chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I tested positive for covid-19; I tested positive for covid-19; sick; This is a spontaneous report from a contactable Other Health Professional (patient). A 68-years-old male patient received BNT162B2 (Formulation: Solution for injection, Batch/Lot Number: EN6206), via an unspecified route, administered in Left Arm on 17Mar2021 at 10:00 (Age at vaccination 68 years-old) as dose 2, single and received first dose via an unspecified route, administered in Left Arm on 17Feb2021 at 10:00 (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunisation. Medical history included hypertension and blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine (AMLODIPINE) and atorvastatin (ATORVASTATIN) taken for an unspecified indication. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and did not have Known allergies. The facility type was Health Clinic/Veterans Administration facility where the patient administered vaccine. On 08Nov2021 at 19:00 the patient was sick. On 09Nov2021 the patient tested positive for covid-19 and other vaccination failure. The patient reported that adverse effect was the vaccines did not work and tested positive for covid-19 on 09Nov2021, and I am sick. The patient underwent lab tests and procedures which included sars-cov-2 test positive and sars-cov-2 test positive as per Nasal Swab on 09Nov2021. The patient was quarantine, on bed rest and NyQuil and antibiotics had been taken as treatment. The outcome of the events was not recovered.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Sore arm; Tiredness; Shivering; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), CHILLS (Shivering) and CHILLS (Chills) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), CHILLS (Shivering) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), CHILLS (Shivering) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided.
Patient ligthheaded after vaccines; vision went fuzzy while walking past waiting room with mom. (She did not tell mother). She stumbled and recalls waking up on floor. Dr. examined pt. normal findings. Pt waited 20 minutes without dizziness before discharged again. (1st time to visit our office).
Acute onset GERD, gastritis and difficulty swallowing.  Also, asthma exacerbation requiring frequent rescue inhaler doses daily as well as a new prescription for steroid inhaler.  All of these resolved after about 2 months of treatment.
pt recv vax 1045AM;rt leg started swelling & turning very red (where vax given) & pt started crying w/high pitched cry off & on entire day;when mom called @ 5PM MD notified & incident noted on chart no more pertussis;APAP & cool compress;
Sharp heart pain/sharp pain in the heart; chest pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Jul2021 (Batch/Lot Number: ER8731) (at the age of 37-years-old) as dose 1, single for COVID-19 immunisation. Medical history included lower back pain, testicular pain, left knee pain and scabs on his head. Family medical history: father had esophageal cancer and stomach cancer. The patient's concomitant medications were not reported. The patient has no COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 08Jul2021, the patient experienced sharp heart pains, chest pains and shortness of breath. At first it was short sharp pain in the heart but now the pains are lasting longer. The patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jul2021. The patient had an EKG and chest x-ray in the emergency room (ER) on 14Aug2021 and they said everything was fine. The patient was told to follow up with a heart doctor. No treatment was given to patient for the events. The events resulted in ER visit. The patient had not recovered from the events.
Right armpit lymph node is a bit swollen and painful; Right armpit lymph node is a bit swollen and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Feb2021 (Lot number: EN6201) at the age of 38 years as dose 2, single and administered in arm right, administration date 30Jan2021 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Eczema" (unspecified if ongoing); "Contact Dermatitis" (unspecified if ongoing); "Epstein Barr" (unspecified if ongoing), notes: Epstein Barr; "Mitral Valve Prolapse" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing), notes: known allergies : Food: all nuts; "Known allergies: Sea food" (unspecified if ongoing), notes: known allergies : Food: all seafood; "Known allergies: most fruit" (unspecified if ongoing), notes: known allergies : Food:  most fruit; "Known allergies: Avocados" (unspecified if ongoing), notes: known allergies : Food: avocados. Concomitant medication(s) included: SYMBICORT; B12 [CYANOCOBALAMIN]; IBUPROFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MIRALAX. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "Right armpit lymph node is a bit swollen and painful". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Patient reported numbness and tingling in both arms, nausea and dizziness starting 4 hours after vaccination. Patient reported that she went to the ER and adverse events resolved on their own after about 4-5 hours (by 6pm).
was sitting in a chair in the waiting area and within 5 minutes of receiving her vaccination she experienced an episode of syncope and her head and upper body slumped over to the side. A customer in line noticed and rushed over, then the pharmacy technician running the register noticed and pharmacy staff ran out to assist. The syncope only lasted for a couple of seconds before she jerked herself awake. I brought her into the consultation room and she declined to lie down but requested to sit. She drank water but refused any other food or drink. She said she felt better but was visibly shaken up from the incident and was crying. She refused any medical treatment and declined when I offered to call EMS. She called her dad and asked him to pick her up. Then she sat in the consultation room for a few more minutes and left.
