chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Deep Vein Thrombosis/he have numbness , tingling on his left foot. It was also swollen; CT scan shows he have PE; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 24Feb2021 10:15 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The vaccine was administered at the hospital. Medical history included back pains, acid reflux and chest pain; all from an unknown date. Concomitant medication included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported. The patient reported that after several days of getting his first shot, he have numbness , tingling on his left foot. It was also swollen, he went to the Emergency and they found out he have deep vein thrombosis and CT scan shows he have PE on 27Feb2021. The reported events resulted in emergency room/department or urgent care. The patient received treatment for the events which was a blood thinner, Eliquis. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Left arm swelled. The red spot around injection site is a size of orange. Arm is painful as well.
Face bright red and swollen, eyes swollen and left leg-site of injection is red and swollen, very fussy.
Patient received vaccination on 11-16-13. She came to pharmacy on 3-24-14 and stated that her arm was still hurting.
Headache, shivering, muscle/body aches, stomach ache, nausea; These symptoms lasted from 2am until 10:30. After 10:30 headache and body aches remain
Dizziness; nausea; migraine; Vomited then went to sleep and woke up at 11pm and felt fine.
Large local hypersensitivity skin reaction around injection site that developed approximately 7 days later. Also the presence of a tender supraclavicular node on the affected side that developed a few days prior to rash onset.
Approximately 20 minutes after vaccine, employee was on the highway driving to work and felt lightheaded. Then felt a strong skipped heart beat, then several more. Has a history of palpitations, but had never felt this before. Stopped after a few minutes. Lightheaded for a few hours afterwards.
Localized hives that was treated by the patient with localized topical witch hazel. Hives resolved after two days. Patient had experienced full-body hives at another time in her life (many years previously).
Fatigue sudden.  Headache. Took tylenol every 4 to 6 hours.
Fever of 102.4, lethargic, whimpering, doctor visit, blood draw, WBC 16,300.
swelling under his left armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER2613) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "keep hair from falling out" (unspecified if ongoing), notes: keep hair from falling out; "heart health" (unspecified if ongoing), notes: heart health. Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for blood cholesterol increased, start date: Dec2010; ASPIRIN 81 taken for heart alternation, start date: 2000; FINASTERIDE taken for alopecia. Vaccination history included: Bnt162b2 (Dose 1, Injected in left arm, Lot: EN6202), administration date: 08Mar2021, when the patient was 61 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 2021, outcome "recovered", described as "swelling under his left armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling.  Additional information: Caller says he has been on the same medications for a long time. He says he takes a statin for cholesterol taking this over 10 years ago, an 81mg Aspirin daily, he probably started taking this 20 years ago, and Finasteride to keep his hair from falling out. Caller says that Aspirin was probably for heart health, he didn't have a heart condition and they said to take low dosage Aspirin every day for healthy heart. No follow-up attempts are possible. No further information is expected.
"She had a shingles vaccine on 05/28/21; This is a spontaneous report from a Pfizer- sponsored program XELSOURCE. A contactable other HCP (nurse) reported that. A 67-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (age at vaccination 67-years) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; tofacitinib citrate (XELJANZ, 5 mg tablets), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Nurse stated, She had a shingles vaccine on 28May21. She would have a second vaccine done after July 28 up to September. The action taken in response to the events for xeljanz  was unknown. . The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021846249 same reporter/patient/drug, diffent event/dose
September 16, approximately 30 hours after receiving the vaccine I experienced upper abdomen and chest discomfort, similar to pressure or indigestion along with muscle pain in my legs and headache.  Upon waking the next day, September 17 my arms and legs felt tingly and the muscle pain was in my lower legs. The abdominal and chest pain described now as burning pain. I had not eaten anything since before this symptom began.
Pentacel vaccine components should not be used separately/ the Hib lyophilized component administered separately will count as a valid dose only if it was reconstituted with the proper diluent, i.e. 0.4% NaCl saline solution/ no AE; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 2 months old male patient who was vaccinated with 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number: UJ032AA and expiry date: 04-Jul-2020) via intramuscular route in the right thigh on 16-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) on an unknown date.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Redness, warmth, itchy around injection sites the night after he was given the injection.
Fever, vomiting, muscle pain, dizziness over a 2-day period. Sore arm, of course.
PATIENT DEVELOPED PRURITUS WIHTIN 20 MINUTE POST INJECTION. RECEIVED  BENADRYL 50 MG ORAL, AND AFTER PATIENT'S PRURITUS WAS RESOLVED.
After vaccine administered, c/o being lightheaded, dizziness, neck heavy, jaw numbness.  Pulse 90-130.  Chills
After the second Covid vaccine I notice ma fibrocystic disease seem to have gotten worse. Had my follow up mammogram a few months after receiving the second shot. They mammographer noticed that my fibrocystic disease was worse than before. Severe inflammation of the breast
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with M-M-R II (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 9°C but less than 25°C for 1 hour and 13 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002917: US-009507513-1706USA002916: US-009507513-1706USA002914: US-009507513-1706USA002915:
HCP has no further AE information; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; HCP called to report a TE for ROTATEQ, and MMR II. HCP reports that there were multiple doses given on unspecified dates to multiple patients.; This spontaneous report was received from a medical assistant concerning to a 13-month-old female patient.  Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 19-SEP-2023, according to a digital data logger, there was a temperature excursion in clinical practice at 9:28, temperature was 8.3 Celsius degree and at 10:02 the temperature was 7.5 (units not provided) for a total excursion time of 34 minutes for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number reported as 1933911 (expiration date 18-APR-2024) and with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot  number reported as W001598 (expiration date 14-JAN-2024), albumin status was not provided, however, upon internal validation it was stablished as rHA. On 25-SEP-2023 at 11:08 temperature was at 9 Celsius degree and at 15:01 it was at 8.0 Celsius degree, for a total excursion time of 4 hours. On 11-OCT-2023, the patient received the improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, and route of administration were not provided) (product administered to patient of inappropriate age) and the improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, and route of administration were not provided), (product storage error) both of them administered as prophylaxis. It was reported that the patient received the vaccination in a private doctor's office.  No adverse effect was observed (no adverse event).        This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2311USA002926: US-009507513-2310USA010775: US-009507513-2311USA002931: US-009507513-2311USA002932: US-009507513-2311USA002927: US-009507513-2311USA002928: US-009507513-2311USA002929: US-009507513-2311USA002930:
20 minutes after the shot my face/neck/chest broke out in a rash that would tingle and feel numb. It went away in about 2 hours My arm hurt and still does some I?ve had a horrible headache since I received the shot  Shortly after the shot my left breast muscle started to hurt and has been hurting since receiving the shot; that is a big complaint I don?t understand why the left breast hurts so bad and I just want it to atop
10NOV93 pt c/o (via telephone) about sharp pain stomach & not feeling well; kidney stone & hematuria;
Patient has felt Blurred vision, extreme nausea. Numbness in hands and legs. sweaty and most imp. Felt CHEAST PAIN from it.
leg was swollen shortly p/shot was given ice was applied, swelling went down;some redness was noted
Lethargy - started about 6 hours after dose Body aches/Chills/fever - started about 6-8  hours after dose Nausea/vomiting - about 12 hours after dose
Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.
was recently treated with baricitinib and dexamethasone for COVID-19 pneumonia in early February elsewhere. Progressive respiratory failure due to critical COVID-19 pneumonia, requiring mechanical ventilation/proning - initially treated elsewhere with dexamethasone and baricitinib (without antivirals or antibodies), now started on remdesivir and convalescent plasma  Vaccine given at (Privacy)
Patient who has completed primary COVID vaccination series who admitted to hospital with a COVID detected PCR.  Patient discharged home with hospice and subsequently died on 10/17/22.  Provider d/c note:  "77-year-old female past history of coronary artery disease, CHF preserved EF, hypertension gout hyperlipidemia aortic stenosis status post AVR recent COVID/urinary tract infection.  She presented for chief complaint of generalized weakness.  She is found to be in third-degree heart block on arrival to now was emergency department.  Patient was admitted to intensive care unit and at drip and had transvenous pacemaker placed.  She was treated for urinary tract infection.  Patient was transferred to intensive care unit to the floor.  Patient developed cardiorenal syndrome fluid overload on the floor.  Despite aggressive diuresis patient required hemodialysis.  Her stay was complicated by bacteremia completed course of vancomycin.  Patient tolerated dialysis poorly.  After trial of 3 days of dialysis patient did not want to continue.  She is seen by palliative and hospice services.  Patient plans to go home with hospice" Patient expired 7 days after discharge on 10/17/2022.
FREEZING; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 11-MAR-2021 03:00 for prophylactic vaccination.The batch number was not reported and has been requested.  No concomitant medications were reported. On 11-MAR-2021, the patient experienced freezing. On 11-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from freezing, and nausea. This report was non-serious.
1st dose over 4 years ago, has not received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: Age at vaccination was not reported. Pharmacist reported that patient received the first dose of Shingrix over 4 years before reporting  and had not received second dose, which led to incomplete course of vaccination. Consent to follow up granted.
headache, pain in left breast and arm, nausea, fatigue, diarrhea and shortness of breath night of vaccination into next day.  Patient had to use rescue inhaler.
He became very ill and died this past Wednesday because he was told to get the shot even though he wasn't feeling well.  There is no excused for perpetuating the myth that everyone should get the shot no matter what.  A negative covid test and thorough physical should be required before people take this vaccine.
About 12 hours later I started having a headache, extreme chills to the point of shaking to warm up under 2 blankets, stuffy head and pain in the right shoulder.
Passed Out; Felt Faint; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The consumer's husband's adopted daughter, that passed out after receiving a Covid Vaccine. Stated she felt faint and because of her, she knew to get down on the floor and she passed out and woke up to her dogs licking her face but she didn't do any damage because she got down on the floor. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Information has been received on 05-FEB-2019 from a lawyer and a male patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2012 at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also known as shingles and other complications. The patient was treated by a healthcare provider at a medical center for a blistering vesicular outbreak which was diagnoses as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt recvd 1st dose of Hep B vax on 18JUN91 & devel tiredness; Pt recvd 2nd & 3rd dose of Hep B vax on 30JUL91 & 18DEC91 & lab eval on 20FEB92 showed no detectable Hep B surface antibody; No further details were provided;
About 4 hours after vaccine, patient reported feeling very ill, sick to stomach, and feverish. Bad enough to come back and report it to us.
Patient states onset of severe pain and tenderness from Left shoulder blade to Left wrist on Wednesday 09/18/2019. Unrelieved by extra strength Tylenol or lidocaine patch. States unable to raise Left arm above ear level.
This case was reported by a consumer via call center representative and described the occurrence of skin mass in a 73-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 7th July 2018, the patient received SHINGRIX. On 7th July 2018, less than a day after receiving SHINGRIX, the patient experienced skin mass. On an unknown date, the outcome of the skin mass was unknown. It was unknown if the reporter considered the skin mass to be related to SHINGRIX. Additional details were reported as follows: The patient reported that a bump on her arm, about 3 inches from the needle puncture site on the left arm, appeared a few days after a SHINGRIX injection. She thought it was a tick bite, and she went to an urgent care. The physician said that it did not appear to be from the SHINGRIX injection. The bump was removed, and the patient tested negative for any tick borne diseases, including Lyme disease. The reporter was asking if she can get the 2nd shot. If its ok for her to take the 2nd shot. The reporter said a 3 of her friends had also experienced the same thing. This is one out of 4 linked cases reported by the same reporter.
Above person given Tdap booster in left arm on 5/8/13. Within 24 hours developed swelling, pain, redness, warmth, itching at injection site extending down to left elbow area. No fever. Treated with CLARITIN daily and KEFLEX x10 days.
healthy female with prior COVID infection (not recent)  who got Left arm injection site pain 1st day that worsened and persisted. In the ED has about 6 cm of erythema around the injection site with severe tenderness, moderate deltoid swelling/tenderness, with axillary lymphadenitis.  Suspect may have sterile abscess. Likely immune mediated reaction
sore throat, ache feeling, coughing, t102, ATB given w/o effect;27NOV CXR looked okay;3DEC t100.1, sl better cough;
1.5 days after, terrible pain at site of injection, muscle aches, weakness, nausea, chills, body aches, brain fog
Tinnitus worsened substantially a few months after getting the 2nd Pfiser vaccine.   Additional symptoms included.  Peripheral neuropathy, elevated blood pressure spikes, constant headaches and what seemed like POTS (Postural orthostatic tachycardia syndrome.  In August 2021 I joined the covid clinic and was referred to a neurologist, endocrinologist, rheumatologist, a Physical therapist, and cardiologist.   Separately I visited two ENTs.   2nd one did MRI to rule out brain tumor.   Visited two audiologists to get base line hearing tests.   Now am being treated with TRT (Tinnitus retraining therapy) with a hearing aid.   Have been taking 1.5mg Ativan daily since Aug 2021 due to anxiety from tinnitus.    Have done acupuncture with no benefits.  I have been seeing a physical therapist to see if TMJ could be culprit of the tinnitus but no benefits.   I did a full heart stress test with my cardiologist which came back with a healthy heart.   Both my Neurologist and Rheumatologist believe my symptoms are due to the vaccine or long covid.  All of my symptoms have gone away except for the tinnitus which I still suffer from 24/7 today.   Also my I have tested positive for Rheumatoid arthritis antibodies, however, have no physical symptoms.
Severe shortness of breath; Wet cough; Weakness; This is a spontaneous report received from a contactable consumer, the patient. A 21-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 08:15 as a single dose (at the age of 21-years-old) for COVID-19 immunisation. Medical history included asthma. The patient had a history of allergy to penicillin. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 24Mar2021 at 08:00, the patient had experienced severe shortness of breath, wet cough and weakness. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe shortness of breath, wet cough, weakness was not resolved at the time of this report.  Information on lot/batch number has been requested. No further information is expected.
Severe shoulder joint pain(level 9) first night following injection, unable to sleep. Second night some sleep with pain medication. Third night(last night ) some sleep without pain medication. Pain located deep in arm/shoulder joint. Getting better each day, still painful lifting arm straioght up or swing out. WHERE SHOULD I GET MY SECOND INJECTION?
Arm hurt at site of shot, Very Tired, Very Thirsty (drank 3 full glasses of water in a couple minutes), Weak leg, (briefly, Aching, Dry eyes even with home humidifier on furnace, ribs hurt for about 5 min. and wheezing upon awakening at 4:45am, most symptoms gone by about 7:30am, Thursday.
Patient describes numbness in arm where IM injection was given from injection site to fingers and on cheek to ear on face on the same side as the injection. No facial droop, just small area feels "numb"