOT GIVEN; ACHES; HAIR HURT (PHANTOM HAIR PAIN); RELATIVE HYPOTENSION; UNCONTROLLABLE RIGORS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced administration error 2nd shot given, aches, hair hurt (phantom hair pain), relative hypotension, uncontrollable rigors, and fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, aches, hair hurt (phantom hair pain), relative hypotension, and uncontrollable rigors, and the outcome of administration error 2nd shot given was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine
Clinical narrative: MIGRAINE HEADACHE; LITTLE DIZZINESS; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2062A21A expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the subject experienced migraine headache. On 03-AUG-2021, the subject experienced little dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little dizziness on 03-AUG-2021, and had not recovered from migraine headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Thrombosis
Clinical narrative: BLOOD CLOT; UNABLE TO WALK; This spontaneous report received from a patient concerned a male of unspecified age with unknown race and ethnicity.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 13-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In JUL-2021, the patient had a blood clot and 2 weeks later patient could not walk.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and unable to walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210806835- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced administration of expired vaccine. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Neck pain, Pain, Pyrexia
Clinical narrative: BODY ACHES; WORSENED BACK PAIN; WORSENED NECK PAIN; FEVER; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included neck pain, and back pain, and other pre-existing medical conditions included the patient had no known allergies and did not have any medical conditions.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-AUG-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 04-AUG-2021, the subject experienced body aches. On 04-AUG-2021, the subject experienced worsened back pain. On 04-AUG-2021, the subject experienced worsened neck pain. Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, worsened back pain, and worsened neck pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, and start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188388.; Sender's Comments: V0:20210807962-covid-19 vaccine ad26.cov2.s-SUSPECTED CLINICAL VACCINATION FAILURE . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis, X-ray
Clinical narrative: MULTIPLE BLOOD CLOTS IN LUNGS; MULTIPLE BLOOD CLOTS IN LEGS; This spontaneous report received from a patient concerned a 57year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 82286 and expiry: 23-JUL-2021) dose was not reported, 1 total administered to left arm on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-JUN-2021, the patient experienced cough and fatigue. Two weeks later on 30-JUN-2021, the patient's feet and ankle started swelling. Two weeks later, the patient went to doctor. Her doctor took an X-Ray and everything was fine. Then the patient started having shortness of breath. On 14-JUL-2021, shortness of breath was pretty good and it got worse and the patient was taken to emergency room. On 01-AUG-2021, the patient was found to have multiple blood clots in lungs and legs and was hospitalized. The doctors couldn't determine why the blood clots developed. The patient was hospitalized for 3 days and was discharged on 03-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from multiple blood clots in lungs, and multiple blood clots in legs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210808076-COVID-19 VACCINE AD26.COV2.S- multiple blood clots in lungs, multiple blood clots in legs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; SUSPECTED VACCINATION FAILURE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity unknown. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that on an unspecified date, the patient experienced confirmed covid-19 infection, suspected Vaccination Failure. On an unspecified date in Jul-2021, the patient died from confirmed covid-19 infection. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Suspected Vaccination Failure was not reported. This report was serious (Death).; Sender's Comments: V0-20210808115-covid-19 vaccine ad26.cov2.s-Confirmed COVID-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210808115-covid-19 vaccine ad26.cov2.s-Suspected Vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: CONFIRMED COVID-19 INFECTION