Father wrote DOB, one date, on vaccine consent form. Patient actual DOB is another date. Patient received vaccine at 11 years old when it is only indicated for 12 years old and up. No adverse reactions happened to patient.
He later found out the vaccine he received was undiluted; had a fever kind of thing; feeling under the weather or whatever; This is a spontaneous report from a contactable consumer (other health care professional). A 29-years-old male patient received second dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration in Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunisation. Patient received second dose two weeks ago and for 6 hours afterward had a fever kind of thing, feeling under the weather or whatever. He later found out the vaccine he received was undiluted. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts are completed. No further information was expected.
Fever of 102 all day. Nausea, but never vomited. Was in bed sleeping All day. Recovered the following day, 3-26-21
Information has been received from a physician concerning an 11 year old female patient with no medical history or drug reactions/allergies who was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 666118/1539Y) on 13-AUG-2010, and the second dose (lot number 666118/1539Y) on 20-OCT-2010. Concomitant therapy included meningococcal vaccine (unspecified) with the first dose and influenza virus vaccine (unspecified) with the second dose. It was reported that the patient experienced loss of movements and sensations of the vaccine injected arm on both occasions after receiving first and second dose of GARDASIL. The patient developed the symptoms several hours after receiving the vaccines and recovered the next day. The patient sought unspecified medical attention. No laboratory diagnostic tests performed. Additional information has been requested.
Pt recvd vax & a few days following vax pt devel pancreatitis & serum glucose changes, believed to be hyperglycemia; No further details were provided;
Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Health care professional (HCP) administered expired vaccine to 450 patients, after the manufacture date of expiration. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. Dates of administration of vaccine were reported as 10-Nov-21, 11-Nov-21 The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received on 08-Jun-22, non-significant information reporter details added.
Persistent pain in left upper arm over three months after first injection.  Worse at night. For the first month, some loss of function in left arm/shoulder but that has resolved now.  Dull pain persists.
Pt received the Pediatric Hep A vaccine. I stepped away from imz booth to fill out form for mom and when I returned, mom said he isn't feeling well. Pt looked pale, head was hanging down, and eyes closed. I shook pt, called his name, and asked if he could hear me and only nodded his head. He was not very responsive. Checked his breathing and pulse, both were fine. After talking to him a little longer and he was still responding poorly, I decided to move pt to the floor and so I could prop up his legs. During this time I had pharmacy tech go get water for him and a pillow to put pt's head on. Mom also went to get a sugary soda. We also placed a cold rag on his forehead. After laying there a few more minutes and sipping some soda and water, pt became more responsive and talking more. Mom wanted to get him up, so I help stand him up and he seemed a little unsteady but able to walk. I advised for them to stay longer, but mom thought he was okay, just had become a little light headed. I told them if he did not continue to get better and got worse, to go to ER. So with Mom walking at his side, they left the store. I followed up with mom a couple of hours later and said pt was playing video games and doing well. She also said she was checking on him frequently.
