chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blurred vision that lasted nearly two weeks; Headache; bedridden due dizziness; bedridden due dizziness; extreme debilitating aches and pains; body felt numb; fever; chills; This is a spontaneous report received from a contactable nurse (who is also the patient). A 69-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: RH9899, expiry date: unknown), intramuscular in left arm, on 21Dec2020 09:30, at single dose, for COVID-19 immunization. Medical history included allergies to shellfish and bee stings. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and is not pregnant. On 23Dec2020 at 20:00, the patient experienced headache, blurred vision that lasted nearly two weeks, extreme debilitating aches and pains, body felt numb, bedridden due dizziness, fever and chills. Treatment for the events included ibuprofen (ADVIL). The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. The reporter assessed this case as non-serious.
COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. This consumer reported 2 reports for herself and her husband. This is the 1st of 2 reports. A 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Jan2021, shortly after the first dose, the patient experienced COVID-19 virus test positive. Therapeutic measures were taken as a result of the event and included treatment with monoclonal antibodies on 24Jan2021. She was scheduled for the second dose on 09Feb2021.  The information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092581 Same reporter/drug, different patient
Rash all over body, Treatment Zovirax 1 1/2 tsp, QID x 5 Days.
This spontaneous report as received from a other health professional refers to a 17 year old female patient. On an unknown date the patient was vaccinated with PROQUAD for prophylaxis. On 01-AUG-2017 the patient experienced drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. The outcome of drug administered to patient of inappropriate age and no adverse event is unknown. The reporter considered drug administered to patient of inappropriate age and no adverse event to be not related to PROQUAD.
1 or 2 days p/vax pt devel lymphadenitis of the lt side of neck;pt recovered w/o treatment;
Pfizer dose #2 given 14 days after dose #1. Dose given too early. Teen and parent notified.
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 1:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:37 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 35.31.  No concomitant medication was reported by reporter.  On 28-Feb-2021, Excursion time was 9 AM and 1 PM at temp of  27 and 26 respectively, total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. Vaccine BUD date was 26-Mar-2021. Number of vials sent to clinic 20. The batch number of product was 014M20A.  On 28-MAR-2021, Excursion time was 10 AM and temp was 35 , total doses given for the day was 150, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-MAR-2021, vial was moved to clinic on 29-MAR-2021. Vaccine BUD date was 22-APR-2021. Number of vials sent to clinic 15. The batch number of product was 019B21A .  It was reported that patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vial was punctured right before administration.   No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Moderna COVID?19 Vaccine EUA The patient received the 1st Moderna vaccine at age 17.  The Moderna EUA states that it is authorized for emergency use for age 18 and over only. The patient did not experience any adverse reactions from the vaccine.  The parent of the patient signed the consent prior to vaccine administration.  The parent (-Mother)  and patient have been notified that they received the vaccine outside of the EUA guidelines. The patient reports only mild arm discomfort and mild headache.  No adverse reactions noted. Patient's mother advised to wait until her 18th birthday to recieve the 2nd dose of the vaccine and consult her provider for further guidance.
Nasal congestion, chills no fever, exhaustion, pain at injection site. Palpitations and arrythmla.  Tylenol and bismuth subsalicylate for bloating and chest pain.
Information has been received from a pharmacist concerning his wife, a 36 year old female with celiac disease and no known allergies, who on 01-JUN-2007 was vaccinated with a dose of PNEUMOVAX 23. There was no concomitant medication. On 02-JUN-2007, the pharmacist's wife started to experience soreness at the injection site (unspecified arm). On 03-JUN-2007, she developed a headache, fever, chills, body aches, nausea, and redness with pain and swelling at the injection site. The redness at the injection site spread around the arm, and became a patch measuring 3 x 6 inches, and included a more localized injection site reaction described as a pink, warm, triangular patch. The pharmacist noted the swelling and pain had decreased, but reported that his wife "can't do much but lay on the couch." At the time of this report, the patient had not recovered from the events. The patient sought unspecified medical attention. The pharmacist considered one or more of the events to be significantly disabling/incapacitating. Additional information has been requested.