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: ARM SWOLLEN WHERE PATIENT GOT THE VACCINE; ARM SORE; MAJOR HEADACHE; NAUSEA; TIREDNESS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 04-AUG-2021, the subject experienced arm swollen where subject got the vaccine. On 04-AUG-2021, the subject experienced arm sore. On 04-AUG-2021, the subject experienced major headache. On 04-AUG-2021, the subject experienced nausea. On 04-AUG-2021, the subject experienced tiredness. On 04-AUG-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm swollen where patient got the vaccine, major headache, nausea, tiredness, fever and arm sore was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ARM SWOLLEN WHERE PATIENT GOT THE VACCINE; ARM SORE; MAJOR HEADACHE; NAUSEA; TIREDNESS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 04-AUG-2021, the subject experienced arm swollen where subject got the vaccine. On 04-AUG-2021, the subject experienced arm sore. On 04-AUG-2021, the subject experienced major headache. On 04-AUG-2021, the subject experienced nausea. On 04-AUG-2021, the subject experienced tiredness. On 04-AUG-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm swollen where patient got the vaccine, major headache, nausea, tiredness, fever and arm sore was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye irritation, Fatigue, Influenza like illness
Clinical narrative: FELT LIKE HAVING THE FLU (EVERYTHING HURT, CONGESTION, FEELING FLUSHED, FEVER GOT UP TO 102 F, AND WENT BETWEEN THAT AND 100 F, HEADACHE, MUSCLES ACHED, FELT WEAK WHOLE TIME); FELT REALLY TIRED WHOLE TIME AND DID NOT WANT TO GET OUT OF BED; EYES BURNING 10 HOURS AFTER VACCINATION; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-JUL-2021 10:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-JUL-2021, the subject experienced eyes burning 10 hours after vaccination. On 27-JUL-2021, the subject experienced felt like having the flu (everything hurt, congestion, feeling flushed, fever got up to 102 f, and went between that and 100 f, headache, muscles ached, felt weak whole time). On 27-JUL-2021, the subject experienced felt really tired whole time and did not want to get out of bed. On 29-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 102 F, 100 F. On 04-AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 05-AUG-2021, treatment medications included: chlorphenamine maleate/paracetamol/pseudoephedrine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt really tired whole time and did not want to get out of bed, and felt like having the flu (everything hurt, congestion, feeling flushed, fever got up to 102 f, and went between that and 100 f, headache, muscles ached, felt weak whole time), and the outcome of eyes burning 10 hours after vaccination was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Paraesthesia
Clinical narrative: BURNING ON BACK OF THE HEAD; STINGING ON BACK OF THE HEAD; TINGLING ON BACK OF THE HEAD; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced burning on back of the head. On 10-APR-2021, the subject experienced stinging on back of the head. On 10-APR-2021, the subject experienced tingling on back of the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning on back of the head, tingling on back of the head, and stinging on back of the head. This report was non-serious. This case, from the same reporter is linked to 20210810477.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Neck pain, Pain
Clinical narrative: Since approximately 3 weeks after my second dose, I have been in the worse pain I've ever experienced. The top half of my back, my neck, both shoulders, my entire right arm and sometimes even my hand are affected. This pain is constant and nothing I take for it helps. I have also experienced chest pains at least 3 times a week since getting my shot. I have no health insurance and I am a single mom to 3 kids so I have not seen a doctor about this.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Since approximately 3 weeks after my second dose, I have been in the worse pain I've ever experienced. The top half of my back, my neck, both shoulders, my entire right arm and sometimes even my hand are affected. This pain is constant and nothing I take for it helps. I have also experienced chest pains at least 3 times a week since getting my shot. I have no health insurance and I am a single mom to 3 kids so I have not seen a doctor about this.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Bacterial infection, C-reactive protein increased, Colitis ulcerative, Colonoscopy abnormal
Clinical narrative: Severe ulcerative colitis with pain in lower abdomen..  He's in the hospital at this time, for a week so far.  Diarrhea, gas and pain in abdomen started about 3 weeks after 2nd covid vaccine shot and become worse to the point where he was dehydrated and had to go to the emergency room for fluids.  They assumed it was something common like a virus or bacterial infection but less than a week after the ER visit, he was admitted due to the bloody diarrhea and dehydration along with the fact that they didn't know what was wrong.  Colonoscopy performed at the hospital confirmed  it was ulcerative colitis and one of the worst cases the doctors have ever seen.  They treated with steroids which didn't improve the situation.  Now they've treated with REMICADE (given via IV) and they say it's not having the effect they want (not helping to improve his severe ulcerative colitis) so they will evaluate again today (8-6-2021) and try another infusion  of REMICADE on 8-7-2021 if they don't see improvement today (8-6-2021).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Diarrhoea haemorrhagic, Flatulence, Infusion
