chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sunday evening at 5:00 PM I took second dose of Tylenol for splitting headache.  I took a nap as headache faded and awoke at 7:00PM and had hives on extensively on left arm and partial on right arm.  I took a Benadryl capsule  which had no effect, so I went to the Hospital Emergency room.  Saw MD.  I was given Benadryl at 12:49 25 October, I also received Fepcid, and predniSONE at the same time. I was released from the hospital at 3:00.
Pt. called over office 12/27/13 stating he developed fever and chills last night. T 103. Took BENADRYL feeling better today. Denies rash or SOB.
Patient has a knot at injection sight, with large area of swelling, redness and warmth. (Red area width is as large as a new roll of toilet paper.)
Patient was mistakenly given 0.1ml of the Moderna COVID-19 vaccine by a staff member.  The mistake was recognized on August 4, 2021 and we attempted to reach patient to let her know several times.  We left a message with her mother on 8/5/21 at 11:20 am, then called again and got no answer the same day at 4:09 pm. Unable to leave a voicemail as it was not set up. We called again on 8/6/21- no answer.  We called again on 8/12/21 and no answer. Patients mother or grandmother called back and we asked her to please have patient call us back asap. We still have not heard back from patient.
Arm still hurting; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that his/her arm was still hurting after getting the shot almost 2 and one half weeks ago from the date of reporting. Additional supportive information: The follow-up would not possible as no contact details were available.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 14-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
1-8-02, Local swelling and redness Left deltoid 7 cm diameter around injection site. Pt reports ';low grade" fever and chills. No other symptoms reported. Swelling completely resolved by 1/12/02
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 41 year old male of unknown ethnicity. The patient's weight was 210 pounds, and height was 70 inches. The patient's concurrent conditions included: allergic to bee stings, social alcohol drinker, and non-smoker. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 02-JUN-2021 for prophylactic vaccination. Concomitant medications included guaifenesin. On 20-SEP-2021, patient experienced cough and runny nose that started Monday at night. His last interaction with other employees was at his last visit to a work site which was this past Monday. On 21-SEP-2021 night, he had a fever with chills. On 22-SEP-2021, patient reported having a rapid test for covid-19 and the results came out to be positive (suspected covid-19 and suspected clinical vaccination failure). He did not took any prescription medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000194921.; Sender's Comments: V0;20210952710-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event is considered not related. The event has a Compatible/suggestive temporal relationship is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
A rash appeared on the upper portion of my left arm about 7 days exactly from the date of the vaccine. The rash felt swollen with bumps under the skin and not the surface of the skin.  It felt more like small curdles of hard cottage cheese under the skin.  There was a slight itch, but nothing irritable.  The area was wider the next morning.  The itch was slightly more, still not irritable.  The swelling stopped and the area did not increase on the third day.  Everything began to go back to normal.  I did use Keep It Hemple - CBD oil for the itching.  I have used it for mosquito bites and itching many times.  The rash lasted for about 5-6 days.
Fever for 4days so far (073121) from date of shot; chest burning sensation; congestion; chills; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot Number: EW0173) via an unspecified route of administration, administered in right arm on 28Jul2021 14:30 (at the age of 21-years-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included meningococcal vaccine a/c/y/w and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication on 26Jul2021. On 28Jul2021 23:00, the patient experienced running fever for 4days so far (073121) from date of shot, chest burning sensation, congestion, chills and fatigue and treatment received for the events were unknown. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Rapid heart rate occurred on 05/11/2021 and again on 06/09/2021, both events requiring visit to hospital. Have been diagnosed with afib.
pt states she woke up with a very sore left arm.  She was very stiff and sore to where she only could hardly move.  She had a bad headache.  she hurt from her head down to feet and every bone in her body hurt as well as her feet.  She used a heating pad, took aspirin, and Benadryl.  pt says by this day her symptoms were better and gone by the next day.
shaking, like cold, lethargic;started 1hr p/vax;taken to ER p/duration of 2hrs;non responsive, staring;exam was nl;vomited x2;on the way home just perked up & appeared fine
Fever of 102 F, body and joint aches, lasted @ 24 hours then a diffuse rash occured and is slowly fading.  Used tylenol, ibuprofen.
Injection site pain making my right arm unusable, splitting headache, sharp, short pains on different places in my body including my back and knees, fatigue. Some mild nausea/loss of appetite. From the beginning of my symptoms to the end of them, my best estimate is about 36 hours. Taking an aspirin alleviated most of the symptoms to where I was more functional. I did call into work and skip a meeting the day after.
