chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fell to the ground. I had no control over my legs/legs gave out and I fell to the ground; fell to the ground. I had no control over my legs/legs gave out and I fell to the ground; This is a spontaneous report from a contactable other hcp (Patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 36-year) in left arm on 04Sep2021 at 11:00 AM as dose 1, single for COVID-19 immunization. Medical history included Sulfa allergies, COVID-19 (COVID prior vaccination: Yes), both from an unknown date and unknown if ongoing. There were no concomitant medications. Reported facility type vaccine was Pharmacy or Drug Store. Patient not tested COVID post vaccination. Patient received no other vaccine in four weeks. Patient received no other medications in two weeks. On 05Sep2021 at 07:00 AM the patient experienced fell to the ground. She had no control over my legs/legs gave out and she fell to the ground. It was reported that "the patient received her initial COVID vaccine dose on 04Sep21 at 1100. On the morning of 05Sep21 around 0700, she walked outside her back door, stepped down two steps onto the patio then took a few more steps walking onto the patio and then fell to the ground. She had no control over her legs. The very same thing happened, the very same day later that evening around 1700. Her legs gave out and she fell to the ground." The patient received no treatment for the adverse events. The clinical outcome of the events was resolved on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
This spontaneous report was received from a Registered Nurse concerning an unknown number of patients of unknown age and gender. On unknown dates incorrectly stored doses of GARDASIL (lot # L038135, Exp date: 27-MAY-2017 could have been administered. It was reported that, on an unknown date, the refrigerator was out of range for 22 hours with a highest temperature of 48.6 F. Temperature was back in range at the time of call. The Registered Nurse reported that vaccines could have been administered before the excursion was identified. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
itching; burning; shingles; stomach ache; shiver; headache; dizziness; muscle ache; Rash; Injection site pain; red; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax vaccine  with an associated reaction of herpes zoster (Shingles many years ago and had Zostavax vaccine many years back).   On 23rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, rash and erythema. On 24th October 2019, the patient experienced shingles, stomach pain, shivers, headache, dizziness and muscle pain. On 25th October 2019, the patient experienced burning sensation. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the shingles, injection site pain, stomach pain, shivers, headache, dizziness, muscle pain, rash, burning sensation, pruritus and erythema were unknown.   It was unknown if the reporter considered the shingles, injection site pain, stomach pain, shivers, headache, dizziness, muscle pain, rash, burning sensation, pruritus and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in left arm and experience stomach ache, shiver, headache, dizziness, muscle ache. The injection site was painful with redness but she states about 2 inches below the injection site also it is slightly red with itching. She stated at the time of reporting she started to experience burning sensation from the left side of her back to the left breast, and stating she was feeling that she might be getting the shingles. No blisters observed at this time. The reporter consented to follow up.
Arm painful, extending from mid shoulder to elbow and shoulder blade to sternum. Weak; severe headache, nauseous, low fever for 5 days. Recovery took 12 days.
about 8 to 10 hours after the vaccination started with extreme fatigue, then turned into sweating then chills accompanied by severe joint pain and the injection site was very painful, that last until Monday morning once those symptoms cleared I developed a genital ulcer. I do not have a history of having genital issues and I had no clue you could even get an ulcer in that area.
Syncopal reaction related to the HPV vaccine.  Recovered well with fluids and food.  Remain in the clinic for about 30 minutes and was able to leave in good standing with his father.
Generalized itching with hives that developed. 8 hours after vaccine administration per client. Client took a few spaced doses of BENADRYL with relief from symptoms. No itching or hives noted 48 hours after admin. When client seen for follow-up of something else.
Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; This is a spontaneous report from a contactable other health care professional. A 45-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose (lot number: EH9899); via an unspecified route of administration on 17Dec2020 14:00 at single dose at arm left; second dose (lot number: EK9231) via an unspecified route of administration on 08Jan2021 00:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, chronic back pain, Allergies to medications, food, or other products: Avocado. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), celecoxib (CELEBREX), pregabalin (LYRICA), triamcinolone acetonide (NASACORT), omeprazole. On 08Jan2021 09:00, the patient experienced Headache, pain at injection site, nasal congestion, nasal pain. The events were assessed as non-serious. There was no treatment received for the events. The outcome of the events was recovering.
She developed 3 isolated episodes of 30-90 minutes where she has tingling and burning in bilateral hands, worse in right, and worst in the thumb. No symptoms in feet.
got the shot and is now  having shingles outbreaks/ suspected vaccination failure; shingles outbreaks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. The patient got the shot and was now constantly having shingles outbreaks all the time. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
acute back pain of which they found it was a pinched nerve; acute back pain of which they found it was a pinched nerve.; May or may not receive second dose in time (may be greater than day 36); This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (acute back pain of which they found it was a pinched nerve), BACK PAIN (acute back pain of which they found it was a pinched nerve.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May or may not receive second dose in time (may be greater than day 36)) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NERVE COMPRESSION (acute back pain of which they found it was a pinched nerve), BACK PAIN (acute back pain of which they found it was a pinched nerve.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May or may not receive second dose in time (may be greater than day 36)). At the time of the report, NERVE COMPRESSION (acute back pain of which they found it was a pinched nerve), BACK PAIN (acute back pain of which they found it was a pinched nerve.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May or may not receive second dose in time (may be greater than day 36)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Tinnitus. Quite loud. Hissing like steam coming out of  radiator. Both ears. Constant. I can sleep without hearing it. If distracted by work or home project, it goes into background, still there but less annoying. If quiet, or just watching tv, always they?re  and quite annoying.
pt recvd vax & reported swollen rt eye; pt did not rub eye; no fever; adm mom to call PMD; pt taken to ER: generalized hives;
Rash that is papular, ecchymotic and extending round patch approximately 4-5 cm on the right hip proximal to area of thigh vaccinated. Mother self-treated with hydrocortisone and area persisted for 8 days at my evaluation. Additionally child with hives erupting 8 days after vaccination with fever 9 days after vaccination without other clear etiology.
