chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 virus test positive; COVID-19 virus test positive; Frustration; Sickness; Head discomfort; Vomiting; Migraine; Joint pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4248486-00.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster) single, intramuscular, administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 virus test positive"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "Frustration"; ILLNESS (non-serious), outcome "unknown", described as "Sickness"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "Head discomfort"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; MIGRAINE (non-serious), outcome "unknown", described as "Migraine"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown. On unknown dates, the patient was tested positive for covid-19, frustrated, sick, throwing up and could not lift head, migraine and joints were hurting. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of tested positive for covid-19, frustrated, sick, throwing up and could not lift head, migraine and joints were hurting was not provided. Causality for bnt162b2 (BNT162B2): The reporter's causality for the event(s) of could not lift head, throwing up and migraine was possible. The reporter's assessment of the causal relationship of the events tested positive for covid-19, frustrated, sick and joints were hurting with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded.
pt inadvertently was given DTP; that evening devel fever, seen in ER dx pneumonitis; tx included ATB; pt fully recovered w/no residual sequelae;
Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with abdominal pain, nausea, then an episode of liquid stool. These continued throughout the next day until the evening of day 2. By morning of day 3 they were gone
Respiratory symptoms beginning  48 hours after getting vaccine that are still evident 8 days later.  Bronchial/asthma symptoms along with congestion controlled with Allegra and inhaler.  Not sure if I should get second vaccine.
Cough beginning day after vaccination and continuing now 7 weeks later; no chest pain, no shortness of breath.  possibly coincidental
ACUTE RESPIRATORY FAILURE 6/10/2022 -- RECURRENCE OF SAME SYMPTOMS
COVID 19 "over holiday weekend and  was hospitalized; COVID 19 "over holiday weekend and  was hospitalized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 21Mar2021 as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "COVID 19 "over holiday weekend and  was hospitalized". The events "covid 19 "over holiday weekend and  was hospitalized" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Her husband took primary series of Covid-19 vaccine and he had covid went to ER and she would like to know if he is immunocompromised and if he can take the booster dose. Caller stated her husband received his Primary Pfizer-BioNTech COVID-19 Vaccine series 10Feb2021 and 21Mar2021. Her husband also received 2 Primary Pfizer-BioNTech COVID-19 booster doses  and last booster dose was 19Apr2022. The caller stated her husband had COVID 19 "over holiday weekend and was hospitalized on the following Wednesday after holiday." The caller stated he received the IV medicine while he was hospitalized. He just finished rehab for 5 weeks following his hospitalization for COVID 19 . The caller asked when can he get the bivalent booster dose? Is he considered immunocompromised from already getting booster doses and should he wait?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
chills; fever; aches; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020.  This case involves a patient of unknown demographics who experienced chills, fever (Pyrexia) and aches (Pain), while the patient received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter stated that he/she had 4 flu shots in life and experienced chills, fever (Pyrexia) and aches (Pain) each time within 24 hours of getting the Flu shot. The patient could not believe his/her luck of getting the flu randomly each of those 4 times was extremely unlikely. The patient believed that it was a weakened virus that antibodies react to in order to fight off the full strength virus.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all events.  There will be no information about the batch number in this case.  The reporter assessed the causal relationship with suspect vaccine as related.  No further relevant information was reported.
Mom states child had no problem after vaccine til next day after waking from 2 hour nap; states child had problem standing on rt leg; took to Dr. and stated Dr stated did not find any redness, swelling or problem at injection site and stated was told by physician may be some muscle cramping or spasms.  Stated no treatment ordered at that time.  States today child was walking on rt leg for 20 mins at a time and then would not stand on rt leg for approx 40 mins before walking on rt leg again.
Fever; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (unknown route) 75 mg. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PYREXIA (Fever) and FATIGUE (Tiredness). At the time of the report, PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown. 1st dose AE      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Fever at 5pm after injection.  Patient at 9am, pain up to 103 - came to ER with severe H/A.
Rash on upper arm around the vaccination site = originally 1 inch/diameter; over the next ten days, spread to about 4 x 1 inches, with red pin-head size blisters
Patient has developed motor tics and vocal tics and worsening of ADHD following vaccination of MMR 02/16/2015 and 06/02/2015 and especially the Tdap 07/16/2015.
The vial was not diluted before the injection therefore the patient received a 20mcg dose instead of a 10mcg dose. The patient did not have an adverse reaction, they were simply given the incorrect dose.
Information has been received from a licensed practical nurse concerning a 6 year old male who on 10/30/1996 was vaccinated SC with the first dose of varicella vaccine. Recently, the pt was exposed to another child with chicken pox and developed chicken pox. On 04/26/2001 the pt developed the first signs of a rash and on 04/27/2001 the pt developed over 100 lesions. The pt did not have a fever. The nurse reported on follow-up that the pt developed multiple lesions over the face and trunk. He had greater than 100 lesions and was diagnosed with chicken pox. He subsequently recovered from the chicken pox. It was also reported that the pt's sister was vaccinated with varicella vaccine and experienced similar events. Additional info is not expected.
