chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a female consumer, reporting on herself, who in September 2010, was vaccinated with a dose of RECOMBIVAX HB (Lot # and route not reported), 40mcg/ml. The consumer reported that 12 hours later she experienced vomiting and diarrhea. Consumer reported that she received a second dose of RECOMBIVAX HB 40mcg/ml, in October 2010 with no known adverse effect. No treatment was given for the events. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was recovered. Additional information has been requested.
Pain; she cant move; cant sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: E200162) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Spine surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "she cant move"; INSOMNIA (non-serious), outcome "unknown", described as "cant sleep".  Additional information: Patient was told to take Tylenol even before the vaccine but Tylenol did not help nor did any of the other aspirins. She asks if she can start taking the Aleve to help her with the pain the back. Aleve works for her. Patient clarifies that the Spine Surgery was a while ago prior to the first dose, she was actually due to go back to surgeon next week.  No follow-up attempts are possible. No further information is expected.
This case was reported by a other health professional via sales rep and described the occurrence of herpes zoster in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, 7 days after receiving SHINGRIX, the patient experienced herpes zoster and rash. On an unknown date, the patient experienced shooting pain. The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. On an unknown date, the outcome of the herpes zoster, rash and shooting pain were unknown. It was unknown if the reporter considered the herpes zoster, rash and shooting pain to be related to SHINGRIX. Additional details were provided as follows: The patient never had an episode of herpes zoster or chicken pox. About 1 week after receiving SHINGRIX, the patient had an outbreak of herpes zoster rash on the right abdomen, back and flank. The patient went out of town when she experienced the rash. She contacted her doctor via phone and was advised to get evaluated. The patient would come back 2 weeks later to see her doctor. Her doctor diagnosed her with mild case of herpes zoster, along with shooting pain. The doctor also noticed the presence of new lesions along the same dermatome. He prescribed the patient gabapentin and valtrex.
On 10/30/2022 I received the Pfizer Bivalet vaccine. I had no problems other than a sore arm at his time. On 11/07/2022 I woke up with a raspy, breathy, quiet voice. I had no other symptoms. No sore throat, rhinorrhea, congestion, cough, sneezing, headaches, nausea, vomiting, diarrhea.  I had to over exert myself to speak and I could not make any sound over a whisper. There was no sound quality to my voice. After seeing no improvement I was seen by an urgent care on 11/22/2022 where I was given a 10 day course of prednisone dose pack. I had no improvement and was seen my my PCP, on 11/29/2022 where she referred me urgently to ENT for asymptomatic coice loss. I was seen by Dr. on 11/30/2022 where a largyngoscopy was performed and I was given a diagnosis of left vocal cord paralysis. He sent me for a CT Head w/ and w/o, CT Neck w/, and CT Chest w/ all of which were unremarkable. I had a CBC and TSH done and both were unremarkable. On 12/22/2022 I noticed a difference in the quality of my voice. Where I had not yet had any phonic sound produced since 11/07/2022 there was a minor improvement. I have been seen by speech therapy and voice hasgradually improved. It is still deeper and raspier than before.
sore throat; burning in my chest; had a reaction to something I ate; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support via medical information team. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, on an unspecified date (at the age of 59-years-old), at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore throat, burning in chest and the patient had a reaction to something he ate. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness @ inject site occuring in more than usual number of pts (?); Redness & pain; local reaction; these were booster shots, pts did not know if they had recvd booster shots;
Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; Severe malaise; Severe headache from 12-36h post administration impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia; loss of appetite; Transient dysgeusia; Mild nausea; Pleuritic chest pain; This is a spontaneous report from a non-contactable physician. This 27-year-old female physician (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=E15249), via unspecified route at left arm on 08Jan2021 07:30 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization. Facility type of vaccine was hospital. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination. On 08Jan2021 06:00 PM, patient experienced severe headache from 12-36h post administration (as reported), impairing ability to perform ADLs with inability to turn head from side to side or to change positions without lancing temporal pain and a/w photophobia (nearly meningeal signs); mild nausea; pleuritic chest pain; severe malaise; transient dysgeusia; loss of appetite. Treatment for events included initially NSAIDs until had difficulty tolerating was received. Outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Initial report received on 03 August 2011 from the Investigator under the reference number M5A16. A case of pertussis disease in an 18 month-old female subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included three doses of PENTACEL; lot number C3554AA was received on 12 March 2010, lot number C3591AA was received on 14 May 2010 and lot number C3591AA was received on 16 July 2010 (routes and sites of administration were not reported). The subject developed a cough on 11 July 2011, approximately 12 months after the last dose. On 11 July 2011, the subject developed a paroxysmal cough without a whoop and posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR and culture on 13 July 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 15 July 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 25 July 2011, the subject's cough was still persisting. The duration of the cough was reported at the time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sore arm; headache; Minor nose bleeding from left nostril; This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Minor nose bleeding from left nostril), VACCINATION SITE PAIN (Sore arm) and HEADACHE (headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 025C21A) for COVID-19 vaccination.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced EPISTAXIS (Minor nose bleeding from left nostril). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EPISTAXIS (Minor nose bleeding from left nostril), VACCINATION SITE PAIN (Sore arm) and HEADACHE (headache) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Following the vaccine I experienced swelling of the arm and underarm, fatigue, chills, body aches, and itching/pain at the injection site.  These symptoms resolved within about 2-3 days except for the arm swelling and pain/itching at the injection site which took about 1 week to resolve.  Around the time of 12/23/21 I began experiencing hives/large red rash marks that itch that primarily occurred on my neck.  The hives continued and worsened, the hives primarily appear on my face, neck, behind my ears, and upper body/chest area.  I kept a food diary and was seen by Dr. who conducted allergy tests and no food allergen was identified that appeared to be the cause.  I began taking Zyrtec which resolved the hives although occasionally red markings (that look like scratch marks would appear).  I attempted to stop the Zyrtec after 6 weeks of hives although the hives continued and worsened appearing at least 10 times a day.  I saw my PCP, Dr. who felt the vaccine may have been the cause.  I followed up with Dr. who conducted more lab (blood) work to determine if the hives could be from a medical cause and the results were negative.  I attempted to stop taking the Zyrtec last week on 3/8/22 although the hives continued to appear.
It started this last Saturday the 6th of November. I felt some numbness on my, face towards to my eye. It was the side of my face, and I thought it was a pinched nerve. I went to the ER on Monday the 8th they prescribe two different medication prednisone 20mgs and take 3 tablets once a day. The other medication acyclovir 800mgs one table 5x a day.  I don't feel as much, but it's more of a paralyses issue. The ER doctor stated this could take a few months to clear. I had a schedule to see doctor today, but they're a bit full at the time to get an appointment set up immediately.
Within 5 minutes of vax, the pt felt very faint. Mother reports the child passed out form 1 minute and was brought back to the clinic. The pt was observed for 30 minutes. BP improved.
Had 4 injections (DTap, PREVNAR, HIB and INFLUENZA vacc.) and one oral vacc. (ROTAVIRUS) @ 6 month WCC. The night of receiving vaccines had fever, temp 103.7 w/o Tylenol. Later next day > 24 hrs post vaccines developed rash - florid, generalized urticaria and erythema c/w erythema multiforme.
She had blood coming from her vagina; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she got the vaccine on 17th and last night she had blood coming from her vagina and she needed to know if she was okay. She was feeling better, and she was not bleeding anymore. The outcome of the event was recovered on an unknown date in 2021.   No follow-up attempts are possible, information about lot/batch number cannot been obtained
pt recv vax 18JUL95 & became pregnant;11MAY96 pt delivered a female infant 5lb 13oz by cesarean section  d/t face presentation of the infant;pt was nl however, pt did exp transient hyperbilirubinemia which was treated w/phototherapy;
In addition to the same reactions that I experienced with my first injection; which were chills, fever, body aches & fatigue that lasted the second & third day following injection.  I have developed red blisters on the left side & middle of my forehead which are sore to touch.  I also have pain in the left side of my face & neck. A picture was sent to  pharmacist and he suggested that I report this to you.
