chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches all over her body/everything hurt/Felt like she got hit by a truck after the first shot, achy all over; general malaise/she didn't feel like doing anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 (Lot number: EL8982) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rotator Cuff Tear" (unspecified if ongoing), notes: happened before the she got the shots, Old injury coupled with a new injury (6-8 months ago); "Rheumatoid Arthritis" (unspecified if ongoing); "headaches and aches and pains" (unspecified if ongoing); "headaches and aches and pains" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for rheumatoid arthritis, start date: 03Mar2021 (ongoing); ADVIL [IBUPROFEN] taken for headache, pain; TUMS ANTACID. Past drug history included: Keflex, reaction(s): "Allergy to Keflex", notes: had an unusual rash, in a prickly heat type of rash over her body (1982-1983 after a mischarge). Vaccination history included: Flu shot (got it along time ago before she got married), for immunization, reaction(s): "got deathly ill". The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches all over her body/everything hurt/Felt like she got hit by a truck after the first shot, achy all over"; MALAISE (non-serious), outcome "unknown", described as "general malaise/she didn't feel like doing anything". Additional information: Patient had no Prior Vaccinations (within 4 weeks). Patient said that she was told not to take a anti-inflammatory even though you feel like crap and you want to. She said that she just kind of laid there and just binged watched some TV.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021340952 same patient/SD/event, different dose
Dizziness; Loose muscles in my legs; Tingling in my right hand; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MUSCLE ATROPHY (Loose muscles in my legs) and PARAESTHESIA (Tingling in my right hand) 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 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced DIZZINESS (Dizziness), MUSCLE ATROPHY (Loose muscles in my legs) and PARAESTHESIA (Tingling in my right hand). At the time of the report, DIZZINESS (Dizziness), MUSCLE ATROPHY (Loose muscles in my legs) and PARAESTHESIA (Tingling in my right hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
This spontaneous report as received from a nurse refers to a 5 year old patient of unknown gender. On 14-SEP-2014, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (Lot # J014152 exp 07-NOV-2015) (dose and route not reported). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Severe headache, fatigue and chills that lasted 24 hours, moderate headache, chills and mild nausea still continue after 72 hours.
Patients daughter called in to pharmacy stating that patient was claiming of a swollen elbow (elbow appears purple). The area where the shot was admistered is not painful.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 22nd June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 23rd June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. On 24th June 2018, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were recovering/resolving. The reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient experienced swelling and soreness at the injection site and about 2 inches below the injection site. No emergency room or doctor visit was required.
This spontaneous report as received from a pharmacist refers to a 68 year old male patient. The patient's concurrent conditions, concomitant medications, drugs reactions and allergies were not reported. The patient received PREVNAR in January 2016. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. On an unspecified date in April 2017, reported as "last week", the patient was hospitalized for an unknown reason. The pharmacist was not sure if the patient received PNEUMOVAX 23 in the hospital. The pharmacist was unable to obtain record of vaccination from the hospital. The outcome of the event that caused hospitalisation was unknown. The relatedness between the event and PNEUMOVAX 23 was not provided. Additional information has been requested.
She reported feeling dizzy. Assisted by EMS onto cot, monitored for additional 30min. No further complications. Symptoms resolved spontaneously w/o medical intervention. She stated she felt better and was going home.
Patient reports she has autoimmune disorders, lupus, rosacea and others.  She's reporting that since getting the vaccine she has not felt well, had chills, myalgia, joint pain- woke up feeling worse "hit like a truck", still can barely get out of bed and still feels this way.  She states she is declining and canceling coming back for second dose.
-Rash (Day after shot) -Hoarseness, cough (1-2 days after) -Fever (101.6 F; 10 days after) -Swollen Glands (7-10 days after)
couldn't breathe; Severe sinus blockage rt. side; constant sneezing (50 times); Severe headache going down into jaw and teeth; Severe headache going down into jaw and teeth; watery eyes; couldn't sleep; Diarrhea; Right sinus and head started hurting; It hurts into her jaw and that makes her teeth ache; Right sinus flare ups; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration in Arm Left on 27Feb2021 14:00 (age at vaccination:72 Years) as DOSE 1, SINGLE for covid-19 immunisation (at hospital. Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received Rosuvastatin 5mg and Alprazolam 0.5mg within 2 weeks vaccination. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for arteriosclerosis from Feb2021 and ongoing; alprazolam (ALPRAZOLAM) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported. Patient didn't had covid prior to vaccination. On 28Feb2021 14:00 the patient experienced couldn't breathe on 28Feb2021 14:00 with outcome of recovered with sequelae, severe sinus blockage rt. side, constant sneezing (50 times), severe headache going down into jaw and teeth, severe headache going down into jaw and teeth, watery eyes, couldn't sleep, diarrhoea, right sinus and head started hurting, it hurts into her jaw and that makes her teeth ache, right sinus flare ups. Patient had Emergency room visits for the events. No Therapeutic measures were taken for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Mar2021 covid test type post vaccination: Nasal swab. The outcome of the events dyspnoea, sinus congestion, sneezing, headache, pain, lacrimation increased, insomnia, diarrhoea, sinus pain, pain in jaw, sinusitis was recovered with sequela.  No follow-up attempts are needed. No further information is expected.
