chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid rebound/Treatment of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid rebound/Treatment of COVID-19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002m21a) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: morphine. Past adverse reactions to the above products included Allergy with morphine. Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus and Adhesive tape allergy.    On 12-Apr-2022 at 11:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid rebound/Treatment of COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid rebound/Treatment of COVID-19) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Company Comment: This is a spontaneous case concerning a 75-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 6 days and had COVID rebound. No other clinical or treatment details were given. The reported outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 6 days and had COVID rebound. No other clinical or treatment details were given. The reported outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
sick; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a consumer via Social Media. This case is linked to case 2020SA317914 (female patient).  This case involves a male patient (age unspecified) who was sick (llness) after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was sick (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  The reporter asked why the parents got sick almost every year after getting the vaccine   No laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
A report has been received from a Health Professional concerning a 6 years old male patient, who had been receiving FLUMIST. FLUMIST started on an unknown date. It was reported that a FLUMIST that expired on 04-Jan-2016 was administered to a patient on 12-Jan-2016. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious. The reporter and the company physician considered that there was no causal relationship between received expired FLUMIST and FLUMIST Quadrivalent.
Five days after the first injection, I experienced debilitating vertigo; my primary care clinic diagnosed BPPV (benign paroxysmal positional vertigo); she prescribed Meclizine and Zofran, and home treatment with the Epley maneuver until symptoms resolved. It took eight days for the condition to resolve.  During that time frame, I had two virtual visits with my primary clinic. The doctor could not say for certain this event was related to my first COVID vaccination. However, I have never experienced this condition in my life, and it occurred within the 7 day window for adverse effects.
covid test result=Positive; covid test result=Positive; myocarditis; heart arrhythmia; tachycardia; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2, administered in arm right, administration date 16Mar2021 09:00 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: LEVOTHYROXINE. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 09Nov2021, outcome "unknown" and all described as "covid test result=Positive"; MYOCARDITIS (medically significant) with onset 16Mar2021 21:00, outcome "not recovered", described as "myocarditis"; ARRHYTHMIA (medically significant) with onset 16Mar2021 21:00, outcome "not recovered", described as "heart arrhythmia"; TACHYCARDIA (non-serious) with onset 16Mar2021 21:00, outcome "not recovered", described as "tachycardia". The events "myocarditis", "heart arrhythmia" and "tachycardia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) positive, notes: covid test name post vaccination: PCR; magnetic resonance imaging heart: (2021) unknown results, notes: AE treatment: Cardiac MRI; echocardiogram: (2021) unknown results, notes: AE treatment: Echocardiogram. Therapeutic measures were taken as a result of myocarditis, arrhythmia, tachycardia (treatment AE: beta blocker medication).  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Geographic tongue; This spontaneous case was reported by a nurse and describes the occurrence of TONGUE GEOGRAPHIC (Geographic tongue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 032M20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TONGUE GEOGRAPHIC (Geographic tongue). At the time of the report, TONGUE GEOGRAPHIC (Geographic tongue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient reported that they had geographic tongue 7 days after receiving the booster dose of the Moderna Covid-19 vaccine and mentioned that it was resolving at the time of the call.
pt devel high fever & short sz; when seen in ER few minutes later acted nl; lab WNL; observation of 24 hrs-no sign neuro deficit; no fever;
The patient was nervous and tense about getting a vaccine, so I was trying to have her relax prior to administering the immunization. Immediately after giving the vaccine (<2 seconds), she started coughing as if she was choking on her saliva. I gave her water and she was calming down, but complained of slight itchiness in her throat. I immediately administered diphenhydramine 50mg and patient was instructed to be observed for 30 minutes. After the observation period, she stated she was feeling better, but the itchiness was still there, only to a lesser magnitude than initially. She was consulted that she may want to get the second dose at a doctor's office for her safety.
Swelling and redness to left thigh, temp 101. Advised to apply cool compress and give Tylenol for discomfort - was later seen by MD on 2/22/06.
