chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive/Treatment of COVID-19; Tested positive/Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6202, Expiration Date: Jun2021), in right arm, on 21Mar2021 as dose 2, single (Lot number: ER8727, Expiration Date: Jul2021), in right arm, on 16Aug2021 as dose 3 (booster), single (Lot number: EW0172), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FP4554), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild case asthma" (unspecified if ongoing), notes: diagnosed 6 years ago when her cats came into her life., Takes Dulera 100mcg/5mcg, one puff.; "High Blood Pressure" (unspecified if ongoing); "keep iron up" (unspecified if ongoing). Concomitant medication(s) included: IRON taken for blood iron decreased, start date: Oct2022 (ongoing); VITAMIN D [COLECALCIFEROL] (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Mar2023, outcome "unknown" and all described as "Tested positive/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Mar2023) positive; (17Mar2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes: Coricidin High Blood Pressure, tried Mucinex maximum strength and Mucinex Sinus Max that did not work.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300128503 same reporter, product and event, different patient;
p/vax pt became pale;mom stopped nurse to ask about color;pt given some apple juice;pt vomited small amount;stayed @ clinic for 20-30min;when pt left clinic looked great color returned only emesis x1;
pt is a resident of a long tern care facility. Vaccination requested by facility. Facility unaware that patient was previously fully vaccinated before request was made and patient was inadvertently given a 3 dose of vaccine. Error found after administration.
Information has been received from a nurse practitioner concerning a 13 year old female with no relevant medical history who at around 14:00 on 25-MAY-2011 was vaccinated with the third dose of GARDASIL into her deltoid in a local clinic. There was no concomitant medications. At around 16:00 on 25-MAY-2011, the patient developed headache, nausea, vomiting, chest pain, short of breath and erythema of her face, stomach and back, further described as erythema of the trunk of her body. On 25-MAY-2011, the consumer reported to a local hospital and she was being observed there. There was no relevant laboratory data. As of 25-MAY-2011, it was unknown if the consumer will continue on GARDASIL. She no longer experienced shortness of breath, but she continued to have headache, chest pain, nausea and vomiting. No further information is available.
plantar wart disappeared; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included plantar warts.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.     Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The reporter was the patient's wife's friend. She states that the patient's plantar wart disappeared after receiving SHINGRIX. She did not know if it was after his first or second dose.  The reporter did not consent to follow-up Additional supportive information: This case has been linked with case US2022134442 reported by same reporter.; Sender's Comments:  US-GSK-US2022134442:Same reporter
he remembered receiving Boostrix in May this year.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 22-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 32D42, expiry date 26-SEP-2025) for prophylaxis.   Previously administered products included Shingrix (received a dose of Boostrix in May 2023).   On 23-AUG-2023, the patient received the 2nd dose of Boostrix. On 23-AUG-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: he remembered receiving Boostrix in May this year.).  The outcome of the extra dose administered 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: 23-Aug-2023 The pharmacist who stated that a patient went to the pharmacy on the day of reporting and received a dose of Boostrix.  According to reporter the patient told the reporter that he was due for the vaccine and after getting the vaccine the patient went home and called back the pharmacy to report he remembered received Boostrix in May this year.  The Patient was doing alright.  The reporter was transferred to medical information for advise on this situation. The patient received additional dose of Boostrix, which led to extra dose administered.
30 min after Hep B vaccine injection pt complained of itching on arm, neck and head. Also reported tenderness on left side of throat. Tx :Zyrtec 10mg PO;Benadryl 25mg PO;Decadron 4mg IM
Chills, malaise, fatigue, muscle and joint aches, left shoulder pain at and around injection site, mild fever: 99.6; took Tylenol. Haven?t taken temps when feeling at worst. Second day symptoms continues, but not as bad. Temp 99.5 second day.
