chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; Fever of 102.7; Body aches; Lethargic; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM9809) via an unspecified route of administration in the Left arm on 11Feb2021 09:45 as a single dose for COVID-19 vaccination. Medical history included allergies; Prior to vaccination, the patient was diagnosed with COVID-19. The patient concomitant medications were not reported. On 11Feb2021 17: 00, it was reported patient had pain at injection site. Fever of 102.7. Body aches. Lethargic. There was no treatment received for the adverse events. the patient not received any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The reported seriousness was non serious. The outcome of the events was not recovered.
Patient has history of COVID19 infection on November 2020.  He received first dose of pfizer COVID 19 vaccine on 2/2/21.  Six days later on 2/8/21, the patient presented to the ED with complaints of cough, dyspnea, and vomiting.  Patient was breathing on room-air, blood pressure was stable, and he wasn't febrile. Patient was admitted for bilateral pneumonia.  Initial COVID test on 2/9/21 was negative and patient received 7 days of antibiotic therapy.  Throughout the patient's stay, his respiratory function was stable on room air.  Patient was to be discharged at the end of the antibiotic therapy but a follow-up COVID PCR test on 2/17 resulted POSITIVE.  Patient's s/s for infection were already improving and the providers held off on discharging to be sure the patient was asymptomatic for COVID 19.  Patient was uneventfully discharged on 2/26/21 for a total stay of 18 days.
9 days after vaccination (3/18/21), extreme itchiness from neck through trunk of body. 11 days after vaccination (3/20/21) rash from neck through trunk of body with extreme itchiness. Went to urgent care on Monday (3/22/21) and was told unsure of how vaccine is effecting people as it is too new. Was given steroid cream for the rash. Recommended see dermatologist. Saw dermatologist on Tuesday (3/23/21) with a similar comment and was advised to report and try to get some direction. Said to continue on steroid cream. Bumps are improving but red rash and itching still persists and continues to spread to new spots. Overall feeling tired. working to get a doctor that will test for internal adverse effects.
Client and guardian lied and reported to clinic that their birthdate was in 2008 and that they were 12 years old. It has been found out later that Client was 11 at the time of vaccination.
Significant joint pain in the hips for two days after the shot. Pain/stiffness at the injection site for two days after shot. Lethargy day after shot.
"big red spot grapefruit size on injection site"; injection site was swollen; cannot sleep; stomach upset; headache; nausea; throw up; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (cannot sleep), ABDOMINAL DISCOMFORT (stomach upset), HEADACHE (headache), NAUSEA (nausea) and VOMITING (throw up) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE (Hydrocholorothiazide), BISOPROLOL, NICOTINIC ACID (NIACIN) and LETROZOLE for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced SLEEP DISORDER (cannot sleep), ABDOMINAL DISCOMFORT (stomach upset), HEADACHE (headache), NAUSEA (nausea) and VOMITING (throw up). On 28-May-2021, the patient experienced VACCINATION SITE ERYTHEMA ("big red spot grapefruit size on injection site") and VACCINATION SITE SWELLING (injection site was swollen). At the time of the report, SLEEP DISORDER (cannot sleep), ABDOMINAL DISCOMFORT (stomach upset), HEADACHE (headache), NAUSEA (nausea), VOMITING (throw up), VACCINATION SITE ERYTHEMA ("big red spot grapefruit size on injection site") and VACCINATION SITE SWELLING (injection site was swollen) outcome was unknown.            Other concomitant medicine: Calcium +D complex    No treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: patient went to doctor and got treated for AE. No consent for further follow up.
Evening of injection 2/16/21: arm pain, headache, feverish, flu-like feeling, lethargy. Next day and on and off on days since: gastrointestinal discomfort, loose bowel movements, lethargy, occasional headache.
Lump above injection site, right deltoid X 2 weeks; ice. Large area (2" X 3") of paresthesia on LUQ X 2 weeks. One vesicle in same area appeared 2 weeks after injection. Some itching in area of paresthesia X 2 weeks.
Stuffy nose; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose) and OROPHARYNGEAL PAIN (Sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, NASAL CONGESTION (Stuffy nose) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were reported.  Treatment medications were reported.
Headache, Myalgia, Arthralgia, Fever, flu-like symptoms, sinus drainage, left arm pain at injections site, pressure in chest, cold, eyes are sensitive to light Narrative:
Was screaming off and on as if in pain on 09/07,09/09,09/10/2005. Developed hives, red papules all over face, trunk and extremities on 09/07. Worsened until 09/10 and then began to improve. Had fever to 102 on 09/07 - 09/10/2005.
pt recvd 3 doses of Engerix-B & failed to seroconvert;
Foggyhead; Impairment while driving; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggyhead) and VISUAL IMPAIRMENT (Impairment while driving) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING ABNORMAL (Foggyhead) and VISUAL IMPAIRMENT (Impairment while driving). At the time of the report, FEELING ABNORMAL (Foggyhead) and VISUAL IMPAIRMENT (Impairment while driving) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initially had fever, chills, nausea, joint pain and loose stools. Fever chills and loose stools resolved after 1 day. Joint pain persists - to shoulder, wrist and elbow with decreased range of motion. Mild nausea perists.