Needed to get the shot to continue to participate in schooling.  Although I didn?t experience any immediate side effects, I did catch Covid-19 almost exactly three weeks later.  I?m believe I was considered fully vaccinated 14 days after the second shot.  I think the nurses around my school were calling it a breakthrough infection?  Covid-19 didn?t really slow me except that I lost my tase and smell for a good couple weeks.  I also had a case of the diarrheas which also lasted about the same amount of time.  My friend suggested I file a VAERS just in case there is a class action lawsuit as it?s turning out there are a crazy amount of deaths and severe adverse reaction as result of these now seemingly worthless vaccines.  In hindsight these experimental shots are beyond worthless and downright dangerous.  Obviously I will not be getting anymore shots, I assuming now all vaccines might be quackery?  Let?s see how long it take to publish this report?  You better welcometheeagle!
Patient reported difficulty breathing, throat swelling, rash/hives/welt, itching. Patient was seen in ER and given several prescriptions to treat allergic reaction.
nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) since an unknown date, Anxiety since an unknown date, Cholesterol since an unknown date, Hypertension since an unknown date and Pain since an unknown date. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), GABAPENTIN for Anxiety, SIMVASTATIN for Cholesterol, ATENOLOL and LISINOPRIL for Hypertension, NAPROXEN SODIUM (NAPROXENE [NAPROXEN SODIUM]) for Pain, VITAMIN B COMPLEX for an unknown indication.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (nasal congestion). At the time of the report, NASAL CONGESTION (nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (esophageal) since an unknown date, Anxiety since an unknown date, Cholesterol since an unknown date, Hypertension since an unknown date and Pain since an unknown date. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), GABAPENTIN for Anxiety, SIMVASTATIN for Cholesterol, ATENOLOL and LISINOPRIL for Hypertension, NAPROXEN SODIUM (NAPROXENE [NAPROXEN SODIUM]) for Pain, VITAMIN B COMPLEX for an unknown indication.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (nasal congestion). At the time of the report, NASAL CONGESTION (nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details 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 78-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 02Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient did not receive any other medications within two weeks of vaccination. COVID 19 treatment from 16Jun2022 to 20Jun2022. No known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt. called 12/5 complained of soreness/pain of left arm and she has been taking DILAUDID and apply lidocaine patch over the painful area. She was seen in the ER 12/8 and doctor diagnosed her w/ cellulitis and was treated w/ clindamycin and DILAUDID.
Severe  headache,  Severe Shakes, Stiff Neck, Very Sore Leg Muscles
patient presented to emergency department on 11/11/21 with shortness of breath patient was admitted for further management of pneumonia due to covid-19 patient did require treatment for symptoms associated with covid-19 infection. treatment included dexamethasone, remdesivir and baricitinib patient required intubation on 11/17/21 and transferred to intensive care unit patient expired on 12/6/21 due to hypoxemic respiratory failure and compensated respiratory acidosis
I had a sore throat, runny nose, and coughing. Happened four days after my vaccine.
24 hours of Chills & body aches, plus 36 hour headache  Nursing 13 mo old also was extra irritable 2nd night after shot
Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (On 14th Jun 2022 1st dose received .) and hiberix (On 14th Jun 2022 1st dose received .).   On 14th September 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171044, US2022AMR171050, US2022AMR171052   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on right thigh that have been noted on patient's legs after receiving Pediarix and Hiberix and Prevenar. The reporter consented to follow up. Additional supportive information:This case has been link to the case US2022AMR171050 reported by same reporter for hiberix suspect. This was 1 of 19 linked cases, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
pt said he had chills, not feeling well at all as well as neck pain for 7 days.
Got the vaccine on sept 27 and october 18 without realizing i got pregnant a week after i got my first dose. I was concerned. I did the Nipt test at 11wks. On my 12wks ob appt and ultrasound was the same day i got the result back- trisomy 22, baby had no heartbeat and stopped growing during ultrasound. Needless to say, i had a miscarriage and did d&c.