Severe joint swelling and pain and all of my joints like toes ankles knees fingers wrist elbows shoulders in it it?s so bad at times I can?t even walk or use my hands it?s been going on since I got a shot and I hope it is not done no long-term damage I am going to see a rheumatologist on September 16, 2021
Patient fainted in car 10 minutes after receiving vaccine. Misunderstood standard waiting procedure. Felt tired at first and pulled over/parked and called parents.  Short-lasting symptoms, just felt exhausted an hour and a half later.
Report A0360975A describes hearing loss in a female of unspecified age who received Lyme disease vaccine. Medical history, concurrent conditions, and concurrent medications were not specified. On unspecified dates, the vaccinee completed "a series of injections" of LYMErix. One year later, the vaccinee experienced hearing loss, "vibrations," and pain. The vaccinee was treated with unspecified steroids, which provided "temporary relief." As of 2/28/02, the outcomes of the events were unknown. The adverse event "vibrations "does not meet serious criteria but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Approximately 3 hours after leaving the doctors office the baby screamed for over 3 hours.  Was given Tylenol with no relief.  Low grade fever was noted.  One day later he became hoarse.  Doctors office felt it was not related to his immunizations.  That night he ended up in the ER with croup and was hospitalized for treatment for 1 more day.  04/07/2008 MR received for DOS 12/20/2008 with final DX:  Croup.  Minimal thrush. Child presented to ER with respiratory difficulties following a 2 day hx of hoarseness and nasal congestion.  Inspiratory stridor noted on PE as well as white patches in the mouth. Txd with racemic epi as well as albuterol with some improvement noted. Lungs CTA and breath sounds =, O2 sat 98% on RA prior to d/c.
On 12/18 faint papular rash on face. Peeling hands. Throat culture negative. 12/28/09 onset Henoch Schonlein Purpura.
A report has been received from a Health Professional concerning a 14 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST started on 17-Sep-2013. The patient experienced FLUMIST which started on 17-Sep-2013. FLUMIST was discontinued on 17-Sep-2013. The outcome of the event of FLUMIST is unknown. The report was considered to be non-serious.
10/14/2006 rash appeared on torso. Came to office today for DX no fever, fluid filled vesicles. DX chicken pox.
Fever, chills, and expanding local pain, redness, and swelling. Cellulitis was diagnosed and treatment was given.
After patient received vaccine she was accompanied by RN to observation area. In observation area patient was sitting in the chair with her head against the wall. RN asked patient if she was alright, patient stated, "she was not well". She was noted to be pale, glassy eyed. RN called for immediate assisatance. Pt was transferred with assitance to recliner. Patit responded to verbal commands, leaned back with feet elevated. Within Vitals 4 minutes were B/P 118/82, HR 99, Spo2 99% on room air, patient noted to be responsive. Patient stated she thinks she was having a panic attack. Vitals were taken B/P 56/40, unable to get reading for heart rate or pulse ox. Code called, Pt was transferred to ED, patient responsive.
Information has been received from a 79 year old female consumer with no pertinent medical history and no drug reactions/allergies, who on 24-OCT-2007 was vaccinated SC with a 0.65 mL dose of ZOSTAVAX.  Concomitant therapy included "avadone", "rely" and "topral".  On 03-NOV-2007 the patient was seen in the office with bullous rash on the right thigh.  On 07-NOV-2007 the patient had a tooth removed.  On 09-NOV-2007 the patient stated that she developed approximately 12 lesions after receiving the vaccine.  Lab diagnostic studies performed included a biopsy which the patient indicated was inconclusive.  Wound culture was negative.  Applied topical antibiotic and it eventually resolved.  No additional information was available.  Unspecified medical attention was sought, patient was seen in the office.  The outcome was reported as recovered.  There was no product quality complaint.  Follow-up information has been received from a pharmacist indicating that the patient was experiencing a reoccurrence of the symptoms that she experienced on 09-NOV-2007.  On 28-FEB0-2008 the patient began to experience redness and rash in the exact area where she first experienced the symptoms on 09-NOV-2007.  On 29-FEB-2008 the patient noticed a blister on one of the rashes and also noticed that the rash was spreading.  No further information was available.  Additional information has been requested.
