chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8-10 hours after injection: high fever (103), chills, muscle pain, rapid breathing,  4 days after injection: dizziness, room spinning feeling, vertigo,
Patient received Pfizer COVID-19 Bivalent Booster vaccine which was beyond the manufacturer recommended use time of 10 weeks at the refrigerated temperature. Has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. Clinically, the patient is considered to have adequate protection against COVID-19 from this vaccine dose compared to if the dose was administered within 10 weeks. Thus, there are no additional clinical recommendations at this time. Patient should continue to receive the recommended COVID-19 vaccination doses on the usual schedule.
lost strength in left thigh and then all the muscle seemed to melt away in about a week. Still can not support self from left knee, it gives out and I fall
2-3 weeks post vax the pt developed and itchy rash on her face accompanied by fever and chills. The reporter noted an approximate total of 30 lesions widely spread on the arms and upper chest. Pt was presented to ER with the symptoms.
- Soreness at injection site began within a couple of hours. Similar intensity to flu shot.  - Tenderness at injection site began ~12 hrs after injection. Worsened in intensity until 48 hrs after injection. At worst, limited shoulder abduction beyond 100?. Steady improvement and resolution ~80 hrs after injection.  - Myalgia began 27 hrs after injection in bilateral upper extremities and had spread throughout body within 3 hrs. Worsened with time. Sudden, significant improvement identified without intervention around 50 hrs following injection. Completely resolved by 72 hrs. Most debilitating symptom in my experience. - Chills, fatigue, low-grade fever (100.4? F), and headache began simultaneously around 30 hrs after injection. Fairly mild. Resolution of chills and fever coincided with significant improvement in myalgia (50 hrs). HA resolved around 60 hrs.  - Erythema and edema at injection site first noticed 36 hrs after injection but hadn't been checked prior. Erythema was 1" diameter at the time. Expanded to ~2" over the next 24 hrs but also became less prominent. Resolved by ~80 hrs after injection.
Information was received on 13-JUL-2017 from a registered nurse who was reporting on an unspecified patient of unknown age and gender. No medical history or concomitant medications were reported. The nurse reported that on 13-JUL-2017. the patient was administered a dose of VARIVAX (lot L025207, expired 07-JUL-2017)(dose and route not reported) that was expired. The nurse reported that the sterile diluent (lot L001533, expires 24-OCT-2017) used to reconstitute VARIVAX was not expired. No adverse effect reported. No other information was provided. Additional information has been requested.
Extreme redness & soreness & swelling at site. All symptoms of Covid. Dizziness weak fatigued ache all over.  Still day #5
From telephone conversation with reporting nurse, it was stated that 4 year old patient (2 of 2) was administered Tripedia Lot #UO532CA, administered date not provided. Sometimes after the vaccination, the patient developed a large local reaction consisting of redness, swelling and warmth from shoulder to elbow area. Patient was seen in office. This case is linked with case # U200100975
I was great until the 8th day.   I have a huge painful, itchy rash on my arm and I feel very tired
pt was very scared before vaccine, after vaccine passed out, i suspect syncope , came back fast sat and was fine
64 y/o F received Tdap on 8/30/11 at her initial visit to a new PCP. Apparently, the arm had became red, hot and swollen. Pt had put ice compresses on the area. No fever or vomiting. Pt did not report this to PCP till next apt on 9/13/11.
