chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt is 18 yo female s/p full Pfizer COVID vaccination: dose 1 on 4/7 and dose 2 on 4/28. On 8/5, patient reports new onset cough, muscle aches, congestion, fatigue, and chills. She confirms close contact to a person who is suspected/known to be COVID positive in the last 30 days. She also reports a recent trip (7/21 - 7/28). Novel Coronavirus PCR resulted positive on 8/5.
several antibody tests and they come back negative even though she has had both shots of the Covid vaccin; This spontaneous case was reported by an other health care professional and describes the occurrence of ANTIBODY TEST NEGATIVE (several antibody tests and they come back negative even though she has had both shots of the Covid vaccin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (several antibody tests and they come back negative even though she has had both shots of the Covid vaccin). At the time of the report, ANTIBODY TEST NEGATIVE (several antibody tests and they come back negative even though she has had both shots of the Covid vaccin) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Initial information received on 30-Jul-2018 regarding an unsolicited valid serious case received from a physician. This case involves male patient (age not reported) who experienced guillian-barre syndrome, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Oct-2017, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route. On an unspecifeid date, the patient developed a serious guillian-barre syndrome (guillain-barre syndrome) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event on 23-Oct-2017. Laboratory data was not provided. Final diagnosis was guillian-barre syndrome. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for guillian-barre syndrome. Documents held by sender: none.; Sender's Comments: This case concerns a patient who developed Guillain Barre Syndrome (GBS) post-vaccination with FLUZONE HD. The time to onset is not known. There is no information reported regarding use of Immunoglobulin Therapy. There is no information provided regarding patient's past medical history, medical condition at the time of vaccination and lab tests ruling out alternate etiologies, particularly neurologic and infectious. There are multiple possible etiologies for this disease which need to be ruled out before a causal role of the vaccine can be assessed. Based upon the reported information, the role of the vaccine cannot be assessed.
Erythema around injection site. Oral sensitivity and pain with gingival bleeding beginning day after injection.
4 hours after injection patient experienced headache, nausea, vomiting, fever and bronchial soreness.
Sore Arm at injection site for 2 days. On day 7 after getting vaccine, I developed rash about baseball size around injection site. Rash was initially itchy for 1 day which altered me to rash but no longer itches.  Rash was initially raised and slightly red but is now not raised and slighty red with outer ring.
1.Nausea with abdominal discomfort 2.Mild fever(99.1F) with body ache  Tab. Tylenol one tablet given
Extreme confusion and lethargy.  High levels of anxiety.  Overly exhausted all the time
Chills, rash, swollen glands, joint pain, wrist fingers & ankle, 12/27/99.
IMMEDIATELY FOLLOWING ADMINISTRATION, PATIENT BECAME FAINT AND LEANED OVER IN CHAIR. HER EYES ROLLED BACK. SHE CONTINUED BREATHING BUT BREATHS WERE SHORT AND HEAVY. SHE WAS FLUSHED. AFTER A MINUTE SHE CAME TO AND WAS RESPONSIVE. PATIENT REMAINED COHERENT AFTER COMING TO BUT WAS NOTICEABLY OUT OF IT.  SHE WAS GIVEN A BOTTLE OF WATER AND REMAINDED IN OBSERVATION FOR 30 MINUTES. AFTER OBSERVATION SHE CONFIRMED THAT SHE WAS OKAY TO LEAVE.
Warm flush feeling, sweating, nausea, and diarrhea starting 3 hours after vaccine lasting for 24 hours
pt recv vax that had expired on 7/10/97 & a MMR titer done on 9/30/97 was WNL mumps 2.43, measles 3.10 & rubella 2.08;
Garbled speech, mouth twisted to left, excessive salivation, confusion, altered mental status requiring intubation and mechanical ventilation.
Patient was administered VAXELIS on 22NOV2022 and the excursion occurred on 09NOV2022/ Temperature it reached was 10.1C; This spontaneous safety report, with reference number 2022SA509263 (Inquiry Number 01407148) was received by the partner on 14-DEC-2022 and forwarded to Agency on 16-DEC-2022, from a health professional.   Due to the nature of the event, the causality between the event "Patient was administered VAXELIS on 22NOV2022 and the excursion occurred on 09NOV2022/ Temperature it reached was 10.1C" and Vaxelis was not applicable.   Further information is expected.