Piercing screaming episodes beginning 24hrs p/vax occurring on & off for several days;
This spontaneous report as received from a pharmacist refers to a 75 years old male patient. The primary reporter is pharmacist. Pharmacist called to report that an unspecified patient received ZOSTAVAX vaccination at an unspecified healthcare facility by an unspecified healthcare provider on 01-NOV-2012 and developed a round oval rash 3 inches in diameter at the injection site a couple of days later after vaccination. No further information is available. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced injection site pruritus. No treatment information was reported. The relatedness for injection site pruritus is unknown for ZOSTAVAX. {Additional information has been requested./Additional information is not expected.}
Sciatic nerve inflammation/; Unable to walk; Permanent nerve damage; Weakness in that nerve; This case was reported by a consumer and described the occurrence of neuritis sciatic in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced neuritis sciatic, unable to walk, nerve damage and sciatic nerve injury. On an unknown date, the outcome of the neuritis sciatic, unable to walk, nerve damage and sciatic nerve injury were not recovered/not resolved.   It was unknown if the reporter considered the neuritis sciatic, unable to walk, nerve damage and sciatic nerve injury to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix in late 2019 and experienced very severe side effect. The patient had severe inflammation in sciatic nerve and not able to walk for two months and then required cane. The patient could walk but not normally and had permanent nerve damage and still going to address weakness in that nerve. The patient would send itemized list via registered mail to corporate office. The reporter reported that if no reply was forthcoming and would engaged an attorney to assist in this matter.
arm swollen, peripheral edema, 10lb weight gain, petechiaeal rash, flu-like symptoms
Headache; Fever with temperature of 100 [unknown unit], 102.0 [unknown unit] 99.6 [unknown unit]; body aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3302; expiration date: May2021) at 54-year-old vaccination age via an unspecified route of administration in the left arm on 11Feb2021 10:30 AM at a single dose for covid-19 immunisation. Medical history included ongoing diabetes. Concomitant medications included dulaglutide (TRULICITY) from 11Feb2021 to an unspecified date for diabetes. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date: unknown) at 54-year-old vaccination age via an unspecified route of administration on 21Jan2021 at a single dose for covid-19 immunisation but had headache, low grade temperature and pain at the injection. The patient was reporting on the COVID vaccine which was given by her employer at her nursing home and who states she is experiencing some side effects. She mentioned that she had headache at 6:00 PM or 7:00 PM which was bad last night (11Feb2021) but now (12Feb2021), it was like it was when she first got it. She had a fever started around 7:00 PM or 8: 00 PM on 11Feb2021. She got up and started shivering with her temperature of 100 [unknown unit] then throughout the night it went up to 102.0 [unknown unit] and now (12Feb2021), it is 99.6 [unknown unit]. She also noticed when she noticed the fever. She took ibuprofen (ADVIL) and acetaminophen (TYLENOL). She also spoke to one of the girls in her doctor's office and was told to speak to the place where she got the vaccine, they would tell her what to do. It was also relayed if her fever got too high go to the ER (emergency room). The events did not require an ER or physician's office visit. The outcome of the events was not recovered.
How long does the shivering side effect last; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was not recovered/not resolved.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient asked how long does the shivering side effect last.
Vaccine had been placed from the freezer and fridge which expired on 10/11/21 and had been given on 10/12/21
Patient experienced swelling, redness, & warmth at injection site approximately 10.5cm x 14cm.
Approximately five days after receiving the injection; sharp, stabbing to dull abdominal pains started concentrated and emanating from about two inches to the left of my umbilicus.   Many tests have ensued without findings.
He got snotty, really snotty, sneezing and stuffed up. He had lots of drainage and also wanted to lay down after a little activity. Then I got him tested. He was tired and snotty for 2 weeks and loss of appetite lasted longer.
Irritability - loss of vocalization continues to smile/good eye contact/otherwise nl exam on visit of 12/30/10 was very vocal & interactive.
