chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID test result after full vaccination series; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID test result after full vaccination series) in a 36-year-old female patient who received mRNA-1273 (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (COVID test result after full vaccination series). At the time of the report, COVID-19 (COVID test result after full vaccination series) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 antibody test positive: unknown (Positive) positive.     For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications include  berry syrup. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-100431 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100431:Husband's case crosslinked
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Tingling in left arm and hand/fingers, numbness in hand.  Constant first 2 weeks then intermittent.  Still occurring intermittent (a couple hours a day). Had second shot 4/26
The day after vaccination, patient state that the injection site started to itch almost immediately after injection. He state that injection site itched all evening but had stopped itching by morning.
Information has been received from a physician concerning a 6-12 week old patient who was vaccinated orally with a first dose of ROTATEQ. On an unspecified date the patient experienced bloody stools. The patient sought unspecified medical attention. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Upon internal review, "bloody stools" was considered an other medically important event (OME). This is one of several reports received from the same source. Additional information has been requested.
night sweat; arm little red; little warm; injection site was little bit red/redder; Feverish/98 on my forehead/102 in my arm; injection site was tender; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site was tender), INJECTION SITE ERYTHEMA (injection site was little bit red/redder), NIGHT SWEATS (night sweat), PYREXIA (Feverish/98 on my forehead/102 in my arm) and FEELING HOT (little warm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE PAIN (injection site was tender). On 13-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site was little bit red/redder) and PYREXIA (Feverish/98 on my forehead/102 in my arm). On 15-Mar-2021, the patient experienced FEELING HOT (little warm) and ERYTHEMA (arm little red). On an unknown date, the patient experienced NIGHT SWEATS (night sweat). At the time of the report, INJECTION SITE PAIN (injection site was tender), INJECTION SITE ERYTHEMA (injection site was little bit red/redder), NIGHT SWEATS (night sweat), PYREXIA (Feverish/98 on my forehead/102 in my arm) and FEELING HOT (little warm) outcome was unknown and ERYTHEMA (arm little red) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Pyrexia: 98 (Inconclusive) temperature for my forehead: it was 98 something degrees. and 102 (Inconclusive) in my arm it was 102..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included "supplements" for an unknown indication  No treatments were reported.
Diarrhea 2d after Rotavirus, abdominal pain, possible intussusception. Sent to ER.
EXPIRED JANNSEN COVID-19 VACCINE ADMINISTRATION AT 10:15 AM; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-JUN-2021 10:15 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUN-2021, the subject experienced expired jannsen covid-19 vaccine administration at 10:15 am. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired jannsen covid-19 vaccine administration at 10:15 am was not reported. This report was non-serious.
woozy, poor balance; extreme weakness and stiffness; slipped off bed--unable to bend joints.  Extreme muscle rigidity.  Flare-up of M.S. symptoms and UTI.
Patient presented with large red rash covering 90% of upper arm. Inflammation of the area was noticed.  Patient has been taking Ibuprofen to help with pain as well as OTC Hydrocortisone.
My asthma took a turn for the worse. I have had more headaches than I have had before. I am also more tired. My ability to focus has also decreased. I went to the doctor regarding my asthma. I was prescribed an allergy medication to deal with the asthma opposed to another inhaler. It has been a few days so I have not noticed a difference yet.
RPH  GAVE VACCINE ON THE 3RD WEEK INSTEAD OF GIVING IT 4 WEEKS AFTER THE 1ST DOSE.
At midnight patient reports aching, sore muscles, and blood pressure spikes. Patient felt like coming down with a virus and did not have fever. Patient couldn't go back to sleep and stayed on recliner all night. Symptoms started easing up about 12 hours later. Patient had a headache and took TYLENOL. Patient did not call the doctor. Patient was too tired the rest of the day to be active. Patient still has soreness on arm both sides. Patient mentioned that she had shingles in her right eye on 2012 and took ZOSTAVAX.
This spontaneous report was received from a nurse referring to herself as approximately 60 year old female patient No pertinent medical history and concurrent conditions reported. On 16-JUN-2014 the patient's husband was vaccinated with ZOSTAVAX, subcutaneous (dose not reported). No other concomitant therapies reported. The reporter suspects that she has contracted shingles from her husband. On 07-JUL-2014 the reporter developed pustules which spread to her forehead, her ear, her thigh and currently she is beginning to developed pustules on trunk region. The patient had secondary transmission. The patient did not sought medical attention. The patient also stated that her husband did not develop rash nor he experienced any adverse effects after receiving ZOSTAVAX. The outcome of the events was unknown. The causality of the events was unspecified. No PQC reported. The reporter accepted VZVIP to be faxed to her physician. Additional information has been requested.