Well until 10/23/13 2pm while playing, suddenly became unresponsive w/ eyes deviated to left; he was unresponsive, stiff, focal jerking and apneic. Upon arrival EMS found child still in seizure. Upon arrival to ER was apneic/agonal breathing requiring BMV, several doses of ATIVAN to stop seizure. He was monitored in PICU x 24 hours and on regular floor x 24 hours. Work up in question # 12. He was back to normal activity 10/25/13. Seizure lasted approximately 75 minutes. No fever until at hospital T. 101 degrees after seizure.
Symptom onset 11/29/22. Treatment includes oxygen, IV therapy, and medication.
This spontaneous report has been received from a consumer via web site, referring to her 16 year old daughter. The patient's historical condition included a perfectly, healthy and an athletic patient, concurrent conditions were not provided. On 2010 the patient was vaccinated with GARDASIL (dose, strength, frequency and indication were not provided). Concomitant therapies were not provided. On an unknown date the reported stated that her daughter developed multiple illness, also experienced nausea, stomach virus that was incurable, and vomit after all solid food, she reported that it was placing in deadly situation, and her quality of life decreased. At the time of the report the outcome of malaise, quality of life decreased, vomiting, gastroenteritis viral and nausea was reported as not recovered. The reporter considered nausea, malaise, quality of life decreased, vomiting and gastroenteritis viral was related to GARDASIL. This is one of several reports from the same source. Additional information is not expected because the consumer did not provide contact details.
Information has been received from a pharmacist concerning unspecified number of patients of unknown age and gender. There were no concurrent condition, medical history and concomitant therapy reported. On an unknown date, two doses of improperly stored (Merck) VARIVAX (lot # K010337, Expiration Date 22-JUL-2016) (strength, dose and route not provided) were administered. The vaccines were exposed to 27 F for 1 hour and to 15 F for 1 hours and 35 minutes. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
ON 4th March had pfizer covid vaccine #2 and immediately developed right sided trigeminal sensory neuropathy on the right face  with the right sided ipsilateral facial sensory impairment suggestive of ipsilateral trigeminal neuropathy (not true bell's palsy) as he has no motor weakness on rt face as he described.
Patient reported severe nausea 2 hours after vaccine was administered. She said it also felt like her stomach was burning. Pt said she has hx of IBS and acid reflux. She said she had no appetite. I called her 24 hours later and she said things had improved but still slightly nauseated.
blood in my eye;This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (BNT162B2, Lot number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 26Feb2021 13:00 (at the age of 42-year-old) at single dose for COVID-19 immunization. The patient is not pregnant. Medical history included a leiden factor a blood disorder. The patient had no known allergies. Concomitant medications included ibuprofen (MOTRIN); ashwagandha; ascorbic acid (VITAMIN C); and an unspecified Pfizer vaccine on 12Mar2021 administered in the left arm. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. On 11Mar2021 12:00 AM, the patient experienced blood in her eye. There was no treatment for the event. No COVID prior vaccination and was not tested with COVID post vaccination. The outcome of the event was recovering.  Information about lot/batch number has been requested.
AE due to comingling of Moderna and Pfizer dose; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (AE due to comingling of Moderna and Pfizer dose) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 031A21A and 030M20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (AE due to comingling of Moderna and Pfizer dose). At the time of the report, IMMUNISATION REACTION (AE due to comingling of Moderna and Pfizer dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history information was reported.  It was reported that patient received Pfizer bivalent.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2023: Live Follow-up appended significant- event vaccination adverse reaction added.
Next morning, after the vaccine, I had nausea and urinated very often, chills. I went to the ER locally; they took blood and urine for the tests. EKG was done. The urine test was normal, but it shows a urinary tack infection; they gave me medicine.
p/2nd set of immun (DTP/HIB/OPV) pt cried inconsolably x 45 mins, then had different sounding cry for about 2 hrs; @ 3rd set of vax pt had DT/HIB/OPV & has had no known residual for 2nd set of immun;
Extreme fatigue started 4 hours after shot as well as pain in left arm and heaviness in left arm. That night, couldn?t sleep, ran a fever, and severe headache.  Since then, still fatigued and difficulty working out.  I did have COVID in June, 2020. I had long lasting effects, including headaches, fatigue and altered taste/smell.
