chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart is racing; This is a spontaneous report from a Non contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Says she has an appointment with her doctor. She had the Pfizer Vaccine 2 Thursdays ago. States she hasnt had problems except that her heart is racing. The patient experienced heart is racing on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I got the first dose of the Moderna COVID-19 vaccine last Thursday (1/14/21) at clinic and had a pretty severe reaction within a few minutes of the receiving the vaccine. I didn?t alert anyone because I wasn?t sure if it was related to the vaccine or not. I felt hot suddenly, then very dizzy/faint, then experienced very bad tinnitus and couldn?t hear any of the words being spoken around me, just muffled sounds. I felt slightly nauseous, was seeing spots, and felt very close to fainting. My pulse was racing. I did deep breathing  until it subsided (which was about 10 minutes later). For the next 5 days after the vaccine, I experience extreme soreness and weakness in the left arm where the injection was given. I also had redness and itching and it was hot to the touch and slightly swollen. I had extreme fatigue and a headache and a loss of appetite. After 5 days, those subsided. 1 week after the vaccine (01/21/21),  I experienced intense itching at the injection site and redness and it was hot to the touch. I also experienced intense itching on my chin and skin numbness in that area of my chin. The chin area resolved after about 4 hours. The arm itching did not resolved. i woke up on 01/22/21 with the entire left shoulder area swollen, red, hot to the touch, and extremely itchy. it lasted all day. I woke up on 01/23/21 and the swelling had gone down, but the redness spread to a larger area on the upper left arm and the itching persisted all day. I woke up on 01/24/21 and the redness and swelling was almost gone but the itching was still there and the area that had swollen up felt very bruised, but no visible bruising. Today (01/25/21) there is no more itching or redness but the bruised sensation continues.
Information has been received from a physician concerning an 88 year old male with parkinson's disease and no known drug allergies who on 17-SEP-2009 was vaccinated IM into the right arm with a 0.5ml dose of PNEUMOVAX (lot# 662785/1124X), concomitantly with a dose of influenza virus vaccine (unspecified). Concomitant therapy included MIRAPEX, methimazole, docusate Na, carbidopa/levodopa, SENNA LAX and TYLENOL. The physician reported on 18-SEP-2009, the patient developed cellulitis. The patient's right arm was swollen and red. On 19-SEP-2009 he experienced severe diarrhea and fever. He was admitted in a hospital on 19-SEP-2009. He was treated with antibiotic and BENADRYL. He was released from the hospital on 21-SEP-2009. On unknown date, the patient recovered. A lot check has been initiated. Additional information has been requested.
Fever; chills; extreme fatigue; ever joint in my body hurt.; was painful just to move my fingers or any joint in my body; I felt like I was freezing but I was wrapped in blankets.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 13:15 (Lot number: 33026130) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LYRICA. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 20Feb2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "extreme fatigue"; ARTHRALGIA (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "ever joint in my body hurt."; PAIN (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "was painful just to move my fingers or any joint in my body"; FEELING COLD (non-serious) with onset 13Nov2021 20:00, outcome "recovering", described as "I felt like I was freezing but I was wrapped in blankets.". Therapeutic measures were not taken as a result of pyrexia, chills, fatigue, arthralgia, pain, feeling cold.  Additional Information: Patients had no other vaccines in four weeks, the patient had no covid prior vaccination and have not been tested since the vaccination   No follow-up attempts are possible. No further information is expected.
04/02/2005-after MD visit- throat felt like it was closing. Saturday- DR - pills for "allergic" MD said only take 2 days Before she went took Benadryl x2 days herself. Rash, swelling to face- 03/31/05 and 04/01/2005- arm redness, face and neck rash, pain, throat tight.