Excessive sleeping, hand shakes and had trouble holding spoon and fork.  Use walker and could not balance (very groggy). Kept wanting to fall.  Had to have wife help to get into bed on Friday night.  Saturday was better, but still needed help.  Sunday better and today Monday doing better.  If Moderna  second shot is known to be much worse for side effects, should it be taken?
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Iodine allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for COVID 19 Treatment from 21Mar2023 to 26Mar2023. Patient reported that after finishing Paxlovid 5 days treatment, 5 days later she had Covid-19 rebound symptoms include running nose, fatigue and dry cough.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID-19, which is considered as ineffectiveness of the vaccine, and the administration of BNT162B2, BNT162B2 OMI BA.4-5, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.,Linked Report(s) : US-PFIZER INC-202300147508 same patient, different drug/event;
weak and tired; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date May2021 (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 1), for Covid-19 immunisation. The following information was reported: ASTHENIA (non-serious) with onset May2021, outcome "not recovered", described as "weak and tired"; FATIGUE (non-serious) with onset May2021, outcome "not recovered", described as "tired".  Additional Information :He took the second shot on Saturday, and then he was okay. He feels so tired, and weak.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives that blew up into a 1-1/2x1 inch lesion that formed a large blister.  After it popped I had a lot of raw flesh that looked like a burn wound.
Severe tightness in shoulder and pain; unable to close car door with normal arm; unable to undress without help. Pain still exists as of 11/18/11.
my arm was very sore but I was concerned with a lump on the back of my skull of my left ear, after 3 days the lump had not subsided and it hurt, I went to urgent care. I was prescribed a painkiller cyclobenzaprine 5mg  but I didn't take any of it and provided information regarding lymph nodes and that it was normal . lump went away after a few days and came back after the second shot.
felt very weak; really bad headache; fever; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt very weak), HEADACHE (really bad headache), PYREXIA (fever) and NAUSEA (nauseated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     no medical history information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced ASTHENIA (felt very weak), HEADACHE (really bad headache), PYREXIA (fever) and NAUSEA (nauseated). The patient was treated with IBUPROFEN for Headache, Fever, Weakness and Nauseated, at an unspecified dose and frequency and ACETAMINOPHEN for Headache, Fever, Weakness generalised and Nauseated, at an unspecified dose and frequency. At the time of the report, ASTHENIA (felt very weak), HEADACHE (really bad headache), PYREXIA (fever) and NAUSEA (nauseated) outcome was unknown.            no concomitant product was reported. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
mom called stating leg red & had bled following vax; mom stated pt had t104.8 orally; instructed to given APAP; instructed to call MD:
hair hurting; fever ( 102.7 F ); chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of HAIR INJURY (hair hurting), PYREXIA (fever ( 102.7 F )), CHILLS (chills) and MYALGIA (body ache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced HAIR INJURY (hair hurting), PYREXIA (fever ( 102.7 F )), CHILLS (chills) and MYALGIA (body ache). At the time of the report, HAIR INJURY (hair hurting), CHILLS (chills) and MYALGIA (body ache) outcome was unknown and PYREXIA (fever ( 102.7 F )) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, Body temperature: 102.7 (High) fever ( 102.7 F ).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 26-NOV-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022 at 12:21 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Feb-2022 at 12:21 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
5/30/2022-Presents to ED, c/o of abrupt chest pain. AAA repair done on 5/3/2022. Covid + test. Afebrile BP 86/62. Resp 24. Admit septic shock  and b/l Covid PNA. Not hypoxic on 2 mic of Levophed. Maintaining 02 on RA. UA revealed WBC above 180. CXR: multilobar r lung infiltrate. Cardiomegaly with signs of pulmonary edema: Ordered Lasix, prednisone, bebtelovima, cefepime and Doxy. Urology consulted continue with IV antibiotics.  5/31/2022- On heparin gtt, off Levophed. Continue cefepime and doxy.  6/1/2022- Transfer out of ICU. Continue IV lasix,  Follow up with Urology for stent outpatient. Off pressors. VSS stable on RA. D/C home.
Information has been received from a health professional concerning a female who on an unspecified date was vaccinated with a dose of Zostavax. On day after vaccination the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint was involved. Additional information has been requested.
RN) failed to dilute the Covid vaccine prior to administering.  The child received 0.2 ml Pfizer Bivalent vaccine undiluted.
This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-000002896. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". Additional information: On 05Aug2022, it was reported that a patient started treatment on an unreported date with mRNA vaccine at an unreported dose/frequency for an unreported indication. It was reported the patient had an allergic reaction and was seeing an immunologist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red itchy bumps appeared on the right side of my abdomen. They were in a strip around the area of my bra strap around the middle of my ribs. After about 3 or 4 days, these areas became sensitive and  painful, like a moderate sunburn. the itchiness and pain has begun to subside as of Sept. 27.
Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed the event as possibly related to Moderna vaccine and did not provide any causality assessment for the event with Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.