chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excessive burping.; Experiencedmore serious GI discomfort 3 days; nausea; Body aches; Mild fever; Mild headache; Malaise; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) as a single dose via unspecified route of administration in left arm on 13Mar2021 at 14:00 (at the age of 53-year-old) for COVID-19 immunisation. Medical history included GERD (Gastroesophageal reflux disease). Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) taken within two weeks of vaccination. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since the vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 12:00, the patient experienced mild fever, mild headache, body aches, malaise and typical GERD (Gastroesophageal reflux disease) symptoms of nausea and excessive burping. Experienced more serious GI discomfort 3 days after vaccine but no need to hospitalized. Patient did not receive any treatment for adverse events. The clinical outcome of mild fever, mild headache, body aches, malaise, nausea and excessive burping was recovering. No further information is expected. Information about lot/batch number cannot be obtained.
STOMACH PAIN; HEARTBURN; SWELLING; LEG PAIN; ANKLE PAIN; RASH ON FACE, NECK AND ARMS; FEVER; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stomach pain, heartburn, swelling, leg pain, ankle pain, rash on face, neck and arms, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach pain, heartburn, rash on face, neck and arms, fever, leg pain, ankle pain and swelling was not reported. This report was non-serious.
Itchy rash on stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash on stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported
This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored RECOMBIVAX HB injection 2.5/0.5, lot# K018180, exp. date: 27-SEP-2016 (dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
After receiving the vaccine I had a rash appear within a few hours, the more I scratched it the worse it got. It was all over my arms as well. I applied hydrocortisone and it went away and then a few days later it came back. It was then I decided to see the doctor and they said it was Dermatographia. They also did an allergy test.
Patient had a vasovagal episode.  She stayed sitting in chair, but her head was flexed forward and wasn't taking obvious breaths.  After lifting her head, she took some deep breaths and opened her eyes.  She had similar episodes with fainting.  EMS was called.
feels like her tongue is swelling up; sore throat; chills; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (feels like her tongue is swelling up), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue). On 25-Sep-2021, the patient experienced SWOLLEN TONGUE (feels like her tongue is swelling up) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, SWOLLEN TONGUE (feels like her tongue is swelling up) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown and CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This spontaneous report was received from a nurse and refers to a  20 year old female patient with no medical history and drug reactions or allergies. Approximately in September 1994, the patient was vaccinated with first dose of RECOMBIVAX HB 2.5/0.5 (units not provided) injection (lot#, expiration date, dose, route and site of vaccination were not reported). On 30-NOV-1994, the patient was vaccinated with second dose of RECOMBIVAX HB 2.5/0.5 (units not provided) injection (lot# 612506/0956A, expiration date 27-MAY-1997, dose route and site of vaccination were not reported). On 08-JUL-1995, the patient was vaccinated with third dose of RECOMBIVAX HB 2.5/0.5 (units not provided) injection (lot# 613926/0516B, expiration date 28-JUL-1997, dose, route and site of vaccination were not reported). Concomitant therapies included NASONEX. On 19-MAY-2015, the patient had negative titers. On 20-MAY-2015, as a treatment, the patient received first dose of repeat vaccination series of RECOMBIVAX HB 2.5/0.5 (units not provided) injection (lot#, expiration date, dose, route and site of vaccination were not reported). The outcome of the event was unknown. The patient sought medical attention and saw the physician. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information has been requested.
I was diagnosed with Bell's Palsy. Half of my face began to droop. My right eye watered continuously 3 days after word. I can only smile on the left side of my face. The muscles on the right side of my face simply will not work. I have never had anything like this occur and had no previous sickness in over a year. I am currently being treated with prednisone and valacyclovir.
Mid October, 2023, pt started having left leg/knee pain and swelling.  Was diagnosed with left DVT after office visit 2 weeks later and started on Eliquis for treatment
PFIZER-BIONTECH COVID-19 VACCINE EUA.  ADMINISTRATION ERROR:  It has been discovered that patient received 2nd dose of Covid-19 vaccine too early.  The 1st and 2nd doses are recorded to be given 7 days apart at 2 different nursing facilities.  The patient received the 1st dose on 1/4/21 at a facility.  On 1/11, the patient received a dose at a facility.  Consent form stated no prior doses received.  No adverse events have been reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 at 11:00 as dose 2, single (Lot number: FJ8757) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: I started feeling sick a few days later and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment with Paxlovid.  Additional information: patient had no known allergies.   Information about lot/batch number cannot be obtained. No further information expected.