Red and swollen area (approx 31/2"0 left thigh. Pt. was advised to continue cold pack and BENADRYL. If condition worsens to to E.R.
she can be cold sometimes and hot sometimes; purple spot on arm; Pee is very yellow; not much of an appetite; chest hurts; fever; chills; feeling tired; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04May2021 at 9:00 am as DSOE 1, SINGLE for covid-19 immunisation (at the age of 47 years). The patient medical history includes she is allergic to sulfa. The patient's concomitant medications were not reported. The patient reported no investigation assessment. No history of all previous immunization with the Pfizer vaccine considered as suspect and also no additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient did not received prior Vaccinations within 4 weeks and no adverse events following prior vaccinations. The patient experienced on 04May2021 that she received her first vaccine injection on Tuesday and about 2 hours afterward she started getting a fever, chills and feeling tired and it has lasted on and off ever since them. She also reported that her pee is very yellow on 05May2021. She reported that if she drinks a lot of water it changes the color of my pee. And also reported a purple spot on her arm where she got the shot on 06May2021. Stated fever is not worse because she is taking Tylenol. It comes and goes. Caller stated that right now she is okay but she gets more tired in the afternoon. When she gets more tired, the chills start. When she breathes it starts to hurt her chest on 04May2021. She stated that maybe she should call the doctor because she doesn't know how long she is going to be like this. And she doesn't know if its normal from the shots. Also stated that she can be cold sometimes and hot sometimes. She doesn't want to do anything, just be in bed, and she doesn't have much of an appetite either on 05May2021. It was reported that everyone is saying to get the vaccine for their safety, she stated that her husband said she should do it and because she has a granddaughter, so for her and for everyone's safety. Now she is not sure she should of done it. The patient did not visited Emergency Room/Physician Office. The clinical outcome of the events fever, chills, feeling tired, pee is very yellow, not much of an appetite, chest hurts, purple spot on arm was not recovered, she can be cold sometimes and hot sometimes outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: pt said she has swallon limph node at neck - on left side and also experienced some pain on lower left calf for couple days which was resolved today. but she was worried about clots (after hearing about J&j vacine). pt has no PCP. so advised to go to urgent care to have blood work done and check out with professional
Excruciating headache, nausea/vomiting, chills,fever, body aches, and dizziness
Itchy redness at shot site starting 24 hours after and persisting for 8 days and counting now
Sore arm and aches for 2 days, then flu like symptoms, sneezing, coughing, running nose, breathing issues, headaches and body aches, Then yesterday, my left pinky finger turned blue and cold.  It appears to be cold agglutinin disease which i did not have until the 3rd vaccination.  The first 2 vaccinations only resulted in sore arm for 2 days.
When I got the shot I thought that the shot was given higher than I was accustomed to. I had left shoulder pain after injection which progressively got worse to the point it hurt to lift arm up, limited range of motion without pain, and chronic dull pain at rest. I took an NSAID around the clock since the vaccine was given but it had little affect on the pain.