5 pts exp pain @ inject site immed p/3rd dose of Engerix-B; no tx given; event resolved;
Nausea; Chills; Low grade fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Low grade fever) and PAIN (Body ache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Low grade fever) and PAIN (Body ache). At the time of the report, NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Low grade fever) and PAIN (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
shortness of breath/progressed until I went to urgent care; I started to really bad cough and then it actually got worse and worse; I was so weak like I am breastfeeding, I couldn't even hold my baby; extreme fatigue; I couldn't stay awake for more than a few hours at a time; Headache; lung problem; This is a spontaneous report from a contactable physician (the patient).   A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EH9899, via an unspecified route of administration on 16Dec2020 13:00 at single dose for COVID-19 immunisation. Medical history included history of reaction to mango (like face swelling and just a rash) and then gluten intolerant: if she eat it she doesn't have difficulty breathing. She never had problems with asthma in the past. The patient previously took BENADRYL for shortened like when she had a reaction with mango many years ago. In the past the patient had problems with cold and problems having bad cough that linger but she never needed Albuterol or steroids before. The patient had flu vaccine a month before, administered in deltoid left. The patient's concomitant medications were not reported. The patient experienced extreme fatigue on 19Dec2020 with outcome of recovering, shortness of breath/progressed until she went to urgent care on 21Dec2020 with outcome of recovering, She started to really bad cough and then it actually got worse and worse on 21Dec2020 with outcome of recovering, She was so weak like she was breastfeeding/She couldn't even hold her baby on 19Dec2020 with outcome of recovered on 20Dec2020, She couldn't stay awake for more than a few hours at a time on Dec2020 with outcome of unknown, headache on Dec2020 with outcome of unknown, lung problems on Dec2020 with outcome of unknown.  The patient underwent lab tests and procedures which included chest x-ray: normal on unspecified date; SARS-COV-2 test: negative on 23Dec2020.  The vaccine was administered at Hospital Facility. The patient was treated with steroids (20mg for 5 days) and an albuterol inhaler (2 puff every 4 hour). The events required visit to Emergency Room. The events were non serious.
Patient was given a Tdap on 9/15/2020 and he had already been given a Tdap on 5/21/2019.
3:00 a.m. - Arm hurting,  9:00 a.m. - achy all over; 8:00 pm - temp 99.8 (Normal temp is 97.6)
Initially symptoms were fatigue. About 64 hours after my second vaccine dose I began feeling slightly dizzy. This has continued for an entire week (10 days after shot) and still persists, also some tingling and numbness in my legs and feet.
red area 4 1/2 x 6cm to lt arm DTP inj site
Both hands turned blue; broke out in hives; This is a spontaneous report from a contactable consumer (reported for herself). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231; expiry date: not known), via an unspecified route of administration in the right arm on 17Jan2021 09:00 at single dose for COVID-19 immunization. There was no medical history. No known allergies. The patient is not pregnant. Concomitant medication included unspecified multivitamin (other medication taken in two weeks). The patient experienced both hands turned blue, broke out in hives on 17Jan2021 15:30. It was resulted in emergency room/physician office visit. The patient had no COVID prior to vaccination and had COVID tested post vaccination by nasal swab (COVID) on 17Jan2021 with pending result. Therapeutic measures were taken as a result of both hands turned blue, broke out in hives as the patient took Benadryl. The outcome of the events was recovering.
Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, chills and fatigue. pain at the injection site. Narrative:  Other Relevant History:
Excessive hair loss staring 3 days following vaccine. Issue was sudden and continues weeks later.
Information has been received from a physician concerning a 53 year old white female with hypertension, hypothyroidism, Sjogren's Syndrome, fibromyalgia, GERD, allergic rhinitis and menopause who on 10/10/01 at 10:30 was vaccinated IM in the left deltoid, with a dose of pneumococcal vaccine 23 polyvalent (lot 636158/1456K). Concomitant vaccination the same day included a dose of influenza virus vaccine (Fluzone) (lot U0573AA) given IM in the right deltoid. At the time of vaccination, the pt was experiencing constipation and oral thrush. On 10/11/01, at 10:15, the pt developed erythema and induration at the left deltoid injection site. The pt sought medical attention and the pt subsequently recovered. It was also reported that another pt (WAES 0112USA02132) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. No further information is available.
Headache, NauseaVomiting, Fatigue, Chills, Flu-Like Symptoms, Hot Flashes Narrative:
fatigue, chills, nausea passed out approx several minutes;happened @ home;slept a few hours & completely recovered;
Reaction normal for first two days but fell asleep on left shoulder about 2nd or 3rd night and woke up in AM with large (3") red ring around injection site. Left shoulder muscles have been sore and stiff ever since, can barely lift left hand above shoulder due to acute muscle pain. Haven't been able to work out the stiffness despite plenty of exercise.