Tingling of feet then hands and chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 18Sep2021 as dose 1, single (Lot number: FE3592) at the age of 38 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: DICLOFENAC; OMEPRAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: PARAESTHESIA (disability) with onset 24Sep2021, outcome "not recovered", described as "Tingling of feet then hands and chest". The events "tingling of feet then hands and chest" required physician office visit. The patient underwent the following laboratory tests and procedures: Test: (29Dec2021) diagnosed with Multiple sclerosis; SARS-CoV-2 test: (unspecified date) Negative, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of paraesthesia. Clinical course: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks: Diclofenac, omeprazole, Zyrtec, pine bark extract. Started with tingling of feet then hands and chest. Soon the chest and feet stopped tingling but the hands never did. Had multiple tests ran and was diagnosed with Multiple sclerosis on 29Dec2021. Adverse event treatment: Kesimpta. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated with the first and second dose of GARDASIL (Lot # unspecified) on 20-JAN-2011 and 19-APR-2011. No other co-suspects were reported. No concomitant medications were reported. At time of the report the patient was in the office to receive the final dose of GARDASIL (Lot # unspecified) on 09-AUG-2012. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Intense shivering from 9:00-9:30 PM day of injection; fever from 5:10 PM day of injection until about 7 PM day after injection (ranging from 100.5-101 before beginning to drop late the next day after injection). One dose of ibuprofen was taken at 9 AM the morning after injection. All symptoms were gone by 7 PM the day after the injection.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL8982), in right arm, on 25Feb2021 as dose 2, single (Lot number: EN6200), in right arm, on 04Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in right arm and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "known allergies: Lisinopril". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2023) Negative, notes: I tested negative for COVID; (25May2023) Positive, notes: Three days later, I tested positive for COVID as symptoms returned; (04Jun2023) Negative, notes: Ten days later, I finally tested negative again. Therapeutic measures were taken as a result of covid-19, vaccination failure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant therapies were not reported. On 08-FEB-2017, the patient was vaccinated in error with an expired dose of PNEUMOVAX23 lot # L024132 with expiration date 21-JAN-2017, intramuscularly (dose and frequency were unspecified) for prophylaxis. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Positive rash on back of neck 3-5 hrs after Hep B immunization rash expanded unto chest and face, positive itchy.
5cm X 4cm erythema, minimal induration on left deltoid. Treated with Benadryl and Keflex.
Shingles; Pain on skin on backside; This is a spontaneous report from a contactable consumer or other non hcp.   A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. Historical Vaccine first Dose: Date Administered: 06Apr2021; Lot Number: EP6955; Anatomical Location: Caller reported that she doesn't remember, but probably her left arm for covid-19 immunisation. on 06Jul2021 20:00 Caller reported that she went to her health care provider today because she had a pain on her skin on her backside. 07Jul2021 20:00 Caller reported that she was diagnosed with shingles and the health care provider asked if the caller had gotten the Covid-19 vaccine.  Outcome of the event back pain was not recovered, for the event shingles was unknown.   Follow-up attempts are completed. No further information is expected.
ADE illness due to her Moderna vaccines; Lung fibrosis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINE ASSOCIATED ENHANCED DISEASE (ADE illness due to her Moderna vaccines) and PULMONARY FIBROSIS (Lung fibrosis) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINE ASSOCIATED ENHANCED DISEASE (ADE illness due to her Moderna vaccines) (seriousness criterion medically significant) and PULMONARY FIBROSIS (Lung fibrosis) (seriousness criterion medically significant). At the time of the report, VACCINE ASSOCIATED ENHANCED DISEASE (ADE illness due to her Moderna vaccines) and PULMONARY FIBROSIS (Lung fibrosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Patient did not develop antibodies to the nucleocapsid and spike antibody was off the chart, more than 2400.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported. No treatment details were reported.  The patient had lung fibrosis from antibody-dependent enhancement (ADE) illness due to Moderna vaccines.  Company comment: This spontaneous case concerns a female patient (age unspecified), with relevant medical history of pulmonary fibrosis, who experienced the unexpected serious (medically significant) events of Vaccine associated enhanced disease (AESI) and Pulmonary Fibrosis, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The outcome of the events was reported as unknown. Details of duration of pulmonary fibrosis, concomitant medications, clinical course, further investigation reports, and treatment were not provided. Medical history of Pulmonary fibrosis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient (age unspecified), with relevant medical history of pulmonary fibrosis, who experienced the unexpected serious (medically significant) events of Vaccine associated enhanced disease (AESI) and Pulmonary Fibrosis, on an unspecified date after receiving a dose of mRNA-1273 vaccine. The outcome of the events was reported as unknown. Details of duration of pulmonary fibrosis, concomitant medications, clinical course, further investigation reports, and treatment were not provided. Medical history of Pulmonary fibrosis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
LD RED AND PAINFUL TEMPURATURE 98.6 NO PAIN ONLY SORENESS.  WAS INSTRUCTED TO SEEK MEDICAL ATTENTION IF GOT WORSE.
