chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed abscess on left breast within a week or two.; swelling to left axilla; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6201) via an unspecified route of administration in the left arm on 13Feb2021 at 11.00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. The patient did not have allergies to medications, food, or other products. Concomitant medications included acebutolol (ACEBUALOL), cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLOVENT). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el9263) via an unspecified route of administration in the left arm on 23Jan2021 at 16:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks prior to COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 21Feb2021 at 13.00, the patient experienced an abscess developed on left breast within a week or two and swelling to left axilla. The patient received antibiotics (unspecified) as therapeutic measures for the reported events. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the events abscess on left breast and swelling to left axilla was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Pt described a local rash (not painful) about the size of a sand dollar, and then it went away a few days later. Denies any other sx.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 29-SEP-2017, the patient was inoculated with the ZOSTAVAX vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (lot number, dosage and route of administration not provided). "Shortly after" receiving ZOSTAVAX, the patient suffered from shingles and extreme mid-thoracic pain. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the shingles and extreme mid-thoracic pain was considered to be not recovered. Shingles and extreme mid-thoracic pain were considered to be disabling. Additional information has been requested.
Instant extreme redness, about 6 inches long and all across my arm, heat, pain, swelling, redness lasted almost 2 weeks with gradual fading after about 8 days. It still hurts occasionally now. I have never had any problems in the past. I don't know if I will get again it still hurts. ODD.
Hives. Feels itchy in random places on the body for a couple of minutes. Started taking Antihistamines both Allegra and zyrtec.  From March 28th  I stopped Antihistamines as the doctor suggested the hives started coming back again.
6 hours post vaccination I felt very tired.  By 9pm I had a muscle aches and pain (I felt like I had the flu, but I had no respiratory symptoms..no cough nor congestion)  and a fever greater than 101F.  This lasted until approximately 12 noon 6/11/19.   Fever resolved...muscle pains slowly went away.
Pt vaccinated w/DT and experienced reaction from elbow to shoulder.  Taken to ER.
Injection site redness, swelling, hot/warm; injection site redness; Injection site redness, swelling; Injection site redness, swelling, hot/warm, painful; fever; Chills; On and off headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site redness, swelling, hot/warm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (Injection site redness, swelling), VACCINATION SITE PAIN (Injection site redness, swelling, hot/warm, painful) and PYREXIA (fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LISINOPRIL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Supplementation therapy.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site redness, swelling, hot/warm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (Injection site redness, swelling), VACCINATION SITE PAIN (Injection site redness, swelling, hot/warm, painful), PYREXIA (fever), CHILLS (Chills), HEADACHE (On and off headache) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE WARMTH (Injection site redness, swelling, hot/warm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (Injection site redness, swelling), VACCINATION SITE PAIN (Injection site redness, swelling, hot/warm, painful), PYREXIA (fever), CHILLS (Chills), HEADACHE (On and off headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment for these events.
I was tachycardia at 105/110, hypertensive  at 180/110 , riggers and a temp at 102.4
Extremely sore arm, very hot, red and swollen, fatigue, dizziness, chills.  These symptoms continued to get worse throughout the day and I spent next couple of days sleeping with high fever ranging from 100.8 to 102.1, body aches, extreme dizziness, sick stomach, headache.  To date, 6 days later, many symptoms have gone away, but my arm is  still very red, swollen and hot.  Fever has dissipated, but fatigue and soreness continue.
every part of his body hurt like he has been beaten with a bat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (every part of his body hurt like he has been beaten with a bat) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (every part of his body hurt like he has been beaten with a bat). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 13-Feb-2021, PAIN (every part of his body hurt like he has been beaten with a bat) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.   This case was linked to MOD-2021-272289 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received contain no significant information but initial version missed to capture latency and onset date of event.
Tinnitus, Anxiety Attack requiring paramedics to be called on 12/20/2021.  Huge drop of adrenaline in to the body with shortness of breathe, rapid heart rate and feeling like I was having a heart attack and pass out.    Second episode on evening of 12/20/2021 while at dinner. Another random drop of adrenaline in the body with rapid heart rate.    Two mini episodes of adrenaline/anxiety attack on 12/22/2021.
