chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 at 11:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Mar2021 at 11:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Jun2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reflux" (unspecified if ongoing), notes: Other medical history: Reflux, asthma, allergies, high blood, pressure, anxiety; "asthma" (unspecified if ongoing), notes: Other medical history: Reflux, asthma, allergies, high blood, pressure, anxiety; "allergies" (unspecified if ongoing), notes: Other medical history: Reflux, asthma, allergies, high blood, pressure, anxiety; "high blood pressure" (unspecified if ongoing), notes: Other medical history: Reflux, asthma, allergies, high blood, pressure, anxiety; "anxiety" (unspecified if ongoing), notes: Other medical history: Reflux, asthma, allergies, high blood, pressure, anxiety; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa, penicillin, erythromycin, doxycycline; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: Sulfa, penicillin, erythromycin, doxycycline. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: erythromycin", notes: Known allergies: Sulfa, penicillin, erythromycin, doxycycline; Doxycycline, reaction(s): "Known allergies: doxycycline", notes: Known allergies: Sulfa, penicillin, erythromycin, doxycycline. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (11Jun2022) Positive, notes: positive test 11Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 28May2022 to 02Jun2022 for the treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Limited information precludes a comprehensive causality of event , based on temporal association the causal role of suspect cannot be excluded.Case will be reviewed on receipt of FU information.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
Started as acid stomach and bloating. Bloating continues till I felt I had obstructions in my colon.  Sever Abdominal pain that was felt under my right side and rib cage. So painful I could barely walk or move.
Experienced muscle pain, severe chills (3 hours), nausea and vomiting, and a high fever - I had contracted COVID-19 back in October 2020
No additional AE/PQC; PROQUAD administered post temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: S031881, expiration date: 07-APR-2021, route of administration was not provided) 0.5 ml diluted in properly stored sterile diluent. The vaccine was stored in temperatures between -9 and 8 degrees Celsius (-2.8 degree Celsius) for 5 hours and 2 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported.
Patient had syringe inserted into his right deltoid, no vaccine was introduced into arm and patient was not vaccinated. Syringe was removed from arm and disposed of in sharps container, bandaid was placed on patient?s arm, he and mother were informed of what occured. Syringe had been prepared at event 3 hours earlier and was accidentally frozen during travel. Two other syringes that were also affected were immediately disposed of. Mother was informed and gave her option of waiting while new syringes were drawn up. She declined and decided to not have her son vaccinated today.   Patient had no symptoms or adverse event reported from Mother after vaccination.
sore arm; chronic orthostatic hypotension; This is a spontaneous report from a Pfizer-sponsored program . This consumer reported (Reporter's father) that a 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7534), dose 2 via an unspecified route of administration on 20Mar2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient took first dose of BNT162B2 on 27Feb2021 for covid-19 immunization. On an unspecified date, the patient experienced sore arm and chronic orthostatic hypotension. Wanted to know what EH6205 means. States it says that or EN6205. States in a row on his dads card it says 1st dose Covid 19 and has that number then the 2nd dose is also stamped Pfizer EP7534. Outcome of the events was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site eruption in a adult female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 22nd April 2018 16:30, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, several days after receiving SHINGRIX, the patient experienced injection site eruption, injection site warmth, injection site swelling and injection site hives. On an unknown date, the outcome of the injection site eruption, injection site warmth, injection site swelling and injection site hives were recovered/resolved. The reporter considered the injection site eruption, injection site warmth, injection site swelling and injection site hives to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient was given first dose of SHINGRIX series and a few days later experienced bumps, hives, warmness, and swelling at the injection site. The health care professional reported symptoms resolved after a couple of days. The patient contacted their doctor who recommended using ice on the area.
Bleeding at injection site at time of injection; bleeding was a bit more than normal (usually no bleeding for vaccine injection or small dot). Bleeding required nurse to wipe blood away and apply pressure. Bruise developed at injection site 12 hours later with pain to touch and muscle fatigue/pain (low difficulty to lift/move arm). Pain to touch and muscle fatigue/pain at injection site lasted 3 days and gradually subsidized. Bruising is slowly fading.
