chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Pharmacist reports that they administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home. Pharmacist's stated that the beyond the use date is 09Dec2021 at 10:00PM and they administered the vaccine from 10Dec2021-13Dec2021.
vertigo, double-vision, vomiting, sweating, high blood pressure (170/100)
Pt tested + for Covid  1 day after vaccine and a 4 days later was coughing up blood with no hx of pulmonary problems.  Feeling entirely well prior to receiving vaccine.  Non-smoker.
"cognitive fog"  Five days after 2nd Moderna shot, I started to work at my computer, and, in my brain, I felt like I was swimming through molasses. For 2 days after, the "fog" lessened. Since then, no change: not worse and not better.
SORE THROAT; FELT LITTLE SLOWER THAN NORMAL; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced felt little slower than normal. On 14-APR-2021, the subject experienced sore throat. Laboratory data included: Body temperature (NR: not provided) 99.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt little slower than normal on 07-APR-2021, had not recovered from body aches, and the outcome of sore throat was not reported. This report was non-serious.
Tingling in Hands and Feet Blood Pressure Spike Nausea Cramping Dizziness / Lightheaded
The morning of 3/2 around 4AM - abdominal cramps with nausea (vomited once), achiness, headache,  fever (100.4) and chills.  Felt better by the end of the day.  Much better the next day.
patient reported on 03/06/2021 she developed arm soreness that lasted for one day/ patient reported on 03/09/2021 she developed high fever, headache, chills that lasted for one day. patient reported on 05/15/2021 she developed fever, chills, and headache.
After the vaccine was administered I experience aching joints and nausea. I had to stay in bed 2 days. My appetite has decreased since that time and I have not bad a BM. My cycle came around 7/3/13, and it was backwards in its flow. Last night I experienced numbness in my legs and when I attempt to eat something I get nausea. I contacted the County Registrar.
First shot 6/9/21, started noticing symptoms by 6/26/21, day I helped someone move and was feeling lightheaded/tired/weird. Got second shot 7/1, severe onset of symptoms started setting in a couple weeks later. I had what felt like gas, pressure in my abdomen, fatigue, anxiety. By the beginning of August I could not walk up the stairs without being out of breath. Third week in August I was waking up in the middle of the night and couldn't breathe. Assumed these were panic attacks and that I was just sick with something. I spent the following three weeks doing very little, bedridden waiting for it to pass. The last week in August I was getting bruising all over. The first week in September I swelled up, swollen feet, calves, and thighs. I finally went to the Dr., ordered x ray and blood work. She called me an hour later and told me to immediately go to the ER.
noticed welt on left arm, very itchy; Noticed welt on left arm; lips kinda tingled; achiness since date of injection, barely noticeable; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lips kinda tingled), PAIN (achiness since date of injection, barely noticeable), PRURITUS (noticed welt on left arm, very itchy) and VACCINATION SITE URTICARIA (Noticed welt on left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PARAESTHESIA ORAL (lips kinda tingled) and PAIN (achiness since date of injection, barely noticeable). On 07-Jan-2021, the patient experienced PRURITUS (noticed welt on left arm, very itchy) and VACCINATION SITE URTICARIA (Noticed welt on left arm). On 30-Dec-2020, PARAESTHESIA ORAL (lips kinda tingled) had resolved. At the time of the report, PAIN (achiness since date of injection, barely noticeable), PRURITUS (noticed welt on left arm, very itchy) and VACCINATION SITE URTICARIA (Noticed welt on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment details were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that unknown number of doses of (Oka/Merck) VARIVAX (0.5 ml, subcutaneous ) that had been exposed to 18 degrees F for 14 hours were administered. Pertinent medical history and concomitant medications were unspecified by reporter. No adverse effect reported. The outcome of the events was unknown. No other information was available. This is one of several reports received from the same source. Additional information has been requested.
sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was been updated as adult as per vaccine indication. The reporter stated that, the patient's arm was sore immediately the next day after vaccination. This case has been linked with case US2019118444, reported by the same reporter.
chills; a low temperature; This is a spontaneous report from a contactable consumer (patient's son) from a Pfizer-sponsored program, Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 25Jan2021 02:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that his father (patient) had the first shot yesterday (25Jan2021) at 2:30 and ran some chills and has a low temperature on Jan2021. The outcome of the events was unknown.  Information on batch/lot number was requested.
Patient vaccinated with Pfizer vaccine 12/21/21 and 1/11/2021. He was diagnosed with Covid on 8/8/21 and admitted to the hospital on 8/16/21. He received casirivimab-indevimab on the morning prior to his admission. Double organ transplant patient on immunosuppression.