Clinical narrative: Severe ulcerative colitis with pain in lower abdomen..  He's in the hospital at this time, for a week so far.  Diarrhea, gas and pain in abdomen started about 3 weeks after 2nd covid vaccine shot and become worse to the point where he was dehydrated and had to go to the emergency room for fluids.  They assumed it was something common like a virus or bacterial infection but less than a week after the ER visit, he was admitted due to the bloody diarrhea and dehydration along with the fact that they didn't know what was wrong.  Colonoscopy performed at the hospital confirmed  it was ulcerative colitis and one of the worst cases the doctors have ever seen.  They treated with steroids which didn't improve the situation.  Now they've treated with REMICADE (given via IV) and they say it's not having the effect they want (not helping to improve his severe ulcerative colitis) so they will evaluate again today (8-6-2021) and try another infusion  of REMICADE on 8-7-2021 if they don't see improvement today (8-6-2021).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: Severe ulcerative colitis with pain in lower abdomen..  He's in the hospital at this time, for a week so far.  Diarrhea, gas and pain in abdomen started about 3 weeks after 2nd covid vaccine shot and become worse to the point where he was dehydrated and had to go to the emergency room for fluids.  They assumed it was something common like a virus or bacterial infection but less than a week after the ER visit, he was admitted due to the bloody diarrhea and dehydration along with the fact that they didn't know what was wrong.  Colonoscopy performed at the hospital confirmed  it was ulcerative colitis and one of the worst cases the doctors have ever seen.  They treated with steroids which didn't improve the situation.  Now they've treated with REMICADE (given via IV) and they say it's not having the effect they want (not helping to improve his severe ulcerative colitis) so they will evaluate again today (8-6-2021) and try another infusion  of REMICADE on 8-7-2021 if they don't see improvement today (8-6-2021).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Periarthritis, Sleep disorder, X-ray limb
Clinical narrative: approximately 8 days after the shot, early symptoms of "Frozen Shoulder" began - has progressively got worse, EXTREME PAIN, sleepless nights, loss of range of motion
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Systemic: heart pounding through chest and rapidly-Mild
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient informed that she hasn't eat anything since the morning.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Pt was ambulatory but got lightheaded for about five minutes
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain continuing months after shots were administered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Flushing, Heart rate irregular
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Parametics noted irregular rhythm of heart-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: EMS recommended him come into ER but patient refused stating he feels fine, will followup with md about event and recommendation for 2nd dose
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Parametics noted irregular rhythm of heart-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: EMS recommended him come into ER but patient refused stating he feels fine, will followup with md about event and recommendation for 2nd dose
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Nerve block, Nervousness, Syncope
Clinical narrative: Systemic: Flushed / Sweating-Mild, Additional Details: Patient had a syncope for a few seconds, due to nerveousness on the new vaccine.  Patient laid on the floor and felt better afterward.  The ambulance came into the store and checked on the patient.  He was fine when the ambulance arrived and denied medical service.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: After the patient (my daugther's mother-in-law) coming back home, she could stick three stainless steel fork on to the site of the vaccination as if with magnetism. I attach a picture for your consideration to my email to VAERS on August 6, 2021.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Malaise, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: patient had episode of syncope, fainted for about 10 seconds after receiving vaccine. we kept him down on floor until he felt well enough to sit up.  took BP and HR, initial reading 89/62 HR 75... instructed patient to keep head down and try to relax, also gave patient water. took BP and HR again 10 minutes later, BP 107/69 and HR 77... patient remained in store for 30 minutes total then felt well enough to leave.  contacted patient 8/5 and patient said he is feeling much better and doing fine
