chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19was Paxlovid. Treatment start date: 08Jul2022, Treatment stop date: 13Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 13-DEC-2016, the patient was vaccinated with an expired dose of ROTATEQ (lot # reported as K010223, expiration date 13-MAY-2016; dose was not reported, orally). No adverse effects were reported. Additional information has been requested.
Severe Headache the day following vaccine administation which lasted several days.  Severe case of Shingles starting December 1, 2007 which is just now starting to fade.  Patient has had Shingles in the past 2-3 times yearly for the last 10 years.  However, he states he has never been treated with antiviral medication.
site of injection rash; blister; This case was reported by a physician via sales rep and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site rash and blister. On an unknown date, the outcome of the injection site rash was unknown and the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had site of injection rash over one month ago still a blister. The reporter agrees to follow up.
2" wide slightly red streak at injections reached top of shoulder and then down to humours sight.  Had slight low grade fever 99 with chills all day long
Severe reoccurring chest pains, heart racing, fluttering, nausea/vomiting, sweats, tingling in my arm down to my hand
Employee called her work unit to say she went shopping after receiving H1N1, employee had finished working night tour, received vaccine at 8:30 am, while driving home at 10:30 experienced chest pain, pain in left arm (received vaccine in left arm) difficulty breathing, called 911 went via ambulance to Hospital called at 2:30 pm to notify of condition will remain for observation for 24 hours as per employee. 11/3/2009 records from ED date 11/2/2009. Patient with c/o's lt sided chest pain that radiated into lt shoulder, arm, neck and jaw, also c/o's SOB and anxiety. Tx: Telemetry, Lopressor, ASA.Nitro paste.Cardiology consult neg. Dc Dx Chest pain, SOB.
Patient says that the immunization was received too high in the arm and experienced extreme pain the day of and the next day. She followed up with her physician and is still experiencing pain. She iced the area and it helped with the pain.
sharp pain/tingling  at/around injection site 7+ days after injection when arm is moved into a particular position. pain goes away when arm is not in particular position inducing pain. pt still reporting pain 5+ weeks from injection. pt received flu shot in same arm 11 days prior to pfizer injection. pt has not tried any thermal therapy or medication related therapy due to the pain going away quickly when out of the position that causes it.
Narrative:  Patient contracted covid infection 7 days after receiving covid vaccine dose #1. Pt was treated at private sector hospital with BAM-EUA . Pt was instructed to wait 90 days before receiving covid vaccine dose #2. Pt received the dose#2 on 4/30/21. This is when the patient reported this information.
Sudden rash, developing night of 6Mar04, to forearms, soles of feet, palms of hands and thighs. Treated with Benadryl 7Mar04. Next day spread to chest and back. Rash on chest radiated from smallpox vaccination site. Complained of widespread itching both visits. Given Allegra 8Mar04  and light duty x 10 days.
Site of injection is a  large 3" raised welt, red, hot and tender to touch.  Vomiting begin about 3 hours after injection, headache and minor dizziness with fatigue.  Day after some minor vomiting, headache, fatigue continued.  Day 2 & 3 no vomiting, nausea, lessened headache, fatigue lessened but continued.   Day 3 p.m. feeling very tired but mostly recovered.  Red welt is down to 2", still tender to touch, warm instead of hot.  Feeling mostly recovered but not 100%.
felt faint while driving; This spontaneous report as received from an office manager via a company representative refers to a non-pregnant 19-year-old female patient. The patient had no pertinent medical history, concomitant therapies and drug reactions or allergies.  On 09-JUN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) to protect against human papillomavirus (HPV). On the same day, on 09-JUN-2020, the patient started therapy with levonorgestrel (KYLEENA) intrauterine device (IUD) (strength, dose, frequency, indication, lot # and expiration date were not reported).  On 09-JUN-2020, the patient felt faint while driving. It was reported that the patient pulled her car over and the patient was transported via an ambulance to an emergency room (ER). The patent was given something to eat and something to drink as treatment. No laboratory test were performed. The patient was not hospitalized, she was discharged home from the ER on the same day on 09-JUN-2020. The outcome of the event was reported as recovered/resolved on an unknown date in June 2020.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and levonorgestrel (KYLEENA) was not provided.
