chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight sore arm; fever; malaise for 1 day; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0158, Expiration date: unknown), via an unspecified route of administration, administered in Arm Right on 11Apr2021 12:30 (age at vaccination was 62 years) as dose 2, single for COVID-19 immunization. The patient's medical history included obesity, vertigo positional, hypertension, lipids increased, glucose tolerance impaired and covid-19 from Mar2020 to an unknown date. The patient have known allergies. Patient received bisoprolol, atorvastatin calcium (LIPITOR), paracetamol (TYLENOL) and calcium concomitant medications or other medications in two weeks. The patient previously took codeine and experienced pruritus and drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown that the patient was diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP7534, Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 21Mar2021 12:30 (age at vaccination was 62 years) as dose 1, single for COVID-19 immunization. After first dose patient experienced Slight sore arm, body aches, fever and malaise. On 11Apr2021 at 19:00, after second dose the patient experienced slight sore arm, fever and malaise for 1 day. No treatment was received for the adverse events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Menstruation cycle (period) started the day after the vaccine was given, which is when it was due. It's been over 3 weeks, and I am still having vaginal bleeding. My cycles have always been normal and consistent prior to this month. No other factors have changed, no pregnancy, no birth control, no stress, no diet changes, etc. The only thing that has changed is receiving the first dose of Moderna.
Patient reported numbing on the left face and ear and blue tongue that started the next day. Numbing resolved after one day and blue tongue resolved itself after 3 days. Patient went to urgent care and ER. Patient also reported higher than normal blood pressure (156/80). Normally has low blood pressure (100/70).
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 73-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN6202), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 30Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CARDIAC PATIENT" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 01Jul2022; ZETIA, start date: 01Jul2022; METFORMIN, start date: 01Jul2022; ASPIRIN (E.C.), start date: 01Jul2022; ROSUVASTATIN, start date: 01Jul2022, stop date: 04Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid test positive; (Jul2022) Negative, notes: Paxlovid 5 days, then Covid negative; (Jul2022) Positive, notes: Symptoms returned 3 days later Covid tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid treatment from 05Jul2022 to 09Jul2022 for covid-19. Covid symptoms sore throat, cough, mucous in throat build up, covid test positive. Paxlovid 5 days, then covid negative, symptoms returned 3 days later covid tested positive. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Swelling in lymph node under armpit; under armpit is feeling a bit sore; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in lymph node under armpit) and AXILLARY PAIN (under armpit is feeling a bit sore) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling in lymph node under armpit) and AXILLARY PAIN (under armpit is feeling a bit sore). At the time of the report, LYMPHADENOPATHY (Swelling in lymph node under armpit) and AXILLARY PAIN (under armpit is feeling a bit sore) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-417302 (Patient Link).
Information has been received from a registered nurse concerning a female who on 3/22/03, was vaccinated with a dose of varicella virus vaccine live. The RN reported that in March 2003, the patient developed an itchy elbow. The patient was seen in the health room and after examinations, the RN also found small red vesicles around the patient's itchy elbow. The school physician was called. It was noted that the patient had no other symptoms. The RN also reported that the patient's mother indicated that the patient had been exposed to poison the day before the symptoms started. The area was normal the next day. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients might have been vaccinated with improperly stored doses of PROQUAD (Merck) lot # K020748, expiration date 30-APR-2016 (dose and route of administration were not reported). There was no advere effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient reported that she had a rash extend from injection site to elbow. Recommended that pt get seen by a physician. She said she's going to go to urgent care.
Patient returned to RN about 30 minutes after H1N1 flu vaccination c/o "sick to stomach".  (10:40 AM) Pt had red, splotchy rash on back & arms.  BP 122/80, P 84, R 24.  No itching.  Administered 2 tsp BENADRYL PO at 10:44 AM without notifying parent for verbal consent.  At 10:55 AM, there was no rash on arms & decreased redness on back.  Stated he felt better.