disorientation; couldn't properly respond/was speaking gibberish; weakness; cough; now she's dealing with fluctuating fever/running a slight temperature; Chills; was physically shaking, like a convulsion; doesn't feel she's completely okay; A spontaneous report was received from a consumer, who was the husband of a 72-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme chills, was physically shaking, like a convulsion (seizure), disorientation, couldn't properly respond/was speaking gibberish (disorganized speech), weakness (asthenia), fluctuating fever/running a slight temperature (pyrexia), cough, and doesn't feel she's completely okay (malaise).   The patient's medical history was not provided by the reporter.  Concomitant medications included acyclovir.  On 12 MAR  2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On the same day, the patient had extreme chills and was physically shaking, like a convulsion where her husband had to hold her up.  On 12 Mar 2021, she experienced disorientation, she couldn't properly respond/was speaking gibberish, and had weakness.  The husband called 911 and a stroke was ruled out.  At the time of the report, the patient was dealing with a fluctuating fever/was running a slight temperature and a cough.  The husband didn't feel she was completely ok.  Treatment for the events included Gatorade and paracetamol.   The reporter considered the events of disorientation and couldn't properly respond/was speaking gibberish to be disabling.    Action taken with mRNA-1273 in response to the events was unknown except for stroke it was resolved.   The outcome of the events of chills, was physically shaking, like a convulsion, disorientation, couldn't properly respond/was speaking gibberish, and weakness were unknown.   The events of fluctuating fever/running a slight temperature, cough, and doesn't feel she's completely okay were considered not resolved at the time of this report.
w/in 5 mins of vax red, warm, pruritic inject site; 5 cm diameter; no systemic problem; rx'd DPH;
Patient with rash that developed on buttocks 2 days after recieving Moderna Vaccine in left deltoid.
Patient was administered Fluad 65+ when the patient was not 65+. Patient was contacted regarding the error. Patient reported no complications at the time of contact. Patient was advised to contact the pharmacy office if any issues arise.
After 5 minutes of moderna 1st shot administration, pt was feeling very dizzy. Pt was breathing ok. BP was low 104/75mmhg, but said her BP is usually little lower than 120/80. Pt felt ok after 20 min. We called 911. Paramedics  checked her vitals and everything was normal. Pt was able to go with her husband
Suddenly developed AFib; difficulty breathing; large buildup of fluid in my lungs; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Lot number: UNKNOWN) as single dose for COVID-19 immunisation; metoprolol tartrate, via an unspecified route of administration from an unspecified date to an unspecified date, at 50 mg, 2x/day for an unspecified indication; apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date to an unspecified date, 2x/day for an unspecified indication. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced suddenly developed afib, difficulty breathing, large buildup of fluid in my lungs. The patient reported the course of the events as follows: Within 6 weeks after receiving the 2nd Pfizer C19 shot I suddenly developed AFib. I've never had heart problems and all of a sudden I had difficulty breathing. Dr prescribed large doses of Furosemide because of large buildup of fluid in my lungs. I am still on Eliquis 2x a day and 50 mg of Metoprolol 2 x a day. The patient inquired Have there been other patients develop AFib after receiving 2nd shot of Pfizer C19.The action taken in response to the events for metoprolol tartrate and apixaban was unknown. Therapeutic measures were taken as a result of large buildup of fluid in my lungs. The clinical outcome of the events was unknown.  Pfizer is a marketing authorization holder of [Metoprolol Tartrate] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Metoprolol Tartrate] has submitted the same report to the regulatory authorities.  Information about lot/batch number has been requested.
This case was reported by a consumer interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had a shot of Shingles vaccine and had shingles which were terrible. The patient was ready to take 2nd one. The follow-up could not be possible as no contact details were available. Note: Case was conservatively kept valid case it was not clear if the patient experienced shingles before or after administration of 1st dose.
He was in his usual state of good health. 5 days after receiving the vaccine, he complained of brief unilateral shoulder pain (unclear to family which shoulder), which the family attributed to a musculoskeletal source. No chest pains, shortness of breath, or palpitations. He was playing with 2 friends at a community pond, swinging from a rope swing, flipping in the air, and landing in the water feet first. He surfaced, laughed, told his friends "Wow, that hurt!", then swam toward shore, underwater as was his usual routine. The friends became worried when he did not re-emerge. His body was retrieved by local authorities more than an hour later.