Hives appeared at injection site 3 days after administration. Hives spread to upper back/shoulder. Pt with full body itching requiring BENADRYL. Symptoms persisting 1 week after vaccine.
feeling a little nauseated; dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 2nd dose of Shingrix. On 18th January 2020, 1 days after receiving Shingrix, the patient experienced nausea and dizziness. On an unknown date, the outcome of the nausea and dizziness were unknown.   It was unknown if the reporter considered the nausea and dizziness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient felt a little nauseous and dizzy. The patient asked whether the event occurred are from vaccine. This case has been linked to US2020AMR011237 and US2020AMR011209, reported by the same reporter.
pt recvd vax 28OCT94 3PM et no sx or rx; that evening localized redness, achy joints 29OCT94-30OCT94 & today 31OCT94; reddness & itchy site the worse today 31OCT94 localized rxn approx 2"x 1 1/2" lt arm
mom reported that 4 yr old son was vax but her 7 yr old son devel chicken pox;
the patient noticed that his lower back was a bit swollen. The patient does not have any pain, just swelling which seems to be going down.; He experienced some discomfort at the injection site following the vaccination.; This spontaneous report as received from a consumer reporting on himself, a 83 year old male patient. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided.      On 17-JUL-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported).    On 17-JUL-2023, following the vaccination the patient experienced some discomfort at the injection site  (vaccination site discomfort).  On 19-JUL-2023, the patient noticed that his lower back was a bit swollen. The patient did not have any pain, just swelling (swelling). No treatment was given for the adverse events and the patient did not seek medical attention.  At the reporting time, the outcome of vaccination site discomfort was unknown, while the outcome of swelling was reported as recovering as the swelling seemed to be going down. The causality assessment between the adverse events and the suspect vaccine was not provided.
4 m.o. with known Sz d.o. was given the below stated vaccines on 10/13/08 approx 10 am. Approx 7 hrs later had approx 13 sz; Pt had a sz on 10/11 and was on phenobarbital. 12/8/08 MR received for DOS 10/13-16/2008 with D/C DX: Seizures. Pt presented from local hospital via helecopter following increasing  episodes of seizure-eyes rolling back, twitching and tightening of the upper extremities. PE (+) for hypotonia and intermittent bilateral rotatory nystagmus. Pt had continued seizures in ER tx with phenobarb, and Ativan with supression of seizures.  Full genetic and metabolic w/u obtained.  Concern for Williams syndrome due to craniofacial features and increased ionized Ca++. Further studies to be done as outpt.
Three to four hours later patient developed armpit swelling of the arm that  received the second Pfizer vaccine. All so ran a fever, heart pain and sever head pain.
first Shingrix vaccine on 6-30-2020. / will get his second Shingrix vaccine after speaking to his HCP; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 30th June 2020 intramuscularly).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received second dose of Shingrix, which led to  incomplete course of vaccination. The reporter mentioned that, patient would get the second Shingrix vaccine after speaking to his health care professional. The reporter did not consent to follow-up.
Pt developed T 6-8 hrs /p HIB vax, developed high fever (mom documented 104.2 (R)), persistant vomiting & diarrhea requiring IV fluids.
#1 Metal taste in mouth since 30 minutes after injection #2 Pain under left arm pit.  Upon inspection felt a lump and swelling.  Assume it is lymph node swelling.
Within three days of having the shot I started to notice weight gain. On the sixth day I called my doctor and I gained about 12 pounds within that week. When I stood from my knees down to my feet would hurt. I didn't feel stable like I couldn't hold myself up. My doctor told me to go to the ER 03/24/2021 and that they would probably have to do a CAT scan to rule out ascites. The doctor at the ER wanted me to see a GI and he said he didn't find anything and that he ruled out a hernia and pancreas deficiency. All my bloodwork was fine and all my test came back normal. I have three doctors who don't know and sending the U of M this September. I'm seeing a Neurosurgeon and a Endocrinologist on September 23rd. I also have an appointment for a Rheumatologist for September 16th. Right now I've gained 60lbs totally and I look like I'm pregnant. My arms, legs and stomach are firm I feel like I'm in a constant muscle spasm it just never releases. I weighed 105 lbs. and now I weigh 165 lbs. I feel like I'm turning into a statue because everything is hard/tight.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 03-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) while on long term therapy with prednisone 20 mg. On an unknown date in 2013 the patient received blood transfusion (details unspecified) and started therapy with Cellcept (manufacturer unknown). It was also reported that the patient experienced no adverse events. The outcome of the events was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
COVID POSITIVE; UNSTABLE FOR A LITTLE WHILE/SOME REACTION; FELT FAINT; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not aware of any allergic reaction but allergic to so many things. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  The patient had small reaction after each dose, felt faint and unstable for a little while when treated with covid-19 vaccine ad26.cov2.s (Dose number in series 1), which wore off after several minutes (recovered). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had small reaction after each dose, felt faint or something like that, felt unstable for a little while which wore off after several minutes (Dose number in series 2). The patient was tested positive (covid-19 virus test) about six months after booster dose (Dose number in series 2). The covid-19 vaccine ad26.cov2.s worked well for the patient since the patient was allergic to so many thing.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unstable for a little while/some reaction, and felt faint, and the outcome of covid positive was not reported. This report was non-serious. This case, involving the same patient is linked to 20230129371. This case, from the same reporter is linked to 20230128189. This case was associated with product quality complaint: 90000267010 and 90000267011.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Contract employee reports approximately 25 minutes after receiving her second covid vaccination she began to experience mild numbness in and slightly below her right ear. She reports her hearing sounding "muffled" in her right ear. This employee was monitored for a total of 60 minutes in the observation area and reports no worsening of symptoms at the 60 minute mark and felt comfortable leaving the location. She reports having similar symptoms with the first Covid vaccination she received but denies reporting it to Employee Health department or submitting a  report herself. She does state she reported the symptoms on the daily check-ins.