1st dose 1/22/2020,2nd dose 4/7/2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number L9F99, expiry date 10th May 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd January 2020).   On 7th April 2022, the patient received the 2nd dose of Shingrix. On 7th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 19-JUL-2022 Reporter comment: The pharmacy intern called regarding dosing regimen for Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule
fever; chills; body ache/muscle ache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache/muscle ache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 13-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache/muscle ache). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (sore arm), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache/muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
He received the vaccine on 2/13/21 by 2/15/21 he was not feeling himself didn?t really eat by 2/17/21 he couldn?t walk by 2/19/21 he was admitted to hospice and by 2/22/21 he passed away
Patient missed the 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose on 8th March 2021).   On an unknown date, the patient received the 2nd dose of Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, 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. Pharmacy technician reported that, the patient had received first dose of adult  Engerix B. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The patient missed the second dose The reporter did not consent to follow-up.
On Monday and Tuesday, had fatigue, hot then cold, muscle and bone aches. On Dec 1, 2016 began to notice I was off balance when walking, and several near falls.  Fatigue continues.  Chills and muscle aches stopped after the first 2 days.
Pain in right shoulder and neck starting in the evening of 10/03/2012. No pain, inflammation or redness around injection site. Pt. reported to clinic to receive medical care on 10/11/12.
Flu-like symptoms; Twitching in legs; Cold sensations in shins of both leg; Tingling in shins of both leg; Weakness in one leg/foot/ankle; twitching/Spasms in both feet; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 22Apr2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy and seasonal allergies. Concomitant medications included mometasone furoate (FLONASE) and gliclazide (CLARITIN) from an unknown date for seasonal allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 01Apr2021 at 11:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021, the patient experienced flu-like symptoms, twitching in legs, weakness in one leg/foot/ankle, spasms in both feet, cold sensations in shins of both leg and tingling in shins of both legs. The patient had flu-like symptoms for 1.5 days and twitching in legs. It was also reported that 2 weeks from her second dose and she still had nonstop twitching in her feet. Also some tingling/cold sensations in her shins of both legs. She had weakness in one leg/foot/ankle which may be related to a knee issue but not sure yet but looked into that. But the twitching/spasms in both feet started after second dose and had not stopped (and that was definitely not related to a possible knee thing because it was both legs). She had never had this before. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events flu-like symptoms, twitching in legs, weakness in one leg/foot/ankle, spasms in both feet, cold sensations in shins of both leg and tingling in shins of both legs was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Was here with 2 children and wife, infant and wife along with himself was getting vaccine. Was notified that he was given wrong vaccine pt was ok with it and was not up set. asked when he could get the vaccine that he came in for.
On 5/24/10 baby received 2nd Rotavirus vaccine. On 7/17/10 - 7/19/10 was hospitalized for intussusception requiring surgery.
Patient is 10 years old. Float RN in clinic gave 0.2 ml of the 12+ covid vaccine to patient. Patient should have received pediatric formulation because of her age.
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves 16 year old female patient who was vaccinated with 0.5 ml first dose of MENACTRA (Batch number: U5751AB, expiration date: 12-Nov-2018, route and site of administration was not reported) on 16-Nov-2018. The patients medical history was not reported. Concomitant vaccinations included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation; POLIO VACCINE INACT (IPV) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HEPATITIS B VACCINE (HEP-B-VAX) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACC.) for Immunisation; BEXSERO for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
During observation while at the vaccination site I felt like in the middle of my forehead I was starting to have hives. But nothing could be seen. In the middle of the week it started getting red and I used hydrocortisone and it was that. On Friday 04/09 I woke up and my neck was itchy and burning, stingy, like pins or stuck in it, when I looked in the mirror there was a rash, different from hives. Some type of rash, just on the front, right below the crease of the neck and all the way across. I called the advice nurse line and I had a telehealth (video) appointment with the Urgent Care . I was prescribed some topical cream and some oral antihistamine and I just used the topical cream, not the pills. I used the cream as prescribed and I left the message to my doctor and send pics of the site and she sent me a message for an appt but since I kept using the topical cream it has been helping so I have not seen her yet.
