chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fatigue; Nausea; Weakness; Headache; GI distress; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 17Mar2021 at 18:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine, asthma, GERD, obesity. The patient was allergic to avocado, shellfish, penicillin. Concomitant medications included lansoprazole (MANUFACTURER UNKNOWN) , montelukast sodium (SINGULAIR), erenumab (AIMOVIG), nortriptyline (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: C1821), via an unspecified route of administration in the left arm on 24Feb2021 at 18:00, (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Mar2021 at 18:00, the patient experienced chills, fatigue, nausea, weakness, headache and GI distress. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events chills, fatigue, nausea, weakness, headache and distress gastrointestinal was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt recvd vax & 48 hrs following vax had swelling hot entire rt arm; was seen by MD; treated w/DPH;
She got her vaccine, just felt a little bit weirdness in the arm, and felt that she would just give it time.  For the week it was completely sore to the point that she could not lift it up.  She has never had a reaction to any vaccines.  She was told that it was normal and she said OK.  Then about 10/1/21, she noticed that all of a sudden she felt like something was being pulled inside her arm, burning sensation as if she was getting a flu shot.  She started rubbing her arm and scratched it and was trying to feel to see if there was something, it just always pulls and burns now.  She doesn't know if it's a cramp but just a burning sensation.  She cannot carry her purse on her arm now, and swing her arm back as it triggers the pain to the point that she screams in pain.  She took some anti-inflammatories three times (Ibuprofen 800 mg), and this has not relieved her symptoms.  If she needs to use the arm she can't and she works in the hospital and picks up patient's and it's affecting her job performance.
Almost 2 weeks after my second covid shot I had a fever, runny nose, fatigue, and general achiness.  It started on Wednesday and the fever was gone on Friday morning.  I still feel a little fatigue, but am otherwise OK.  This may be unrelated to the vaccine I received on February 18th. I am only reporting it because it might have been related.
WAS NOT ABLE TO WALK; NEUROLGICAL PROBLEMS WITH HIS LEGS; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight was 90.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin.  On an unspecified date, the patient experienced possible reaction to the Covid vaccine, patient was not able to walk and neurolgical problems with his legs. The patient was hospitalized since 14-MAR-2021.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neurolgical problems with his legs and was not able to walk was not reported. This report was serious (Hospitalization Caused / Prolonged).  This case, involving the same patient is linked to 20210132481, 20201218555, 20201109402, 20201033394, A-NJ2017-162166, A-US2016-145072, A-NJ2016-130161, A-US2015-129188, A-US2014-94192, A-US2019-188952 and A-NJ2014-109450.; Sender's Comments: V0: 20210343964-COVID-19 VACCINE AD26.COV2.S - Was Not Able To Walk, Neurological Problems With His Legs. This event(s) is considered Unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Fever, chills, body aches, sore arms, head ache, dizziness, feeling loopy. Treated with Tylenol extra strength every 4 hours. Fever ranged from 101.98 to 99.84 and stayed consistent through out the day. The Tylenol dropped the fever at the beginning of the 4 hours but did not go below 99.84. Body aches started around 6am and continued through out the day. The Tylenol helped lessen the pain. The  dizziness started around 10am and only subsided a bit when I slept for a few hours around 2pm.
Patient stated feeling dizzy and nauseas, patient presented with red hives along right side of the neck, PT also presented as diaphoretic and pale. PTs lung sounds were clear and patients air way remained open.  vitals were  SPo2: 97% HR: 85 BP: 145/90
he puts a bandage on his skin and take it off it pulls layer of  his skin and it bleeds; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (he puts a bandage on his skin and take it off it pulls layer of  his skin and it bleeds) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0321321a) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN HAEMORRHAGE (he puts a bandage on his skin and take it off it pulls layer of  his skin and it bleeds). At the time of the report, SKIN HAEMORRHAGE (he puts a bandage on his skin and take it off it pulls layer of  his skin and it bleeds) outcome was unknown.            Concomitant medication was not reported.No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.
This is a spontaneous report received from a contactable physician. A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had chills (non-serious), with outcome of unknown. Additional information: Patient got chills 8 hours later. No follow-up attempts possible. information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021379915 same reporter/drug/AE, different patient.
Given covid vacc booster from vial that was expired by a couple of hours; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours) and PRODUCT STORAGE ERROR (Product storage error) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for an unknown indication.     No Medical History information was reported.    On 19-Nov-2021 at 8:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 8:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours) and PRODUCT STORAGE ERROR (Product storage error). On 19-Nov-2021 at 8:15 AM, EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours) and PRODUCT STORAGE ERROR (Product storage error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours) and PRODUCT STORAGE ERROR (Product storage error) to be not related.    No concomitant medication information was provided. A vial of Moderna vaccine was opened the day before and and then it was given on 19 Nov 2021. It was left in the refrigerator overnight. On 19 Nov 2021, a vaccine administrator used the same vial outside the recommended 12-hour vial puncture range. 8 patients received the doses.  No treatment medication information was provided.
