chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They have had every symptom from COVID.; This is a spontaneous report from a contactable consumer. This consumer (husband) reported for a 53-year-old female patient (wife) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 24Apr2021 (at the age of 53-year-old) as 1st, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller wanted to know what should he and his wife would do if they developed "every symptom on the list" of COVID-19 after receiving the first dose of the COVID-19 vaccine, as On 25Apr2021, they both had a "pretty severe" reaction, his reaction was "coming down quite a bit" but his wife´s reaction was not coming down as quick. Within 24 hours of after receiving the first dose of the Pfizer COVID-19 vaccine their symptoms started growing like if they got the shot and got the virus at the same time. During the call he mentioned that maybe the virus was on their systems for weeks or months but did not activate until they received the shot. Caller is trying to figure out the shot he got. On the 24Apr2021, Saturday, he and his wife went to an open vaccination clinic where they didn't have to have appointments. They both got the shot Saturday, and by Sunday afternoon, the next day, they were both getting sick. Now for the last week they have been sick as a dog. They have had every symptom from COVID. They were told that someone can't catch COVID from the vaccine. That is not true. What is he supposed to do Is it safe for them to go out after this sickness or cold? Pfizer needs to change the information that says people cannot get COVID. Him and his wife both have symptoms of COVID. Can they get the virus from the vaccine. It is unlikely both had it before the shot. He did not have diabetes, and he doesn't take medications. He has no health problems. He did not have a prescribing doctor. He went through the city's vaccination site. His COVID symptoms are improving. His wife's COVID symptoms are slowly improving. Caller has not received treatment. Him nor his wife have gone to the doctor or ER, not yet. He got the vaccine in his left arm. He had no diabetes, no heart problems, and no high blood pressure. They were feeling perfectly fine. They figured they may have to travel to Germany out of the blue to see family, so they better get vaccinated. The outcome for the event the patient experienced they have had every symptom from covid was recovering.  Follow up #1 (03May2021): This is a follow up-spontaneous report received from a contactable consumer reported for the patient via follow-up letter which included: event details and clinical information.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021494357 same reporter/drug/event, different patient.
24-48 hrs p/lt deltoid inject w/DTAP site became very red, indurated & tender; no fever; s&s subsided & pt has recovered;
1:17 PM shot 10PM EST could not breathe Went to ER 9:24 CST 3 weeks after Senior shot. I sick w/flu like-Congestion, Coughing-went to Dr - Did not have flu but badley congested. Gave me medicine 3 weeks later I was ok
Information has been received from a health professional concerning a 7 year old female who on 11/24/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently in February 2004, the patient experienced breakthrough chickenpox.  It was reported that there was a total of 45 cases of breakthrough in the patient's school, including the patient, and 17 were vaccine recipients.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The reporter indicated that 16 other patients had similar experiences following exposure to varicella virus vaccine live (Oka/Merck).  Additional information has been requested.
Febrile/respiratory illness, COVID antigen and PCR NEGATIVE.  Resolved after 1 week
U07.1 - COVID-19 J12.82 - Pneumonia due to coronavirus disease 2019
Within 60 seconds to 2 minutes, I could feel throat tightness, the upper roof of my mouth started burning, bad, strong taste in my mouth, nausea. Was given Benadryl.
COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 7 decade old. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection (dose number in series 2). It was reported that, "Thank you I am 67 years young and had the J and J covid series. It has been a year since I took the 2nd shot. Today I am on day 11 of covid. I won't say it's been exactly easy but I did not have to go to the hospital. My 70 year old spouse is doing even better than I am. You delivered. We're alive and didn't have to go to the hospital." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint 90000260891.
Immediate chest pounding with tachycardia, short of breath and nausea while driving home from pharmacy.  Went to walk in clinic told to go to ER sent home. Next 2 days fever to 102 F, malaise, fatigue.  Holter monitor placed at second ER visit.  Cardiology follow up x2 Monitor heart rate 76-167 at rest or minimal exertion.  Unable to sit or stand and unable to attend college classes for 6 weeks so far.
Community member stated was seeing "color" in peripheral vision.  Stated more so in right eye.  Denies dizziness or blurred vision. Symptoms resolved, stated vision cleared and ambulated with steady gait without assistance.  Went home from observation area.