Moderna COVID-19 Vaccine EUA 1h15min after injection - inital symptom of sweating without chills or fever,  2hr after injection - significant episode of atrial fibrillation, flutter, and PVCs for approx 90 minutes.  I have a history of a-fib which was successfully treated in 2008 with a PVI, this is only the second episode since that treatment
This is a spontaneous report from a contactable physician. A 42-year-old non pregnant female physician received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK4176 and expiry date was not reported), via intramuscularly, in Arm Left, on 12Jan2021 at 11:00 AM (age at vaccination: 42-years-old), as dose 2 single for COVID-19 immunization. The patient's medical history included mild asthma. Concomitant medications included LO LOESTRIN FE. The patient was allergic to anesthetic. The patient did not receive any other vaccine within four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via intramuscularly, in Arm right, on 22Dec2020 at 3:00 PM as dose 1 single for COVID-19 immunization. On 12Feb2021, the patient developed severe right neck/shoulder pain radiated to arm x1.5 weeks, then as pain subsided developed weakness of long thoracic nerve and anterior deltoid, EMG/NC study showed low amplitude of long thoracic nerve. The patient did not receive any treatment for adverse events. On an unspecified date, the patient underwent lab tests and procedure which included EMG/NC study showed low amplitude of long thoracic nerve and on 07Apr2021, the patient underwent SARS-CoV-2 test (Nasal Swab) which showed negative results. Outcome of the event was not recovered.  Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
pt recv vax 26MAR96 & 28MAR96 pt exp abn platelet count;No further details were provided;
The patient had an immediate swelling of the injection site. The patient denied any pain. Slight redness noted. Vital signs were within normal limits. The patient had no respiratory symptoms. After waiting twenty minutes, the swellin began to subside. Dr. saw the patient and instructed him to come back if the swelling progesses, it becomes painful, or if he has any symtpoms of an allergic reaction.
This spontaneous report as received from a female consumer of unknown age refers to herself. On an unknown date, the patient ws vaccinated with a dose of M-M-R II (route, lot # and expiration date were not provided). On an unknown date, the patient experienced an unspecified allergic reaction after receiving the M-M-R II. The outcome of allergic reaction was unknown. The relationship between therapy with M-M-R II and the event was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Did have a reaction when he was vaccinated, it was not severe and he was fine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Did have a reaction when he was vaccinated, it was not severe and he was fine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Did have a reaction when he was vaccinated, it was not severe and he was fine). At the time of the report, IMMUNISATION REACTION (Did have a reaction when he was vaccinated, it was not severe and he was fine) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
2/27/21 7 pm, started getting chills, then 2/28 had chills, Ha, fever, fatigue, was 101. 8 F, also injection site soreness and skin knot
Initially, patient developed right arm pain at the injection site, then left arm pain. Pain began radiating across his back. He developed a severe headache and The next AM developed weakness. All symptoms worsened Through the day. Parent called at 6 pm on 11/23/2020 with concerns of all symptoms worsened and leg weakness, inability to stand. He was recommended to go to the nearest emergency department. He was told he had a reaction to the Bexsero vaccine and went home. He is reportedly feeling better today on 11/24/2020.
Information has been received from a nurse referring to a 10 year old patient of unknown gender. On 12-FEB-2015, when the patient was indicated for her/his second dose of (Oka/Merck) VARIVAX, she/he was vaccinated with a dose of ZOSTAVAX injection, 0.5 ml (lot number and expiry date were not reported), subcutaneously. The reporter stated that she withdrew 0.5ml from the vial for injection and gave to the patient, but not the 0.65ml as per ZOSTAVAX dosage recommendations. No adverse experience reported. Additional information has been requested.
Chest Pain/pressure  rapid heart rate w/ palpitations elevated blood pressure elevated d dimer suspected pericarditis onset: 8/31 resolution on going
My upper left arm was so painful that I have to stop immediately when I move my left arm in certain direction.And it?s getting worse that now even when I try to put on my coat this would happen.
t106;lifeless, high pitched cries earlier, vomit, diarrhea, stiff body lasted 6 days;
allergic reaction 1 week after 1st dose; swelling in the mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (allergic reaction 1 week after 1st dose) and MOUTH SWELLING (swelling in the mouth) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction 1 week after 1st dose) and MOUTH SWELLING (swelling in the mouth). At the time of the report, HYPERSENSITIVITY (allergic reaction 1 week after 1st dose) and MOUTH SWELLING (swelling in the mouth) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  It  was reported that a patient received his 1st and 2nd dose of the primary series from Moderna COVID-19 Vaccine, and 2 booster shots of J&J vaccine. Patient reported an allergic reaction (swelling in his mouth) 1 week after his 1st dose of the primary series was given, but no AEs after the 2nd dose of the Moderna vaccine. HCP mentioned that patient previously reported his case to Moderna, but HCP did not have a case number, and did not want to provide additional details on the case.  No treatment information was provided.   Reporter did not allow further contact
LEFT UPPER ARM PAINFUL, HOT TO TOUCH, RED FROM SHOULDER TO ELBOW; NO FEVER.  PCP  IS PATIENT'S DAUGHTER, AND GAVE RX ANTIBIOTIC FOR PROBABLE CELLULITIS AND CONDITION IMPROVED AFTERWARD.