This spontaneous report as received from a office manager (other health professional) refers to an unknown number of patients of unknown demographics. Pertinent medical histories, current condition, reactions and allergies were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB dosage regimen were not reported (lot # M020926 expiry date: 11-AUG-2018). Concomitant medications were not reported. On an unknown date, the patients received an unknown number of doses of RECOMBIVAX HB following temperature excursions of 47.5F for 30 minutes and 65.4F for 17 hours 45 minutes and 43.34F for 10 minutes. No adverse effects were reported in any patients. No further information is available. No Product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not give us consent to contact physician. This is one of 3 reports received from same reporter. MARRS # 1611USA008584 and MARRS # 1611USA008534.
p/vax pt devel generalized hives; followed by swelling of the knees; feet & hands; call ER & instructed to take benadryl; MD instructed pt to come see if hives do not go away
~36 hours post-shot woke up in middle of night with migraine, chills and nausea. Took Excedrin, naproxen and Zofran and was able to fall back asleep in about 2 hours.
Information has been received from a 52-year-old female consumer on 06-AUG-2015, who is the patient, who reported receiving PNEUMOVAX 23 injection, sometime in June. The patient stated the next day she "became sick" and had to go to the emergency room (ER). The patient gave no other information due to she wanted to verify everything with the provider. The consumer called back on the same day, 06-AUG-2015 and stated that 24-JUN-2015 was the date she received the PNEUMOVAX 23 injection, intramuscular. She sought unspecified treatment in the emergency room (ER). The patient also reported she was admitted to the hospital, name and location of hospital was unspecified, and it was unspecified the amount of time she spent in the hospital for the event. Outcome of the "became sick" event was unknown. Present status of the patient was unknown. No additional information was provided. Additional information has been requested.
Fever 102.8, pale, resting heart rate 99, sore arm, redness at injection site that is beginning to lessen on the 4th day.
Within the first 24 hours, I did have an egg size knot and soreness on my arm that lasted about 4 days.  I am not able to eat anything with citrus(lemon, cilantro, celery, etc.), fries, potato chips without having a bitter, iron, metal taste in my mouth that makes me gag. I can also taste this when I smell outside, in perfume, deodorizers, etc. I try to avoid this taste and wear a mask to avoid the smell.   The Dr. tested me for Covid and it was negative and treated me as if it was a sinus infection and prescribed antibiotics. No result! I am hoping this goes away soon, but it is bothersome when trying to enjoy the things you love, but not sure what the outcome will be.
Fatigue and tiredness increased after about 2 hours post vaccination and continues on the day after vaccination. I eat a healthy diet; oatmeal and fruit in the morning, yogurt, vegetables and drink water throughout the day.
CHILLS; LACK OF SLEEP; TIRED FROM LACK OF SLEEP; This spontaneous report received from a patient concerned a 50 year old male. 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: Unknown) dose was not reported, administered on 09-APR-2021 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced tired from lack of sleep. On 09-APR-2021, the subject experienced lack of sleep. On 09-APR-2021 20:30, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lack of sleep, and chills on 10-APR-2021, and the outcome of tired from lack of sleep was not reported. This report was non-serious.
Pt developed fever of 100.8 which he had for 4 days. On the fifth day his fever was 105.7 and he went to his PMD and then ED. He was discharged home after tests were done.
Reported on 11/4/16. Patient notified Employee Health and Wellness that she had a flu shot on 10/25/16 and her arm still hurts. She said she experienced pain 30-60 minutes (ache and throbbing) after shot. From day 3 to today day 10 she said her arm hurts when she moves it, she can't sleep on her left side (vaccine given (L) arm) and that it hurts in the morning and when she sleeps. Advised her to see her Health Care Provider or Urgent Care.
Lost balance, severe headache, 101 degree fever, elevated BP, no appetite & fatigue  All symptoms for 35hsr
Systemic: Rash (other than injection site)-Severe, Systemic: Headache-Severe
Arm red and swollen with a bumpy itchy rash at injection site. Rash noticed on day 12  post vaccination.