swelling Lymph nodes in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling Lymph nodes in her left arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for an unknown indication.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swelling Lymph nodes in her left arm). At the time of the report, LYMPHADENOPATHY (swelling Lymph nodes in her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 013M20A), in left arm, on 10Mar2021 as dose 2, single (Lot number: 012A21A), in left arm, on 13Nov2021 as dose 3 (booster), single (Lot number: 069F21A), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: Turkey" (unspecified if ongoing); "Depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE], start date: May1997; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2000; LIPITOR, start date: Jan2000, stop date: 27Feb2023; PROZAC, start date: Apr2000; FLONASE [FLUTICASONE PROPIONATE], start date: May2004; LOPRESSOR, start date: May2009; THORNE, start date: May2011; BREO ELLIPTA, start date: Mar2012; COZAAR, start date: Feb2014; SINGULAIR, start date: Jan2015. Past drug history included: Septra, reaction(s): "Allergy", notes: known allergies: Septra; Bactrim, reaction(s): "Allergy", notes: known allergies: Bactrim. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Patient took Paxlovid from 28Feb2023 to 04Mar2023 for treatment of COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157746 same reporter/patient, different drug/event;
Information has been received from a physician concerning a female who was vaccinated SC with a dose of Zostavax (Oka/Merck). It was reported that immediately after vaccination patient experienced shortness of breath. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
COVID-19 symptoms started 01/23/22 with sore throat, coughing, and basically cold symptoms that lasted a week. Tested positive at Doctor's office on 01/24/22. I have since had a 4th injection on 04/01/22
I26.99 - Pulmonary emboli (CMS/HCC) I26.99 - Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present (CMS/HCC)
Information has been received from a registered nurse concerning an 18 year old female patient who on 19-AUG-2008 was vaccinated with the first dose of GARDASIL(lot# 660620/0571X) IM in the left deltoid. Concomitant therapy included MENINGOCOCCAL vaccine (unspecified) 4 weeks prior to GARDASIL, DROSPIRENONE(+) ethinyl estradiol (YASMIN), fexofenadine hydrochloride (+) pseudoephedrine hydrochloride (ALLEGRA D) and ALBUTEROL( inhaler). The same day, the patient experienced rash on both forearms. The next morning the patient experienced numbness and tingling in her extremities, shaking and lightheadedness that lasted 3 to 4 hours. The patient also experienced nausea for 48 hours on 21-AUG-2008, the temperature was normal. Additional information has been requested.
Injection site swollen, red, feverish, rash and nausea/vomiting  10-19-14 to 10-20-14. Shakiness- 10-19-14 evening. Extra strentgh Tylenol/Cold compress.
Joint and body pain, pain at injection site, fatigue, loss of mental focus, nausea.
I had some tenderness in the injection site. On 06/26/2022 I tested positive for COVID-19. I contacted my doct or and was prescribed Paxlovid. After taking all the prescription I felt really good.  I then felt terrible and had worse symptoms with congestion and cough.  I got in touch with my doctor because of the cough and he thought I had a secondary infection and prescribed Doxycycline.
Patient received his MMR, VARIVAX, HEP A #1 on 04/27/10.  He got a rash a week later which appears to be varicella, as a result of his VARIVAX shot.  He also have fever.
Child was crying for several hours (approximately 5 hours) straight before falling asleep. Child was his "normal self" per mother when he woke up that day. PCP saw child roughly 1 hour after vaccine administered for a previously scheduled appointment. Mother was told to give child TYLENOL, however, mother did not contact PCP after she contacted the health department to let someone now that child had been crying since vaccines were given that morning.
Initial unsolicited report received from a non-healthcare professional (Office Staff) on 01-Aug-2018. This case involves a five-year-old male patient who was inadvertently vaccinated with a dose of 0.5 ml ADACEL (frequency once, lot number: C5467BA, via unknown route in the left thigh) instead of DAPTACEL on 01-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IPOL POLIO VACCINE; MMR; and VARICELLA VACCINE. It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered as patient was administered Adacel inadvertently during his 5th dose of the series of tetanus-diphtheria-pertussis vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Child developed maculo-papular rash over right arm, abdominal wall and right side going up towards chest. This happened, 12 days, post vax. Treated with Amoxicillin.
I received 2 PPD test, a hepatitis B booster (for low titer), an IM seasonal flu vaccine, and nasal H1N1 within approx 2 months of each other.  Recurring periocular dermatitis led to patch testing and this was highly reactive for thimerosal.
Headache, Myalgia, Fever, Diarrhea & NauseaVomiting Narrative:  Employee taking Tylenol for body aches & Fever.
Patient experiencing softball sized red area at injection site that is tender to touch; Benadryl recommended, unknown if taken.
Patient said right after I injected her that she felt as if she was going to faint. I told her to lie down on the couch. she did and I elevated her feet and got a cold paper towel to put on her forehead. I asked her dad to come into immunization room also. I got her some water.  Within a minute she was ok to stand and walk outside the room.
Received Moderna vaccines on 2/28/21, 3/28/21, 11/23/21 tested positive for COVID by PCR on 3/13/22. admitted to hospital 3/13/22 w/ shortness of breath, diagnosis of COVID pneumonia. Underlying HTN, A-fib, biventricular heart failure, OSA on CPAP w/ 1 L supplemental O2.
