chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received first dose of Pfizer Covid-19 vaccination today at 1502. While in the post vaccine observation area pt expressed that she felt nauseous. Vital signs obtained at 1512 at follows: BP 112/75, HR 83, O2 Saturation 97%, RR 18. After moving pt to separate area pt states, "I haven't eaten today and I normally get nauseous when I take medicine". Pt given a granola bar and encouraged to drink water. Pt stated she felt better at 1520 and at 1525 she was escorted out of the clinic by clinical staff
Myalgia, Fever, Abdominal Pain, Neuropathy of hand and feet, fatigue Narrative:
diarrhea for a week due to which she could not leave the house; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea for a week due to which she could not leave the house) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A, 025L20A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DIARRHOEA (diarrhea for a week due to which she could not leave the house). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. In February 2021, DIARRHOEA (diarrhea for a week due to which she could not leave the house) had resolved.            No relevant concomitant medications were reported.
Weakness; Pain on the right arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain on the right arm) and PYREXIA (Fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 031L20A and 010M20A) for COVID-19 vaccination.     No Relevant Medical History was provided.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT FORTE), SALBUTAMOL (ALBUTEROL HFA), LISINOPRIL, FUROSEMIDE, CARVEDILOL and HYDRALAZINE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain on the right arm) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain on the right arm) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not  provided.  Nebulizer (4 treatments per day)   was used as Concomitant medication.   This case was linked to MOD-2021-307454, MOD-2021-307413 (Patient Link).
pt recv vax 9AM 20FEB97 & mom states pt broke out in hives approx 8PM 20JUL97;pt was seen by ARNP rx w/DPH;mom instructed to give DPH until sx subside;
itching at injection site; swelling at injection site; hot to touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE WARMTH (hot to touch at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038k20A and 013l20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and CLONAZEPAM (KLONOPIN) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE WARMTH (hot to touch at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE WARMTH (hot to touch at injection site) was resolving.
This spontaneous report was received from a pharmacist refers to a 71 year old female patient. Patient's pertinent medical history was not reported. Patient was reported to be allergic to penicillin. On 04-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency, therapy route unspecified; lot # K008882, expiration date: September 2014). Concomitant medications were not reported. On 06-DEC-2014, the patient experienced injection site reaction described as red, swollen, itchy, burning and the size of a tennis ball. The patient sought medical attention. On 07-DEC-2014, patient visited emergency room and was treated with BENADRYL, TYLENOL and cold compress. Outcome of injection site reaction described as red, swollen, itchy, burning and the size of a tennis ball was reported as recovering. No product quality complaint (PQC) was reported. No insertion and removal related events (IRRE) were reported. Reporter Causality assessment was not provided. Additional information has been requested.
Chest pain relieved by nitroglycerin per EMS.    Non-ST elevation MI
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported a similar event for two patients. This is the first of two reports. A female patient of an unspecified age and race received for immunization TRUMENBA  via an unspecified route of administration on an unspecified date at single dose and other unknown vaccines.  The patient medical history and concomitant medications were not reported.  The patient fainted after being vaccinated.  The patient recovered quickly with no further complications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017081612 same reporter/suspect product/AE, different patient.
Big Lump under left arm. Swollen and painful; Big Lump under left arm. Swollen and painful; Big Lump under left arm. Swollen and painful; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 (Lot number: 33030bd) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose product: COVID 19, Previous dose brand: Pfizer , Previous dose brand unknown: False, Previous dose lot unknown: True, Previous dose lot unknown reason: Misplaced/discarded, Previous dose dose number: 2, Previous dose vaccine location: Left arm), for Covid-19 Immunization; Bnt162b2 (Previous dose product: COVID 19, Previous dose brand: Pfizer, Previous dose brand unknown: False, Previous dose lot number: 33030BD, Previous dose lot unknown: False, Previous dose dose number: 1, Previous dose vaccine location=Left arm), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "Booster"; MASS (non-serious), PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 02Jan2022, outcome "not recovered" and all described as "Big Lump under left arm. Swollen and painful". Therapeutic measures were not taken as a result of mass, peripheral swelling, pain in extremity.  Additional Information: other vaccine in four weeks reported as no. Ae resulted in reported as none of the above. covid prior vaccination and covid tested post vaccination reported as no.  No follow-up attempts are possible. No further information is expected.
