chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIGH TEMPERATURE OF 100.2; 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 09-MAR-2021 for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 14-MAR-2021, the subject experienced high temperature of 100.2. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high temperature of 100.2. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment is not required per standard   procedure as the case includes non-serious event.
Child received ROTATEQ #1 on 5-27-08.  Started with loose stools 5-28-08.  Stool sent out + for rotavirus.
Pt experienced pain, swelling and redness. Admitted to hospital for IV, antibiotic therapy and observation.
felt dizzy; and fell down to the floor; having slight hypotension at 110-112/70; fatigue; felt very dehydrated; and she fainted; left upper arm pain; This case was reported by a consumer via call center representative and described the occurrence of faint in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 13th August 2020. For the tolerance of 1st dose, refer linked case US2020AMR221163.). Concurrent medical conditions included hypertension.   On 29th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 29th October 2020, less than a day after receiving Shingrix and between 2 and 3 weeks after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm. On 30th October 2020, the patient experienced faint (serious criteria GSK medically significant), dizziness, fall, hypotension, fatigue and dehydration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the faint, fall, hypotension, fatigue and dehydration were unknown and the outcome of the pain in arm was recovered/resolved and the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the faint, pain in arm, dizziness, fall, hypotension, fatigue and dehydration to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient had left upper arm pain for about 4 days.  When the patient woke up in the morning the next day on 30th October 2020, she felt dizzy and she fainted and fell down to the floor and her husband assisted her back up. The patient was taking medication for hypertension and her healthcare professional advised her to stop taking her blood pressure as she was having slight hypotension at 110-112/70 on 30th October 2020 and 31st October 2020 and she restarted her blood pressure medication on 01st November 2020.   The patient had not resumed her exercises as she had fatigue. She continued to be had dizziness every alternate day, she had dizziness on the day of reporting.  The patient stated on 30th October 2020, she felt very dehydrated and drank about 24 ounces of water. The patient received a flu vaccine two weeks prior to the 2nd dose of the Shingrix vaccine. She did not know the name of the flu vaccine. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221163:same reporter
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26May2021 10:00 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2020 (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Keflex, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown, Anatomical site: Left arm), administration date: 05May2021, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 29May2021, outcome "not recovered", described as "Tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) from unknown date and indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
expired TENIVAC was accidently given to a patient with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 37 years old female patient and expired tenivac was accidently given to a patient with no reported adverse event while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On 03-Oct-2022, the reporter stated patient received a dose of expired tenivac with standard strength at a dose of 0.5 mL total (Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test )(lot number: C5779AA; expiry date : 02-Oct-2022) via intramuscular route in the left deltoid for Immunization) was accidently given to a patient with no reported adverse event (expired product administered) (latency :same day).  It was reported reporting an expired TENIVAC was accidently given to a patient. She states that the expiration was on 02Oct2022 and wondered if it was still valid only being given hours after expiring.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
Thursday at noon felt nauseas after waking up, went to bathroom, became sweaty, hot. Woke up laying on bathroom floor, unknown how long was out for. Fainted at least twice. First faint resulted in deep laceration on chip and broken tooth due to fall.
pt recv vax & p/vax it was noted that the glass vial which had contained the rota shield lyophilized pellet was chipped & that the pt had sustained a scratch on the gum;
cramp in her left thigh; pain in her chest; Chills; headache; Fever; muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramp in her left thigh), CHEST PAIN (pain in her chest), CHILLS (Chills), HEADACHE (headache) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), PYREXIA (Fever), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). On 10-Mar-2021, the patient experienced CHEST PAIN (pain in her chest). On 11-Mar-2021, the patient experienced MUSCLE SPASMS (cramp in her left thigh). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (cramp in her left thigh), CHEST PAIN (pain in her chest), CHILLS (Chills), HEADACHE (headache), PYREXIA (Fever), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.            Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 and contains non-significant information. Updated email and address of the reporter
Severe gi issues. Tests run - normal.  Found out later from medical doctor that studied covid that gi issues are rather common with the vaccine.   Then,  I got covid!!