This case was reported by a medical assistant to a sales representative and described the occurrence of allergic reaction in a 4-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis.  The medical assistant reported that, "recently (on an unspecified date on or before 07 February 2006), the child had been started on rice and vitamins (Unknown, non manufacturer)". On 07 February 2006 the subject received 1st dose of Pediarix. On 07 February 2006, the subject was also vaccinated with 7-valent pneumococcal conjugate vaccine (Prevnar) and Haemophilus influenza type b conjugate vaccine (ActHib). On 09 February 2006, 2 days after vaccination with Pediarix, the subject experienced sweating and redness of the ears, urticaria, " a rash from the shoulders down", swollen ears and hands. The subject was seen at a physician's office on 10 February 2006 and was diagnosed with an allergic reaction and noted to have "no fever".The subject was treated with diphenhydramine hydrochloride (Benadryl). The events resolved on an unspecified date on or before 15 February 2006. The medical assistant considered the events to not be related to vaccination with Pediarix and "could have possibly been related to the vitamins and the rice".
Anaphylaxis. Within 15 minutes of Varivax administration, patient developed cough. Patient was given Benadryl, then within the next 15 minutes patient developed wheezing/hives and pulse ox decrease from 100% to 94%. Given Xopenex Nebulizer treatment, PO Prednisone and SQ Epinephrine with good response. Observed times 2 hours, home on nebulizers/Benadryl and Orapned. 02/06/07-records received and reviewed for DOS 01/31/2007 Left office after receiving varivax. Started coughing, complained chest hurting, returned to office. Coughing, negative wheeze, negative hives. Pulse Ox 100%/ Treated with Benadryl. Cough continued, wheezing Pulse ox 94%, scattered hives trunk and neck, swollen eyelids. Given 0.25ml SQ epi 1:1000 and oragned ODI, topenix neb treatment. Improvement. Patient observed for 2 hours. Negative for wheezing. Coughing stopped. Hives resolved with mild eyelid edema. Lungs CTA. Negative for hives. DC to home.
Hard,painful, hot to the touch, egg sized knot @ injection site. Fever up to 100.8, chills, body aches,generalized weakness headache,nausea, loss of appetite,24hrs after received vaccine.Today is my 4th day, symptoms are a little better.
On 11/13/21 Patient was given a Moderna Booster (0.25mL) Lot# 077C21B.  Patient was supposed to get the 3rd dose as he is active for Lung Cancer tx.  Provider contact patient and patient came in on 12/16/21 and received his 3rd Dose (0.5 mL) Lot #067H21A.
Could not raise the arm for several days; swelled up, twice the size of a normal arm; It was so red from the top of the shoulder down to the elbow, wrapped all the way around; Had a bad reaction; she did not feel it when she was given the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not raise the arm for several days), PERIPHERAL SWELLING (swelled up, twice the size of a normal arm), APPLICATION SITE ERYTHEMA (It was so red from the top of the shoulder down to the elbow, wrapped all the way around), LIMB DISCOMFORT (Had a bad reaction) and SENSORY LOSS (she did not feel it when she was given the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical history details was provided.  Concomitant products included METOPROLOL, DOXYCYCLINE and DIAZEPAM for an unknown indication, NSAIDS.   On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced SENSORY LOSS (she did not feel it when she was given the vaccine). On an unknown date, the patient experienced MOBILITY DECREASED (Could not raise the arm for several days), PERIPHERAL SWELLING (swelled up, twice the size of a normal arm), APPLICATION SITE ERYTHEMA (It was so red from the top of the shoulder down to the elbow, wrapped all the way around) and LIMB DISCOMFORT (Had a bad reaction). On 02-Jul-2021, SENSORY LOSS (she did not feel it when she was given the vaccine) had resolved. At the time of the report, MOBILITY DECREASED (Could not raise the arm for several days), PERIPHERAL SWELLING (swelled up, twice the size of a normal arm), APPLICATION SITE ERYTHEMA (It was so red from the top of the shoulder down to the elbow, wrapped all the way around) and LIMB DISCOMFORT (Had a bad reaction) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   Patient was taken tiny amounts of the Moderna Covid-19 Vaccine at different intervals to check for an Anaphylactic reaction.  she had a bad reaction 7 days after receiving the first dose of the vaccine, she got COVID arm, it was unbelievable. She was questioning if she got any effectiveness from the vaccine. Also wanted to knowif Moderna has heard of someone that had a severe reaction to the first dose of the vaccine and no reaction with the second dose. She stated she was unknow if she was Vaccinated.   NSAIDs Concomitant product use was provided.   Treatment information was not  provided.
This spontaneous report as received from a nurse refers to a 4 month old male patient. On 22-JUN-2017 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot# M031802, expiration date 09-NOV-2017, oral) for prophylaxis. It was reported that the refrigerator was out of temperature range. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Patient inadvertently received vaccine after published expiration date. Moderna analyzed batch/lot# 007B21 and advised vaccine maintained activity needed to protect against COVID-19 on date of administration. Also patient did not call in to complain of adverse event. This is administrative error without adverse event.
Approximately 12 hours after receiving the vaccine, I experienced fever, chills, headache, muscle aches, fatigue and nausea. Most of these symptoms lasted about 48 hours but the fatigue lingered another day or two. Approximately 5-6 days after receiving the vaccine, my urine was a brownish color and stools a light grayish color. Stools returned to normal color after 48 hours, but my urine seemed to be off-color for at least a few more days.