12 hours after the shot, I had pain in my arm that woke me up,  I was also very tired a few hours after the shot and the next day.  24 hours after the shot I developed a welt about the size a quarter on my arm, at the injection site, it was slightly raised and red.  I was feeling a general malaise, and had a headache for about 2 days and developed a little bit of a cough.  About 3 days after the shot, I developed mini lumps below the skin of my jaw on both sides, near the Parotid area.  They felt itchy but never broke the surface, they seemed to be like a skin boil.  They were about 1/4 inch round balls, and they lasted for several days.  I also had a few other itchy hard spots on each arm and one on my back.  I massaged the ones on my face and they went away in about a week.   On April 27th I woke up with a itchy painful skin blemish on the inside of my right arm(other side of the elbow), that had broke the skin, 4 days later is is still very itchy.  I was quite healthy the entire time of quarantine for the past year, after the getting the shot, I feel less healthy.  I am only reporting this now, because I am scheduled to get my second dose in a few days.
Patient's mother stated this was the child's first vaccination. She wanted her children to receive Moderna, which was administered. Subsequent records review revealed the child received Pfizer 5 to 11 (batch/lot# FK5127) on 11/4/2021 and 12/1/2021. No known adverse events.
dec 30, a 50 cent piece size red raise lump about the size of a tennis ball with a blister at injection site showed up. Dec 31 it was red raised, hot to touch, aprox the size of a soft ball, blister about the size of a small pea, as the day progressed it wrapped around the upper part of my arm doubling in size, still red, hot, swollen. Jan1st. redness is lighter but still spreading reaching into inner arm, swelling still prominent. Jan 1st clindamycin was started. Swell still prominent, redness has lightened a bit but still spreading, Jan2nd, swelling still noted, not near as bad, redness has lightened to pink, still able to see outline of swelling. Jan 3 no redness noted, itching started. jan4-7, no redness or swelling itching off and on, scab where blister was.
Within minutes of vaccination, client felt "faint & dizzy". (Given juice and client ate crackers). Client observed for 20 minutes. She had complaints of legs feeling "wobbly". She also had tremors of her arms. Client's mom said she is still having difficulty moving her legs. They feel "wobbly". Also client feels her head is in a "whirlpool". Client to see her doctor. This is approximately 15 hours following immunization.
Information has been received from a medical assistant concerning an 8 year old male patient who on 10/1/96 was vaccinated in the right arm with a second dose of varicella virus vaccine live (lot # 619677/0834D). Concomitant vaccination on 10/1/96 included a first dose in the left arm of MMR (lot # 630633/0102K). On 5/3/04, the patient was seen for a doctor visit with 15 to 30 lesions and a low grade fever. The patient was diagnosed with a mild case of varicella and an onset date of 4/30/04 was noted. Treatment was not required. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Patient reported on 12-12-2019 that she has around a 50% reduction in arm movement. Pain with lifting items. Hard to raise arm above head.
Piercing, itching of left eye when in supine position; Piercing, itching of left eye when in supine position; Left eye was cloudy; This spontaneous case was received on 29-May-2021 via Communication (reference number: SEQW21-01390) from other non-health professional and concerned female patient, of an unreported age.  The patient's concurrent conditions included seasonal allergies. The patient's concomitant medications included Zink (zinc gluconate), for an unreported indication.   On 19-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Flucelvax Quadrivalent, the patient experienced piercing, itching of left eye when in supine position and her left eye was cloudy.  On an unknown date, vision test was performed and results were worse in left eye. The patient administered allergy eye drops and an eye doctor gave steroid eye drop to the patient.  On an unknown date, the patient recovered from the events.   The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: A female patient, of an unreported age was administered Flucelvax Quadrivalent. On the same day, after receiving Flucelvax Quadrivalent, the patient experienced piercing, itching of left eye when in supine position and her left eye was cloudy. The patient's concurrent conditions included seasonal allergies. Causal role of the suspect vaccine is assessed as possibly related for all events, due to plausible chronology.; Sender's Comments: A female patient, of an unreported age was administered Flucelvax Quadrivalent. On the same day, after receiving Flucelvax Quadrivalent, the patient experienced piercing, itching of left eye when in supine position and her left eye was cloudy. The patient's concurrent conditions included seasonal allergies. Causal role of the suspect vaccine is assessed as possibly related for all events, due to plausible chronology.