chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIAGNOSED WITH COVID AFTER VACCINE; This spontaneous report received from a patient concerned a 35 year old female. 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) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced diagnosed with covid after vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diagnosed with covid after vaccine was not reported. This report was non-serious.
1st dose vaccine 2/3/21; 2nd dose 2/24/21; developed weakness, inability to keep balance, and worsening LE edema 2/25/21 ; seen in ED 2/25/21 for above symptoms; DX  1.   Hypervolemia, unspecified hypervolemia type            2. Weakness
Fever, shills, muscle/joint/skin pain that last a little over 24 hrs.  Arm pain lasted 3 days
chills; fever; nausea; headache; muscle cramps; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (24Oct2022), this case now contains all required information to be considered valid. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Batch/Lot Number: EW0150), administration date: 31Mar2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "chills", "fever", "nausea", "headache", "muscle cramps"; BNT162b2 (DOSE 2, Batch/Lot Number: EW0170), administration date: 25Apr2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "chills", "fever", "nausea", "headache", "muscle cramps". The following information was reported: CHILLS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021); PYREXIA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "fever"; HEADACHE (non-serious) with onset Nov2021, outcome "recovered" (Nov2021); MUSCLE SPASMS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "muscle cramps"; NAUSEA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021). Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Reporter stated that with Pfizer Covid-19 Vaccines Dose 2, Dose 3 (1st booster) and Dose 4 Pfizer Bivalent (2nd booster) that she experienced similar events as she did with Dose 1.  Reporter mentioned some of the events she experienced are chills, fever (degrees Fahrenheit or Celsius was not provided), nausea, headache, muscle cramps and that every time she gets a Pfizer Covid-19 vaccine that she experiences multiple events and that she has already reported her adverse events to Pfizer. Reporter stated that for each of the 4 doses all events resolved within 36 hours. Reporter consented to follow-up via follow-up letter if additional information required.  Follow-up attempts are completed. No further information is expected.
Roughly 10 days after getting the bivalent booster, he developed dermatitis over the inoculation site of the right deltoid.  This spread to involved both arms.  Rash is pruritic.  He did not present for medical care until February of 2022 after being prompted by his dentist.  He continued to have the most significant dermatitis in a 10cm area around the inoculation site, otherwise had a confluent, pruritic, erythematous macular rash with skin edema involving both upper extremities and sparing all other areas.  Rash improved with prednisone but did not fully resolve and started worsening within a week of stopping prednisone.  He had started losartan about a month prior to getting the vaccine and prior to the onset of the rash.  After biopsy results per below, losartan was stopped and he was started on topical triamcinolone with some improvement in symptoms after 2 weeks which is as of the timing of this report.
6/11/21 - admitted to local hospital, took off 3,000ml fluid in pleural cavity - subsequent to this had kidney failure, other organ failure during this hospitalization. Since this hospital stay has visiting nurse come every couple of days to drain via port in back - and is being followed by cardio and renal MD as well as oncology/hematology. Doctor recently mentioned that patient should be getting fluid analysis.
Patient was given a third dose Pfizer vaccine by having a card that was incomplete with only one dose noted.
Fever, chills, stomach pain, muscle pain, headache, nausea, soft stool, fatigue.
After a few days of testing negative on at home COVID-19 tests, I developed purple blisters on feet making walking impossible. I got a PCR test positive after blisters. Televisit with doctor who advised to treat symptomatically. Apart from blisters, the symptoms were just normal allergy symptoms. Sought dermatologist about the blisters. Dermatologist advised this was not Covid-Toe, provided some creams that cleared up the blisters. Creams included betamethasone dipropionate; clobetasol propionate; and ketoconazole.
Hives/Urticaria generalised; She wanted to rip her skin off; Itching at the back of the neck; Rash at the back of the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives/Urticaria generalised), SKIN DISCOMFORT (She wanted to rip her skin off), PRURITUS (Itching at the back of the neck) and RASH (Rash at the back of the neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 15-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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives/Urticaria generalised), SKIN DISCOMFORT (She wanted to rip her skin off), PRURITUS (Itching at the back of the neck) and RASH (Rash at the back of the neck). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. In April 2021, URTICARIA (Hives/Urticaria generalised), SKIN DISCOMFORT (She wanted to rip her skin off), PRURITUS (Itching at the back of the neck) and RASH (Rash at the back of the neck) had resolved.            concomitant medications include Flavonoid Plus 2 times a day   Treatment information include Steroids, Antihistamine, Topical Cream.   This case was linked to MOD-2021-066172 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up received, patient race and ethnic group ,patient weight and height details updated, events outcome details information updated, concomitant medications updated
Patient presented with hypoxic respiratory failure in the ED. Was diagnosed with COVID 19 pneumonia after r/o other disease states and ensuring proper labs were done. His presentation to the ED  led to hospitalization.  Was treated with a 5 day course of dexamethasone.
