chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Don't still feel good; with pain in side in my head; Slowed down; Extremely tired; Have a burst on energy for an hour or so; and then all of a sudden I can't even hold my head up; Eyes were swollen; Back to my head very weak; My whole body feels like it is bruised; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9262/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 17:30 (at the age of 59 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included rheumatoid arthritis. Concomitant medication included methotrexate 2.5 mg (8 tablets, once weekly), hydroxychloroquine 200 mg, 2x/day and folic acid UNK, 1x/day(1 tablet). On 12Feb2021 (Friday night), the patient reported that she "don't still feel good". The clinical course was as follows: On 12Feb2021, an hour after the receiving the vaccination, the patient reported "it started with pain in side in my head and within minutes it was like I was jelly. I was felt like fall on to the floor. I slowed down and I was extremely tired. I even left work early. I was off Saturday and Sunday. Today I could not even get work. It is like I have a burst on energy for an hour or so.  And then all of a sudden, I can't even hold my head up. My eyes were swollen and back to my head very weak. My whole body feels like it is bruised. Treatment received for the events included ibuprofen. The consumer stated, "I took 4 on Saturday and later on like midday about 4 or 5 O'Clock. That was 200 mg each. It was total of 800mg." The outcome of the events was unknown.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, nausea; headache; fever; exhaustion; muscle and joint aches/pain with 1st and same symptoms with 2nd along with vomiting; diarrhea; runny nose; chest (lung) burning pain
received Hiberix / dose expired; received Hiberix/ patient´s age/ 72; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received Hib (Hiberix) (batch number G4XX7, expiry date 20th May 2021) for prophylaxis.   On 23rd July 2021, the patient received Hiberix. On 23rd July 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient received already expired vaccine at the age of 72 years old, which led to expired vaccine used and inappropriate age at vaccine administration. The health care professional was not sure about the patient's age, mentioned it was 72, although it was explained that that was not the recommended age for the use of the vaccine. The reporter consented to follow up.
The patient received their first AND second Moderna doses before the age of 18. No known adverse effects were known, but I was told by the CDC to fill this form out.
Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. This is 15 of 37, reports on a 59-years-old female. A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 31Jan2021 as dose 2, single, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EH9899) via an unspecified route of administration on 10Jan2021 as dose 1, single for covid-19 immunization at pharmacy. Medical history included ongoing high blood pressure, atrial fibrillation and diabetes. The patient's concomitant medications were not reported. unknown other products. The patient tested positive for Covid virus, after being fully vaccinated on 31Jul2021. The clinical course reported as follows, she stated they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. Caller reclarified later in report that 15% of the breakthrough cases in her county had the same lot number, EN5318, which was concerning. Caller stated, reclarified later in report, she has 37 patients with partial identifiers. Caller stated she cannot provide some identifying details and that she would need to check with her legal department first. Caller provides the details she was allowed to identify. Caller stated unknown or could not provide to other questions. On 31Jul2021, caller stated that covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. The patient underwent lab tests and procedures which included body mass index: 34.9 on an unspecified date, sars-cov-2 test: positive on 31Jul2021. The outcome of events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/AE, different patient
Information has been received from a female patient (who is also a pharmacist) of unknown age referring to herself. The patient's pertinent medical history and concurrent were not reported. No previous drug reactions or allergies were reported. Reproter stated that on 20-OCT-2015, she was preparing a syringe of ZOSTAVAX (dosing details were not reported) (lot # L011537 with an expiry date of 03-JUL-2015) for administration to and unspecified patient, when administering inadvertently splashed some of vaccine "close to or may be into the eye" (accidental exposure to product). Reporter also stated that she flushed her eye with water and that it felt "twitchy". No concomitant medications were reported. The outcome of the event twitching was unknown. Causal relation with ZOSTAVAX was not reported. There was no product quality complaint. Additional information has been requested.
Pt developed swelling and cellulitis of upper arm to mid forearm within 2-3 days of s/c Anthrax. Pt reported no fever but very warm area over the injection site. Pt given antiinflammatory and Tylenol.
Headaches, Fevers /Chills, severe body aches, rapid HR, loss of appetite, vomiting and diarrhea.  Diarrhea for 3 1/2 days, joint pain for 3 days.  Reports completely bedridden on 1/22, was too painful to move.  As of 1/27/10 the patient just has some residual headache.