I got my injcetion on the 'top' of my shoulder.  I didn't see it go in, but noticed entry point at home.  Into the evening I started getting beyond normal reaction.  I had a very stiff shoulder joint with pain, beyond that of my existing condition.  It was severe the next day.  Saw my doctor, for the first time meet, and mentioned the reaction I got, but he said it will go away.  During the doctor visit I had elevated BP identified, which wasn't normal for me either.  That evening I had additional symptoms that included swelling at the proximal points on the thumb and index finger, this also included the wrist.  All symptoms have since subsided to normal.  No other symptoms.
Pfizer bivalent vaccine administered as second dose in primary series, rather than monovalent vaccine.
Received his first Shingrix vaccine on 20Nov2020 and did not receive the second dose until 09Sep2022; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th November 2020).   On 09-SEP-2022, the patient received the 2nd dose of Shingrix. On 09-SEP-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Received his first Shingrix vaccine on 20Nov2020 and did not receive the second dose until 09Sep2022).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter was a medical office manager. The reporter did not had the vaccine lot numbers and expiration dates. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
March 15: 2:45pm Pfizer COVID vaccine 1 March 16; 6am - severe headache: treated with two Excedrins at 8am and then two more Excedrins at 6pm.  March 17: 10am - severe headache: treated with two Excedrins at 10am March 18: Upper neck and shoulder pain: untreated March 19: Upper neck and shoulder pain and hearing loss (approximately 50% hearing loss): untreated March 20: Upper neck and shoulder pain: treated with Arnicare Cream, hearing loss continues, untreated March 21 - 22: Upper neck and shoulder pain: treated with Arnicare Cream: hearing loss continues.  March 23: Upper neck and shoulder pain improved. Hearing loss continues. Notified Dr. (my primary physician)
Vaccine dripping down her arm; Vaccine dripping down her arm; A spontaneous report was received from a consumer who was a 22-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine dripping down her arm.   The patient's medical history was not reported. Concomitant product use reported included unspecified birth control.   On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013Z20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient experienced vaccine dripping down her arm during vaccine administration. The nurse administering the vaccine did not have the needle pushed in all the way into the patient's arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, vaccine dripping down arm, was considered resolved on 15 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and exposure through skin contact for COVID-19 vaccine mRNA-1273, lot # 013Z20A. There were no reported AEs associated with this case of incorrect dose administered and exposure through skin contact .
RED LEFT ARM FORM SHOULDER TO ELBOW, CAME ON AFTER LESS THAN 24 HRS TREATED WITH TYLENOL AND ICE OFFICE VISIT ON 10/14/2020 TO REVIEW NO PREVIOUS REACTIONS TO FLU VACCINE
Within 24 hours red, swelling at site of injection. On June 27, 2018, two days later, the arm was still red, warm to touch in an area of 100mm x150mm. No fever or breathing difficulties. Reported only that arm was tender.
Sharp shooting pain in right ear  Noticed mfufled like sound reception in right ear (got second vaccionation shot in right arm) This has lasted since 3/11/2021 and finally saw ENT and had CT scan to see if neuroma and/or tumor in brain or inner ear  NEGATIVE FOR BOTH  Had hearing test and right ear has severe hearing loss.
No adverse event; patient accidentally received an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient accidentally received an expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) Unknown. On 15-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient accidentally received an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient accidentally received an expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient accidentally received an expired Moderna vaccine). No concomitant  and treatment medication information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Live Follow up- Significant information include suspect product change from MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) to Spikevax and narrative updated.
Fetal demise at gestational age 14 weeks.  Exact age when patient received first dose of COVID-19 vaccine.  Patient had suffered from hyperemesis prior to vaccine, but had improved prior to vaccine.  No other complications in pregnancy estimated date of delivery was July 14, 2021