Experienced mild chest pain two days after vaccination. Visited the ER, and was Hospitalized due to a decreased ejection fraction and elevated cardiac enzymes.  My ejection fraction returned to normal the following day, and I showed a decrease in cardiac enzymes. The pain also subsided about 36hrs after starting. I remained at hospital for a few days to have a cardiac MRI which showed patchy myocarditis. I was discharged that day, and have been taking metoprolol and avoiding physical exertion.  Later, on May 13th I returned to the ER due to an increase in heart palpitations. They turned out to be PVC, which is generally harmless, but I began taking a potassium supplement since my levels were low. I've been taking it easy since.  Currently, I am expected to avoid exercise and exertion for six months, but am waiting for a follow-up to get more details.
Breaking out with a rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 23Jan2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she took the Pfizer vaccination. She took that last Friday and all of the sudden she noticed that she was breaking out with a rash (2021). She asked if it was possibly being from that. She asked a question, she received her first Pfizer vaccine on 23Jan2021, they said to come back on 13th, she could not make that appointment on 13th (further clarification was unknown, hence split was not made), she asked how can she get her second. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
I experienced some fatigue. I didn't have anything major after the vaccination. Then my husband had been having respiratory symptoms, on Thursday night, that would have been 10/6, he tested positive. That following Sunday the 9th, I tested positive for COVID-19. I was hoarse and my sinuses hurt a little. They have been very minor. I have had on again off again nasal congestion. I have felt a little more tired than usual that's it.
On 1/19/21 at approximately 10 pm patient got whole body ache.  She took 2 Tylenol and went to bed. In the morning on 1/20/21  patient couldn't move her legs, needed help to get out of bed and that condition lasts for the whole day. Lost taste and appetite. Reports that she had a fever, but didn't check temperature.
Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023.; No adverse event; 12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date), PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date), PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 adult patients received expired Bivalent Moderna COVID-19 vaccine on 12JUN2023 beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered on 12 Jun 2023 and was expired on 17 May 2023.).    No relevant concomitant medications were reported. Vial size was 2.5 ml. Date the vial was initially stored in the refrigerator was on 12 Jun 2023. The vial haven't undergone any temperature excursions. No treatment medication reported.  This case contains information for the 11th of 12 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Follow-up information included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729389:Master case
fever; aches; chills; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 58 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 25Mar2021 10:00 (Lot number: ER8727) as dose 2, single and intramuscular, administered in arm, administration date 06Mar2021 09:30 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "aches"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: Prior Vaccinations (within 4 weeks) were none. Reporter informed that on 07Dec2021- was administered the Pfizer Booster shot and had similar side effects to the first 2 Pfizer shots, fever, aches, chills, headache etc. It lasted its usual 24 to 48 hours.  No follow-up attempts are possible. No further information is expected.
my lips started tingling 20 minutes after vaccine, only on one side of my mouth, same side as vaccine, right.  Then my throat started to feel funny, like there is something in it.  I called 911, went by ambulance received Benadryl through IV then at hospital I received IV Pepcid.  I am still taking Benadryl and pepcid.  Still experiencing the lump in my throat feeling.
Paleness, dizziness, blurring of vision, sleepiness, weakness & loss of strength in extremities, dilated pupils, low BP, & irregular heart rate & rhythm.  Laid pt down, used ammonia salts as inhalant, gave juice and bite of cheese, cold cloth (pt not diaphoretic) & continued to take VS.  Third party called 911 to get EMTs here.  Worked with pt for approximately 40 min before EMTs arrived.  EMTs called because of pt continued to have loss of strength in extremities and sleepiness.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Narrative: COVID infection following COVID vaccine series 03/31, Pfizer, dose #1 04/12, Pfizer, dose #2 07/30 pt cc: cough, fatigue, headache, loss of smell, myalgias, rhinorrheas, decreased appetite exposure: unknown 08/05 COVID swab, result: detected 08/18 c/o still coughing with brownish phlegm, takes tessalon which helps but ran out. uses combivent prn. not checking pulse O2 but will start. no fever. no sign. worse SOB. 08/12 SARS-COV-2 LINEAGE AY.4 08/12 SARS-COV-2 CLADE 21A DELTA 08/18 clinically resolved 09/09 COVID swab, result: not detected
Patient given Pneumovax on 5-26-09.  He states that he became nauseated within a few minutes, then vomitted.  The following day, he developed blister- like lesions, which later ulcerated.  Lesions located on (R) shoulder, (R) arm, groin area.