Developed rash on arms and itching, progressed to shortness of breath and to feeling of throat closing. EMS called.
pt recvd vax & exp abdo pain; illness began 5 days prior to admission w/onset of acute abdo cramps, vomiting, diarrhea; stools have been bloody & mucousy times 2 days, one day prior to surgery; t101 x 1 day; pt underwent appendectomy;
The day after the vaccine I started itching all over my body. Especially chest, back and hands. No hives or anything like that.
Client received first COVID dose 04/01/21 at 1030 am, noticed adverse reaction at 3 or 3:30 pm.  Reaction is a rash, possibly hives on chest, was kind of red but is now pink in color.  Client report no pain or itching at rash site.  Client has taken an antihistamine and will continue to monitor for symptoms.
Seen in office 12/13/06 diagnose: Shingles, mainly affected on right side sacrum, right thigh. Afebrile, no history of fever prior to breakout or any other signs/symptoms.
Pt complained of generalized itching and presented with a mild facial rash 20 mins post injection
When this mother presented for the second set of shots on 12/05/2006 and advised the nurses in the clinic that after receiving the last set of immunizations on 10/31/2006 he developed "head to toe rash and raised whelts" about two hours after receiving the immunizations.  Both the ER physician and the family physician are not sure which immunization may have caused this reaction according to mother.  Child was given Benadryl and no further problems were encountered.  Since this child is not our health clinic patient (he only comes to the health department for shots) the nurses working the clinic on 12/05/2006 were not comfortable giving any immunizations without something in writing from the family physician.  Mother was advised that she needed to obtain something in writing regarding whether or not child should receive any further immunizations. Mother voiced understanding and will get information needed.
Information has been received from a physician concerning a female who on 16-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 26-SEP-2007 the patient developed a large welt around the injection site.  The patient sought medical attention via a phone call with the physician.  On an unspecified date the patient recovered.  A product quality complaint was not involved.  Additional information has been requested.
Arm swelling and inflammation. Treated with ibuprofen 200 mg q 6 hours as needed for pain and fever.
Product=COVID 19 Treatment; Product=COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW0171), in left arm, on 21May2021 as dose 2, single (Lot number: EW0186), in left arm, on 04Dec2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Apr2023, outcome "unknown" and all described as "Product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2023) Positive; (Apr2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took Paxlovid for COVID-19 treatment from 07Apr2023 to 12Apr2023.
pt recv vax 18AUG98 & approx 1SEP98 pt seen @ office w/MR w/dx of Bell's palsy;
Initial report received from other company on 23 December 2013. The case was initially reported by a consumer. A 65-year-old female patient who had received a dose of FLUZONE HD on 25 September 2013 (anatomical site, dose and batch number were not reported). Patient has history of transplant (kidney, pancreas) and concomitant medications were not reported. On an unspecified date after 2 days of vaccination, the patient developed itching on her body on and off. The same time, the patient also had a purple rash on her groin which comes and goes. It was reported that the color had changed to red, but was persistent on and off. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none. Follow-up information received on 04 January 2014 from non-healthcare professional. The patient received FLUZONE HD on 28 September 2013. The patient had received numerous standard flu vaccines but this was first time she received the "double dose flu vaccine". Stated later that day she had a purple rash about the size of her hand in both of the groin areas between legs and abdomen. Patient had a previous cream medication for rash and she used on other areas. The rash turned from purple to red rash. As of 03 January 2014, the patient continues to experience a red rash on and off all over her body. As of this report, the patient had not recovered from the events. Follow up information was received on 17 January 2014. The patient had received FLUZONE HD vaccine. The patient never had any reaction with regular flu vaccine. The patient developed very bad rash after the vaccination. The patient received treatment with clotrimazole, betamethasone and dipropionate topical cream for her rash. The patient agreed to send the available information. This case is linked with 2013SA134903 being the same reporter. Follow-up  information received from non-healthcare professional on 25 February 2014: The patient had further symptoms of coughing, body discomfort, rash on legs, loses her balance, some left arm problem, not specified.
Starting ~10hr after the shot (Moderna booster) Hot/Cold flashes, soreness at injection site, scratchy throat, slight nasal discharge, generally felt rundown. Symptoms except for sore arm mostly gone by the next day. No treatment of any kind used.
Blurred vision with days of receiving  vaccine. resolved slowly but not completely.  Was seen for this. Received second dose 01/08/2022 .  Blurred vision become worse again within days of receiving second vaccine.  Was seen  by doctor 01/28/2022 due to blurred vision not resolving. Patient also reported headache prior to onset. patient referred to Ophthalmology and Cariology for further testing.