Moderna COVID-19 vaccine EUA Fever, chills, nausea, lethargy, migraine, muscle soreness
Dizzy; Dry cough; Little bit of fever; Bumps on her left front side, like if it was chickenpox/Bumps on inner thigh/One bump got "really agitated"/Bum was getting quite large; Super itchy; Pinchy Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VARICELLA (Bumps on her left front side, like if it was chickenpox/Bumps on inner thigh/One bump got "really agitated"/Bum was getting quite large), RASH PRURITIC (Super itchy), DIZZINESS (Dizzy), COUGH (Dry cough) and PYREXIA (Little bit of fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A or 602F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Previously administered products included for an unreported indication: FLU VACCINE VII in 2013. Concurrent medical conditions included Epilepsy, Allergy (reacting weird to a lot of stuff) and Allergy to arthropod sting. Concomitant products included EPINEPHRINE for Anaphylactic reaction, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Epilepsy.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced HEADACHE (Pinchy Headache) and FATIGUE (Fatigue). On 19-Aug-2021, the patient experienced VARICELLA (Bumps on her left front side, like if it was chickenpox/Bumps on inner thigh/One bump got "really agitated"/Bum was getting quite large) and RASH PRURITIC (Super itchy). On 23-Aug-2021, the patient experienced DIZZINESS (Dizzy), COUGH (Dry cough) and PYREXIA (Little bit of fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) (topical) for Itch, at an unspecified dose and frequency. On 19-Aug-2021, FATIGUE (Fatigue) had resolved. At the time of the report, VARICELLA (Bumps on her left front side, like if it was chickenpox/Bumps on inner thigh/One bump got "really agitated"/Bum was getting quite large), RASH PRURITIC (Super itchy), DIZZINESS (Dizzy), COUGH (Dry cough), PYREXIA (Little bit of fever) and HEADACHE (Pinchy Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Cold-like symptoms; This is a spontaneous report from a contactable consumer (patient herself). A 7-decade old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date of 2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. Patient called in and said she is experiencing "cold-like symptoms". Patient received her first dose "several weeks ago" and guessed that this might just be "the flu" and "not related" to the vaccine. The outcome of event was unknown.  Information on Lot/Batch information has been requested.
Vaccine reconstituted with sterile water; administration of mixed powder vial with a sterile diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number x3p72, expiry date 7th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 23-June-2022 Reporter's comment: Medical assistance reported that a patient was administrated with Shingrix.  The vaccine was reconstituted with sterile water.  The Vaccine Administration Facility was the same as Primary Reporter. No adverse event was reported. No patient's identifiers was provided. No vaccination date was provided. The reporter consented to follow up.  Additional supportive information: The patient was administrated with Shingrix which was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
pt recv vax 2APR99 & 1 day later on 3APR99 pt dropped dead in yard;It was not specified if emergency treatment was administered;COD reported as sudden death;It was not specified if an autopsy was performed nor was the certified COD provided
Within 4 to 5 hours from receiving the PREVNAR 13 vaccine I started having torso pain, (from shoulder blades to lower waistline, front, back, and sides). Feeling needles sticking me, burning sensation in the waistline, knife stabbing feeling in shoulder blades, nothing could touch my torso because it caused pain.
Weakness and cold sensation in left arm and hand lasting from time of waking up until evening. 10-12hours.
Localized urticaria near both both injection sites; This spontaneous case was retrieved on 10-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1816326-1), reported by other health professional and concerned a 55-year-old female patient.  The patient's medical history was not reported. Patient's concomitant medications were Magnesium OTC, Align prebiotic and probiotic, and Zyrtec.  On 22-Oct-2021, the patient was vaccinated with Afluria Quad (influenza vaccine, dose: 'one' as reported, route of administration: intramuscular, anatomical location: left arm, indication: not reported). The batch number reported was P100360866.  On 22-Oct-2021, the patient was vaccinated with non-company co-suspect Pfizer BioNTech COVID-19 vaccine (dose: 'three' as reported, route of administration: intramuscular, anatomical location: right arm, indication: not reported). The batch number reported was ER8729.  On 25-Oct-2021, three days after receiving Afluria Quad and Pfizer, patient developed localized urticaria near both injection sites, radius about one inch.   At the time of this report, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  Company comment: The event 'urticaria' was assessed as related to Afluria QIV. Sender's Comments: The event 'urticaria' was assesed as related to Afluria QIV).
PATIENT CAME BACK TO GET SHINGRIX VACCINE AND SAID SHE HAD A BAD REACTION TO THE PNEUMOVAX VACCINE. SHE BELIEVED THE PHARMACIST HAD PLACED IT IN THE WRONG SPOT (SLIGHTLY BEHIND THE ARM). SHE COULD NOT LIFT OR MOVE HER ARM/SHOULDER FOR SEVERAL DAYS AND IT HURT VERY BADLY.  PATIENT DID GET BETTER AND SHE WAS GOOD BY TIME SHE GOT HER SHINGRIX VACCINE TODAY.