Patient received the booster instead of the 2nd dose of the primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the booster instead of the 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the booster instead of the 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the booster instead of the 2nd dose of the primary series) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the booster instead of the 2nd dose of the primary series).    Patient received the booster instead of the 2nd dose of the primary series. No concomitant medication were reported. No treatment medication were reported.
Strong body aches at hips, lower back, neck shoulders and down spine. Headache. Experienced from  4/10/21-4/13/21
Chills, joint pain, loss of appetite, hives, breathing problems, shortness of breath
Flu like symptoms, headache, all over joint, muscle pain, tingling, heaviness of lower extremities. Diagnosed with Fibromyalgia, Chronic Fatigue, Irritable Bowel Syndrome, Hashimoto's Thyroid Disease, all after receiving two anthrax shots 1st one on 1/10/2003 lot FAV 070 and 2nd one 1/24/2003 Fav 063.
Severe nausea/vomiting 4 days after receiving vaccine; Severe nausea/vomiting 4 days after receiving vaccine; This is a spontaneous report from a contactable other HCP reporting for herself. A 34-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at 09:15 at single dose intramuscular in left arm for COVID-19 immunisation. The patient had no relevant medical history and was not receiving concomitant medications. The patient had no known allergies.   The patient was vaccinated at hospital. Patient age at time of vaccination was 34 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination and was not COVID tested post vaccination. The patient experienced 'severe nausea/vomiting 4 days after receiving vaccine' (as reported) with onset date on 09Jan2021 at 11:00 PM. The patient received treatment for the events with promethazine. The events resolved on an unspecified date in Jan2021.  Information on the lot/batch number has been requested.
Fevers 6+ days, to 103 degrees.  Neutropenia, severe (A.N.C. -89)
Patient noted to be having some reaction symptoms shortly after getting the COVID vaccine.  Vaccine given at 1327 - spouse noted to have given her Benadryl 25 mg at 1338 when she first reported HA and numbness starting on the R side of her body.  Patient was assessed by Dr.  Slurred speech was then noted, as well as patient noting the weakness was now all over.  Dr. recommended patient be evaluated in the ED due to these symptoms - patient agrees, with the agreement that an ambulance would be called to transfer patient also.  Patient then noted that the HA was a constant ache and she continued to c/o nausea.  Ambulance transfer at 1402.
Patient developed chest pain starting 48 hours after the 2nd dose of Moderna vaccine. Progressively worsened. Presented to the hospital 72 hours after the vaccine with mildly abnormal ECG and elevated troponin level. Underwent cardiac catheterization without coronary artery disease. Diagnosis of myocarditis made.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-AUG-2013, the patient was vaccinated with the first dose of VAQTA (route of administration, lot # and expiration date were not reported). On 14-FEB-2014, a few days earlier than minimum interval of 6 months from the first dose, the patient was vaccinated with the second dose of VAQTA (route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Additional information is not expected as there was no consent for follow up.
This spontaneous report was received from a nurse and refers to approximately 25 patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (exact dose and route were not reported, lot # K019560, expiration date: 02-JUN-2017). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse manager refers to unspecified number of patients of unknown age and gender. On an unknown dates, since October 2014, the patients were vaccinated with a doses of RECOMBIVAX HB (doses, routes, lot numbers and expiration date were not provided) which were exposed to multiple excursions. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
arm was warm; arm started itching; arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE PRURITUS (arm started itching) and VACCINATION SITE ERYTHEMA (arm was red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE PRURITUS (arm started itching) and VACCINATION SITE ERYTHEMA (arm was red). On 14-Mar-2021, VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE PRURITUS (arm started itching) and VACCINATION SITE ERYTHEMA (arm was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided. Treatment information included ice pack.