Low-grade fever (99 degrees F to 100 degrees F), muscle aches, nausea, headache, mild weakness.
pt recv vax 21APR99 & PM noticed immed shooting pain going from inj site to lt ring finger;arm cont to hurt, pt applied an ice bag w/some relief;approx 9-10PM noticed blurred vision;dx lt eye oblique nerve paralysis;
BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a 60 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced osteoarthritis, and upper extremity dysfunction (Dose number in series 1). The patient had not recovered from osteoarthritis, and upper extremity dysfunction. The patient additionally received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number was not reported) 1 in total, dose was not reported, administered on 25-AUG-2021 for covid-19 prophylaxis which was off label dosing frequency. The drug was associated with Off label use (Dose number in series 2).  The outcome of off label dosing frequency was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, intramuscular, batch number was not reported) 1 in total, dose was not reported, administered on an unspecified date in JAN-2022 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 60 years old. No concomitant medications were reported. Non-company suspect drugs included: upadacitinib (oral, batch number: 1159488 expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On an unspecified date in 2022, the patient experienced blood pressure high (Dose number in series 3). Laboratory data included: Blood pressure high.  Treatment medications (dates unspecified) included: methotrexate, and celecoxib. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient had not recovered from blood pressure high. This report was non-serious.  This case, involving the same patient is linked to 20220831989 and 20220853756.
Had sudden loss of vision, finger count vision, diffuse optic nerve swelling in left eye starting or noticed on December 9, 2018. Last dose was November 15, 2018.
45 minutes post vaccine, returned with complaint of Headache, fatigue.  BP 199/100.   Gave Acetaminophen 1gm.  She was confused, on 3d asking about additional meds when bp high, she remembered she has Clonidine 0.1mg, had her take.  BP dropped to 179/90, 20 minutes later then 159/90, and went home with husband.
Extremely bad back pain; Extremely bad back pain at right kidney and groin.; Extremely bad back pain at right kidney and groin.; Kept feeling like he was going to throw up, but a cold rag helped him from doing that,; This is a spontaneous report from a contactable consumer. A 62-year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number :FA7485) on 05Aug2021 at 07:45 PM via an unspecified route of  administration, administered in left arm as DOSE 2, SINGLE for COVID-19 immunization(age 62-years-old). No covid prior vaccination and history of allergy was reported. No other vaccine in four weeks. The patients medical history includes cancer free for 3 years no other issues reported. The patients concomitant medication in two weeks includes Centrum Silver / Biotin. Historical vaccination includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number :F46780) on 15Jul2021 at 07:45 PM via an unspecified route of  administration, administered in left arm as DOSE 1, SINGLE for COVID-19 immunization. On 06Aug2021 the patient experienced Extremely bad back pain at right kidney and groin. Kept feeling like he was going to throw up, but a cold rag helped him from doing that, so never actually threw up. Lasted 3 days, almost sending him to the hospital in so much pain. No Covid was tested post vaccination. No treatment was received. The outcome of the event was recovered.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Feels very sick; She has fever; pain in her kidney and legs; pain in her kidney and legs; This is a spontaneous report from a contactable consumer or other non hcp.  An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient's concomitant medications were not reported. On an unspecified date, caller withheld, feels very sick after getting the first dose. She wanted to know what to do. She has fever and was experiencing pain in her kidney and legs. She had COVID before but wanted to know if the side effects will go away and how long will it last. Advised to transfer her to PMI but it was closed already. The outcome of all the events was unknown.  Information about lot/batch number has been requested.
Patient received second HPV vaccine. Approximately 1 hour later he became hot, felt faint, nauseated, weak. Returned to Student Health Center and was evaluated. Symptoms lasted approximately 2 hours. Vital signs were stable and examination of patient was normal.
I received the shot at 08:30 AM by 02:00 PM the same day my arm was sore twenty-four hours later I was feeling exhausted with body aches low grade fever chills with it fluctuating and generally unwell for seven days.
incorrect product storage; No adverse events; This spontaneous report was received from a Medical Assistant and refers to an unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported.  On unspecified date, the patients were vaccinated with a dose of improperly stored Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23)  lot # S018405, expiration date on 28-MAR-2021 (strength, dose number, route and anatomical location were not provided) for prophylaxis.   The vaccine was stored in temperature below 32°Fahrenheit degrees/0°Celsius degrees (31.3°F) for 1 cycle. Digital data logger was not involved. No adverse effects were reported.
Modern a COVID-19 Vaccine EUA.  Headache, fever, stomach pain.  RASH on breast started on Wednesday (shot given Monday AM).  Rash is hot, and red and centers around on on nipple.