Received the shot at 11:15am on 4/4/21. Woke up at 3:30am on 4/5/21 with a fever, chills, body aches, headache and nauseous. It lasted 24hours. Woke up today 4/6/21 with a swollen lymph node in my left arm pit.
Patient received moderna  covid-19 vaccine for ages 6-11yrs of age instead of updated moderna bivalent booster.
Hair loss that started on 4/22/22 and completed by about 5/31/22.  All dark hair lost on head, leaving only some white hair left.  Some hair loss in underarms, arms, and legs.  Minor pubic area hair loss.  No treatments.
Came in 7 days after administration of yellow fever vaccine, for evaluation of large (~3.5 cm) area of erythema, warmth, mild induration.  Was put on KEFLEX 500mg tid for possible cellulitis.
woke up, took off bandaid. it was red and swollen, a little smaller than a golf ball
Vaccine RotaTeq received oraally on 2/28/2007, baby seemed uncomfortable that night and would cry when layed back to feed...when falling asleep would twist and turn a jerk stomach as if in pain. Has not had a bowl movement since Vaccine and has limited urine in diaper. Symptoms started 2/28 evening and continued 3/1 all day. On 3/1 doctor wall called and assured us that the old vaccine caused side affects but not the new one. Baby is obviously in discomfort. Seems fine one minutes then started to get red face and grunt as if in pain...still laughing. Sleeping during day a lot but not at night all of a sudden.
No adverse event; Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient over 65 years old was given today 25May2023 0.25 ml instead of 0.5 ml).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that patient had their monovalent and a previous booster dose of bivalent vaccine. Treatment medications were not provided.  This case contains information about patient 13th out of 20 elderly patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
pt recv vax 17AUG95 & same day devel a fever of up to 1022;pt exp required an ER or MD visit;pt recovered from exp;
Patient reported feeling lightheaded to the nurse. Appeared pale and drowsy according to observers in the room. Patient unable to speak name to nurse when asked or answer any questions. Skin cold and clammy to the touch. Immediately layed patient down onto cot and elevated feet. Vital signs taken at time of reaction (BP 132/70, HR 57, T 96.9, RR 16, O2 97% RA). Patient stated he was starting to feel better, offered and accepted a glass of water. Patient sat up and denied any dizziness, nausea, or lightheadedness. Vital signs upon leaving (BP 124/76, HR 72, T 97.0, RR 17, O2 99% RA). Patient was able to ambulate independently to the outside accompanied by two nurses.
TOOK A DOSE OF VIVOTIF/ DID NOT COMPLETE VACCINATION PRIOR TO TRAVEL; FOUND A CRACKED OPEN CAPSULE; This spontaneous case report was received from a pharmacist (PVX2019-658, PTC-000047) on 15-Mar-2019. It described a 17-year-old female consumer who "found a cracked open capsule" and "took a dose of Vivotif/ did not complete vaccination prior to travel". The consumer was receiving oral Vivotif for typhoid fever prophylaxis.   It was reported that the consumer opened the package of Vivotif and she saw that one capsule was cracked open and there was nothing inside the capsule. She took another capsule of Vivotif on 11-Mar-2019 and had 3 capsules left. She had a planned trip on 20-Mar-2019.  The action taken with Vivotif with respect to the events "found a cracked open capsule" and "took a dose of Vivotif/ did not complete vaccination prior to travel" was not applicable.  The clinical outcome of the events "found a cracked open capsule" and "took a dose of Vivotif/ did not complete vaccination prior to travel" was unknown.  Company's Comment: The causality of the events "found a cracked open capsule" and "took a dose of Vivotif/ did not complete vaccination prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the events "found a cracked open capsule" and "took a dose of Vivotif/ did not complete vaccination prior to travel" was considered as not applicable.
I had the vaccine at 8:00am Saturday and symptoms started after midnight Sunday.  Fever, extreme muscle aches, headache, and fatigue.  A bit of stomach upset as well.  It is now Monday and I still feel achy and have a headache.
Initially severe chills, joint aches all over, dry cough after 1 day. That went away after 24 hours. Then a severe pain only at the Left Iliac Crest and surrounding muscles. At times very difficult to bear weight or ambulate up steps. Continues tenderness in muscle area just above Iliac Crest. Pain and weakness varies with no particular rhythm.  Pain varies from 2-3/10 to 9-10/10 that takes breath away. Pain and tenderness continue to this day.
Woke to small bumps on back w/welts, and all over body itching.
I'm not sure if it was the vaccine, I'm a chaplain at the hospital I didn't eat or drink anything before the vaccine. I had a trauma that day and after the shot my arm was tingling when I was driving home I couldn't focus I had a headache, when I got home I ate and immediately went to bed, I slept for 10 hours and the next day I was getting my son ready and I fell asleep sitting up and by lunch time I felt completely normal again.