Persistent headaches every other day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2022 at 17:00 as dose 2, single (Lot number: Cvs3118) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Rmm , Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 28Dec2021, when the patient was 28-year-old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 23Jan2022, outcome "not recovered", described as "Persistent headaches every other day". Therapeutic measures were not taken as a result of headache.  Additional information: The patient not received any other vaccine in four week. The patient not tested covid 19 positive post and prior to vaccination.    No follow-up attempts are possible. No further information is expected.
I am having a problem of mild fever; I am currently just up to  99.4 Fahrenheit; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 21-year-old patient of an unspecified gender received bnt162b2 (BNT162B2 formulation: solution for injection), dose 2 via an unspecified route of administration on 05May2021 (Batch/Lot Number: EW0176) as DOSE 2, SINGLE (at the age of 21-year-old) for covid-19 immunization. Medical history included ongoing eczema (skin problems like some allergies like eczema). Concomitant medication (other products) included cetirizine taken for eczema, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 14Apr2021 (Batch/lot number: EW0151) (at the age of 21-year-old) for covid-19 immunization. The patient experienced a problem of mild fever; currently just up to 99.4 Fahrenheit on May2021. The patient asking should take some medicine like Tylenol or something else. The patient also stated don't know much if I just should drink water or take Tylenol because currently just up to 99.4 Fahrenheit. The patient did not receive any treatment. The outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
itching swelling rash from shoulder to below elbow for 7 days. Tired and in bed for day and half
MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE 4/21/2023 SPINAL STENOSIS OF LUMBAR SPINE
FLU SHOT WAS GIVEN BY PHARMACIST AFTER A LEGAL HOLIDAY , SOON AFTER THE SHOT SOMEWHERE AFTER SEPTEMBER 07 , MY MOM HAD TO START USING A WALKER , VERY MUCH PAIN ON RIGHT UPPER LEG & BUTTOCKS , SOON MOVED OVER TO THE RIGHR BUTTOCKS , THEN ALMOST COMPLETELY IMMOBILIZED HER  , 5 TOTAL E/R VISITS WITH THE 5TH VISIT ENTERING TO HOSPITAL
no known adverse event.  Too young to receive the vaccine.  received on on 1/23/2021 and 2nd on 2/11/2021
Vertigo lasting several days, severe migraine type headache, Wheezing, coughing, slight chest pain.
Information has been received from a physician concerning a 52 year old female who in June 2007, was vaccinated IM with a dose of ZOSTAVAX. In November 2007, 5 months after vaccination the patient experienced shingles. It was reported that the patient was seen in the office and had vesicles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007.  Information has been received from a physician concerning a 52 year old female who in June 2007, was vaccinated IM with a dose of ZOSTAVAX (Merck). In November 2007, 5 months after vaccination the patient experienced shingles.  It was reported that the patient was seen in the office and had vesicles.  Unspecified medical attention was sought.  A product quality complaint was not involve.  Follow-up information from the physician indicated that this 52 year old female with gastritis, menopause and no known allergies was vaccinated IM in the left deltoid on 20-JUN-2007 with a first dose of ZOSTAVAX (Merck) (lot # 657559/0462U).  There was no illness at the time of vaccination.  On 02-NOV-2007, at that time she had a rash on her back, it was very tender, quite itchy and it had a burning sensation when it was touched.  She was diagnosed with herpes zoster.  There were no lab studies performed.  The patient was treated with oral FAMVIR and recovered on 10-NOV-2007.  No further information was provided.  Additional information is not expected.
1/22: dizziness, chills, hot flashes, diarrhea, nausea for 6 hours. Exhaustion rest of night 1/23: exhaustion, anxiety 1/24: spotting- beginning of period (have not had a period since august 2020) tires, lack of appetite  1/25: period, hot flashes, tired, lack of appetite  1/26: felt better in terms of energy, had period 1/27,28: diarrhea each morning 1/28: swollen, painful lymph node under right arm 1/29: pain at injection site, small red bump, slightly swollen arm 1/30 1/31: diarrhea in the morning Continued lack of app since vaccine
Has experienced chronic hives since administration of her flu vaccine this year. Unknown if just an auto immune response or reaction to the vaccine.
This non-serious spontaneous case, initially received from a pharmacist on 12-Oct-2018, concerns a 73-year-old, elderly male patient. On an unspecified date, due to power off, the vaccine went below 28.4 F for about 6 hours (explicitly coded as incorrect product storage). On 12-Oct-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250794 and expiry date: 30-Apr-2019] which underwent temperature excursion (explicitly coded as drug administration error). No adverse event was reported.
MODERNA COVID-19 Vaccine EUA 12:30 am fever, chills, aches in bones, headache, inability to sleep.  6:30 am fever, chills, aches, headache. With 2 Tylenol, fever broke and was able to sleep some.  12:30 pm on 1/9/21 fever returned. Ongoing aches, headache. Took 2 more Tylenol.. 3-5 pm symptoms seemed to resolve, but then fever returned. At 7:15 pm, temp was 100.3 (baseline is 97.4).  Took 2 more Tylenol and fever resolved. Still achy some.
Got flu vaccine on 10/14/21 in left arm at Pharmacy. Has never had significant pain with needle or sore arm after with past vaccines. When the shot was administered (while sitting), there was immediate sharp pain (different than past dull when liquid infuses) with injection, and immediate pain to move arm at the shoulder joint. Has continued to have sharp pain to move his arm at the shoulder, and has throbbing pain at night. Has not noticed any swelling, redness, or warmth.
Patient alerted pharmacy that she had experienced swelling and itching from influenza shots in the past, and has asthma and allergies, however has never had to use an Epi-pen in the past. Patient seemed very nervous, but insisted she was OK to receive the shot. Pharmacist on duty administered Moderna to patient, and waited next to her for several minutes to observe for possible reaction. Patient felt fine after several minutes of talking, so pharmacist advised patient and her husband to let her know if patient started feeling SOB, or itchy, or swelling of face, and went back to pharmacy to complete rxs in que. At that time a different patient who had just received the Moderna vaccine passed out, and pt witnessed this, further increasing her anxiety. 911 was called for the patient who passed out. During the next half hour, pharmacist kept checking on pt. She indicated her tongue seemed to be swelling. So pharmacist on duty asked EMT to check out pt after they had finished taking care of patient who had passed out. EMT checked pt throat, and assured her there was no swelling, however suggested diphenhydramine 25-50mg to be proactive. Pharmacist on duty asked pt if she would like diphenhydramine, and she said, "Yes, Please." So pharmacist provided the diphenhydramine to pt, and she took 50mg. After that she seemed to be fine, and her husband took her home.
Missed second dose; Itching; big rash on his chest/got a horrible rash all over their entire body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), RASH (big rash on his chest/got a horrible rash all over their entire body) and PRODUCT DOSE OMISSION ISSUE (Missed second dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PRURITUS (Itching) and RASH (big rash on his chest/got a horrible rash all over their entire body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). The patient was treated with PREDNISONE (oral) for Rash and Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) outcome was unknown, RASH (big rash on his chest/got a horrible rash all over their entire body) had not resolved and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included injectable steroids. No concomitant medication was provided. On an unknown date, Biopsy and Throat culture was performed, but result was not available.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Updated event - Product dose omission issue.
Red/swelling at injection site area; per provider patient advised cold compresses 15-20 min 3-4 x daily, take Ibuprofen 600mg, if swelling not relieved or area hardened to go to urgent care.
I had a large, hard knot on my arm near the injection site that appeared 7 days after receiving the vaccine. I experienced soreness and mild itchiness at the site. I did not take any medication for pain or swelling. About 12 hours after it appeared the swelling had mostly subsided, the site was still hard, and mild soreness remained. The swelling and soreness is almost entirely gone 2 days later.
Patient has displayed symptoms of hypoglycemia and hyperactivity since his shots, 11/2/2000. He has a lack of attention and is always out of control. He was diagnosed with asthma and has a sensitivity to any chemicals. Also, has had bloody stools.
back pain; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) at single dose for COVID-19 immunization on 08Jan2021. Relevant history and concomitant drugs were unknown. The patient got the vaccine yesterday and he had back pain on 09Jan2021. The patient asked if he could take Tylenol.  Outcome of event was unknown.  The information on the lot/batch number has been requested.