Pt felt dizzy, saw spots, unable to lift arms because of weakness. This happened 3 times, each for about 45 minutes to 1 hour on 03/22/2000 at 9:30 AM, 4:30 PM, and 8:30 PM. On 03/23 she complained of a headache. Given one dose of Tylenol.
Crippling migraine; Light sensitivity; pain; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Crippling migraine), PHOTOPHOBIA (Light sensitivity), PAIN (pain), VOMITING (vomiting) and NAUSEA (nausea) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 03-Jun-2021, the patient experienced MIGRAINE (Crippling migraine), PHOTOPHOBIA (Light sensitivity), PAIN (pain), VOMITING (vomiting) and NAUSEA (nausea). On 04-Jun-2021, MIGRAINE (Crippling migraine), PHOTOPHOBIA (Light sensitivity), PAIN (pain), VOMITING (vomiting) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by reporter. No treatment information was provided by the reporter.
lymphedema and other issues worse since getting covid shots; lymphedema and other issues worse since getting covid shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization.   The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: Living With Cancer 14 year cancer survivor.; "lymphedema" (ongoing), notes: Have been dealing with lymphedema. The patient's concomitant medications were not reported.  The following information was reported: LYMPHOEDEMA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "lymphedema and other issues worse since getting covid shots".  Additional information: The patient never got or do blood pressure in left arm. Lymphedema and other issues worsened since getting covid shots. The patient would never do the shots and/or boosters again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt. experiencing tingling to the L. leg and warmth throughout the body.  pt. advised to wait an additional 15 mins.
received 1st dose in January 2020 / not received 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but was selected as an adult as per vaccine indication.  The patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
recieved the first Shingrix vaccine was on 7/22/19 and the second dose of the vaccine one 10/17/19. He got the shingles the end of February of this year 2020; He got the shingles the end of February of this year 2020; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number LD3NH, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number N9LG3, expiry date 12th November 2021) for prophylaxis.   On 17th October 2019, the patient received the 2nd dose of Shingrix. On 22nd July 2019, the patient received the 1st dose of Shingrix. In February 2020, between 4 and 5 months after receiving Shingrix and between 7 and 8 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccionation with Shingrix, the patient experienced shingles at the end of February 2020. The reporter did not know if this was first case of shingles or not. The reporter consented to follow up.
presented to hosp p/prolonged crying, lethargic hypoactive & pale; adm overnite hydrated w/IV fluids-cultures & labs neg;
I got this shot about 10;00 am and by 5:00 pm started having bad aching in left arm. Also bad headache in back right side of head. as the evening progressed I had body aches, sore throat, scratchy voice and lungs feeling like they were tight and harder to breath. Next day I started coughing a hard tight cough. If I had a fever it was slight. I also experience stiff sore neck mussels. These symptoms lasted for the best part of four days at which time I returned to the doctor to see what went wrong. He thought most of it was a coincidental viral infection. The worst part was the headache that lasted for 4 days. Tylenol helped reduce the ache but not completely.
7 days later redness and itching below site of shot ... continued to worsen .... and now being treated with antibiotics... ( as cellulitis)
PT DEVELOPED ACUTE PAIN AT SITE DAY OF INJECTION.  CELLULITIS DIAGNOSED 48 HOURS AFTER VACCINATION. ADMITTED FOR IV ABX DUE TO SLOW RESPONSE TO ANTIBIOTICS 8/1/08-records received for DOS 07/04-07/08/2008-DC DX: Right arm cellulitis s/p vaccination. Developed fever, chills, body aches, nausea and pain at injection site with 24 hours of vaccination. Pain over entire right arm.  Pain at injection site with erythema, induration and fever secondary to immunization reaction. Immunology outpatient appointment.