woke up thrashing and had incredible chills; could not keep her arms straight; teeth were chattering and her body would not calm down/and had incredible chills; had no control of anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 10:30 (Lot number: ER8734) at the age of 82 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN B12 [COBAMAMIDE]; VITAMIN D [ERGOCALCIFEROL]. Vaccination history included: Bnt162b2 (Dose 1, lot EP6955), administration date: 11Mar2021, when the patient was 82 years old, for Covid-19 Immunisation. The following information was reported: SLEEP DISORDER (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "woke up thrashing and had incredible chills"; MOVEMENT DISORDER (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "could not keep her arms straight"; CHILLS (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "teeth were chattering and her body would not calm down/and had incredible chills"; FEELING ABNORMAL (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "had no control of anything". Therapeutic measures were not taken as a result of sleep disorder, movement disorder, chills, feeling abnormal.  Additional information: She got the 2nd shot of the Pfizer Vaccine on Tuesday around 10:30 and was ok but in the middle of the night at 02:00-03:00 she woke up thrashing and had incredible chills and could not keep her arms straight and her teeth were chattering and her body would not calm down, states she had no control of anything. Patient keeps getting shorter all the time and stated lets cheat a little bit and say her height is 54; states she weighed herself this morning. She did not look at the clock because it would not do her any good to look at the clock for the time the reported event occurred but states the reported events are not ongoing and resolved but all day yesterday she was not worth anything and poked around. She did not have treatment for the reported events. She is very lucky because she has no prescription medications and has not had prescription medications for a while. She has taken these vitamins for years and years. Her 2nd visit for the 2nd dose was very quick and it might have been a few minutes before 10:30 and they are laid out very well and she went to the next room for 15 minutes to sit and they have movies playing. No prior Vaccinations (within 4 weeks). Her sister is elsewhere and got the whole deal and had COVID and was on a ventilator and everything but she smoked and does not smoke anymore and has heart problems.    No follow-up attempts are possible. No further information is expected.
Flu shot received in left arm with typical mild soreness as with past flu shots in muscle, lasting 2 days. Soreness persisted. About 3-4 days after immunization, got up, got into shower, noticed poorer ability to raise arm, as well as move arm backward and forward, due to pain in upper lateral arm.
The pt complained of chills, fever, ached all over especially eyes and had a hard time getting up and walking. Mother took her to the ER and they kept her for 5 hours. Tylenol was given then she was sent home.
Pt went to MD with swelling and redness. Pt being treated for cellulitis.
Patient has received two Varicella vaccinations.  The first vaccination was given by our office (administer unknown) on 8-19-02.  The second vaccination was the MMRV combo given on 9-6-06.  On 1-10-09 Dominik was seen in our office and diagnosed with chickenpox.
Fatigue, low grade fever, Malalgia surrounding back, shoulder, elbows, hands, knees, hips and feet, arthralgia, severe am stiffness, difficulty straightening arms and raising arms, difficulty walking, abrupt response to Medrol dose pack 2-3 days after taking pain 80--90% improved.  Currently symptoms persist, worse in am and when sleeping prior to steroids unable to sleep due to unretractable sholder and elbow pain.
Injection site become swollen and "hot". Patient was on a trip at the time and was told by a nurse to watch it carefully and see her doctor when she returned home.
She also has a sore arm; has now ran a fever of 100.1°F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She also has a sore arm) and PYREXIA (has now ran a fever of 100.1°F) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064H21A, 013L20A and CB2CA) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Thyroid disorder NOS. Concomitant products included ALPRAZOLAM (XANAX) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced PAIN IN EXTREMITY (She also has a sore arm) and PYREXIA (has now ran a fever of 100.1°F). At the time of the report, PAIN IN EXTREMITY (She also has a sore arm) and PYREXIA (has now ran a fever of 100.1°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2021, Body temperature: 100.1 (High) 100.1 F.         Concomitants Included medication for blood pressure, medication for thyroid, Water pill (once in a while).  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-406406 (Patient Link).
I have my armpit swollen; This is a spontaneous report from a contactable consumer (patient).  A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EJ1484), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported.  It was mentioned that the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH9899) as COVID-19 immunization and had no secondary effects. It was mentioned that with the second dose that was on 04Jan2021, he had armpit swollen (noted in Jan2021) but it doesn't hurt or anything but its swollen. Outcome of the event was unknown.
Major arm swelling, site enlarging every few hours, scabby injection site, rash all over entire right arm and right side of body spreading to abdomen, armpit, chest, lower belly, tiredness, mild fever.