The patient received an inadequate dose of the Pfizer vaccine.  This error was due to a vaccinator preparing the vaccine by reconstituting with an unspecified amount (possibly 1.5ml) of diluent and drawing up 0.15ml of vaccine to be administered.  After realizing the vaccine error, a corrected repeat dose was administered per the CDC Interim Recommendations for COVID-19 Vaccine Administration Errors and Deviations.   Patient was observed for the 15-minute period without any adverse reactions.
the arm and the finger gets cramps, and now on it's neck too; wakes up during the night.; each day the situation its bigger, not in size but the pain is increased.; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (the arm and the finger gets cramps, and now on it's neck too), INSOMNIA (wakes up during the night.) and MYALGIA (each day the situation its bigger, not in size but the pain is increased.) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (the arm and the finger gets cramps, and now on it's neck too), INSOMNIA (wakes up during the night.) and MYALGIA (each day the situation its bigger, not in size but the pain is increased.). At the time of the report, MUSCLE SPASMS (the arm and the finger gets cramps, and now on it's neck too), INSOMNIA (wakes up during the night.) and MYALGIA (each day the situation its bigger, not in size but the pain is increased.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided .  No treatment medications are provided .
This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 17-year-old female patient who received BEXSERO (batch number 151301D, expiry date 31st December 2016). Co-suspect products included MENVEO (batch number U5390AA, expiry date 12th September 2017). On 18th October 2016, the patient received BEXSERO and MENVEO. On 18th October 2016, 5 hrs after receiving BEXSERO and MENVEO and less that a day after receiving MENVEO, the patient experienced swelling arm, vaccine administered at inappropriate site and labeled drug-drug interaction medication error. On an unknown date, the outcome of the swelling arm was not recovered/resolved and the outcome of the vaccine administered at inappropriate site and labeled drug-drug interaction medication error were unknown. It was unknown if the reporter considered the swelling arm to be related to BEXSERO and MENVEO. Additional details were provided as follows: The case was previously reported to Doctor. The age at vaccination was not reported. The patient received unknown dose of BEXSERO on right deltoid and experienced swollen right arm.
patient began feeling like her lips were swelling; This non-serious case was reported by a consumer and described the occurrence of lip swelling in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number F59KR) for prophylaxis.   On 16-OCT-2023, the patient received Arexvy. On 19-OCT-2023, 3 days after receiving Arexvy, the patient experienced lip swelling (Verbatim: patient began feeling like her lips were swelling). The patient was treated with prednisone. The outcome of the lip swelling was not reported.   It was unknown if the reporter considered the lip swelling to be related to Arexvy.   It was unknown if the company considered the lip swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-OCT-2023 The patient received Arexvy vaccine. The reporter stated that 2 days later had swollen lips and they continued to swell and the patient visited an urgent care facility,who gave her prednisone to combat the swelling. The reporter wanted to know if the vaccine had a preservative and was it Thimerosal.
on way to work pt had chills, nausea, vomited & had diarrhea; pt called MD who stated was having a react to the medicine; next morning pt felt better, but not good enough to go to work;
101.5F fever; chills; headache day after injection; This is a spontaneous report from a contactable consumer (patient).    A 33-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198), at single dose in left arm on 08Mar2021 at 12:45 pm (at 33 years) for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included omeprazole, cetirizine hydrochloride (ZYRTEC) and amlodipine , all  taken for an unspecified indication, start and stop date were not reported. Previously on 15Feb2021 at 12:30 PM (at 33 years) patient took the first dose of the vaccine (lot EL9267) in left arm for COVID-19 immunization. On 09Mar2021 the patient experienced 101.5F fever, chills, headache. No treatment given. Patient recovered from the events in Mar2021. No follow-up attempts are possible. No further information is expected.
Headache, Nausea, body ache, fever to 103F, chills.
Patient had her second dose of the H1N1 vaccine on Saturday, Jan. 9, 2010. On Wednesday, Jan. 13, she had her 1st seizure while waking from a nap lasting 20 seconds. Called EMT. Back at home with hospital telling us they did not think it was a seizure because blood work came back normal. At 11:00 PM same day, within 2 minutes of falling asleep, second seizure,this one lasting 2 minutes and stopped breathing. Gave her CPR and called EMT. Was transferred up to Hospital. On the way up, at 3:30 AM in the ambulance, she fell asleep for 1 minute and had third seizure. EMT administered adavan to settle her down. At hospital she had EEG, MRI and Cat Scan which all showed normal conditions.  She was put on Keppra and has not had seizure since.
patient had previously received Pfizer vaccine and requested Pfizer booster but received Moderna booster. patient was informed vaccine card corrected and correct vaccine reported to registry
after 12 hours my fever increased to over 101.  Took 24-36 hours to return to normal.  had headaches, brain fog for up to 14 days.  Brain fog slowly improved day 7-14.  Reported it to my primary when I had the fever.  Primary was in the  network.