Patient tested positive for covid 19 on 1/20/2022.  Nurse Went in to check resident@ 7:35am on 01/28/2022, obtained vitals BP : 50/?, HR: 76, T: 98.1, R: 40, 02: 98% @ 3.SL, resident noted to be unresponsive, shallow breathing. This nurse was notified@ 8:55am of resident not having respirations. Went into resident room, noted resident to not have respirations or heart rate. Pupils noted to be fixed, unresponsive.
administrated third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number zaa27, expiry date 31st January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date).   On 5th November 2021, the patient received the 3rd dose of Shingrix. On 5th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient inadvertently received a third dose of Shingrix, which led to extra dose administered. No further events were reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. This case had been linked with case US2022016973, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022016973:same reporter
Amenorrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 16:00 (Lot number: EW0UZ) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "high BP" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: VIT D; ALBUTEROL HFA; ADVAIR; MONTELUKAST; HYDROCHLOROTHIAZIDE; LISINOPRIL. Vaccination history included: Bnt162b2 (dose 1, single, vaccine location: Left arm, lot number: E86955, administration time: 02:15 PM), administration date: 17Mar2021, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to drug". The following information was reported: AMENORRHOEA (non-serious) with onset 09May2021, outcome "not recovered", described as "Amenorrhea". Therapeutic measures were not taken as a result of amenorrhoea.  Additional information: No other vaccine in four weeks. Adverse event Amenorrhea, last period 8-11Apr2021 no subsequent period after second dose of the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This event was a vaccine administration error.  No adverse reactions have been reported for this patient. The Pfizer pediatric Orange cap vial  ( ages 5-11) administered was not diluted. The vaccine should have been diluted with 1.3 mL sterile 0.9% Sodium Chloride. The amount of vaccine administered was  0.2mL of undiluted serum, resulting  in a dose 3 times more concentrated than the advised dose.  This patient was 1 of 7 individuals to have received improperly diluted vaccine.  Only one staff member that was responsible for the errors, but all staff were retrained on storage, dilution, and administration of the vaccine. Chart audits were preformed to identify affected patients.
This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the TWINRIX injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot. Linked case include: A0752087A, A0752088A, A0752089A, A0752090A, A0752091A, A0752092A, A0752093A, A0752094A and A0752095A. Follow-up information was received on 04 November 2008, by a physician and described the occurrence of injection site stinging in a 39-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject had no adverse events were reported with previous vaccinations. On an unspecified date, the subject received 2nd dose of TWINRIX (unknown). On 03 October 2008, at an unspecified time after vaccination with TWINRIX, the subject experienced injection site stinging, injection site burning and TWINRIX AHABB128AB batch has problem. The physician considered the case as medically serious. On 03 October 2008, the events were resolved. The physician considered the events were related to vaccination with TWINRIX.
Reported nausea on 2nd day post vaccine. Worked 3 twelve hour shifts in the days following vaccination. Began to get worse. On wednesday last week she was weak, dizzy, nausea, back pain, shortness of breath. All seem to be worsening.  Was seen in ED with negative labs and CXR.  Rested at home the next several days. Still having sx as of today. Advised to seek out COVID testing to rule this out and contact her PCP..
Increasing arm pain over time, including tingling waves and numbness of neuropathy.  The second dose in May increased my symptoms that still wake me in the night with pain. Recent administration of the regular seasonal flu vaccine in October reinvigorated the duration and frequency of arm pain.
This spontaneous report was received from a nurse and refers to multiple patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). The reporter stated that the vaccines reached a temperature of -11 Celsius degrees for an unspecified amount of time (dates were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
blotchy redness with itching to injection site Narrative: At 12:15 pt c/o increased HR with blotching, redness and itching to injection site. Denied any SOB or Dizziness. Ice pack applied with sips of water. VS: HR 91 BP 158/91 AT 12:30 Pt. reported feeling better with no changes with redness and blotching not worsening. VS: (12:35)HR 77, BP 119/86 AT 12:40 Pt reported no itching VS HR 77 , BP 126/87 AT 12:50 VS HR 77, BP 119/84 12:53 Pt was discharged from vaccine clinic , Stable and symptoms improved
Pregnant; Pain in the injection site; sore arm; This spontaneous pregnancy case was reported by an other health care professional and describes the occurrence of PREGNANCY (Pregnant), INJECTION SITE PAIN (Pain in the injection site) and PAIN IN EXTREMITY (sore arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Jul-2021. On 14-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection site) and PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) had resolved and INJECTION SITE PAIN (Pain in the injection site) and PAIN IN EXTREMITY (sore arm) 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.   Concomitant medications were not provided. Treatment details were not provided; Sender's Comments: This is a case of product exposure during pregnancy in this 34-year-old female patient who also experienced Injection site pain and Pain in extremity. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
A report has been received from a Physician concerning a male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. On 21-Jan-2014, patient received expired FLUMIST QUADRIVALENT (Preferred Term: Expired drug administered). The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
injection site warmth; Injection site erythema; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (injection site warmth) and VACCINATION SITE ERYTHEMA (Injection site erythema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site erythema). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site warmth). At the time of the report, VACCINATION SITE WARMTH (injection site warmth) and VACCINATION SITE ERYTHEMA (Injection site erythema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient admitted for Covid-19 pneumonia and acute metabolic encephalopathy in the setting of Covid-19 infection. Patient received Rocephin, Remdesivir, Decadron IV. Patient was discharged home.