I got very ill after both shots, tho the second shot was worse. I was not able to taste or smell. but months after the shots ive been having phantom pains where both injection shots were. It's very painful and makes my arms very numb almost heavy. ive also been sick more often than usual. i haven't yet got my flu shot this year.
Day after: started with 2 inch radius of hot, red skin; enlarged to 7 inches; changed to purple in color.
Lethargy around 7pm.  Night sweats and hot then cold sensation all night and ever since 2nd shot.  I also did not get my period, which was due 3days after the 2nd dose.  I?ve had hot flashes and cold/hot sensations every day and night since the shot.  I had not, ever, experienced hot flashes prior to the 2nd shot.  It feels as if the 2nd shot brought on instant menopause.
Vaccine was administered on the right deltoid IM, on 9/3. Pt complained of swelling on the evening of 9/4. Pt came to our pharmacy to have it looked at on 9/5. Apparent swelling on right deltoid muscle. Pt was referred to the emergency room. There was fluid build up on right shoulder and fluid was drained in the E.R. Diagnosis was inconclusive. Can be from the shot or it may also have something to do with a shoulder operation pt has had in the past.
Breakthrough case admission after 3 vaccines Moderna 2/9/21 Lot# 007M20A;  Moderna 3/9/21 no lot#; MOderna 1/10/22 lot# 084J21A
I went to the doctor the early part of July. I had trouble breathing and they took x-rays of my lungs. They told me it was bronchitis. They prescribed me antibiotics. I still have a cough now.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-DEC-2015 at 03:57, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.4 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Client had never received flu shot in past. Administered at flu clinic at 11:00am. Client noticed itching tongue at 4:00pm. It then became swollen and she went to the Emergency room at 5:00. She was given Benadryl and a shot?? Client unsure what the shot was. She states symptoms were gone within 1 hour and she was discharged. She took 3 more doses of Benadryl throughout the evening/night. No further problems.
BOOSTRIX, instead of INFANRIX, was administered the doses of the Tetanus, Diphtheria and Pertussis are less then the INFANRIX.
It was mild symptoms. I had headache, nasal congestion, sore throat, fatigue and muscle aches. They lasted 7 days and I still have fatigue. I was prescribed Paxlovid.
Right deltoid erythematous and warm to touch, several blanching red areas of skin - face & upper torso.
Arm is sore; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and VACCINATION SITE PAIN (Arm is sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is sore). At the time of the report, FATIGUE (Tired) had resolved and VACCINATION SITE PAIN (Arm is sore) outcome was unknown.        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.   Concomitant product details was provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
Pt started to feel like her chest was tight approx 15 mins after admin of vaccine, she then developed SOB, tongue swelling and wheezing.  Pt took a dose of her inhaler which did not help.    Pt was taken to exam room where 50 mg of Benadryl and 20 mg of Famotidine were given.  Pt continued to have increased wheezing and chest tightness.  Pt was then given 125 mg of Solu-medrol.  Pt was observed for approx 1 hour and wheezing improved and pt O2 sats were 97%.
Dizziness, Headache, Chills, fatigue, Pain at injection site Narrative:   Other Relevant History:
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-FEB-2019, the patient was inadvertently vaccinated with an expired dose of PROQUAD subcutaneously for prophylaxis (dose, strength, dose number, vaccination site, #lot, expiry date unspecified) along with a sterile diluent (dosing details unspecified). Product quality complaint (PQC) was not reported.
Facial swelling. Hives. Injection site swelling. From initial information received on 07/Jan/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 15-month old female patient received DAPTACEL administered intra-muscularly in the right thigh, COMVAX, manufacturer Merck, administered intra-muscularly in the left thigh and PREVNAR, manufacturer Wyeth, administered intra-muscularly in the left thigh on the morning of 06/Jan/2004. That afternoon, the patient was brought back to the office with dramatic facial swelling with decreased eye opening, patchy hives on her torso and "dramatic cool swelling of the right thigh". The patient was examined by a physician. The patient's recovery status is unknown. The reporter of this case is the same reporter of case number U2000-00665.
my edc is 5/23/21. Monday march 22- woke up sore neck, grew worse over day, severe headache at night with tachycardia- went to hospital. heart rate 125 baby was tachycardic in 170s resolved with po fluids. labs ekg normal. went home. tuesday march 23. went to work. saw pcp- fever 100.6 sent home, severe worsening headache, malaise, neck pain, huge lymph nodes cervical and occipital very painful nodes. heart rate 125- went to hospital again. Severe pain due to lymph nodes needing iv pain meds. hospital work up started in ER. Started on iv antibiotics. imaging/lp done. 4 nights in the hospital, it took at minimum 10 days to feel better after. sent home on antibiotics azithromycin and a cephalsporin