On Tuesday, 9/20/2022 Pt. stated she experienced left arm pain after I extracted the needle from her arm. She left the office and an hour later, she sent a message on her portal account stating she had pain up to her neck and down her arm. She said her arm felt weak and she couldn't perform normal tasks such as opening a door or chop vegetables. On Friday, 9/23/2022 she stated there is still pain in her left shoulder, arm, neck but getting better. She stated she played golf on Thursday, 9/22/2022. On Friday, 9/30/2022 she stating she had a two-hour deep tissue massage on Wednesday, 9/28/2022 to help relieve the stiffness in her neck and shoulder. She stated she was taking Advil. On Saturday, 11/12/2022 Saturday, 11/12/2022 she stated her shoulder was worse: constant aching, limited range of motion when lifting up, pain is constant whether washing & drying her hair, playing golf, doing normal daily activities. Pt. was seen by her PCP on Monday, 11/14/2022 and stated pain is worse with overhead flexion. Takes Aleve before playing golf. Per PCP objective assessment: left shoulder with 160 degree of flexion which reproduces pain. No drop sign. No AC TTP. No bicep tendon TTP. Stated pain level 5 on a 1-10 pain scale.
Her lips are really dry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 11:30 (Batch/Lot number: unknown) as dose 1, single and administration date 16Mar2021 10:22 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIP DRY (non-serious), outcome "unknown", described as "Her lips are really dry".  Additional information: The reporter reported ulcers in her mouth, her niece 23 years old also has ulcers in her mouth , and sister, 67 y/o, complains her lips are really dry and asked if these are common and can caller receive the second dose. When speaking to caller myself she had only made mention of the ulcers she is experiencing and that she has seen her doctor and was prescribed  Magic Mouth wash. The caller reports on herself and says her sister-in-law said her lips were really dry and she didn't correlate it to the vaccine. She says her sister-in-law hasn't called in any of this information yet. The patient did not have Prior Vaccinations (within 4 weeks). Follow-up attempts ae needed. Further information is requested. Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient describes "numbness" in his left arm. He also claims that this is the same arm of which he has had surgery on in the past.
Nose bleed for a minute or two on 4 consecutive days - 11/29/2021, 11/30/2021, 12/01/2021, 12/02/2021 so far.  Don't know whether this will continue.
I can no longer thunk straight, things r being confiscated in my head. Extreme anger, axgiated madness. Intense migaines  and muscular weakness. Bell's palzy.
None at time of moderna vaccine 1 or 2 but on the 3rd day after vaccine 2, 02/11/2021, I was given the degarelix injection in the stomach which resulted in an allergic reaction with hives and difficulty breathing. and swallowing.  The second degarelix injection on 03/11/2021, was no reaction but on the third injection on 04/08/2021, 911 was called at the Urologists Office to take me to ER in Medical Centre with a  severe life threatening allergic reaction, difficulty breathing, hives, swollen face, hands arms, body., sickness and wanting to clear my throat.  I have been having degarelix injection on a monthly basis since 2017, with no adverse reaction.
Mother of pt called and said 2 days post vaccinations child's left leg was red, warm, tender and swelling. Comparable to half dollar size of coin. Denies crying or fever and afebrile.
lower back pain; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2), on 19May2022 at 11:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Mange symptoms of Hereditary angioedema" (ongoing); "Genetic blood disorder" (ongoing), notes: Hereditary angioedema type 1; "Hereditary angioedema type 1" (unspecified if ongoing). Concomitant medication(s) included: HAEGARDA intramuscular taken for hereditary angioedema, start date: 2018 (ongoing). Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Vaccination; Bnt162b2 (Dose: 02), for COVID-19 Immunization, reaction(s): "like being crushed underneath a train car for 4 days". The following information was reported: VACCINATION SITE PAIN (medically significant) with onset 20May2022 at 11:00, outcome "recovering", described as "injection site pain"; BACK PAIN (medically significant) with onset 20May2022 at 11:00, outcome "recovering", described as "lower back pain".  Clinical course: The patient reported that "on 20May2022 the day after my booster; I had lower back pain and injection site pain that was extreme couldn't bend, sit or get up from any position. This was strong and disability for 5 days. Another 8 days the pain was more tolerate. At this point I feel some pain briefly for seconds some. Where in my day to day activities."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.