Information has been received regarding a case in litigation concerning a 30 month old male who on 10/6/95, 12/6/95 and 5/1/96 and vaccinated with a first, second and third dose of hep B virus vaccine, respectively. On 12/6/95, 2/16/95, 5/1/96 and 2/25/97 the pt was vaccinated with a first, second, third and fourth dose of DTP and a first, second, third and fourth dose of Hib conj vaccine, respectively. It is alleged that as a result of the mercury overdose the pt sustained via these thimerosal-containing vaccines, the pt suffered severe neurodevelopmental injuries. The multiple symptoms of the pt's injuries occurred and were first manifested by approximately April 1998. Upon internal review, severe neurodevelopmental injuries and mercury overdose were considered to be other important medical events (OMIC). No further info is available.
Patient called on 11/17/15 stating they have a developing rash on their back, only on the back, but that it is all throughout, and it is beginning to itch. She is unsure if it is from the vaccine, as are we, but she was advised to see an md as it is progressing.
nauseated after the 2nd Primary dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseated after the 2nd Primary dose) in a 52-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseated after the 2nd Primary dose). At the time of the report, NAUSEA (nauseated after the 2nd Primary dose) had resolved.            No Concomitant Drug details were reported.  No Treatment information was provided.  The patient mentioned feeling nauseated after the 2nd dose of Moderna but it only lasted a couple hours.   This case was linked to MOD-2022-546339 (Patient Link).
Site: Swelling at Injection Site-Medium, Additional Details: Arm swelled immediately upon recieving covid 19 booster bleed a little and then swelled to the size of a golfball instanlty.   ice was applied in the first 2 minutes and  one 25mg benydryl was given in 5 minutes. paitent waited and swelling decreased by time 25 min elapsed sent pt home with ice and instructed to call if any other symtoms.
Reported tenderness & lump at injection site swelling & redness decreased in size seen 10/25/10 Tx with ice, KEFLEX, NSAID OTC prn. Would recheck.
See first page Significant increase in tinnitus. Prior to 1st & 2nd dose of Moderna, I had had mild tinnitus for 10-15 years that was rarely bothersome. However, 12-15 hours after 2nd dose, I was dizzy, had reverberations in my ears & the significant increase in tinnitus. I can't sit in a room that is quiet; I need to have music on or I use a white noise app on my phone. To sleep, I must use the white-noise app or the tinnitus won't allow me to go to sleep.   On Mon. Oct. 25, 2021, I received the Moderna Booster of .25 cc
I felt so tired that I could not stay awake. I had really severe muscle and joint aches with overall achiness. Moving felt uncomfortable. I also had a really bad headache. I took a COVID-19 Home Test and it was positive. We all quarantined together and my additional family members also tested positive.  I took a PCR COVID-19 Test at an urgent care center upon my return.It took 11 days to test negative. I rested and stayed in bed. I took Nyquil at night and Dayquil during the day as I did not qualify for Paxlovid.
Local erythema, edema and raise of temperature. Area measured 11cm by 10cm.
Patient reported numbness and loss of use of arm starting the evening following the vaccination. The symptoms persisted throughout the weekend (2-3 days) and resolved by Monday. No treatment was necessary.
After receiving the vaccine the patient tested positive for Covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (After receiving the vaccine the patient tested positive for Covid) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (After receiving the vaccine the patient tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (After receiving the vaccine the patient tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time. However, the event COVID-19 Positive is unlikely related to m-RNA-1273.
PATIENT RECEIVED FLUZONE HD AT 12:30PM AND 4 HOURS POST INJECTION EXPERICENED CHILLS, NAUSEA, UNSTEADY GAIT, DIZZINESS LASTING SIX HOURS...NO TREATMENT SORT AND 24 HOURS LATER PATIENT REPORTED FEELING FINE OF ABOVE SYMPTOMS