Pain in upper left arm that progressed to her elbow then down to her hand; Redness in upper left arm that progressed to her elbow then down to her hand; Swelling in upper left arm that progressed to her elbow then down to her hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in upper left arm that progressed to her elbow then down to her hand), VACCINATION SITE ERYTHEMA (Redness in upper left arm that progressed to her elbow then down to her hand) and VACCINATION SITE SWELLING (Swelling in upper left arm that progressed to her elbow then down to her hand) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in upper left arm that progressed to her elbow then down to her hand), VACCINATION SITE ERYTHEMA (Redness in upper left arm that progressed to her elbow then down to her hand) and VACCINATION SITE SWELLING (Swelling in upper left arm that progressed to her elbow then down to her hand). At the time of the report, PAIN IN EXTREMITY (Pain in upper left arm that progressed to her elbow then down to her hand), VACCINATION SITE ERYTHEMA (Redness in upper left arm that progressed to her elbow then down to her hand) and VACCINATION SITE SWELLING (Swelling in upper left arm that progressed to her elbow then down to her hand) had not resolved.            No concomitant medications were reported. Treatment medication included over the counter pain medicine. Reporter stated that in six months, after her 2nd dose her arm hadn't gotten better, it got worse. Patient saw her primary doctor and couple of specialists. They do not know what is wrong.
Arm red, warm to touch & itching.  W/ soaks, BENADRYL 25mg B.I.D. elevate.
On 05/18/2022 I woke up with a terrible fever blister that lasted around a week. On 05/22/2022 I felt like I had a cold and could not quit coughing. On 05/25/2022 my ear felt stopped up and I seen the doctor the next day and was told I had an upper respiratory infection and an ear infection. On 06/14/2022 I visited an ENT had a hearing test which showed hearing loss in the right ear. I will return to him in August for another test. I am still having problems with my ear as of today.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypertension-Mild, Additional Details: 12:20pm\r\n24/Male fainted after administration of Janssen vaccine. No other symptoms noted. Had patient sit on the floor and elevate legs. Assessed for anaphylaxis, epinephrine was not indicated.\r\n12:24pm BP 140/75 (unsure of patients baseline, no diagnosis of hypertension). Ambulance was called. When ambulance arrived patient felt better. May have just been nervous due to needle itself, not COVID vaccine. followed up with patient 4:20pm and he states he feels perfectly normal now.
No adverse effects; administered an improperly stored VARIVAX; This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R018142 and expiration date 25-JUN-2020) (product storage error). The temperature excursion of vaccines was at 15 F to 46F (39) (F degree Fahrenheit) for 19 hours 15 minutes. The Previous temperature excursion was not reported. Data logger was not involved. There was no product quality compliant reported. The patient experienced no adverse event.
chest pain/SOB; chest pain/SOB; large pericardial effusion; hemodynamic instability; started exploring Lupus; joint pain; low WBC; This is a spontaneous report from a contactable pharmacist (patient). A 31 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 07Jan2021 (Lot Number: EL1283) at the age of 30 years old, as single dose for covid-19 immunisation. Medical history included sulfa products cause rash, anxiety, migraine. Concomitant medications included sumatriptan succinate (IMITREX); ibuprofen (MOTRIN); paracetamol (TYLENOL), OTC vitamin B complex supplement, OTC iron supplement. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 16Dec2020 (Lot Number: EK9899) at the age of 30 years old, as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient came to the ER on 14Jun2021 for chest pain/SOB, CT scan found large pericardial effusion, had to undergo emergency pericardiocentesis due to hemodynamic instability and hospitalized from 14Jun2021 and until 17Jun2021. Labs on fluid ruled our infectious or cancer origin. The patient had no prior medical history aside from anxiety and migraines, although the patient had recently started exploring Lupus but not confirmed. The patient have biomarkers consistent with Lupus, minor and infrequent joint pain, and chronically low WBC but WBC is unaffected by plaquenil (plaquenil started after vaccine) and no trademark rash. Events started from 06Jun2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment pericardiocentesis, prednisone, ibuprofen, colchicine, Nexium was received. The outcome of the events was Recovered with lasting effects/ Recovered with Sequel.  Follow-up attempts are possible. Further information is expected.; Sender's Comments: Based on known safety profile and lack of close temporal association the reported events are assessed as intercurrent medical conditions and unrelated to  BNT162B2.  Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Muscle ache, joint pain, chills, hot flashes, migraine; Muscle ache, joint pain, chills, hot flashes, migraine; Muscle ache, joint pain, chills, hot flashes, migraine; Muscle ache, joint pain, chills, hot flashes, migraine; Muscle ache, joint pain, chills, hot flashes, migraine; This is a spontaneous report from a non-contactable other hcp. A 27-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), intramuscular, administered in Left Arm on 12Jan2021 07:30 as single dose for covid-19 immunization. Medical history included, food allergy; Known allergies: Ceclor, peanuts. There were no concomitant medications. The patient previously took ceclor and experienced drug hypersensitivity. The patient previously took BNT162B2 on an unspecified date. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination and post vaccination, patient had not tested with covid 19. On 04Feb2021 11:00 the patient experienced muscle ache, joint pain, chills, hot flashes, migraine.  No treatment was received for these events. The outcome of event was recovering.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Initial adverse symptom:  Headache On April 4, 2021, woke up since my left arm had a burning sensation.  Noticed that it was very red around the injection site. It was a bit tender too.