Sore in neck and lower back; Sore in neck and lower back; Body aches; Lightheaded; Fatigue; A spontaneous report was received from a nurse concerning a 29  year old, male patient  was participating in the mRNA-1273 Emergency use  program and experienced sore in neck and lower back, body aches, lightheaded and fatigue.  The patients medical history included allergy to orange juice and COVID-19 positive. Concomitant medications included fluoxetine, trazodone and amphetamine/dextroamphetamine .  On 23 Dec 2020, 15-20 minutes prior to the onset of sore in neck and lower back pain, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. A few hours later he experienced body aches,lightheaded and fatigue . No treatment information was provided.   Action taken with mRNA-1273 in response to events, sore in neck and lower back, body aches,lightheaded, and fatigue was unknown.  The  events were considered not recovered as of 24DEC2020.; Reporter's Comments: This case concerns a 29 year old male patient who experienced non-serious unexpected events of Neck pain, Back pain, Pain, and Dizziness, and a non-serious expected event of Fatigue. The events of Neck pain and Back pain occurred 15-20 minutes after first dose of mRNA-1273 administration. The events of Pain, Dizziness, and Fatigue occurred a few hours after first dose of mRNA-1273 administration. Very limited information regarding this events has been provided at this time.  Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Skin rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 30Jan2021 08:00 (at the age of 69years) as single dose for Covid-19 immunization. Medical history included hypertension and allergies: penicillin, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 13 days after first dose on Friday 12Feb2021 (22:00), a skin rash occurred in all of the patient's body. The patient used Benadryl in tablets and topical Benadryl. Rash worsened 5 hours after first Benadryl dose. The patient was still monitoring the symptoms. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering.  Information about batch/lot number has been requested.
Redness, swelling, pain, itching and induration of approx. 4" X 4" to injection site w/c is the left lateral thigh. Area also feels hot. Follow-up call on 3/6/01, pt recovered.
Patient removed bandage one day after vaccination. Area was red, slightly swollen and slightly itchy, about the size of a silver dollar when observed on 10/21/17.
Patient came in to get a pneumonia and pfizer bivalent covid vaccine. When preparing the paperwork and pulling the vaccine from the fridge a pharmacy technician  grabbed a non-bivalent covid vaccine. While verifying the prescription and the vaccine that was selected the pharmacist failed to identify the incorrect product. Patient was given the non-bivalent vaccine in his right arm and the Prevnar 20 vaccine in his left arm. He was contacted 2 hours after receiving the vaccine and notified of the incident. He was very upset regarding the incident but did not report any adverse events. The pharmacist has reorganized the COVID Vaccine  drawer in the fridge, more clearly separating the non-bivalent vaccines from the bivalent vaccines.
INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On 11-JAN-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000237049. This case, from the same reporter is linked to 20220649045, 20220649137, 20220649370, 20220649417, 20220649488, 20220649626, 20220649803, 20220649804, 20220649884, 20220649915, 20220649704, 20220649421, 20220650185 and 20220650111.
PAIN IN LOWER BACK; GOUT IN LEFT KNEE; COVID-19; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On AUG-2021, the patient experienced covid-19. On an unspecified date, the patient experienced pain in lower back, and gout in left knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from covid-19, and had not recovered from pain in lower back, and gout in left knee. This report was non-serious.
Administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.   It was reported that the vaccine was stored in freezer, one of two vials were taken out and placed in fridge each day as needed.  No treatment given to the patient.
Joint pain in the left foot and ankle, and both wrists.  Started about 3 to 4 days after first Moderna vaccine.  Progressively worsened over the next week until I had sever pain-8 out of 10 in joints of both shoulders, elbows, wrists, hips, knees, and the left foot/ankle.  Pain became debilitating and went to local medical clinic.  Ran blood tests. A week later pain worsened and went to ER.  Could barely get out of bed, walk.   ER doc put me on a tapering course of Prednisone for 12 days.  Almost complete relief of joint pain within 4 hours.  Once down to 10 mg per day the pain returned.   Had a GP telemed appointment and doc put me back on prednisone-30mg per day.  Not complete relief of pain but certainly better than nothing.