Fever immediately. Dizzy couldn't walk. Lower back pain spasms in ribs and arms. Diarrhea couldn't eat. Fever lasted three days. Took until next Friday to feel better.
Left underarm lymphoma 2 days after vaccine; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown and expiration date was not reported), via an unspecified route of administration, in left arm on 08Apr2021 at 10:15 (at the age of 43-year-old) at single dose for COVID-19 immunization. Medical history included fibrous breast, known penicillin allergy and bee allergy; patient was not pregnant. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient received the vaccine at a Public Health Clinic/Veterans Administration facility. The patient experienced left underarm lymphoma, two days after vaccination, on 10Apr2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of the event was not resolved.  Information about the Lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal association, a causal relationship between the suspect drug bnt162b2 and event 'lymphoma' cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was needing MMR vaccine for school based on titer results. She was given the correct vaccine but it was expired. The patient was called and informed of the error and has said she will go back to the clinic in 28 days to get it again.
Urticaria, induration erythema, lasting from 11/6/99 through 11/7/99.
left axilla lymph node swelling; left out arm upper with erythema/edema/warmth/pain localized around site
Previously received a complete series of a non-WHO approved vaccine; Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021) and INTERCHANGE OF VACCINE PRODUCTS (Previously received a complete series of a non-WHO approved vaccine in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE INACT W.VIRION NIV-2020-770 ([COVID-19 VACCINE INACT W.VIRION NIV-2020-770]) for COVID-19 vaccination.    No Medical History information was reported.   On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE INACT W.VIRION NIV-2020-770 ([COVID-19 VACCINE INACT W.VIRION NIV-2020-770]) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Previously received a complete series of a non-WHO approved vaccine ()). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine were inadvertently given past the vaccine beyond-use-date (i.e. past 30 days at fridge temperature) of 05-Sep-2021) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Previously received a complete series of a non-WHO approved vaccine had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported. The date of manufacture of vaccine was reported as 12-Mar-2021. The date that the vial was 30 days in the refrigerator was 05-Sep-2021.   This case was linked to MOD-2021-320340, MOD-2021-320812, MOD-2021-320833, MOD-2021-320902, MOD-2021-321000, MOD-2021-321030, MOD-2021-321058, MOD-2021-321061, MOD-2021-321072, MOD-2021-321076, MOD-2021-321086, MOD-2021-321106 (Patient Link).
I received my second dose of the fiber vaccine at 9 in the morning felt fine all day and night and around 3 in the morning I started breathing like I was running a marathon out of nowhere I had cold chills and my body was like basically shaking like I was had a serious hypothermia shock I was shaking so much I could not even stand I had to get dressed laying on the ground called out before someone and no one was home had to crawl down my stairs and go outside an try to find help since I  could not speak. I didnt call 911 but should have so i would have had documentation.  I regret taking this vaccine but had to as my employer strongly suggested i do so if i want to work without using n95 every day and get tested weekly.
Patient reported that Vaccine site became swollen red and itchy and was progressive daily  until seen by practitioner and prescribed Benadryl ( OTC ) and Azithromycin Zpac
TOOK LAST DOSE LATE; ATE DINNER AFTER TAKING VIVOTIF; This spontaneous case report (PVX2019-2498) was received from a nurse on 04-Oct-2019. It described a female consumer who "took last dose late" (PT: Inappropriate schedule of product administration) and "ate dinner after taking Vivotif" (PT: Product administration error), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took Vivotif on 19-Sep-2019, 21-Sep-2019, 23-Sep-2019, and 03-Oct-2019. The reporter also stated that she ate dinner after taking the last dose of Vivotif.  Action taken with respect to reported events was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: The causality of the event "took last dose late" and "ate dinner after taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose late" and "ate dinner after taking Vivotif" was considered as not applicable.
Late onset (48hrs) large local inflammatory reaction in left thigh, with erythema, disconfort upon palpation , swelling. No fever, no systemic reaction.
About 12 hours later I had a mild headache, body aches, chills that lasted another 18 hours. 36 hours after the shot I felt a lump under my left armpit and there was visible swelling about the length of my fist. The lump was sore and pain could be felt with touch and with squeezing my arms across my breasts. 4 days after the shot, the lump under my arm isn't very painful but there is still some swelling.
