chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NECK PAIN; ARM PAIN; 40 DEGREE FEVER; STRONG HEADACHE; MUSCLE PAIN; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced neck pain. On JUL-2021, the subject experienced arm pain. On JUL-2021, the subject experienced 40 degree fever. On JUL-2021, the subject experienced strong headache. On JUL-2021, the subject experienced muscle pain. On JUL-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 40 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck pain, arm pain, 40 degree fever, strong headache, muscle pain, and nausea on 17-JUL-2021. This report was non-serious.
Visiting Teammate requested to receive her Pfizer vaccination on 4/9/21, stating this was her first dose.  Immediately after the dose was administered, the Facility Administrator attempted to enter the data into the computer and the Teammate had an entry from another facility on the day prior. Facility administrator contacted the other facility who verified that the Teammate did receive their first vaccine on 4/8/21.  Teammate did not recall receiving the vaccine the day prior. Administrator spoke with teammate on four occasions since 4/9/21 to ensure there have been no side effects. Teammate states there have been no issues.
sore arm (injection site); headache; he just felt bad; poor appetite; sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm (injection site)), HEADACHE (headache), FEELING ABNORMAL (he just felt bad), DECREASED APPETITE (poor appetite) and HYPERSOMNIA (sleeping a lot) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm (injection site)), HEADACHE (headache), FEELING ABNORMAL (he just felt bad), DECREASED APPETITE (poor appetite) and HYPERSOMNIA (sleeping a lot). At the time of the report, VACCINATION SITE PAIN (sore arm (injection site)), HEADACHE (headache), FEELING ABNORMAL (he just felt bad), DECREASED APPETITE (poor appetite) and HYPERSOMNIA (sleeping a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Having some pain at the injection site; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable female consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced having some pain at the injection site on an unspecified date. She had one dose and she was having some pain at the injection site and basically she was wondering if she should be using, she should use heat or cold for that. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
experiencing neck pains and stiffness of the neck, arm has a continuing burning feeling and skin feels like its switching
No adverse reaction, but pt was given Hepatitis A at 2 months when it should have been 12 months.
Pt recv vax & exp febrile sz. Pt taken to ER. Awake & playful in ER. Tympanic membrane red, exp fever 104f. Pt dx w/ear infect at ER.
Racing heart, lower abdominal pain, weakness, muscle aches, nausea, headache.
Neck pain the day after injection with swelling/lump appeared at base of neck with pain lasting 4 days. Pain in neck changed to swollen lymph nodes is collar bone protruding through collar bone, lymph nodes in breast swollen and painful. Swelling, tightness and burning sensation throughout left upper chest, collar bone, breast, ribs and shoulder blade. Pain and swelling still occurring. Having trouble sleeping due to issues. Have been applying warm compresses to areas and taking over the counter pain meds. Starting to worry that sus tons aren?t subsiding.
Pt received influenza vaccine 10/2/14. Called office 10/3 with c/o developing tight chest, red itchy eyes, then cough. Just wanted noted in chart 10/13 presented for office appt, c/o fever, chills, malaise, body ache and headache. Was hypotensive. Received TYLENOL, antiemetic, fluids, improved and sent home. Pt presented to hospital 10/13 in the evening critically ill, was intubated and on meds to maintain BP. She passed away 10/15/14 at 5P of multi-organ failure/septic shock.
Passing out; Feeling very faint; high fever (103 degrees Fahrenheit); Body aches; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27May2021 16:00 (at the age of 17years) (Batch/Lot number was not reported) as unknown, single for Covid-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder) and known allergies to Sulfate. Concomitant medication included tilactase (LACTAID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021 12:00, the patient experienced very high fever (103 degrees Fahrenheit) for at least more than 2 days, body aches, feeling very faint, passing out whenever she stands up for more than a couple of minutes. There was no treatment received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Nonerythematous papular rash, pruritic, generalized @ 10 days; began @ 3 d p/immunization; rx: DPH/chlortrimeton;
Severe pain in upper right arm.  Fever - 102 F;  Dizzy;  Headache;   Body ache..
I felt a sore arm for the first few days and a little nauseous but it was minor and I was able to continue working from home no problem. I felt fine when I went to bed Thursday (3 days after the vaccine) night but was awakened suddenly feeling very ill at 3am. I went to the bathroom and my face was void of color as were my lips. I then dropped to the floor as I was passing out. It was a very scary unnatural feeling. I think I passed out but I don't remember because then suddenly I was vomiting and had diarrhea. The whole episode came on suddenly (awakening me from a sound sleep) and ended about 2 hours later. I felt exhausted and nauseous for a few hours after but nothing further. It was a sudden drop in my blood pressure that was so frightening and I thought important to report. I've never had the experience before or since.
I was red and warm to touch around the injection site. It started the day of the vaccination and got larger. Patient went to her MD and MD diagnosed it as cellulitis. Patient got BACTRIM DS to treat it 2 days after getting the vaccination and it started to get better 2 days after starting antibiotic.
Myalgia, Arthralgia, chills,fatigue and injection site pain Narrative:
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 24-JAN-2017, the patient was vaccinated with an improperly stored dose of varicella VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013082.