Patient states he has rash on both the inside of his forearms. Rash is raised red itchy bumps on forearms. Pt also states he has some itching in genital area
chills; severe headache; malaise; being confined to bed for the first and second days; receiving first dose of Shingrix 7-8 months ago and the second dose today, 6-9-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 09-JUN-2023, the patient received the 2nd dose of Shingrix. On 09-JUN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: receiving first dose of Shingrix 7-8 months ago and the second dose today, 6-9-2023). On an unknown date, the patient experienced chills (Verbatim: chills), headache (Verbatim: severe headache), malaise (Verbatim: malaise) and bedridden (Verbatim: being confined to bed for the first and second days). The outcome of the chills, headache, malaise and bedridden were resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the chills, headache, malaise and bedridden to be related to Shingrix.     It was unknown if the company considered the chills, headache, malaise and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUN-2023 The patient reported that he received first dose of shingrix 7 to 8 months ago and second dose on 09th June 2023 just 30-45 minutes prior to filing report. After the administration of first dose of Shingrix patient experienced chills, severe headache, malaise and was confined to bed for the first and second days. The symptoms resolved after second day.  The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
had chills; hives; This is a spontaneous report from a Pfizer sponsored program. A contactable female patient reported for herself.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.   On an unspecified date of 2021, the patient (caller) had bad reaction to first vaccine, patient experienced chills and hives. Adverse event due to bad reaction after first vaccine. Wanted to know if she should take second vaccine or not. There were no unaddressed medical questions referred or forwarded to Medical Information. The clinical outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Apr2021 12:15 (Lot number: EW0171) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE PRURITUS (non-serious) all with onset 29Apr2021, outcome "recovering" and all described as "raised, round, reddish, itchy spot at injection site of right arm"; INJECTION SITE INDURATION (non-serious) with onset 29Apr2021, outcome "recovering", described as "injection site of right arm continued to be hardened"; DIZZINESS (non-serious) with onset 28Apr2021, outcome "recovering", described as "Light-headed"; NAUSEA (non-serious) with onset 28Apr2021, outcome "recovering", described as "nauseas feeling". The events "raised, round, reddish, itchy spot at injection site of right arm", "injection site of right arm continued to be hardened", "light-headed" and "nauseas feeling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site erythema, injection site pruritus, injection site induration, dizziness, nausea. Additional information: This report was received via COVEAS. The patient received vaccine in pharmacy/drug store and she was not pregnant when administration and had no known allergies. Patient didn't receive other vaccine in four weeks and didn't take other medications in two weeks. The patient had no COVID-19 prior vaccination and she tested COVID-19 post vaccination. It was reported that shot 1 - 3 days later, patient found raised, round, reddish, itchy spot at injection site of right arm. The injection site continued to be hardened, raised and itchy for next 3-4 weeks. Additionally, patient had light-headed & nauseas feeling - come and go 4-5 times a day lasting approximately 2-3 months post 1st dose. Patient visited doctor but no treatment available. No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 15 year old female who was vaccinated with the third dose of Gardasil (Lot #658222/0927U) on 21-AUG-2007. On approximately 21-AUG-2007, the patient complained of a headache with a short duration after the third dose of Gardasil.  This is one of three reports from the same source/siblings.  Additional information has been requested.
Large, protruding blister on the inside of the right cheek. Smaller blister nearby on the same cheek. Swollen gums, slightly swollen on roof of mouth. Very dry lips.
History of stroke and had severe, paralyzing stroke-like symptoms following initial Pfizer vaccine and have multiple medical letters of exemption against 2nd dose after month of testing and specialists. Seeking alternative forms of protection so that I can work and live.
Developed a double ear infection about 7-8 days post vaccination, did not have any pain only discomfort and impaired hearing. Went to an urgent care and was prescribed optic neomycin which helped, I feel 100% better now. Not sure if because of vaccine or just my bad luck, better safe than sorry to report it.
Fever, plus swelling, inflammation and cellulitis at site of injection.  S/S 2 days.  Patient treated with oral antihistamine, topical steroid, antibiotic and NSAID for pain and fever
Injection 9/16/03 left deltoid. 9/17/03 increased temperature/cellulitis. Rx Keflex, Motrin. Seen in ER 9/17/03 Rx IV antibiotics. Seen in ER 9/18/03 Rx IV antibiotics. 9/18/03 admitted to hospital. 9/19/03 discharged.
Swollen arm at site of shot 8 days later. Within 24 hours I've developed a hot, red, itchy rash in the same area.