Within 3 hours of receiving the injection on 12/16/2021, I felt "pins and needles" from fingers to shoulder in the vaccinated arm. This briefly extended upwards to include the side of my neck, jaw and cheek on this same side. Although the ?pins and needles? dissipated after 2 hours, I developed numbness from elbow to fingertips, generalized weakness in my wrist and hand, finger tremors and a loss of sensation with impaired fine motor control. A tender area in the middle of my forearm felt bruised, and although the skin in that area showed no difference in color or temperature,  I felt a sharp shooting pain whenever the area was touched. I believe these symptoms were neuropathy.   By 12/19/2021, the neuropathy disappeared with the exception of the forearm bruise/shooting pain, but I then began to experience chest tightness and shortness of breath which increased in response to minimal exertion and worsened at night. By 12/20/2021, I recognized these symptoms as the same that I had suffered when I had mild childhood asthma (from around age 4 to 19) and had needed to use a rescue inhaler. However, for the past 15 years my asthma has been completely resolved, and prior to the Pfizer vaccine I was a healthy, active, physically fit 34-year-old who enjoyed hiking, aerobics, dancing, etc. without any breathing issues.  On 12/20/2021, I had a doctor visit which resulted in a diagnosis "shortness of breath" and "adverse effect of vaccines and biological substances", caused by the Pfizer vaccine, and a prescription for an Albuterol rescue inhaler. I used this rescue inhaler for a week but my breathing difficulties did not improve at all.  On 12/27/2021, I had another doctor visit with a pulmonologist who diagnosed me with moderate adult asthma and prescribed Advair Diskus. I began taking Advair that day but by 1/10/2022 I was still suffering from asthma. A second visit with the pulmonologist resulted in a prescription for Trelegy Ellipta, a stronger inhaler for asthma. To this day I am still experiencing asthma that was caused by the first dose of the Pfizer vaccine.
Information has been received from a pharmacist who is also the patient's sister via a company representative, concerning a male patient of unknown age. The patient's concurrent conditions included diabetes. The patient's historical conditions included hospitalisation. No drug reactions or allergies were reported. On an unspecified date in approximately November 2015 (reported as one year ago), the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. The day following the vaccination, the patient was more sick (malaise) that when he was in the hospital (unknown date). The patient also developed cough the day after receiving PNEUMOVAX 23. No product quality complaint was involved. The outcome of malaise and cough was unknown at the time of reporting. The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Elevated A1C; COVID arm; Sick for like 3 weeks; Knot in her arm for 3 weeks; COVID arm with swelling; Fever; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Nov2021 15:00 (Lot number: FH8027) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing); "obesity" (unspecified if ongoing); "prediabetic" (unspecified if ongoing), notes: she has been prediabetic for several years now. She said her numbers were at a 6 for several years. There were no concomitant medications. The following information was reported: GLYCOSYLATED HAEMOGLOBIN INCREASED (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Elevated A1C"; LIMB DISCOMFORT (non-serious) with onset 09Nov2021, outcome "unknown", described as "COVID arm"; ILLNESS (non-serious) with onset 09Nov2021, outcome "recovered" (Nov2021), described as "Sick for like 3 weeks"; NODULE (non-serious) with onset 09Nov2021, outcome "recovered" (2021), described as "Knot in her arm for 3 weeks"; PERIPHERAL SWELLING (non-serious) with onset 09Nov2021, outcome "unknown", described as "COVID arm with swelling"; PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "Fever". The events "elevated a1c", "covid arm", "sick for like 3 weeks", "knot in her arm for 3 weeks", "covid arm with swelling" and "fever" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A caller stated that she had her first dose of covid adult vaccine on 08Nov at her left arm. She had COVID arm with swelling, she had a fever and was sick for like 3 weeks. She had a knot in her arm for 3 weeks. She went to the doctor, and he checked her blood work. Her A1C levels were elevated was the only thing he could find. They have been monitoring it for the last 5 years. She is calling about the COVID vaccine. The first dose was on 08Nov2021, given in her Left arm, around 3pm. Her second one was given 30Nov2021 with lot FF2593, in her left arm, around 2pm. She didn't get it for any particular reason. After the first dose is when she experienced all of these side effects. Her A1C is still elevated. 54-year-old female said she has been prediabetic for several years now. She said her numbers were at a 6 for several years. Then after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, her A1C levels became elevated. Patient wants to know if this is normal.  No follow-up attempts are possible. No further information is expected.
Flushing of the face; Muscle ache in the body; Headache; Itchy feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 40-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FLUSHING (non-serious), outcome "unknown", described as "Flushing of the face"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache in the body"; HEADACHE (non-serious), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "Itchy feeling". Additional information: patient is calling about side effects she's experiencing with the Pfizer Covid Vaccine such as flushing of the face, muscle ache in the body and headache. When clarified about the flushing of the face, she said there's itchy feeling but no rash.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19; This spontaneous report received from a consumer concerned a male 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) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patent experienced suspected clinical vaccine failure and suspected covid-19.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected clinical vaccine failure and suspected covid-19 was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210436442, 20210422101 and 20210423050.; Sender's Comments: 20210423002 Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS