chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistent cognitive impairment evidenced by inability to think clearly. Unable to focus/concentrate on tasks. Unable to express thoughts with words. Unable to focus eyes; migraine headaches; insomnia; tinnitus; forgetfulness/dementia; dizziness and lack of energy/lethargic. Cardiopulmonary distress evidenced by pain in the chest; pain in legs; low blood pressure; difficulty breathing and coughing.
Vaccine was given beyond use date, expiration date was incorrectly listed on the vaccine. BUD: 2/27/2023.
Patients have been administered from vaccines that experienced a temperature excursion; Patients have been administered from vaccines that experienced a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion). On 14-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. It was reported that the temperature excursion duration was approximately 7 hours. The vial had reached the max temperature of 64 degree F.  It was reported that the vial was stored in refrigerator at the time of excursion. After administration the vial was returned to refrigerator. The date vial was moved from freezer to refrigerator was unknown. It was reported that the vaccine did not presented any state change on visual inspection. It was unknown the number of vials/doses impacted. Pertinent details of the vial was reported as unpunctured. It was reported that patient did not experienced any adverse events. Treatment medications were not reported.
Hand pain more intense; Vertigo; Inflammation arm, face, left hand; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in right arm on 02Feb2021 13:30 (Lot Number: EL9263) as dose 1, single for COVID-19 immunization. Medical history included diabetes from 1993 and ongoing, cancer from Jul2017 to Nov2018 (received chemo, lumpectomy radiation), high blood pressure, depression,inflammation in both wrists hand from 30May2020 (incisions in left hand), had both knees replaced in Oct2018 and Nov2018 (however right knee collapsed & had to be redone same day+ time), inflammation in back and knee, and stroke. Concomitant medication(s) included diclofenac sodium taken for inflammation from 2020 and ongoing; hydrocodone taken for pain from 2019 and ongoing, cancer, diabetes, high blood pressure, depression and cholesterol medications. The patient previously received second dose of shingles vaccine on 11Jun2021; within time frame for COVID vaccine. The patient's HbA1c was 6.9 in fall 2020. The patient's blood pressure was 137/70 in Dec2020 ( was taking 3 medication for blood pressure). The patient experienced vertigo and inflammation arm, face, left hand on 03Feb2021 and had hand pain more intense on an unspecified date. The patient did not receive treatment for vertigo and inflammation. The outcome of vertigo and inflammation was not recovered and outcome of hand pain more intense was unknown. The patient's doctor wanted patient to go to local hospital for work; however the patient had not done so because of skepticism.  No follow-up attempts are possible. No further information is excepted.
rash on injection site and under breasts/across front torso. started night of vaccine or next day and continued a week. rash would go away and come back on torso/under breasts faintly. notices that rash begins after playing sports in the heat. rash has resolved now and patient doesn't have any ongoing issues. patient is consulting with md to see if can get dose 2.
Sore arm after the 1st dose, no other symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 29Apr2021 09:15 (Lot number: ER8737) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Apr2021, outcome "recovered", described as "Sore arm after the 1st dose, no other symptoms". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient had not received any vaccination prior to Covid vaccination and was not tested positive post vaccination. She had no known allergies.  No follow-up attempts are possible. No further information is expected.
pt recvd vax 1050AM went home & slept 1 hr from 1230PM; mom states pt had a terrible hard cry; cry for 15mins & calm for 10 mins; afeb 98.8; would calm down to nurse & nursed well;mom instructed to give APAP;pt to have Dt instead of DTP
Within 10 minutes pt had slight redness and itching. She was given oral BENADRYL 25 mg tablet. I called pt 2 hours later and she felt somewhat better. She complained of more swelling/itching. Eventually went to ER and got a steroid shot on 4/30/16.
fogginess; headache; muscle ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle ache), FATIGUE (fatigue) and FEELING ABNORMAL (fogginess) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (headache), MYALGIA (muscle ache), FATIGUE (fatigue) and FEELING ABNORMAL (fogginess). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, HEADACHE (headache), MYALGIA (muscle ache), FATIGUE (fatigue) and FEELING ABNORMAL (fogginess) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 15 March the symptoms diminished but are still present off and on.   No concomitant medications were reported.
He had the vaccine, everything was fine until he got up around 12:30 AM.  He was shaking really, really bad with tremors.  His wife got up and he had urinated on himself, and his wife felt his forehead and he did not feel hot.  Went back to bed, he went to sleep and the next morning 2/13/21, wife got up and when he got up around 7:30 he was dressed, but not buttoned right and had his hat on and was confused.  He sat in front of the fireplace not moving, and starting talking nonsense until 9:00 - 9:30 when he started talking to her.  He could not differentiate between morning and night, and then slowly progressed back to normal.  Did not eat much, and said that he could eat anymore.  He was pacing back and forth and then finally cleared mentally and was ok around 10:00 AM.   He is now back to his normal self today 2/16/21.   She gave him 250 mg of Tylenol around 9:30 AM on 2/13/21 as his temp was 100.1.  HIs blood pressure at that time was 103/59 and pulse 100.   She then checked it in the other arm and it was 104/60, pulse 99.  She then checked it again on Monday and it was 108/61 with 68 pulse rate which is normal for him.
Muscle aches; Extreme fatigue; sore arm; This is a spontaneous report received from a contactable (reporting on herself) via Pfizer Sponsored Program. A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 29Jan2021 14:15 as single dose for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: (diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) was Animal dander, Pollen and Asthmatic from 1966 to an unknown date. Family Medical History includes: Father Asthmatic and Mother Allergies. The patient's concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 on 08Jan2021 and patient experience sore arm. It was reported that on 29Jan2021patient got the vaccine shot (yesterday) and said that she got a sore arm. On 30Jan2021 at 12:00 Extreme fatigue and at 15:00 Muscle aches. Patient took Advil on 29Jan2021 and stop on 31Jan2021. The outcome of the events recovered on an unspecified date.   Information on the lot/batch number has been requested.
Patient reported feeling lightheaded and dizzy minutes after receiving vaccine. Some diaphoresis.  No overt fainting. VS:  BP 110/66;  P82;  RR 16;  Pulse Ox:  98%
Rheumatoid arthritis flare up; Soreness following COVID vaccine; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4384720-00.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 12Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown) oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; PAIN (non-serious), outcome "unknown", described as "Soreness following COVID vaccine". On unknown dates, the patient experienced rheumatoid arthritis flare up and soreness following COVID vaccine. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect.  Patient had rheumatoid arthritis flare and soreness followed by COVID vaccination. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  The action taken for upadacitinib was unknown.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" and "soreness following covid vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    Seq.No. : 1  Drug : Rinvoq (Upadacitinib)   Causality  1) Rheumatoid arthritis flare up (Rheumatoid arthritis) Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccine) : Not Reported  Dechallenge : N/A   2) Pain (Pain)  Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccine) : Not Reported  Dechallenge : N/A   Seq.No. : 2  Drug : Pfizer BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Unknown  1) Rheumatoid arthritis flare up (Rheumatoid arthritis) Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccine) : Not Reported  Dechallenge : N/A   2) Pain (Pain)  Action(s) taken with drug : Unknown  Causality as per reporter (Drug/Vaccine) : Not Reported  Dechallenge : N/A  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Seen by MD temp 101.6;  w/in 1.5 to 2 hrs p/receiving immun, devel "huge, mosquito-like spots" on legs, then elsewhere; MD advised APAP, DPH & baths w/baking soda; Joints were swollen 2 times the normal; not sleeping well;
side effect with my back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK DISORDER (non-serious), outcome "unknown", described as "side effect with my back". Additional information: The patient was wondering if there's something in the formulation that caused a particular side effect with my back.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Hives occurring 3 hrs after vaccine - Took BENADRYL. Better next day.
Got vaccine this am. Within a few hours developed pain and swelling at injection site. Also got flu shot in other arm.
pain; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer of an unspecified age reported for herself that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an 22May2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23May2021 patient experienced too much pain. Patient asked if she could go to the hospital or take Advil. The outcome of the event pain was unknown.  Information about lot/batch number has been requested.
Patient reports swelling/bulging of muscle in (L) arm which vaccine was administered. Saw MD thinking it was blood clot. MD did not have any findings
This spontaneous report was received from claims management service refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry and route was not reported). Concomitant medications were not reported. On an unknown date, the patient experienced adverse reaction. The outcome of adverse reaction was unknown. Additional information has been requested.
No additional AE; Incorrect product storage; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 12-JUL-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) (lot # X002292, expiration date reported as 21-JUN-2024, however upon internal validation established as 21-JUL-2024, 1 dose; strength, route were not reported) for prophylaxis (product storage error). Temperature excursion was 6.93 F for 1 Hour 13 Minutes 0 Seconds. Previous temperature excursion was 52.01 F for 2 hours 6 minutes 0 seconds; 9.74 F for 4 hours 34 minutes 0 seconds. No additional adverse event was reported.
Recipient told medics on site that he was having trouble  breathing or swallowing. airway still patent and intact.  He was alert and oriented x4. His breathing improved, but the trouble swallowing continued.  They could not provide a full med list, but remembered that he takes kepra. Recipient received hepatitis vaccine within past 30 days, but not within the past 14 days. EMS arrived immediately and transported to hospital.
This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 81-year-old subject of unspecified gender who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis. Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue (product complaint) with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
Headache, body ache, cough, fatigue, and eye pain. Tylenol and Ibuprofen around clock to help with symptoms.  Today is 8/20/2021 and still having symptoms.
During the night of receiving the injection when getting up to use the bathroom, felt very dizzy and almost fell over. In the morning she felt better but very tired. Dizziness continued at nights mostly but some during the day. Also has had extreme fatigue days 6-8. Also on day 4 had elevation in blood pressure, will have it checked again later this week on day 12.
This morning 19Jun at about 6:35 am I woke up with chest pains that feel like burning; accelerated heartbeat; shortness of breath; on Thursday morning 17Jun I woke up with a 101degree fever at 5:20; body aches; chills; extreme fatigue; nausea; headache; This is a spontaneous report from a contactable consumer. A 29-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, batch/lot number: unknown), via an unspecified route of administration on 16Jun2021 3:15 PM as unknown dose single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient had no known allergies. Historical vaccine included first dose of BNT162b2 on 22May2021 at 02:30 AM on left arm for covid-19 immunization. Patient did not have covid prior to vaccination. Patient was not tested for covid post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient provided privacy policy consent. On Thursday morning 17Jun patient woke up with a 101degree fever at 5:20 along with body aches, chills, extreme fatigue, shortness of breath, nausea, and headache. On 18Jun she woke up with a continuing headache, slight fever of 99.6, fatigue, and shortness of breath. On 19Jun at about 6:35 am she woke up with chest pains that feel like burning, along with shortness of breath, accelerated heartbeat, and fatigue. Patient reported that this was awful. The outcome of events was recovering.  Follow-up attempts are needed; information about lot/batch number has been requested.
Painful arm, dry throat, dizzy, faint, dehydrated, freezing and sweating, unable to walk or move, body aches, swollen throat for 5 weeks. Diagnosed with Hashimotos and now take .50 synthroid medication daily
Painful pin feeling stabbing in the back of tongue, tongue swelled, tip of tongue went numb, lips went numb, pain in left part of chest, difficulty breathing, started to break out in hives, bloody nose. The medics did nothing for me as I am allergic to albuterol. After I felt like I could breathe properly, I went back to work and took some allergy medicine to help stop my reactions. It took four hours for the reactions to subside.
10-15min p/vax local rxn to both;varicella site red one hive & reddened area (size of a silver $) given DPH;
pain, edema, warmth, redness from top of shoulder to below the elbow;extreme pain w/palpation or movement;19MAR98 DPH ordered;
itchy mouth, felt like oral tissue was swelling administered 50mg of diphenhydramine orally and observed patient for 30 minutes. her symptoms did not progress and she felt fine when she left.
Fever (102 degrees F) from evening of 8/29/15 until she woke the next morning. Body aches and headache through Sunday 8/30/15. Symptoms resolved.
Left arm/ neck/ back pain 2 days after injection. Elevated BP 2 days after shot.
pt recv vax & 1hr p/vax pt exp a raised red rash around the inj site 4cm in diameter;rash cleared p/a few days;
Bone and joint pain from neck to toes; Bone and joint pain from neck to toes; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 09:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included escitalopram (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 09:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient previously received paracetamol; oxycodone hydrochloride (PERCOCET) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021 at 21:30, the patient experienced bone and joint pain from neck to toes. The clinical outcome of the events bone and joint pain from neck to toes were resolving at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After receiving immunization, patient noticed expected symptoms of myalgia and arm weakness/soreness.  Patient saw the doctor when it was lasting longer than expected, received a steroid shot and physical therapy from her dr, but called to report that she is still experiencing the symptoms at 6 months after her shot.
near "end of July" dev one day of chest pain, SOB, HA.  Then 1 AUG dev severe chest pain, diagnosed with STEMI/trop 15, clean cath, ultimately diagnosed with myocarditis