GIVEN INJECTION AROUND 12:50 pm, patient moved to waiting area, patient passed out around 12:55 and hit head on floor.  Pt was conscious quicky, was sweaty, hot, dizzy before passing out. Applied cold rag to neck, fanned pt, eventually moved to chair.  Asked if he needed ambulance, he refused. Feeling better within about 15 minutes and patient wanted to leave.
Patient contracted COVID after 2 boosters; Patient contracted COVID after 2 boosters; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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: "COPD" (unspecified if ongoing), notes: Other medical history: COPD; "EBV" (unspecified if ongoing), notes: Other medical history: EBV; "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "HLD" (unspecified if ongoing), notes: Other medical history: HLD; "Hypothyroid" (unspecified if ongoing), notes: Other medical history: Hypothyroid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Patient contracted COVID after 2 boosters". Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient took Oral Paxlovid as anti viral for Covid-19 Treatment. Paxlovid via orally started on 25May2022 and stop on 01Jun2022. She had not any no known Allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Itching all over the body; Red injection site about a quarter size; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body) and INJECTION SITE ERYTHEMA (Red injection site about a quarter size) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (Itching all over the body) and INJECTION SITE ERYTHEMA (Red injection site about a quarter size). At the time of the report, PRURITUS (Itching all over the body) and INJECTION SITE ERYTHEMA (Red injection site about a quarter size) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Information has been received from a physician concerning a female pt who was vaccinated with a dose of varicella zoster virus vaccine live. Subsequently the pt developed a rash of one pock on the opposite are she was injected in. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/10/2006. Information has been received from a physician concerning a female patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. Follow-up information indicated that the patient developed a mild case of shingles. There was no post-herpetic lesions as of yet and mild pain. The patient later stated that "maybe I didn't have chickenpox". Although she said first that she did not have them. The patient recovered on an unspecified date. The patient had no adverse events following prior vaccination. Additional information is not expected.
Left ear tinnitus.  Started after second shot.  Persistent for 6+ months now
Generalized nonconvulsive epilepsy; Literature Report: Information has been received from the authors of a published literature article, title as stated above regarding to a child patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions and concomitant therapies.  On an unknown date, the patient was vaccinated with at least the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to prevent measles (dose, vaccination scheme, route of administration, anatomical injection site, lot number and expiration date were not reported).  On an unknown date, the patient experienced generalized non-convulsive epilepsy (generalised onset non-motor seizure). At the time of the report, the outcome of the event was not reported.  The authors considered that the event generalised onset non-motor seizure was considered to be related to suspect vaccine as this event was considered a rare consequence of routine childhood measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination.  Upon internal review, the event generalised onset non-motor seizure was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2010USA001144:
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 07-Mar-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 07-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 07-Mar-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 07-Mar-2022) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 048C21A and 053C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 07-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 07-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 07-Mar-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 07-Mar-2022) 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.  The date the vial initially stored in the refrigerator was 11-Jan-2022 which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the  Reportedly, the vial didn't undergo any temperature excursions.   The patient had not reported adverse reaction to the reporter's knowledge.  No treatment information was provided.
Facial numbness/muscle spasms in my left cheek; dizziness/brain fog/limps feel very heavy
Patient began having psoriasis; This spontaneous case was reported by an other health care professional and describes the occurrence of PSORIASIS (Patient began having psoriasis) in an 8-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 028L20A, 007B21A and 056M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (About 20 years ago). Past adverse reactions to the above products included Autoimmune disorder with Flu shot.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Patient began having psoriasis). At the time of the report, PSORIASIS (Patient began having psoriasis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 1st booster dose. No concomitant medications were reported. Patient not had COVID. It was stated that patient has funny immune system. No treatment information was provided.
11yr old patient received adult dose of Pfizer bivalent booster instead of pediatric dose
Pt developed a knot on her arm at the injection site and reported that the pain continued to her elbow.
SEVERAL DAYS AFTER IMMUNIZATION (2ND DOSE) PATIENT EXPERIENCED A RASH ON LEFT ARM IN INNER ELBOW AREA AND EXTERNAL ARM AREA ADJACENT TO ARM PIT AS WELL A LESSER INFLAMMATION ON THE LEFT REAR SECTION OF NECK. BOTH AREAS HAD EXTREME ITCHINESS WHICH LASTED SEVERAL WEEKS (OVER 4 WEEKS) NO PAIN OR OTHER SYMPTOMS. APPLIED TOPICAL BENDADRYL THAT PROVIDED RELIEF.
Patient was seen at the R by Dr. for c/o weakness and abdominal pain.  Patient was admitted with a Dx of weakness, acute kidney failure, abdominal pain, covid-19
large red swelling at the injection site; large red swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (large red swelling at the injection site) and VACCINATION SITE ERYTHEMA (large red swelling at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE SWELLING (large red swelling at the injection site) and VACCINATION SITE ERYTHEMA (large red swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (large red swelling at the injection site) and VACCINATION SITE ERYTHEMA (large red swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided
pt recvd vax; w/2nd dose of vax, pt exp weakness, dizziness & a dragged out feeling; pt had flu-like illness;
Dose 1 on 22-Jun-2021 and dose 2 on 04-Aug-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 22-Jun-2021 and dose 2 on 04-Aug-2021) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 22-Jun-2021 and dose 2 on 04-Aug-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 22-Jun-2021 and dose 2 on 04-Aug-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2022-540807 (Patient Link).