Approximately 5 minutes after receiving the FLUAD vaccine, patient began experiencing a rash on the left hand and wrist and feeling dizzy. Patient reported the rash to remain the same within one hour after vaccination and slight improvement in dizziness with no other symptom.
Day 1: extreme fatigue all day and night. Day 2: slight fatigue, extremely sore left arm. Day 3: no more fatigue, left arm slightly less sore. Day 4: continuing soreness, but to a lesser degree. Itchiness. Day 5: Soreness gone, but swelling, itchiness, small patch of rash or hives around injection site. Day 6: Swelling still apparent, spreading rash or hives with a strange band of lighter skin going around the arm just below injection site. Less itchy. Hives responded to Blemish Stick. The redness left, but returned a few hours after application.
Patient received 1st dose of vaccine elsewhere (not within our healthcare system). She received 1st dose of Pfizer.  Attended Hospital clinic for 2nd dose, where she was given Moderna vaccine.  Both vaccines were being given at the clinic on that date, with separate lines for each vaccine. Vaccinator said "send dose of Moderna today" to the patient, which the patient didn't confirm, deny, or question. Only after the Moderna dose was administered was it realized that the patient was there for a Pfizer vaccine.
Pt states that after getting JEV vaccine earlier in the day on 2 Jul 18 he noticed that night that he had bruising about 3-4 inches above the injection site. Pt was seen in clinic today by a provider and was diagnosed with thrombophlebitis. Pt was told to follow up if the Sx didn't resolve.
This spontaneous case, initially received on 12-Oct-2016, was reported by a non health professional and concerns a 55-year-old female patient. Weight: not provided; Height: not provided. Past medical history included sensitivities to some meds. The patient has no known allergies. Drug history includes the flu shot (reaction: shivering, feeling like she was going to pass out). Administration of company suspect drug(s): The patient received AFLURIA for influenza vaccination from 10-OCT-2016 to 10-OCT-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT56707. No additional suspect drugs. Adverse reactions/events and outcomes: On 10-Oct-2016, the patient experienced a rapid pulse (120 pounding out of her chest for 5-10 minutes and then went down), 3 or 4 episode of dizziness, numb lips and chin, shakiness and shivering uncontrollably. The patient went to the ER (Emergency Room) on 10-Oct-2016 and was given antihistamine. The patient states she does not have hives or anything. Symptoms resolved after receiving IV (intravenous) diphenhydramine, took 40 minutes after treatment to resolve. All events: medically significant, outcome: recovered / resolved, stop date: 10-Oct-2016). Sender's Comments: Company comments: Listedness: Assessment according to the agency for CSL's Inactivated Influenza Virus Vaccine, rapid heart rate and all other events are unlisted. Chills is listed. Causality: Related. Time to event onset is same day following vaccination. Events suggest an autonomic reaction to vaccine. Causality is considered related to Influenza vaccination due to temporal association and no other triggers reported.
The second dose, he had a little bit less the first couple of days achy muscles, 11 days now since that shot and today he is starting to feel very nauseated, achy muscles again, headache, chills; The second dose, he had a little bit less the first couple of days achy muscles, 11 days now since that shot and today he is starting to feel very nauseated, achy muscles again, headache, chills; The second dose, he had a little bit less the first couple of days achy muscles, 11 days now since that shot and today he is starting to feel very nauseated, achy muscles again, headache, chills; The second dose, he had a little bit less the first couple of days achy muscles, 11 days now since that shot and today he is starting to feel very nauseated, achy muscles again, headache, chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 27May2021, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient previously was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021, as a single dose for COVID-19 immunisation and had achy muscles, headache, nausea and even a little bit of the blurry vision. It was reported that patient and reporter both received the Pfizer vaccine, they received first dose on 05May2021, and the second one on 27May2021. On 27May2021, after the second dose, the patient had a little bit less the first couple of days achy muscles but it then, they are going on 11 days, since that shot and today, he started to feel very nauseated, achy muscles again, headache, chills. The reported asked "Is that a normal thing even after 11 days after the shot. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested
Received expired vaccine beyond the 30 day refrigerator shelf life; Received expired vaccine beyond the 30 day refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Received expired vaccine beyond the 30 day refrigerator shelf life) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received expired vaccine beyond the 30 day refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Received expired vaccine beyond the 30 day refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that 6 patients received expired Moderna COVID-19 vaccine, from 05 May 2022 through 23 May 2022. 3 patients received first booster, 1 patient received a second booster, 2 patients received 2nd primary dose. 1 patient received on 05-May-2022, 1 patient on 06-May, 1 patient on 18-May, 2 patients on 19-May, and 1 patient on 23-May-2022. On 30-Mar-2021 the vial was initially stored in the refrigerator and was administered to the patient on 06-May-2022. The vial did not undergo any temperature excursion.  No treatment medication reported.