chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus, abstain alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included rituximab.  On 23-SEP-2021, the patient experienced confirmed immunological vaccine. Patient doctor had recommended to get the Pfizer vaccine and patient mom doctor also had recommended to get a booster shot of the Johnson and Johnson COVID 19 vaccine. Patient was inquired about how would to know if the Johnson & Johnson COVID 19 vaccine worked, if patient had a negative antibody test before patient gets the booster of J&J vaccine. Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196337; Sender's Comments: V0:20211011523-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure .These events are considered not related. The events 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.
SUPRAVENTRICULAR TACHYCARDIA  (SVT); This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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, and batch number were not reported and expiry: Unknown) dose,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced supraventricular tachycardia (SVT).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of supraventricular tachycardia (svt) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220524538  -Covid-19 vaccine ad26.cov2.s -SUPRAVENTRICULAR TACHYCARDIA . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Developed hives at about 2 weeks following vaccine? started gradually but now at one month later it is debilitating.
body aches; Rigors; A spontaneous report (United States) was received from a physician concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Body aches and rigors.  The patient's medical history, was not provided by the reporter. Concomitant medications reported included Ibuprofen.  On 13 Jan 2021, the patient received their planned dose of mRNA-1273  for prophylaxis of COVID-19 infection.   Since 21 Jan 2021she was taking ibuprofen at that time. When she stopped the ibuprofen she's had been experiencing  body aches and rigors..The physician worked it up and there's no infection  Treatment for the events not reported. Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the events was  also not reported.
Marked worsening of ringing in ears, ringing in ears started after 2nd covid vaccine with insomnia, lightheadedness. loss of appetite. HSV rashes after each vaccine(3). Treated w oral prescription medication. Had fever, chills, fatigue, post nasal drip and in a week turning into sinus infection treated with steroids and presently antibiotics since finally seen by PCP, not video practitioner or walk in clinic MD.
after getting the vaccine concerning hypersensitivity; reported lip swelling; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that patient experienced an adverse event after getting the vaccine concerning hypersensitivity and reported lip swelling in a patient after COVID-19 vaccination. The outcome of the events was unknown.   Information on lot/batch number has been requested.
Doses were administered after temperature excursion in the refrigerator; Doses were administered after temperature excursion in the refrigerator; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after temperature excursion in the refrigerator), PRODUCT STORAGE ERROR (Doses were administered after temperature excursion in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was Unknown if patient had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, 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 an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after temperature excursion in the refrigerator), PRODUCT STORAGE ERROR (Doses were administered after temperature excursion in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after temperature excursion in the refrigerator), PRODUCT STORAGE ERROR (Doses were administered after temperature excursion in the refrigerator) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Doses were administered after temperature excursion in the refrigerator) and PRODUCT STORAGE ERROR (Doses were administered after temperature excursion in the refrigerator).    No concomitant medications were reported.  Batch/lot number for suspect product was reported as 215K22A, AS7171B.  Excursion happened at less than 2C from 9:41 am to 10:23 am. Minimum temperature reached was 1.1C. Less than 2C from 17:43 to 18:04, minimum temperature reached was 1.8C. No treatment details were reported.   Reporter did not allow further contact
Reported face swelling of L side of face on 9/22/21, 9 days after receiving second dose.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received a couple of years before the reporting date). On 22nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 µg. In June 2018, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills. In June 2018, the outcome of the injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, influenza-like symptoms, general body pain, pain in arm, fever, tiredness, lethargy, listless, injection site erythema and chills to be related to SHINGRIX. Additional details were received as follows: By the next day of vaccination, the patient experienced soreness, redness and swelling at the injection site. By 48 hours later flu like symptoms and pain in his arm occurred. The patient also noted that all issues were resolved by 72 hours later. The patient would discuss with his doctor about receiving 2nd dose of SHINGRIX, as he was unsure at the reporting time. The patient had denied permission to contact their physician.
Had varicella vaccine 11/13/01 and developed the disease 07/11/02, had aprox. 30 spots.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with M-M-R II, subcutaneous (dose not reported). No other concomitant therapies reported. On an unknown date the patient was tested negative for mumps titres. The outcome of negative for mumps was unknown. The causality of the event was unspecified. The case has been linked with the cases (same reporter link) # 1406USA008681 and 1406USA012141. Additional information has been requested.