temperature excursion that was intermittent beginning 7/28/2020 involving PROQUAD states that there have been administered doses; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  Since 28-JUL-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) had intermittent temperature excursion between a temperature of minus 14 degrees Celsius to -10C (max -9.5C) for 38 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion.  On 21-AUG-2020, the patient was administered an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T009929, which has been verified to be valid, expiration date reported and validated as 16-SEP-2021) as prophylaxis (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014709: US-009507513-2008USA014811:
Ten minutes after receiving the vaccine started to feel hot; sweating; nauseated; and dizzy. At that time the doctor evaluated client was found blood pressure and heart beat were WNL. Since 01/16 client has had the following symptoms: nauseous, dizzy,  fatigue, fever, sweating intermittently on a daily basis.
Collapsing glomerulopathy; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHROPATHY (Collapsing glomerulopathy) in a 67-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHROPATHY (Collapsing glomerulopathy) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHROPATHY (Collapsing glomerulopathy) outcome was unknown. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: glomerular disease Biopsy-proven glomerular disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHROPATHY (Collapsing glomerulopathy) to be related.    No concomitant and treatment medication were reported.  The patients with collapsing glomerulopathy were of this descent and had two APOL1 genomic risk alleles.  Company Comment: This literature-non-study case concerns a 67-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of collapsing glomerulopathy (biopsy-proven glomerular disease) after administration of the second dose of the Moderna mRNA-1273 vaccine. The start date of the event was not provided. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2022-539890, MOD-2022-539891, MOD-2022-539892, MOD-2022-539893, MOD-2022-539894, MOD-2022-539895, MOD-2022-539896, MOD-2022-539897, MOD-2022-539898, MOD-2022-539899, MOD-2022-539900, MOD-2022-539901, MOD-2022-539902, MOD-2022-539903.; Sender's Comments: This literature-non-study case concerns a 67-year-old, female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of collapsing glomerulopathy (biopsy-proven glomerular disease) after administration of the second dose of the Moderna mRNA-1273 vaccine. The start date of the event was not provided. No further details were provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Patient received dose of vaccine that was not diluted properly, diluted with .18ml diluent rather that 1.8ml.  Administered 0.3ml dose to patient, however does was more concentrated than should have been. Peds doctor of the day Dr. consulted.  She spoke with Peds infectious disease Dr. who said no additional concern for reaction or side effects, no additional monitoring or follow-up required.  Patient should receive second dose as scheduled.  Parent informed of extra concentrated dose given.   No adverse effects or reaction noted.
Vaccine that was draw up into the syringe on 14Apr2021 @ 214pm, syringe was left out over night and administered today 15Apr2021; This spontaneous case was reported by a nurse and describes the occurrence of MEDICATION ERROR (Vaccine that was draw up into the syringe on 14Apr2021 @ 214pm, syringe was left out over night and administered today 15Apr2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 8:06 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MEDICATION ERROR (Vaccine that was draw up into the syringe on 14Apr2021 @ 214pm, syringe was left out over night and administered today 15Apr2021). On 15-Apr-2021, MEDICATION ERROR (Vaccine that was draw up into the syringe on 14Apr2021 @ 214pm, syringe was left out over night and administered today 15Apr2021) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Pre-drawn syringe left at room temperature for over 12 hours was then administered.
16 days after receiving vaccine - developed petechiae & mild cold symptoms - resolved 22 days after vaccine given (plt - 146).
This spontaneous report as received from a pharmacist refers to an 8 week old female patient. On 19-AUG-2013 the patient was vaccinated with "about half" of a dose of ROTATEQ (lot number unspecified) orally. The patient then vomited immediately following the administration. The outcome of adverse event was unknown. The patient did not seek medical attention. Additional information has been requested.
