chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting 5/20 at around 2PM, experiencing cough (productive), nasal congestion, sinus pressure, slight headache. 5/21 - 5/22 symptoms were cough (productive), chest congestion, sneezing 5/23 - cough (productive), nasal congestion, chest congestion, sneezing, very raspy voice 5/24 through present - cough (productive), chest congestion, raspy voice
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Patient ID was reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. No treatment drug was reported
102 degree fever, unable to raise or use arm of injection, nausea, headache, body aches, joint aches
5 December received shot in my left arm, my arm was sore for a few days, now that the soreness has gone away my left shoulder joint hurts. The pain is worse when I pick something up with my arm. Especially if I rotate my wrist as I pick something up.
doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
This case was reported by a healthcare professional and described the occurrence of injection site swelling in a 42-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included IPOL (non-gsk); non-GSK manufacturer; unknown; unknown given on 21 January 2011. Concurrent medications included (Non-GSK) Yellow fever. On 21 January 2011 the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). On 21 January 2011, immediately after vaccination with TWINRIX, the subject experienced injection site swelling, injection site redness, and injection site pain; the size was described as a fourth to half a dollar size. Intervention to prevent further swelling was performed at the physician's office and included application of ice. On an unspecified date in January 2011, three days after vaccination with TWINRIX, the subject reported having pain and a little bruising at injection site. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with Ice pack. At the time of reporting the outcome of the injection site swelling, injection site redness, pain and bruising at injection were unspecified. This is the first of two cases reported by the healthcare professional; for the second case see A0910940A. Follow-up information was received on 16 February 2011 via healthcare professional who reported as of 24 January 2011 the injection site swelling and injection site redness injection site pain and bruising at injection site had improved. The immunization series was not delayed or discontinued.
Fever up to 106 degrees and irritability following vaccines, brought to ER by parents approx 12 hours following immunizations.  Was observed and treated for fever in ER and discharged to home after several hours.  Pt. resting comfortably at home about 20 hours after vaccines.
Mild cramping; spotting; and it started about 04:00 on Sunday. I called my physicians' office on Monday am and was seen on Monday afternoon. Symptoms continued until about Friday. And then they stopped. No treatment was needed.  Pregnancy history: 3rd pregnancy  - for first pregnancy was full term; and second pregnancy ended in miscarriage; October 4, 2021.
Bright redness and hard swelling first noticed in the evening of 1/16/21. By the morning of 1/17/21, the redness had spread to an oval about 2.5 inches.
expired doses of TENIVAC were administered to patients with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a Nurse.  This case is linked to case 2023SA304016.  This case involves a 75 years old female patient to whom administered the expired doses of diphtheria-2/tetanus-5 Adsorbed toxoids No Preservative Adult [Tenivac] were administered to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine for Immunization.  On 27-Sep-2023, the patient received expired dose of 0.5 ml of suspect  diphtheria-2/tetanus-5 Adsorbed toxoids No Preservative Adult Suspension for injection (strength: standard, frequency: once, expiry date: 24-Sep-2023 and lot 47183AA) via intramuscular route in unknown administration site as immunization (expired product administered) (same day latency).  Action taken: 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.
R09.02 HYPOXIA 4/11/2023 DM 2 W HYPERGLYCEMIA
patient received 2nd dose 5/10/19. complained to pharmacy 7/5/19 12:40pm that there is soreness in right arm, where vaccine was given for close to 60 days.
Information has been received from a female physician concerning her husband who had received a 3 doses of RECOMBIVAX HB (manufacturer unknown) and was found not to be protected so he was vaccinated with 2 more doses and now was protected. This is one of several reports from the same source. No further information is available.
Shingle blisters on Right foot (toes); Nausea; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles and nausea. On an unknown date, the outcome of the shingles and nausea were unknown.   It was unknown if the reporter considered the shingles and nausea to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and 2 weeks post injection developed Shingle blisters on my Right foot toes. The reporter not sure whether to have the 2nd dose and asked was this a common side effect. This was not listed on side effects of the shot.  The patient also had nausea the night of shot.
Patient received 3 vaccines on 08/18/2020. 2 (Havrix and Engerix) in the left arm, and 1 (Fluzone) in the right arm.  Patient reported to pharmacist on 11/25/2020 that she has been having pain in her right arm since the vaccination.  She consulted with her physician on and on 11/24/2020, the physician prescribed MAPAP Arthritis strength and Gabapentin 100 mg for 10 days.
Client reported minor itching after vaccination. Advised to remain for 30min in obs. Refused medical aid.
First dose of shingrix on 5/27/2019 did not receive 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix on 27th May 2019, batch number-494PR, expiry date-13th September 2019).   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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter enquired to restart series or one dose should be given. The reporter consented to follow up.
2nd shot 10th  @ 1115 , 1st shot 1/13/2021 lymphedema, red, itchy, fatigue lump under arm that has moved to breast.
Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever; headache; bodyaches; cough; tiredness; sore throat; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 05Jan2021 at 08:15 AM at a single dose for COVID-19 immunization in a hospital.  Medical history included known allergies to mold, dust mites, grass and tree pollen, cockroaches. Concomitant medications included hydroxyzine, ergocalciferol (VITAMIN D), vitamin c, calcium, and glucose (GLUCOS).  The patient experienced fever, headache, bodyaches, cough, tiredness, sore throat on 10Jan2021 at 08:30 AM. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received zinc, vitamin D, ibuprofen, and Tylenol as treatment for the events. Since the vaccination, has the patient been tested for COVID-19: Yes.  The patient has no COVID prior to vaccination and she was tested for COVID post vaccination (nasal swab; COVID-19 Ag test) with COVID test result as positive on 12Jan2021. The patient did not receive other vaccine in four weeks.  Outcome of the event "Since the vaccination, has the patient been tested for COVID-19:Yes" was unknown, while recovering for the remaining events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for COVID test based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
This spontaneous prospective pregnancy report has received from a 26 year old female patient, who was referring to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-MAR-2017, the patient was vaccinated with VARIVAX subcutaneous injection (dose, lot # and expiration date were not reported) for prevention of varicella. On 14-MAR-2017 (reported as the next day after receiving the injection), the patient found out that she was pregnant (unspecified duration). The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. The pregnancy outcome was pending. The fetal outcome was unknown. The patient stated she had not been able to reach her physician. No treatment was given. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
10 days post vax pt devel temp 103.2, cranky, cried alot-devel raised red rash on face-rash has persisted x 3 days;
Intense chills; Fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Intense chills), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced CHILLS (Intense chills), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, CHILLS (Intense chills), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided          No concomitant medication were reported The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up Telephone Contact Report (TCR) received on 06-May-2021 contains first doing details for the vaccine.
This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender. Information regarding patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 21-DEC-2017, the patient was inadvertently vaccinated with improperly stored doses of VAQTA, intramuscular injection, lot # N017094, expiration date 31-AUG-2017, for prophylaxis (strength, dose and frequency were not reported). The following temperature excursions were reported: temperature below 32°F during 6 hours 9 minutes, 30.8°F during 2 hours 57 minutes and 31.9°F during 3 hours 12 minutes. Temperature excursion was of 32°F to 35°F during 3 hours 4 minutes, multiple excursions were reported. Previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1801USA001528: US-009507513-1801USA002098: US-009507513-1712USA013720: US-009507513-1801USA002097:
Large area over injection site that is warm; Very small bumps; Itchy; Injection arm is red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Large area over injection site that is warm), VACCINATION SITE MASS (Very small bumps), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Injection arm is red) and VACCINATION SITE SWELLING (Swollen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001530) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced INJECTION SITE WARMTH (Large area over injection site that is warm), VACCINATION SITE MASS (Very small bumps), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Injection arm is red) and VACCINATION SITE SWELLING (Swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Large area over injection site that is warm), VACCINATION SITE MASS (Very small bumps), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Injection arm is red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 01Nov2022 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "asthma", start date: 01Nov2022, stop date: 01Nov2022; "hypothyroidism" (unspecified if ongoing); "hyperlipodemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Known Allergies: Demerol"; Codeine, reaction(s): "known Allergies: codiene". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid received).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Pain in upper left shoulder, radiating into left side of neck.  Occurred almost nightly, just seems to be subsiding recently (past two weeks.)
tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 09:30 (Lot number: EN6202) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1; Batch/lot number: EN6202; anatomical location: left arm), administration date: 27Feb2021, when the patient was 51 years old, for COVID-19 IMMUNISATION, reaction(s): "tinnitus, ringing in her left ear and it hasn't gone away", "slight loss of hearing in her left ear". The following information was reported: FATIGUE (non-serious) with onset 21Mar2021, outcome "unknown", described as "tired". Additional information: The patient was reported to be perfectly healthy and doesn't take anything. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional administered vaccines administered on same date with the Pfizer vaccine considered as suspect. It was reported that the patient's primary care doctor gave her a prescription for prednisone for 5 days to take after getting the Covid 19 vaccine. The patient didn't want to take the prednisone. She thought it was too soon. Her doctor told her to start it 24 hours after she received the vaccine. She still hasn't started taking it yet. She wanted to give her body more time. She didn't want anything else in her body. This past Sunday and Monday she's been tired.  She has not started the prednisone yet.   No follow-up attempts are possible. No further information is expected.
pt recv vax on rt thigh IM on 14mar97; 29mar97 mom called & stated "it looks infected" pt admitted w/ dx of cellulitis r/o bateremia area reddened edema, no feber qruater size area; pt sent home w/ meds;
LEGS PAIN; HEAVINESS IN LIMBS; FATIGUE; WEAKNESS; RED FLUSH FACE; FELT PASSING OUT; GASPING; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included antibiotic allergy, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known medical history. patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced felt passing out. On 09-APR-2021, the subject experienced gasping. On 09-APR-2021, the subject experienced red flush face. On 09-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced heaviness in limbs. On 14-APR-2021, the subject experienced legs pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt passing out, gasping, red flush face, and weakness on 09-APR-2021, heaviness in limbs on 11-APR-2021, and fatigue on 10-APR-2021, and had not recovered from legs pain. This report was non-serious.