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot#L026553, expiration date 16-JUL-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022) in a 42-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. It was unknown if other vaccines were given on the same day as Moderna COVID-19 Vaccine to the patient. It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.     On 17-Feb-2022 at 3:18 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 17-Feb-2022 at 3:18 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the MFG expiry date of 04-Apr-2022. No treatment medications were provided.   This case was linked to MOD-2022-542869 (Patient Link).
Patient had received Flu vaccine on 02/22/21 and there should have been 14 day period between his COVID19 Vaccine and Flu shot. Patient got COVID19 Vaccine on 02/25/21
Developed a fine bright red macular rash on face, neck, arms, chest, back and thighs resembled a sun burn.   Palms of hands and ears were cherry red.   Skin felt warm to touch but no Temp. No itching.  No difficulty breathing. No enlarged lymph nodes. Treated with Benadryl which resolved some of the redness, but it reoccurred within 6 hours. Seen at facility told to continue on Benadryl or Claritin.
Severe body aches especially neck and back pain, nausea/vomiting, severe headache unrelieved by over-the-counter medication, light sensitivity, fatigue, severe injection-site pain, chills with low-grade fever (99.8F). Symptoms listed began approximately 18 hours after 2nd COVID-19 vaccine was given and lasted until 48 hours after vaccine was administered.
Fever, cough, respiratory difficulties interfering with sleep, runny nose, hoarse cry. Ongoing for 5 days at time of notification. Received phone call regarding what to do about infant's ongoing symptoms.
patient received pfizer covid-19 dose 3 on 17Nov2021 and FLU vaccine also on 17Nov2021; patient received pfizer covid-19 dose 3 on 17Nov2021 and FLU vaccine also on 17Nov2021; dose number 3; Very sore arm; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: FF8841) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer,, Previous dose brand unknown: False,, Previous dose lot number: EP-6955,, Previous dose lot unknown: False,, Previous dose administrator route: Intramuscular, Previous dose administration date: 01Apr2021, Previous dose number: 2, Previous dose Vaccine location: Left arm), administration date: 01Apr2021, when the patient was 41 years old, for Covid-19 immunization; Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer,, Previous dose brand unknown: False,, Previous dose lot number: EL3247,, Previous dose lot unknown: False,, Previous dose administrator route: Intramuscular, Previous dose administration date: 11Mar2021, Previous dose number: 1, Previous dose Vaccine location: Left arm), administration date: 11Mar2021, when the patient was 41 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "dose number 3"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "recovered", described as "Very sore arm"; PAIN (non-serious) with onset 17Nov2021, outcome "recovered", described as "Body aches"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 17Nov2021, outcome "unknown" and all described as "patient received pfizer covid-19 dose 3 on 17Nov2021 and FLU vaccine also on 17Nov2021". Therapeutic measures were not taken as a result of pain in extremity, pain.  Additional information: Facility type vaccine: Workplace clinic. Other vaccine in four weeks: No. It was reported that patient had no COVID prior vaccination nor been tested for COVID post vaccination. Known allergies, other medical history: NA.  Follow-Up (24Nov2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 08-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degree C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
PT PRESENTS WITH SHAKING, NUMBNESS IN ALL EXTREMITIES, HEADACHE, DIZZINESS, AND FEVER.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed generalized chickenpox mainly on the trunk and face and less on the extremities. It was indicated that some of the rash had blistery centers.
Itchy rash on thigh; Hives on chest, breast, on both arms, ears, and face; Fire ants crawling all over/ itchy and painful; Itchy and painful; Face is flush; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on thigh), URTICARIA (Hives on chest, breast, on both arms, ears, and face), PAIN (Fire ants crawling all over/ itchy and painful), PRURITUS (Itchy and painful) and FLUSHING (Face is flush) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Drug allergy (cleocin). Concomitant products included TRIAMTERENE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on thigh), URTICARIA (Hives on chest, breast, on both arms, ears, and face), PAIN (Fire ants crawling all over/ itchy and painful), PRURITUS (Itchy and painful) and FLUSHING (Face is flush). The patient was treated with PREDNISONE at a dose of 10 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LEVOCETIRIZINE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash on thigh), URTICARIA (Hives on chest, breast, on both arms, ears, and face), PAIN (Fire ants crawling all over/ itchy and painful), PRURITUS (Itchy and painful) and FLUSHING (Face is flush) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
male in his early twenties with no allergies and no pertinent medical history, who on an unspecified date in February 2005 was vaccinated intramuscularly with a second 1ml dose of Hepatitis B virus vaccine.  There was no concomitant medication.  It was noted that 10 minutes after the vaccination, the patient arms, from his elbows to his hands, turned bright red and started itching.  The patient sought unspecified medical attention.  The reaction fully resolved in one hour and the patient recovered.  There were no laboratory studies performed.  No further information was available.  There was no product quality complaint reported.  Followup information received on 09/12/2005 indicated that the vaccine given to the patient was not Recombivax HB.  There was no information regarding what company's vaccine it was.  There is no further information.
76 y/o man with a history of CAD s/p 3 way CABG in 1998 and hx of "heart murmur" and hx of PAF with new onset of  associated with new atrial flutter with rate in the 40s.  Interestingly strongly associates the timing with 3rd dose of COVID vaccine (felt perfectly fine, quite active before dose #3, this started abruptly after dose #3)  In clinic with bradycardia, self reports hypoxia on RA with exertion, pitting 2+ edema BLE,
Client given adult dosage 1CC IM of Hep A vaccine instead of Pediatric dosage of 0.5 cc no adverse reaction noted at time of injection, no reactions reported at this time.
Severe pain over the whole body, swelling of left upper arm with dark red coloring and irritating itchiness, weakness - 6 days.
It was like I had a severe earache & I couldn't hear very good it was like swimmers ear so I went to dr. & was put on antibiotics.
I have become tired all the time.  No treatment yet. Outcome will eventually be falling asleep while driving and harming myself and/or someone else.
Presented 10/7/13 with left elbow pain and swelling, warmth, consistent with acute bursitis/cellulitis. Treated with cephalexin 500mg BID and MEDROL dose pack.
increasingly weak; tired; sleepy; nauseous; not hungry; This is a spontaneous report from a contactable consumer (patient). A 74-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9269, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 08Feb2021 at 11:00 hours, as dose 1, single (at the age of 74-years-old) for covid-19 immunisation. Medical history included myalgic encephalomyelitis (ME), Chronic fatigue syndrome (CFS) and penicillin allergy (all from an unknown date and unknown if ongoing). Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination. Since vaccination, patient had not been tested for COVID-19. Concomitant medication(s) and other medications in two weeks included atorvastatin, liothyronine (NP Thyroid), multivitamin and calcium (all taken for an unspecified indication, start and stop date were not reported). Historical vaccine included patient took tetanus vaccine and had allergy to tetanus vaccine. Patient was ok for first few days. On 10Feb2021 at 09:00 hours, patient was increasingly weak, tired, sleepy, nauseous and not hungry. Patient had no treatment for all the events. The outcome of all the events was not recovered.   Follow-up attempts completed. No further information expected.
Two weeks after the vaccine I began to experience pain in my upper right arm and breast. I found inflammation under my arm. The inflammation was coming from my lymph nodes.
Per pt, area of injection site was "sore" and "red, itchy, warm to touch" and the sensation radiated into biceps area the following days after the injection, but resolved after several days/weeks.
I had a breakthrough case of Covid-19 had a sore throat, cough, congestion and fever. It was a mild case and I was prescribed PAXLOVID and benzonatate, zinc and AIRBORNE.