This case was reported by a physician via sales rep and described the occurrence of localized erythema in a 52-year-old male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a day after receiving SHINGRIX, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was recovered/resolved. It was unknown if the reporter considered the localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness on chest. Limited information was provided by the sales representative from the physician.
get another booster shot by accident on 09Nov2021/received 2nd booster dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (get another booster shot by accident on 09Nov2021/received 2nd booster dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (get another booster shot by accident on 09Nov2021/received 2nd booster dose). On 09-Nov-2021, EXTRA DOSE ADMINISTERED (get another booster shot by accident on 09Nov2021/received 2nd booster dose) had resolved.            No treatment medications were reported by the reporter. No concomitant medication were reported by the reporter.   Patient was then taken to urgent care. Per staff patient did not had any reactions and the doctor said that if he was going to have a bad reaction, he would have had it immediately. Per caller, patient was fairly healthy, did not know the medical conditions in detail. No concomitant medication were given.
felt like her arm was bothering her on the first dose only; felt very tired; felt unusually tired; A day after getting the vaccine, she experienced trouble of breathing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA, LIMB DISCOMFORT, FATIGUE, and FATIGUE 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 31-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced DYSPNOEA. On an unknown date, the patient experienced LIMB DISCOMFORT, FATIGUE, and FATIGUE. At the time of the report, DYSPNOEA, LIMB DISCOMFORT, FATIGUE, and FATIGUE outcome was unknown. Not Provided.          Action taken with mRNA-1273 in response to the event was not applicable. Patient was given oxygen treatment.  Concomitant medication included blood thinners and blood pressure medicines.
diarrhea; being very fatigued, she has to spend most of the in bed; headache; felt dizzy; 10 minutes after leaving she felt hungry, the hunger just kept becoming worse and worse. She became ravenous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), HUNGER (10 minutes after leaving she felt hungry, the hunger just kept becoming worse and worse. She became ravenous), DIARRHOEA (diarrhea), HEADACHE (headache) and FATIGUE (being very fatigued, she has to spend most of the in bed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Hypertension and Cancer. Concomitant products included ALPRAZOLAM (XANAX), TRAZODONE and ESTRADIOL (ESTROGEN) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (felt dizzy), HUNGER (10 minutes after leaving she felt hungry, the hunger just kept becoming worse and worse. She became ravenous) and HEADACHE (headache). On 24-Mar-2021, the patient experienced FATIGUE (being very fatigued, she has to spend most of the in bed). On 27-Mar-2021, the patient experienced DIARRHOEA (diarrhea). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Headache, at an unspecified dose and frequency. On 23-Mar-2021, HUNGER (10 minutes after leaving she felt hungry, the hunger just kept becoming worse and worse. She became ravenous) had resolved. On 28-Mar-2021, DIARRHOEA (diarrhea), HEADACHE (headache) and FATIGUE (being very fatigued, she has to spend most of the in bed) had resolved. At the time of the report, DIZZINESS (felt dizzy) 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 medication was provided also includes the diabetes medication, Hight blood pressure medication, Cholesterol medication.