I was feeling messed up; Like feverish; dizziness; This is a spontaneous from a contactable consumer (patient). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0161) (age at the time of vaccination was 45-years-old) via unspecified route of administration, administered in arm right on 14Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included high blood pressure. Concomitant included Amlodipine, Atorvastatin, Hydrochlorothiazide. It was stated that when I took 1st vaccine last Tuesday, 14th and on Friday I have been feeling like feverish like dizziness. For first 3-4 days I was dizzy like I have been like dizzy since Tuesday (14Apr2021). I have been like low down with fever like this morning I woke up with fever, took Tylenol to came down. What you have been best me to do? I mean I woke with the feverish in this morning (16Apr2021). I took Tylenol and it came down but yesterday I was feeling. I was feeling fine yesterday. The day before yesterday I was feeling messed up (20Apr2021). I am really scared to take that second vaccine you know. It was stated that the patient did not go to the doctor. It was stated that I really want to know if I should take this second shot because had an experience like this you know. The outcome of the event dizziness was recovered in 2021, outcome for feverish was not recovered and unknown for other event.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Cellulitis in injection arm, started 2 days after vaccination. started in wrist/forearm area
got a rash and itching all over both legs on inner thighs, both arms in the back and front of the arms; got a rash and itching all over both legs on inner thighs, both arms in the back and front of the arms; This is a spontaneous report received from a contactable consumer (reported for herself)  A 79-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24 APR 2021 patient received the first dose of the Pfizer vaccine, That night patient states, "I got a rash and itching all over both legs on inner thighs, both arms in the back and front of the arms., just wandered if it is okay to get the second shot?". The patient inquired stating "I had a side effect after the first dose of the vaccine. Should I get the second dose?". Seriousness and outcome of the events were not reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Approximately ten hours after being injected with PNEUMOVAX 23 I experienced a severe headache, fever, and I was unable to use my left arm.  It is now twenty eight hours later and I am still suffering headache, fever, and have limited use of my left arm.
Superficial bleeding left leg; Numbness in l. arm; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Superficial bleeding left leg) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (gradual improvement) since 1996 and Hypertension (stable) since 2018. Concomitant products included METOPROLOL from 2018 to an unknown date for Hypertension, METHOTREXATE from 1996 to an unknown date and HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) from 1996 to an unknown date for Rheumatoid arthritis.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness in l. arm). On 16-Jun-2021, the patient experienced HAEMORRHAGE (Superficial bleeding left leg) (seriousness criterion medically significant). On 05-Jul-2021, HYPOAESTHESIA (Numbness in l. arm) had resolved. At the time of the report, HAEMORRHAGE (Superficial bleeding left leg) had resolved with sequelae. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: elevated (High) Elevated. In 2021, Ultrasound scan: normal (normal) Normal.         The patient reported that signs of bleeding were still present .Ten days later bleeding in left leg, area 4 in. x 8 in.  Treatment information was not provided.  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.   This case was linked to MOD-2021-163325 (Patient Link).; 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.
This case was reported by a consumer and described the occurrence of autism in an 18 month old male subject who was vaccinated with Diphtheria and tetanus toxoid and acellular pertussis vaccine (Infanrix) for prophylaxis. The reporter is the subjects mother. A physician or other health care professional has not verified this report. The subjects medical history included hand and foot and mouth disease, following a previous vaccination (vaccine not specified). Previous and or concurrent vaccination included Diphtheria and tetanus toxoids and acellular pertussis vaccine (DTPa, manufacturer unspecified), inactivated poliomyelitis virus vaccine (IPV), live attenuated measles, mumps (Strain not specified), rubella vaccine (MMR), pneumococcal vaccine (manufacturer unspecified), varicella virus vaccine (Varivax), and combination haemophilus influenzae type B conjugate, hepatitis B vaccine (Comvax). On April 20 2002 the subject received the first dose of Infanrix (lot number not specified) 0.5 ml to the left thigh. Approximately on year later on an unspecified date in 2003, the subject experienced a change in behavior subject was diagnosed with autism. This case was assessed as medically serious by manufacturer  (OMIC). At the time of reporting, on Nov 21 2005, the events were unresolved.
Chills, dizziness started within 24 hours of second injection. By Sunday, 6 days after second injection, he was hospitalized with nausea, vomiting. Day 7 he had a stroke and NSTEMI heart attack. He required ventilation twice and several modes of respiratory assistance. Currently, he is on 4 liters of oxygen and battling end stage renal disease related to diffuse disease from hypovolemic shock and infection. He remains hospitalized and deconditioning.
no adverse event; expired dose administered; This spontaneous report as received from a study coordinator (Researcher) refers to a 4 month old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 26-SEP-2019, the patient was vaccinated with properly stored but an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # R002805, Expiry date : 23-SEP-2019) for prophylaxis (expired product administered).  The patient had no adverse event.
SORE ARM; SLIGHT FEVER; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, slight fever, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, slight fever, and extreme fatigue. This report was non-serious.