Had headache/vomiting/facial swelling and facial petechiae day after vaccination. No fever/itch. Given Benadryl and facial swelling improved, petechiae persisted.  No wheeze, no rash to rest of body. Headache resolved after vomiting ended.
runny nose; runny eyes; clammy; chills; nausea; tiredness; sore throat; recieved the Pfizer Covid 19 Vaccine Booster; Her son got the Johnson and Johnson.He wanted to get Pfizer so, he got Pfizer; recieved the Pfizer Covid 19 Vaccine Booster; Her son has a current diagnosis of cancer; This is a spontaneous report from a contactable consumer (Patient's mother). A 49-year-old male patient received BNT162B2 (COMIRNATY) on unspecified date at dose 2 booster single dose for COVID-19 immunization. Medical history included active cancer. Concomitant medications were not reported. Historical vaccine included first dose of Johnson and Johnson COVID-19 vaccine on unspecified date for COVID-19 immunization and experienced Totally panic stricken (got the Johnson and Johnson and he won't go around anyone. He was totally panic stricken). Her son has a current diagnosis of cancer. Caller reporting also on this call that her son recieved the Pfizer Covid 19 Vaccine Booster. He has experienced runny nose, runny eyes, clammy, chills, nausea, tiredness, and sore throat. Caller was initially reporting symptoms her husband had after receiving the Pfizer Covid booster shot. She had mentioned that her son has been having other symptoms. Her son got the Johnson and Johnson and he won't go around anyone. He was totally panic stricken. He knew Johnson and Johnson was not such a hot product, that they had problems. He wanted to get Pfizer so, he got Pfizer. The outcome of the events was unknown. The outcome of the events was Serious was No.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Medication error: vaccines given to 7 patients that were in the freezer, for longer than 2 weeks.; Medication error: vaccines given to 7 patients that were in the freezer, for longer than 2 weeks.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: FA6780) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "Medication error: vaccines given to 7 patients that were in the freezer, for longer than 2 weeks.".  Additional information: The reporter was originally told that the Pfizer BioNTech Covid 19 vaccine, could be kept in the freezer for one month. The reporter states that 09Jun2021, will be one month, that some of the vaccine has been in the freezer. Some vaccine, was given to patients, outside of the recommendations. As of 06Jul2021 (reported as today), the vaccine has been in the freezer for 26 days, at -7 degrees Fahrenheit, but between -18 and -5 degrees Fahrenheit, but it has been 26 days, and it has been given to some patients.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021847153 Same reporter/ AE/ drug, different patient
Swelling at the injection site after 7 days. Spot is warmer than surrounding area and itches
This spontaneous report as received from a medical assistant refers to multiple unspecified patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. Since 28-OCT-2016, on multiple unspecified dates, these patients' were vaccinated with improperly stored doses of M-M-R II (lot # M004063, expiry date 25-JAN-2018) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. On 13-OCT-2016, the vaccine was exposed to the temperature of minimum 9 degree Celsius and maximum 25.5 degree Celsius for 2 hours and 18 minutes. On 28-OCT-2016, the vaccine was exposed to the temperature of minimum 9 degree Celsius and maximum 25.5 degree Celsius for 2 hours and 57 minutes. There were no previous temperature excursions. The temperature excursions were recorded by a data logger. No product quality complaint was involved. This report is linked to case # 1611USA007950, due to same reporter source. Additional information has been requested.
gout flareup in the left heel; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of GOUT (gout flareup in the left heel) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gout. Concomitant products included METHYLPREDNISOLONE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GOUT (gout flareup in the left heel). The patient was treated with METHYLPREDNISOLONE for Adverse event, at a dose of 4 mg. At the time of the report, GOUT (gout flareup in the left heel) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. ON 06-APR-2015 the patient was received a dose of improperly stored LIQUID PEDVAXHIB (lot# reported as K016965, expiration date: 20-JUL-2017, route and dose were unknown). The temperature excursion for LIQUID PEDVAXHIB was supported with in-house stability data. No adverse symptoms reported. Additional information has been requested.
an expired dose of Pentacel was administered; Initial information received on 02-Dec-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old female patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that an expired dose of Pentacel was administered (expired vaccine used).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 02-Dec-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5409AA and expiry date: 10-Oct-2019 via intramuscular route in the right thigh.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Sudden onset of crossed-eyes, stopped progress of speech and regressed in speech, became introverted, cautious and quiet.
The Moderna vaccine injection was placed in the acromion process above the deltoid. The placement was just below the joint of my left arm. Immediate burning/tingling sensation began. I was observed for 15 minutes and sent home anyway.  I could not move my arm for 4 days. The pain level was a 9 out of 10. If I had to move or turn, I involuntarily would cry out in pain. There was no redness, rash or swelling at the injection site. Just intense pain that shot down the left arm to my middle and ring fingers, top of the hand, with pain in my left shoulder blade and mild pain in the left side of my neck. Fatigue and chills started the evening of day 1 and lasted 7 days. The fatigue intensified in day 2 and dissipated on days 5 and 6. No fever was present at any time. On day 2, the nausea started and I vomited twice- the night of day 4 and morning of day 5. Intense headaches with light sensitivity were present from the night of day 3 through day 6. These felt like extreme migraines. These, combined with nausea and arm pain, prevented/interrupted my sleep. I also had loose stools on days 2 and 4.