3JUN91, 6hrs p/vax, expd muscle aches & pains esp ankles, wrists, & hands; c/o feeling sick & achy; took APAP @bedtime & felt OK next AM 4JUN91; 5JUN91, 48hrs p/dose, Pt expd intense "deep" itching @ inject site, resolved in 48hrs 7JUN91;
Patient received ZOSTAVAX on 11/13/2012. Approximately 2 weeks later the patient had shingles. Patient has Crohn's disease and had resumed her ENTOCORT a week prior to acquiring her third case of shingles.
Swelling of throat and face, hives, took 2 Benadryl.
Given Tdap 5/5/08 -  Experienced nausea and malaise x 2 days (Mon 5/5 & 5/6) - Wed 5/7  all night, Thursday 5/8 (L) elbow pain with limited ROM (L) arm.
Patient reported hives on legs 2 hours after vaccination. She took benadryl and applied hydrocortisone and hives eventually went away
Moderna COVID-19 Vaccine EUA Body shakes (first 10 hours) Joint soreness (first 24 hours) Muscle weakness (since injection) Body sweats (12 hours post shot to 24hours post) Temperatures over 100 (Since 4pm day of shot) Piercing headache (since  4pm day of shot) No appetite (since 4pm day of shot)
This spontaneous report as received from a nurse practitioner refers to a 14 month old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with a dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31 Mar 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31 Mar 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31 Mar 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31 Mar 2022) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022 at 12:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022 at 12:24 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31 Mar 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31 Mar 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Ethnicity was reported as private. No concomitant information was reported. Patient took the second booster dose. No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Injection site Itchy; swollen circle around the injection site/swollen circle around the injection site; red circle around the injection site; circle sized like a golf ball in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (circle sized like a golf ball in diameter), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE SWELLING (swollen circle around the injection site/swollen circle around the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Migraine.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE MASS (circle sized like a golf ball in diameter), VACCINATION SITE SWELLING (swollen circle around the injection site/swollen circle around the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site Itchy). At the time of the report, VACCINATION SITE MASS (circle sized like a golf ball in diameter), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE SWELLING (swollen circle around the injection site/swollen circle around the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported.
Progressive, transient rash across mid-upper abdomen, right leg and trunk to upper breasts, one day after vaccine admin. Transient rash beginning on back, additionally, with itchiness. Use of diphenhydramine, rash persisted to spread to inner arms after one hour. Non feverish, yet generalized aches.
Red papular rash appeared on buttocks, stomach approx 24 hrs post vax-non pruritic. Extended to include arms by 27Nov & seen in ER & tx /w cortisone inject.ER MD indicated the rash  could be sensitivity rxn to vax.
Red maculopapular rash with conjunctivitis, watery discharge, runny nose and koplik spots after low grade fever started 1/15, rash originally on nape of neck and spreading ant and down c/w measles.
No signs of illness before fall/seizure. Daughter fell on hardwood floor. Unsure if she hit her head. Immediately picked her up and noticed she had a temperature recorded 101 F at home. She cried for about a minute, then started uncontrollable jerking. Immediately took her to doctors office. Seizure lasted approximately 45 minutes. Doctor recorded temperature of 102 F. She was unresponsive during most of the seizure. Made grunting noises, could not talk or control her body/limbs.  Follow-up received states - In addition to initial VAERS report, pt had another seizure in her bed (early morning on 3/13/07). Heard "chocking noise" on baby monitor. Foun dher face down and unresponsive, eye's rolling back, head/neck and arms totally limp. Totally unresponsive for at least 15 minutes. temp was 99.7. Fever later up 101 about 30 min. later 105+. Manufaturer and vaccine lot number provided.