Given a total of 3 doses moderna IM. Documented he previously was vaccinated on 2/3 and 3/2/21.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 at 09:00 as dose number unknown ,  single (Batch/Lot number: unknown), in right arm, on 12Apr2021 at 14:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 at 18:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "miscarriage last month" (unspecified if ongoing); "elevated BMI of 28" (unspecified if ongoing), notes: elevated BMI of 28. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]; AZELASTINE; FLOVENT; PREDNISONE, stop date: 22Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022 at 08:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Bixnar test was nearly negative (faint line barely detectable); (27Jun2022) Positive, notes: I took Paxlovid on day one of symptoms and day one of a first ever positive test; (05Jul2022) Positive, notes: On 05Jul my test became slightly more positive by 07Jul my test was as clearly positive; (07Jul2022) Positive, notes: On 05Jul my test became slightly more positive by 07Jul my test was as clearly positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. She took Paxlovid on day one of symptoms and day one of a first ever positive test. 4 days later my Bixnar test was nearly negative (faint line barely detectable) her symptoms outside of fatigue that had her sleeping 12-18 hours a day and a slight scratchy throat. On 05Jul her test became slightly more positive by 07Jul my test was as clearly positive as she was on day 1 and symptoms of a head cold became noticeable and bothersome. She asked her doctor for a second round of Paxlovid but that was currently not being offered to any patients. other medication details other medication in 2weeks included Zyrtec, Flonase, asalastine, Flovent, metal prednisone (ended on Jun2022). Ae resulted in None of the above. No Known allergies. Other medical history Asthma, environmental allergies, miscarriage last month, elevated BMI of 28. Treatment started on 27Jun2022 and stopped on 02Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
being swollen from arthritis.; 2nd dose had to be rescheduled due to her hand being swollen from arthritis.; Headache after 2nd dose; Chills after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (being swollen from arthritis.), OFF LABEL USE (2nd dose had to be rescheduled due to her hand being swollen from arthritis.), HEADACHE (Headache after 2nd dose) and CHILLS (Chills after 2nd dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     The patient's past medical history included Arthritis since an unknown date.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (being swollen from arthritis.), OFF LABEL USE (2nd dose had to be rescheduled due to her hand being swollen from arthritis.), HEADACHE (Headache after 2nd dose) and CHILLS (Chills after 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (being swollen from arthritis.), OFF LABEL USE (2nd dose had to be rescheduled due to her hand being swollen from arthritis.), HEADACHE (Headache after 2nd dose) and CHILLS (Chills after 2nd dose) outcome was unknown.            No concomitant drugs were reported. Patient second dose has been rescheduled due to Arthritis for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received; NNI.
Headache, Fever, Chills, fatigue, sore left arm Narrative:
Vomiting, diarrhea, low fever (99.5), body aches, chills, headache Symptoms began 12 hours after dose, ongoing for 24 hours
12/10: called day after vaccination c/o pain to right deltoid radiating to shoulder and neck. 12/11: called c/o swelling to both hands and joint pain. 12/15: continues to c/o joint pain.
On Saturday , the day of the shot, felt pain in the right arm, even though shot was given on the left arm. Holding a  TV remote felt heavy. On Sunday, on the upper left side of the chest, series of contractions or spasams. Sporatic through the day both on Sunday and Monday.  Several times on Sunday and multiple time on Monday. Happened more on Monday than Sunday.
WHEN PT WAS GETTING DRESSED SHE SUDDENLY HAD A SHARP CONSTANT PAIN THAT WENT DOWN HER ARM.  IT WAS SEVERE FOR 2 DAYS.  NOW IT IS STILL SORE BUT SHE CAN MOVE HER ARM AND IT IS NOT CONSTANT.
Chills; Diarrhea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program  support. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Apr2021 at age of 50 years old at single dose for COVID-19 immunization. Medical history included he ate spinach which caused him to have loose stools on 05Apr2021. Concomitant medications were not reported. On 08Apr and 09Apr, he began to experience diarrhea. He took pepto-bismol, which didn't help him so he had been following the BRAT diet and drinking coconut water. He went to an acupuncturist who prescribed Plum Flower curing pills. He asked how long this was going to continue. He also reported having chills after the vaccine. The 2nd dose would be on 29Apr2021. Patient experienced diarrhea and chills the next day after taking the 1st dose. He would like to know how long the diarrhea extended to last. As per the patient he took an anti-diarrhea curing pill which was a Chinese herbal. He would also like to take the 2nd dose a week after the 29Apr2021, which would be on 06May2021. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient reports sore arm more than her annual flu vaccination side effects.  She reports that her sore arm extended up her shoulder to her neck.
falling down, crying, @ noc of vax sleepy, listless, very limp, hard time moving;
fever of 100, horrible body aches, headache, dizziness, diarrhea, chills, flushing
Initial misuse report received from a healthcare professional on 04 March 2014. A patient (gender and date of birth was not reported) had administered only the DTaP-IPV portion of PENTACEL vaccine without first reconstituting the ACTHIB component. No adverse event was reported. List of documents held by sender: none.
Pt recv vax on 3/15/99; on same day pt exp nausea, vomiting, diarrhea, body aches, fever/ chills
Low-grade fever, sore throat, minor congestion, fatigue - not major, reporting just for tracking since peds vaccine is new