Gradual onset of muscle aches, productive cough, Temp 38 C, chills- that lasted 5 days.  Her parents had the same reaction to the flu vaccine.
lot of agony; first shot  removed the pain/soreness she was having from flu shot in Nov2020; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (first shot  removed the pain/soreness she was having from flu shot in Nov2020) and PAIN (lot of agony) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2020, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (first shot  removed the pain/soreness she was having from flu shot in Nov2020). On an unknown date, the patient experienced PAIN (lot of agony). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (first shot  removed the pain/soreness she was having from flu shot in Nov2020) had resolved and PAIN (lot of agony) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-276741 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received included event addition and patient initials was updated..
The pt experienced two full weeks of extreme soreness as if the muscle had been both pulled and pummelled.
Disrupted menstrual cycle - did not get my period.  No previous issues - Period had been regular prior to that.
SIGNIFICANT BAD COLD, EXTREMELY SORE THROAT, EYES AND NOSE RUNNING, TOTAL SIGNIFICANT BODY ACHES
received the first dose / in March 2020 / not received the second dose yet.; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 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 for this report. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
not getting second dose on proper time/received 2 doses of the Moderna COVID19 vaccine/-April 7th 2021 and Aug 8th 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not getting second dose on proper time/received 2 doses of the Moderna COVID19 vaccine/-April 7th 2021 and Aug 8th 2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021b21a and 027b21a) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not getting second dose on proper time/received 2 doses of the Moderna COVID19 vaccine/-April 7th 2021 and Aug 8th 2021). On 08-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not getting second dose on proper time/received 2 doses of the Moderna COVID19 vaccine/-April 7th 2021 and Aug 8th 2021) had resolved.            Concomitant medication includes medication for her thyroid No treatment medications provided by the reporter. This case concerns a 64-year-old female patient, with no relevant medical history, who experienced the non-serious event of inappropriate schedule of product administration. The event occurred  on the same day after second dose of mRNA 1273 vaccine. The patient received second dose 4 months after the first dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-390783 (Patient Link).; Sender's Comments: This case concerns a 64-year-old female patient, with no relevant medical history, who experienced the non-serious event of inappropriate schedule of product administration. The event occurred  on the same day after second dose of mRNA 1273 vaccine. The patient received second dose 4 months after the first dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
A blister developed at the site of injection the day after the injection. The blister is approximately 7 mm and slightly raised. It apparently contains fluid. The blister has decreased in size but is still apparent on 11/16/2017. There are no other symptoms.
4th day post vax-exp flu like sx-temp dropped to 96.4, aches, pains, sore throat, congestion, upset stomach;
Patient fainted for a few seconds after he was waiting in the waiting area after receiving the Moderna shot.  He did regain conciousness a few seconds afterwards.
Swelling of vaccine site (tennis ball size), hot to touch, itching. Parents encouraged to give Tylenol, apply ice to site and monitor for serious reaction. ie high fever, weakness, behavior changes, or difficulty breathing. Mom reported on 11/26/19 that pts leg vaccine site was apparent for "4 wks."
Information has been received from a registered nurse, via a company representative, concerning a female who on 05-FEB-2007 was vaccinated with a dose of Gardasil (yeast) in one arm and possibly a meningococcal vaccine (unspecified) in the other arm. Subsequently the patient felt faint, experienced a temporary loss of hearing, and also experienced pain from the injection. The nurse indicated that the patient's "fair hair (red or blonde) made them more susceptible to the adverse events." The patient was observed in the office and after a short time recovered and left. Additional information has been requested.
Pt received 1st dose Pfizer covid vaccine on 8/1/2021. on VAR form pt misspelled her name which was not caught until after vaccine was administered. on chart/Alert iis review- pt has received Moderna Covid vaccine on 1/15/2021 and 2/16/2021 completing her series.
Myalgias, arthralgias, fatigue and abdominal pain onset less 6 hours after receiving 1st dose of hepatitis B immunization. Was in good health at time of vaccination. Seen 4 days after injection. Temperature 99F; Positive orthostatic changes BP and Pulse. No HSM. Referred to ED. IV fluids. Diagnosed as viral syndrome.
Intense Shivering, teeth chattering, 102.8 fever, fatigue, and headache all lasted for a day and a half, then third day everything subsided and I felt great.
Arms are getting sore, and pain has gone down to her legs.; feels tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Arms are getting sore, and pain has gone down to her legs.) and FATIGUE (feels tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Arms are getting sore, and pain has gone down to her legs.) and FATIGUE (feels tired). At the time of the report, PAIN (Arms are getting sore, and pain has gone down to her legs.) and FATIGUE (feels tired) outcome was unknown.            No concomitant medications reported. No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Non significant follow up - AE contact details updated. Reported getting second dose on 16 MAR 2021.
Patient felt chills and body aches after receiving a 2nd dose of Moderna but next day his bupropion xl 150mg and escitalopram 20mg stop working for him.  He felt electricity shock in his head which these two medication stop the sensation but for 2 days he felt the shock in his head.  On the 3rd day shock sensation stopped.