Sore arm; This is a spontaneous report from a non-contactable pharmacist reported for a patient (father in law). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose via an unspecified route of administration on an unspecified date as single dose, second dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a slightly sore arm the first night after his first and second Pfizer shot. Event took place after use of product. Outcome of the event was unknown.                                No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Chills, Headache, Fatigue, Joint Pain, Fever. Nausea
mild arm discomfort; arm turned beet red for 6 hours; This non-serious case was reported by a pharmacist and described the occurrence of arm discomfort in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received the 1st dose, refer case US2023081429).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced arm discomfort (Verbatim: mild arm discomfort) and red hands (Verbatim: arm turned beet red for 6 hours). The outcome of the arm discomfort was not reported and the outcome of the red hands was resolved (duration 6 hrs).   It was unknown if the reporter considered the arm discomfort and red hands to be related to Shingrix.     It was unknown if the company considered the arm discomfort and red hands to be related to Shingrix.   Linked case(s) involving the same patient:  US2023081429   Additional Information: GSK Receipt Date: 09-JUN-2023 The second dose was received and he experienced mild arm discomfort.   On day 5 after the second dose, his arm turned beet red for 6 hours. Follow-up not possible as no contact details provided.; Sender's Comments:  US-GSK-US2023081429:Same patient, same reporter, First dose, different events
PULLING INSIDE OF HER NASAL  CAVITY; DIZZY WHEN STAND UP AND WALK; EARS FELL FULL; PAIN IN BACK OF HEAD/ HEADACHE; NECK PAIN; PAIN AROUND THE EARS; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included factor v ligand blood clotting disorder, and seasonal allergies, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 14-MAR-2021, the subject experienced neck pain. On 14-MAR-2021, the subject experienced pain around the ears. On 14-MAR-2021, the subject experienced ears fell full. On 14-MAR-2021, the subject experienced pain in back of head/ headache. On 14-APR-2021, the subject experienced pulling inside of her nasal cavity. On 14-APR-2021, the subject experienced dizzy when stand up and walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain, pain in back of head/ headache, pain around the ears, pulling inside of her nasal cavity, dizzy when stand up and walk, and ears fell full. This report was non-serious.
pt recvd vax;severe chills,tremors,vasoconstriction;Reynaud's phenomenon w/ white fingers & numbness;absent radial pulses,stiff neck;started 1/2 hr p/vax;had 2 days of mild chills,myalgias;resolved w/IV fluids,dph over 1/2 hr;
It started out as itching, next morning  I had a big red blotch on my left elbow which lasted 2 days then the next day another one came up under my left arm,  then has continued on other parts of my body. I still have a big red plkace where I got the shot and a little white place in the center. I have been taking Benadryl which probably has help me from getting more. My doctor told me to take that. Then I have days that I getting itching spells over my body.
Fussy, "felt warm", red flat rash which began on pale then spread downward to body on May 6, 2008 (MMR and Varicella vaccine were given on 4/25/08). Rec: APAP/Motrin for fever/fussiness-no tx for rash did not seen-Call if sx worsened.
Fever; myalgia; malaise; This is a spontaneous report from a contactable Physician (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), intramuscular (vaccination location: left arm) on 18Dec2020 13:15 at SINGLE DOSE for COVID-19 immunisation. Medical history included COVID-19 (reported as prior to vaccination, patient was diagnosed with COVID-19) from an unknown date and unknown if ongoing. The patient has not received other vaccines within four weeks prior to COVID vaccine and no other medications received within two weeks of vaccination. The patient's concomitant medications were not reported. The patient has no known allergies. On 19Dec2020, the patient experienced fever, myalgia, and malaise. It was reported that patient received paracetamol (TYLENOL) for fever. It was reported that since vaccination, the patient has been tested for COVID-19 with PCR swab test on 28Dec2020 which had negative results. Outcome of the events was recovered.  Information on the Lot/batch number has been requested.
3 complete doses were drawn out of a 6 dose vial of Pfizer vaccine. Reconstitution error expected and found after a dose was given to patient. Client notified of slightly larger dose and educated on possible side effects to expect, per CDC Covid-19 vaccine administration Errors/Deviations information. Spoke with wife and spouse verbalized understanding.
During the vaccine, the nurse struggled with getting the medication to release from the syringe.  It took multiple attempts of moving the needle while injected and pushing the plunger forcefully to get medication to be injected.; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 01Apr2021 at 17:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 17:30, during the injection of the COVID-19 vaccine, the nurse struggled with getting the medication to release from the syringe. It took multiple attempts of moving the needle while injected, and pushing the plunger forcefully to get medication to be injected. The patient was uncertain if he received the entirety of the whole vaccine syringe, or if he got the complete dose. No other reactions had occurred since the injection and the patient felt normal. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event product administration error. The clinical outcome of the event product administration error was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004652: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA004663: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692:
1: Fever up to 103.7 degrees mother states. 2: 10x11 cm red +swollen area. Warm to the touch at the site of injection on left upper arm.
Missed Dose/missed a dose in between the 0 and 6 month dosing of twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Missed Dose/missed a dose in between the 0 and 6 month dosing of twinrix). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter reported that a patient missed a dose in between the 0 and 6 month dosing of Twinrix. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.