Fever of 101, headache, lethargy, nausea which has lasted for 2 days, treated with Advil.The fever has gone down but the lethargy and nausea remains.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored VAQTA lot # N020689 expiry date 22-OCT-2018 for prophylaxis. The medical assistant reports that the details of the excursion are unknown as they are due to a shipping issue. No adverse effects reported. No additional information provided. Temperature and time frame was unknown by reporter. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1801USA008116.
Pain in legs, beginning 10 days or so, post vax. Gradually becoming worse; unbearable by mid November; feet numb; no paralysis. Treated with prednisone and Neurontin.  Diagnosed with autoimmune peripheral neuropathy. Doc 212685, annual follow up states that patient has numb feet and problem with balance.  Follow up 06/20/2001: "Patient has not recovered from adverse event.  1981: Hypothyroidism, prescribed Syntroid-stable.  Patient did not receive any prior similar conditions before this adverse event. Other immunizations for influenza was 10/19/1999.  Final diagnosis if GBS has not been made.  Diagnosis changed from GBS to chronic inflammatory demyelinating polyneuropathy after biopsy. Consents for release of medical records and hospital discharge summary will be signed and returned to VAERS."
After receiving dose 1 of the Moderna COVID19 vaccine on 4/6/2021 I suffered a heart attack (MI) on 4/21/2021.
Bright red hives in 2 spots on upper right arm (one at injection site, one additional spot below the injection site that is not connected to the red spot at the injection site), warm to the touch. Increasing in size. Skin is itchy. No fever or headaches.
Under 18 years of age; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient never had COVID-19 test or diagnosis and did not took other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient's concurrent medical condition includes Blood pressure.  The patient's past medical history included Mitral valve replacement (15 years ago). Concurrent medical conditions included Drug allergy (Beta blockers (some)), Diabetes, Cholesterosis, Heart disorder and Glaucoma. Concomitant products included WARFARIN SODIUM (JANTOVEN) for Anticoagulant therapy, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for Blood pressure management, METOPROLOL SUCCINATE for Cardiac disorder, SIMVASTATIN for Cholesterosis, GLIMEPIRIDE for Diabetes, LATANOPROST and BRIMONIDINE for Glaucoma.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Jan-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On 27-Jan-2021, DIZZINESS (Dizziness) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient stated that AE did not cause patient to seek medical care and patient did not experienced similar events in the past. Patient also stated that due to a mitral valve issue that was diagnosed about 15 years ago she was put on blood thinners once she had the surgery for the mechanical heart valve. Recent status was reported as Stable. Due to this issue, her doctors have categorized her as a high risk patient. She had an increased chance of getting serious infections for even smaller infections like sinus.  No treatment medication information was provided.   This case was linked to MOD-2022-540353, MOD-2022-540288 (Patient Link).
Initial information received on 10-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 35 years old male patient was vaccinated with an expired 0.5 ml dose of MENACTRA (lot UI828AA and Exp. Date 08-Apr-2018) on 10-Dec-2018 in the left deltoid. The patient's past medical history, vaccination(s) and family history and concomitant medications were not provided. It was a case of actual medication error due to expired vaccine used. The nurse gave the patient an expired MENACTRA vaccine. It was unknown whether the patient had any adverse reactions. 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. List of documents held by sender: none.
asking any guidelines on repeat use for Paxlovid; asking any guidelines on repeat use for Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prescriber prescribed the patient Paxlovid 3 times in the past year. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "asking any guidelines on repeat use for Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Call was transferred from Medical Information Department Transferring agent stated, "I do have (redacted) (Further not clarified by the reporter. Hence, capture as consumer or other non health professional by default) on hold. Her first name is (name withheld), I think that was the spelling of (name withheld) (Not clarified with the reporter) and her last name is (name withheld). So, she was reporting, the product is for the Pfizer Covid-19 vaccine Bivalent, the adult formulation. She was reporting that a patient got the Pfizer bivalent vaccine instead of primary series and she also mentioned, the patient never had a vaccine yet." When requested to repeat the concern, Transferring agent stated, "She mentioned that the patient got the Bivalent instead of the primary series and also mentioned the patient never had the vaccine yet (Captured as unspecified vaccine). The next product was for Paxlovid, she mentioned that, there is a prescriber prescribed the patient Paxlovid 3 times in the past year and he is trying to prescribe it again (Event captured conservatively as per the verbatim). When paraphrased the concern: Transferring agent stated, "It is correct, so this the 4th time, that the prescriber gave or prescribed Paxlovid for this patient. That is all the information that I have and the caller disconnected the call already." Call back was done. However, it was unsuccessful as ther was a IVR response.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events drug ineffective and COVID 19  and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201398131 Same reporter, same product, same patient, different event;
Patient stated she developed a rash @ forehead and upper chest the next day after receiving the MMR vaccine . Patient stated went to a dermatologist , being treated with cortisone .  Provider noted multiple papules @ forehead and upper chest , no redness, no oozing