This spontaneous report was received from a medical assistant, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 with lot number M032635 and expiration date on 05-MAY-2018 (strength, dose, route of administration or anatomical location were not provided) for prophylaxis; which was reconstituted with a properly store sterile diluent (manufacturer unknown). The storage temperatures were 47 to 77 degrees Fahrenheit (°F) (47 °F) for a time frame of 21 minutes and 6 to 14 degrees Fahrenheit (°F) (9°F) for 42 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. As of 25-AUG-2017, all telephone attempts to obtain follow-up information have been unsuccessful.; Sender's Comments:  US-009507513-1708USA013008: US-009507513-1707USA005187: US-009507513-1708USA013010: US-009507513-1708USA013011: US-009507513-1708USA013012: US-009507513-1708USA013013: US-009507513-1708USA013006: US-009507513-1708USA013005: US-009507513-1708USA013007:
Initial report received from patient's parent on 08/15/2005.  An 18 year old female patient with a medical history of exercise induced Asthma, had received a subcutaneous injection of Menomune, lot number unknown, in July 2004.  Four to six hours later, the patient developed a stiff neck and back and a fever.  Her hands and feet became extremely swollen and the skin peeled off of them.  As per the reporter, the patient recovered from these events.
had the "usual side effects", aches and pains; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (parent) reported that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that her daughter (patient) who is a nurse experienced the "usual side effects", aches and pains on an unspecified date after her second dose. The patient took ibuprofen as treatment. The reporter's healthcare professional (HCP) told her not to take any ibuprofen because it reduces effectiveness of the vaccine. The reporter wanted to know if it was true. Outcome of the event pain was unknown.  Information on the lot/batch number has been requested.
Pt recvd 3 doses of Hep B vax 27NOV90, 28JAN91 & 27APR91 & 20DEC91 it was determined that the titer was neg; reporter indicated that a booster dose would be given;
Low grade fever, chills, body aches, some tiredness Tylenol, switching to Advil Fluids, cold packs, sleep
Client started feeling of dizziness.  Fire Fighters first responded.  Client presented hypotension, but recuperated by the time of release.  Client was released to his home at 9:18 am.
No adverse event; Caller is medical assistant reporting administered doses of improperly stored vaccines; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # U006485, has been verified to be a valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [rHA] [M-M-R II], expiration date reported and upon internal validation established as 26-FEB-2023) (dose, anatomical location, route of administration, lot#, and expiration date were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U002400, has been verified to be a valid lot number for varicella virus vaccine live [oka/merck] [VARIVAX], expiration date reported and upon internal validation established as 22-JAN-2023) (dose, anatomical location, route of administration, lot#, and expiration date were not reported). Both vaccine doses were given as prophylaxis and were improperly stored (Product storage error) on 20-JUL-2022 as following: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II): Above 8 Celsius degrees (°C) (8.8C) for 1 hour 27 minutes and 0 seconds; above 8C (8.5C) for 6 hours 39 minutes and 0 seconds; above 8C (8.8C) for 8 hours 45 minutes and 0 seconds; above 8C (10.7C) for 11 hours 42 minutes and 0 seconds; above 8C (9.83C) for 18 hours 48 minutes and 0 seconds; above 8C (9.5C) for 14 hours 10 minutes and 0 seconds; above 8C (9.0C) for 9 hours 24 minutes and 0 seconds and varicella virus vaccine live (oka/merck) (VARIVAX) at a temperature of -14°C up to -10°C (-13.1C) for 18 minutes and -14°C up to -10°C (-11.9C) for 21 minutes. The vaccines did not have previous temperature excursions.  No additional adverse events were reported.
Hard knot (L) upper arm at inj. site. Had chills, fever, nausea, dizziness at 8-10 hrs. after receiving inj.
they saw other weird things with the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (they saw other weird things with the vaccination) in a female patient of an unknown age 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 VACCINATION COMPLICATION (they saw other weird things with the vaccination). At the time of the report, VACCINATION COMPLICATION (they saw other weird things with the vaccination) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up information received was contain no new information.; Sender's Comments: Non-serious Case
Got my flu shot...still got the flu; Initial information received on 22-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves adult patient with an unknown gender patient who experienced got my flu shot...still got the flu while receiving vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease, or risk factor. The patient's medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number, dose, expiry date, frequency, formulation, strength was unknown) via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious got my flu shot...still got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event got my flu shot...still got the flu.
Expired Drug Used; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA462A, expiry date 31st October 2021) for prophylaxis.   On 25th February 2022, the patient received Menveo. On 25th February 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Menveo, which led to expired vaccine used. The reporter did not consent to follow-up. The PQC was ruled out because it was discovered the wholesaler provided the expired product to the healthcare professional recently.
My mom never told me she got both vaccines. We all came for a funeral 2 weeks after she got her second dose. She is normally active and energetic but  she was very lethargic and tired. Her heart was racing and her pulse was low. She literally  started contemplating death and planning her funeral. She said this was the worse she had felt in years! Possibly ever! She didn't though thank God.  It took her a couple months and heavy supplements to get back close to normal.
Approximately 8 days after receiving the vaccine the upper arm became sore and there are several red blotchy areas on the upper arm.  The red blotchy areas are sore when you lightly press on them.