Woke up with tinnitus in right ear on April 26, 2021. Lost all hearing in right ear by April 28, 2021.
On Sunday morning, the patient had severe chills, took a nap, and felt very weak after her nap.
Shot administered in left arm however shortly after pain in the right arm pit area. Pain continued for 5 days and then went to see the doctor. They said the lypmh nodes in the under arm area is swollen but they are not sure why.  Pain is still there and it's been a week today.  If it is still painful next week, I will be returning to the Dr's office.
11/29/05 5:00 pm feeling tired. Late that night vomited one time. 11/30/05 Achy body, tired, diarrhea, vomiting, diarrhea through the night to 12/1/05. 12/1/05 Tired, achy. 12/2/05 Sinusitis, Rhinitis. Not sprayed but dripped in when administered.
About 6 hours after the shot, I started getting pain in my arm. 2 hours later, I woke up and was severely shivering for two hours straight. In the morning, I woke up again with a fever of 104 and I dry heaved. My fever broke, but then a few hours later I got another low grade fever. I felt better about 24 hours after my shot.
I felt tired and my head was felt foggy; I felt tired and my head was felt foggy; a little itchy/rash all over that is raised and itchy; Measles-like rash; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported receiving her first dose of BNT162B2 on 02Apr2021. She stated she felt tired and her head was a little foggy. After the second day she reported feeling a little itchy, which continued into a "full-blown " rash all over that was raised and itchy on her entire body. She reported she still had it as of 13Apr2021. She further reported it was little raised bumps (not hives), that itched; it looked like a measles-like rash. When she scratched it, she stated it went away. The patient reported she had it on her leg, chest, stomach, arms, and neck; the only place she didn't have it was on her face. She was unsure if this was a common occurrence and inquired if it was safe to do another vaccine. The patient's doctor told her to call Pfizer. The pharmacist said it was a reaction and some people were reporting a reaction days after the vaccine and not immediately after. The reporter asked for the protocol to follow and about what her doctor should do, further inquiring how well she was covered from the first dose if she did not get the second dose. The clinical outcome of she felt tired and her head was felt foggy were unknown; the outcomes of a little itchy/rash all over that is raised and itchy, and measles-like rash were not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Breast milk supply dropped significantly. Normal output prior to vaccine 35-40oz a day, after first dose 20-25oz a day, then 10-15oz a day after second dose.
Occipital stroke involving vision on 3/14/21, was seen at ophthalmologist and sent to Hospital and stroke confirmed on MRI.
Tingling and pain running up and down arm of injection. Extra-sensitivity / pain and redness on palm of same hand. This occurred one week after the injection and resolved after 3 days.
Pt developed a red rash at location of injection in back of arm. Took BENADRYL, APAP and used cold compress on location to help. Is painful for patient. It is on arm ZOSTAVAX was given.
Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 17-Mar-2021, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) had resolved.            No concomitant medications were reported.  It was reported that the patient only had coughing for 2 weeks each time she received the vaccine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18-Jun-2021 and included significant information such as outcome of the event was updated.
Significant Rigors, fever, nausea, body aches, fatigue, mild headache and mild sore throat. Lasting till morning of 2/7/2021, and fatigue continues at time if filling out this form 6:40pm on 2/7/2021.
This case was reported by a physician via sales rep and described the occurrence of enlargement of lymph nodes in a 17-year-old female patient who received BEXSERO. On 5th July 2017, the patient received BEXSERO (intramuscular) .5 ml. In July 2017, 3 days after receiving BEXSERO, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was recovered/resolved. The reporter considered the enlargement of lymph nodes to be unrelated to BEXSERO. Additional details were provided as follows: The age at vaccination was not provided. The patient had lymph node swelling in the clavicle area. The patient's lymph node was later removed and date of removal was unknown. The patient required emergency room visit.
pt recv vax 13AUg98 & began to run a fever 15AUG98 in the evening;pt cont to have a fever & a h/a through the 16th & 17th;parents were unable to reduce the fever on 17th;MD adm pt to hosp overnight;fever broke about 1AM 18AUG;