Having flu like symptoms; Mild muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Having flu like symptoms) and MUSCLE SPASMS (Mild muscle spasms) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Having flu like symptoms) and MUSCLE SPASMS (Mild muscle spasms). At the time of the report, INFLUENZA LIKE ILLNESS (Having flu like symptoms) and MUSCLE SPASMS (Mild muscle spasms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. It was reported that the patient got the vaccine on Tuesday and was still having side effects. No treatment information provided.   Reporter did not allow further contact
Headache, 2 hours Fever, 5 hours Chills, 18 hours Cold sweats, 8 hours Treated with Tylenol
cramping in the arm / arm cramps; sore arm; This case was reported by a consumer via call center representative and described the occurrence of cramp of limb in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced cramp of limb and pain in arm. On an unknown date, the outcome of the cramp of limb was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the cramp of limb and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient experinced sore arm after receiving the first dose that lasted approximately 3 days.  Also reported experiencing cramping in the arm after receiving the first dose, which was ongoing.  The patient stated that their arm cramps when they put it in an unusual position (such as stretching it behind them).  The patient stated that not experiencing any cramping in the arm prior to receiving Shingrix.
hives immune reaction; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious social media case from the non-healthcare professional.  This case involves an unknown demographic patient who experienced hives immune reaction (urticaria), while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious hives immune reaction (urticaria), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, 6 weeks later the patient had recovered from the event.  There will be no information available on the batch number for this case.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Some doses of ZOSTAVAX lot# L006392, exp. 25-MAY-2016 and lot# L003215 exp. 30-APR-2016 (doses were not reported), which were exposed to temperatures outside of the recommended range, have been adminsitered to unspecified patients on unspecified dates since 14-AUG-2015. No adverse experience has been reported. Additional information has been requested. This is one of several reports received from the same reporter.
Rash over much of body. Resembled erythema multiforme but pathology did not confirm.
Information was received on 10-MAY-2017 from a nurse regarding multiple unspecified patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On multiple unspecified dates, multiple unspecified patients were administered doses of ROTATEQ lot # M040271 expiration 30-APR-2018, oral for prophylaxis and RECOMBIVAX HB lot # L048849 expiration 04-FEB-2018, intramuscular for prophylaxis which were improperly stored. No adverse effects were reported. The vaccines were stored between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because of a data logger. No further information was reported. Additional information has been requested.
Pt was given Moderna vaccine prior to being 18 years old. She did not have any adverse effects from the vaccine.
Crusty blood on her nose; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. Medical history included anticoagulant therapy. Concomitant medications were not reported. The patient experienced crusty blood on her nose on an unspecified date with outcome of unknown.   The information on the lot/batch number has been requested.
6 hours of heartburn and nausea which I do not have; bad body aches and persistent fever of 102 degrees for 48 hours; I had Covid-19 in mid November wonder if this is the reason for such violent reaction to vaccination
Patient was administered an expired varicella vaccine. He was notified immediately, NP in office that day was notified immediately. Patient's questions were answered and plans to return to office for second dose of vaccines administered that day. He was advised that he may need a third dose of the vaccine.
Numb toe for 3 days following injection (fourth toe next to pinky) Sore arm Red itchy spot where injection was. 10 days later and injection spot is still red ans itchy.  Worsens when I drink alcohol.  Spotting occurred on the night I got the vaccine and the following 2 nights. I am breastfeeding and haven't had any menstruation besides those 3 days after getting vaccinated.
Pain in joint of arm, shot was given in.  By 5:00PM could not move arm, pain very severe, arm hung like the shoulder had been dislocated.  5:30 PM nausea, lightheadness, sweating, probably from anxiety.  Called CDC for help, advised to wipe injection site with clean damp cloth and use as compress and to take aspirin, Advil or Tylenol.  Also used ice pack.  Pain subsided but could not raise arm above 45 degrees until 4/4/10.  As of 4/6/10 there is still mild pain with motion.
No additional AEs; patient received an expired PNEUMOVAX 23; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot # T017385, expiration date 01-SEP-2021 (route of administration and anatomical location were not provided) for prophylaxis. No additional adverse event was reported.
This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 28-FEB-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger was used.  No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014153.