slept most of the day; Incredible nausea; Pain in their joints, a pain of 6 out of 10/woke up day after 2nd vaccine with joint and muscle pain; woke up day after 2nd vaccine with joint and muscle pain/Extreme muscle ache all over body; when they woke up they could not move; This spontaneous case was reported by a nurse and describes the occurrence of MOBILITY DECREASED (when they woke up they could not move), HYPERSOMNIA (slept most of the day), NAUSEA (Incredible nausea), ARTHRALGIA (Pain in their joints, a pain of 6 out of 10/woke up day after 2nd vaccine with joint and muscle pain) and MYALGIA (woke up day after 2nd vaccine with joint and muscle pain/Extreme muscle ache all over body) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PCN, NOVOCAIN and Lisinopril. Past adverse reactions to the above products included Anaphylaxis with NOVOCAIN and PCN; and Angio-edema with Lisinopril. Concurrent medical conditions included Atrial fibrillation, Heart attack since 2010 and Blood pressure high. Concomitant products included DRONEDARONE HYDROCHLORIDE (MULTAQ) for Atrial fibrillation and Arrhythmia, AMLODIPINE for Blood pressure, LOSARTAN for Blood pressure high, ATORVASTATIN for Cholesterol, FISH OIL and CALCIUM for an unknown indication.   On 11-Feb-2021 at 12:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 12:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced MOBILITY DECREASED (when they woke up they could not move). On 17-Mar-2021, the patient experienced HYPERSOMNIA (slept most of the day) and MYALGIA (woke up day after 2nd vaccine with joint and muscle pain/Extreme muscle ache all over body). 17-Mar-2021, the patient experienced NAUSEA (Incredible nausea). 17-Mar-2021, the patient experienced ARTHRALGIA (Pain in their joints, a pain of 6 out of 10/woke up day after 2nd vaccine with joint and muscle pain). On 18-Mar-2021, HYPERSOMNIA (slept most of the day), ARTHRALGIA (Pain in their joints, a pain of 6 out of 10/woke up day after 2nd vaccine with joint and muscle pain) and MYALGIA (woke up day after 2nd vaccine with joint and muscle pain/Extreme muscle ache all over body) had resolved. At the time of the report, MOBILITY DECREASED (when they woke up they could not move) and NAUSEA (Incredible nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Pain assessment (0-10): 6 (abnormal) 6.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant follow up received on 27-JUL-2021 updated suspect dosage regimens, patient demographics, relevant medical history, concomitant medications and new events Myalgia and Hypersomnia added.
***Was not checked by doctor*** Experienced angina type pain approximately 2-3 days after initial injection. Have had angina in the past and has always been brief and episodes were far between (not even once per year) but this would last for an hour, onset was independent of stress, either physical or mental with daily recurring episodes for approximately 2 weeks. Pain returned after second dose and remained for approximately 2.5 weeks with a gradual decline in severity/length as time passed. No symptoms for several weeks at date of this report. Possibly completely unrelated but including for completeness, severe pain in elbow and shoulder of injection arm coinciding with date of injection and persisting to his day with no lessening of symptoms which include severe pain when joint(s) moved under stress, stiffness, reduced strength and general soreness even at rest.
chest pain and fluttering  sensation in chest each occurring sporadically throughout the days starting the 11/8/21.
pt recv vax;to hlth ctr;RN noted to be lethargic,cyanotic;pt stopped breathing when taken by amb per R N;to hosp;PC fr grandma,stated on respirator,bilateral pneumonia;Hgb=6.0,WBC dec;MD concerned w/dec WBC since had massive inject;sz;
Hospitalized 8/21/22-8/23/22 Fall, altered mental status, fever, chills, cough, vomiting, dizziness, bradycardia,
Substantial arm soreness beginning 1st day of vaccination. Was given Moderna first dose 7/27/2021 at approximately 9am  in patients left upper arm. Arm soreness has continued since 12pm 7/27. Ice pack has not resolved pain. Burning experience down length of entire arm occurred at 9pm on vaccinated day, that has now subsided.
6" x 5" area - red, warm, swollen; intense pain from clavicle to elbow, including axilla, temp 101.5, headache. Dx: Aggressive cellulitis. Rx: KEFLEX.
Positive covid-19 quick test 1 week after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive covid-19 quick test 1 week after 1st dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INSULIN PORCINE (INSULINA ACTRAPID), ATORVASTATIN and LEVOTHYROXINE SODIUM (LEVOTIROXIN) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (Positive covid-19 quick test 1 week after 1st dose). At the time of the report, COVID-19 (Positive covid-19 quick test 1 week after 1st dose) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details was reported.   Reporter did not allow further contact
VACCINE GIVEN AT 12:00 WITH IN 5 MINS PATIENT BECAME UNRESPONSIVE WITH GCS OF 3 AND POSTURING. EMS WAS CALLED AND PT AIRLIFTED TO ER. THE VACCINE WAS GIVEN TO 2 OTHER SIBLINGS AND ALL 3 SIBLINGS HAD AN ADVERSE  REACTION.
Red rashy/swollen area in the pit of my left arm, which is the same side as the injection. It started on Sunday, 3.7.2021 and is getting worse.