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lethargy, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Medium, Systemic: Nausea-Severe
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: BLISTER FORMED 2 INCHES AWAY FROM INJECTION-Severe, Additional Details: LOOKS LIKE A BURN BLISTER JUST ONE ON ONE END OF BAND AID CONTACT SPOT
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site vesicles, Rash
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: BLISTER FORMED 2 INCHES AWAY FROM INJECTION-Severe, Additional Details: LOOKS LIKE A BURN BLISTER JUST ONE ON ONE END OF BAND AID CONTACT SPOT
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Neuralgia, Pain in extremity
Clinical narrative: leg pain above left leg. Looks like nerve pain that randomly spreads to the right leg, back, arms, groin, inner thigh. Sometimes headaches, feeling tired and unwell
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient described tingling and numbness in right arm after 15 minute wait . Otherwise no complaints of side effects.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bell's palsy, Confusional state, Disorientation, Flushing
Clinical narrative: Systemic: Bell's Palsy-Mild, Systemic: Confusion-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: Approximately 5 minutes after receiving the Pfizer covid vaccine, the patient's mother reported that the patient was having a reaction the vaccine. Upon examination, the patient was sweating profusely, complained of feeling numbness/tingling in her hands and appeared severly disoriented. After approximately 30 minutes she felt well enough to be transported to urgent care to be examined. Several hours later that day, the patient returned to the pharmacy with no issue.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Bell's Palsy-Mild, Systemic: Confusion-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: Approximately 5 minutes after receiving the Pfizer covid vaccine, the patient's mother reported that the patient was having a reaction the vaccine. Upon examination, the patient was sweating profusely, complained of feeling numbness/tingling in her hands and appeared severly disoriented. After approximately 30 minutes she felt well enough to be transported to urgent care to be examined. Several hours later that day, the patient returned to the pharmacy with no issue.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Hypoaesthesia, Hyporeflexia, Magnetic resonance imaging
Clinical narrative: 83F w/ PMH of HTN, HLD, palptiations, presents w/ several days of bilateral LE pain/numbness/weakness.   Patient woke up on 8/3 AM w/ severe pain in her hips shooting down the legs, first on the right then the left. She went to her PCP who prescribed her naproxen/cyclobenzaprine. By the time she arrived home, she was unable to get out of the car due to significant weakness. On 8/5, she start to develop urinary incontinence. Denies any falls or trauma. Of note, patient received Pfizer vaccine 1st dose 7/8 and 2nd dose on 7/29. Denies any history of autoimmune disease or FH of autoimmune disease. No recent viral like symptoms. No sick contacts.  Impression: Paraparesis + urinary continence likely secondary to longitudinally extensive transverse myelitis spanning the distal thoracic level (T11) to the conus. Etiology uncertain, but possibly vaccine related myelitis. The hyporeflexia in her LE are discrepant from a myelopathy, though this could be due to conus involvement (UMN/LMN signs) or age-related. I doubt this is an AIDP given the radiographic findings but CSF analysis will clarify this.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Muscular weakness, Myelitis transverse, Pain, Pain in extremity
Clinical narrative: 83F w/ PMH of HTN, HLD, palptiations, presents w/ several days of bilateral LE pain/numbness/weakness.   Patient woke up on 8/3 AM w/ severe pain in her hips shooting down the legs, first on the right then the left. She went to her PCP who prescribed her naproxen/cyclobenzaprine. By the time she arrived home, she was unable to get out of the car due to significant weakness. On 8/5, she start to develop urinary incontinence. Denies any falls or trauma. Of note, patient received Pfizer vaccine 1st dose 7/8 and 2nd dose on 7/29. Denies any history of autoimmune disease or FH of autoimmune disease. No recent viral like symptoms. No sick contacts.  Impression: Paraparesis + urinary continence likely secondary to longitudinally extensive transverse myelitis spanning the distal thoracic level (T11) to the conus. Etiology uncertain, but possibly vaccine related myelitis. The hyporeflexia in her LE are discrepant from a myelopathy, though this could be due to conus involvement (UMN/LMN signs) or age-related. I doubt this is an AIDP given the radiographic findings but CSF analysis will clarify this.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Paraparesis, Urinary incontinence