Fasting Blood sugar - 141 on 2/15 - 6 AM.  Fasting Blood sugar - 124 on 2/16 -  6AM, 2/20 - Blood sugar - 183, 2 hours after eating.  2/15 - Fever 100.1 and agitation all day and high pulse all day
Patient presented with sensation of diffuse vibrating of body and upper and lower extremity muscle fasciculations. Described sensation as "nerves jumping". Particularly noticeable at night but constant throughout the day.  Symptoms have now been present for 6 months. Wife notices muscle twitching at night. Awakens patient from sleep periodically. Referred to neuro and nerve conduction studies and EMG studies pending.
This case was reported by a consumer and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine (intramuscular), the 2nd dose of Hepatitis B vaccine (intramuscular), the 3rd dose of Hepatitis B vaccine (intramuscular), the 4th dose of Hepatitis B vaccine (intramuscular), the 5th dose of Hepatitis B vaccine (intramuscular) and the 6th dose of Hepatitis B vaccine (intramuscular). On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.
Patient broke out in welts on the back of his neck and chest and face and chin. No respiratory distress or SOB patient was given benadryl symptoms went away. Symptoms continued to reoccur for 2 days straight.
Syncope s/p vaccine #1, full body spasm, tingling>ED  w/ pain meds/ IVF>dc'd home
extreme pain at the injection site; difficulty raising arm and lifting objects; sirva; vaccine was administered too high on the deltoid resulting in symptoms that occur with Sirva.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number E975Y, expiry date 25th June 2020) for prophylaxis.   On 17th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). On 17th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the shoulder injury related to vaccine administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Tetra 2019-2020 season.  Additional case details were reported as follows: The patient received a dose of FluLaval Tetra in an unknown deltoid. The patient had extreme pain at the injection site. The patient had difficulty raising his arm and lifting objects.  The reporter suspects the vaccine was administered too high on the deltoid, which led to vaccine administered at inappropriate site. This resulted in symptoms that occur with Sirva (shoulder injury related to vaccine administration).  The reporter consented to follow up. This is 1 of 9 linked cases, reported by same reporter.
Severe local reaction to INFANRIX, she was scratching injection site on and off x 24h then area became much more swollen and "hot".
My arm aches all the time. It is painful from the shoulder down. It is weak. It restricts a lot of activities now that I was always able to do before. I have reported it to Dr. but have not taken any treatment. This is my left arm where I had the Tetanus vaccine.
non responsive to Hepatitis B vaccine; This information has been received from the authors of the published literature article. This report was regarding a female medical resident of unknown age. Her medical school records noted that she was a non-responder to Hepatitis B vaccine (HBsAg status was not assessed).   On unspecified date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dosage, route, anatomical location, lot # and expiration date were not provided) for prophylaxis in order to meet criteria as the patient was a healthcare personnel (HCP). She had been evaluated by Occupational Health Service (OHS) at initiation of her residency.  On unspecified date, the medical resident was tested by her obstetrician and was found to be HBsAg positive, subsequently she was referred to our Occupational Health Service (OHS). Later, she was referred to hepatology for further evaluation and treatment. The student health department at her medical school was contacted, and current Centers for Disease Control and Prevention (CDC) and Advisory Committee on Immunization Practices (ACIP) guidelines for prevention of hepatitis B in HCP were provided. The authors considered that patient fail to respond to a complete HBV vaccine series (vaccination failure). The authors considered that the patient failed to respond to a complete HBV vaccine series (vaccination failure). At the reporting time, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-1912USA012702:Original Case : 1912USA011716 US-009507513-1912USA012700:Original Case : 1912USA011716 US-009507513-1912USA012700:Original Case : 1912USA011716
Patient diagnosed with Guillain-Barré syndrome, paralyzed from the neck down, unable to breath on his own.  Patient started having symptoms about a week before full paralysis on 11/18/2019.  Patient was on vacation and is now hospitalized.
Gave pediatric dose of Hepatitis B vaccine. Error reported to patient, who returned for the adult dose.
Maculopapular skin rash: trunk, arms , legs.  Still ongoing, 16 hours after onset.
Headache, chills, fever of 101.4, redness and swelling at injection site.
Pt got FLUMIST vaccine 9-28-15 (while still 9 yrs old). She came in 12-5-15 with a history of cough for 3-4 wks and had wheezing (for the first time). Wheeze onset about 5 weeks after FLUMIST dose.
my immune system is a little bit damaged; I felt a little bit in the second one; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 01), for COVID-19 immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "my immune system is a little bit damaged"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I felt a little bit in the second one".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101393020