Clinical narrative: 83F w/ PMH of HTN, HLD, palptiations, presents w/ several days of bilateral LE pain/numbness/weakness.   Patient woke up on 8/3 AM w/ severe pain in her hips shooting down the legs, first on the right then the left. She went to her PCP who prescribed her naproxen/cyclobenzaprine. By the time she arrived home, she was unable to get out of the car due to significant weakness. On 8/5, she start to develop urinary incontinence. Denies any falls or trauma. Of note, patient received Pfizer vaccine 1st dose 7/8 and 2nd dose on 7/29. Denies any history of autoimmune disease or FH of autoimmune disease. No recent viral like symptoms. No sick contacts.  Impression: Paraparesis + urinary continence likely secondary to longitudinally extensive transverse myelitis spanning the distal thoracic level (T11) to the conus. Etiology uncertain, but possibly vaccine related myelitis. The hyporeflexia in her LE are discrepant from a myelopathy, though this could be due to conus involvement (UMN/LMN signs) or age-related. I doubt this is an AIDP given the radiographic findings but CSF analysis will clarify this.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, Pain in extremity, Skin burning sensation, Tenderness
Clinical narrative: Initially hot shooting pains in calves 6 hours after first shot.  Within 36 hours hot, burning pain and tenderness in hands and feet, especially strong in left hand. Then a bunch of broken blood vessels in palm and fingers of left hand lasting more than a week.  Nerve pain continued for three weeks in left hand and soles of feet. After 4 weeks I reluctantly got 2nd shot which resulted in intense hand tenderness and nerve pain mostly on left hand and left foot.  At about three weeks after 2nd shot, developed  hot, burning (nerve?) pain like fire under the skin of my chest and stomach that would come in waves.  This lasted about a month, currently not happening.  In the past 2 weeks (3 months post 2nd shot) the pain and tenderness in my left hand has increased dramatically and begun to ache.  Cannot grip, grab or touch most things with my left hand without pain.  Sometimes I see the blue vessels come close to the skin on  left hand where they were broken after 1st shot.  Some neuropathy remains in the sole and toes of my left foot as well.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Initially hot shooting pains in calves 6 hours after first shot.  Within 36 hours hot, burning pain and tenderness in hands and feet, especially strong in left hand. Then a bunch of broken blood vessels in palm and fingers of left hand lasting more than a week.  Nerve pain continued for three weeks in left hand and soles of feet. After 4 weeks I reluctantly got 2nd shot which resulted in intense hand tenderness and nerve pain mostly on left hand and left foot.  At about three weeks after 2nd shot, developed  hot, burning (nerve?) pain like fire under the skin of my chest and stomach that would come in waves.  This lasted about a month, currently not happening.  In the past 2 weeks (3 months post 2nd shot) the pain and tenderness in my left hand has increased dramatically and begun to ache.  Cannot grip, grab or touch most things with my left hand without pain.  Sometimes I see the blue vessels come close to the skin on  left hand where they were broken after 1st shot.  Some neuropathy remains in the sole and toes of my left foot as well.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Platelet count
Clinical narrative: Severe leg pain in both legs for 3 1/2 weeks.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Tremor
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Anxiety-Mild, Systemic: Shakiness-Mild, Additional Details: We called 911 the patient was able to walk out with them.  We will call him for follow up.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Head injury, Loss of consciousness, Nodule, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fell over off chair and hit head on floor within 5 min of receiving vaccine. Pt quickly became responsive. Epipen was not given. EMT arrived shortly after to check patient. Patient did not leave in ambulance. Pt's family member came to pharmacy to ask me if I thought pt should go to ER, I said abosuletely being that patient hit head and had a raised knot on forehead. Pt did explain AFTER he became conscious that he always passes out after receiving a shot.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Concussion, Electrocardiogram, Head injury
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fell over off chair and hit head on floor within 5 min of receiving vaccine. Pt quickly became responsive. Epipen was not given. EMT arrived shortly after to check patient. Patient did not leave in ambulance. Pt's family member came to pharmacy to ask me if I thought pt should go to ER, I said abosuletely being that patient hit head and had a raised knot on forehead. Pt did explain AFTER he became conscious that he always passes out after receiving a shot.