Went to emergency room at Medical Center Hospital  with chest pains.  Was given ECG, chest X-ray, Potassium/Magnesium IV treated as an outpatient.
This spontaneous report as received from a physician refers to a 73 year old female patient with coronary disease, gastroesophageal reflux disease, depression, arthritis and hyperlipidemia. The patient's medical history included coronary bypass surgery, compression fracture in her back, shingles, and no drug reactions/allergies. On 12-JUN-2014 the patient was vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. Concomitant therapies included ZYRTEC, aspirin, ZOCOR, CELEXA, ibuprofen, omeprazole (manufacturer unknown), alprazolam, acetaminophen/hydrocodone, NORFLEX and vitamin D. The physician reported that the patient developed shingles in April 2014 (wild-type shingles). She had recovered from the shingles sometime in June 2014. She then received ZOSTAVAX from an unspecified pharmacy. At the time of this report on 24-JUN-2014 she came to the physician's office with a vesicular lesion on her left cheek. It was not painful. Physician said it looked similar to a fever blister (approximately in June 2014). The outcome of vesicular lesion on her left cheek/looks similar to a fever blister was reported as not recovered. Treatment was given for adverse event, acyclovir. No lab studies were performed. Patient sought medical attention, office visit. Additional information has been requested.
Trouble falling asleep night of vaccine, headache, nausea,,dizzy, off balance (slight).
shingles; She says that the pain was unbearable; This is a spontaneous report from a contactable consumer. This 47-year-old female consumer reported for herself that she received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 10:30 as DOSE 1, SINGLE for covid-19 immunisation (age at time of vaccination 47 years). Medical history included blood cholesterol abnormal (Caller says this was diagnosed about a year ago), hypertension (Caller says this was diagnosed about two years ago), Prediabetes (Caller says this was diagnosed about a year ago) Caller says that she is prediabetic about a year ago told about this month tests again came out the same way. No PQC Present. She did not get any other vaccines the same day as the Pfizer COVID-19 vaccine or in the four weeks beforehand. She says that the only medications she takes are cholesterol and high blood pressure, which she was taking previously. On an unspecified date in May2021 the patient experienced shingles, on 2021 she says that the pain was unbearable. She has an appointment to get the second dose on Friday, she don't know if she should receive it or if she should wait. Therapeutic measures were taken as a result of events. She says that for her shingles treatment she is taking pills now, caller provides no further information about the pills. The outcome for event shingles was unknown for pain it was recovering.   Information about lot/batch number has been requested.
Sneezing; Coughing; Nasal congestion; Felt Effie; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), COUGH (Coughing), NASAL CONGESTION (Nasal congestion) and MALAISE (Felt Effie) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Pollen allergy.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MALAISE (Felt Effie). On 15-Apr-2021, the patient experienced SNEEZING (Sneezing), COUGH (Coughing) and NASAL CONGESTION (Nasal congestion). On 22-Mar-2021, MALAISE (Felt Effie) had resolved. At the time of the report, SNEEZING (Sneezing), COUGH (Coughing) and NASAL CONGESTION (Nasal congestion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non significant follow up received on 17-MAY-2021, no new information
RASH AND RED SPOTS ON BOTH UPPER LEGS IN LOCALIZED AREA.
Full body chills; Teeth-chattering shivering; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 22Apr2021 at 13:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included iron supplement (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 23Apr2021 at 03:00, the patient experienced full body chills and teeth-chattering shivering 13-15 hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events full body chills and teeth-chattering shivering were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a 35 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unspecified date "5 or 10 years ago", the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for prophylaxis. Since an unknown date, the patient had been experiencing "pneumonia a lot", and for that reason, she had been requesting a revaccination of PNEUMOVAX 23. The outcome of pneumonia and the causal relationship between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of pneumonia was considered to be as medically significant.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medications details were not reported by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Treatment details were not reported by the reporter.  This case was considered for the 64 adult patient out of 190 reported who was received the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Patient called evening of 7/24, arm had red, hard lump. 7/25 redness and swelling had spread down to elbow. Patient went to ER and was told it was cellulitis and was given a prescription for KEFLEX.
COVID-19 virus infection dyspnea on exertion that started 5 days ago that has progressed to him feeling short of breath even at rest Headache chest pressure
abdominal pain; lightheaded; tachycardia; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ablation for the tachycardia" (unspecified if ongoing), notes: in the past; "ablation for the tachycardia" (unspecified if ongoing), notes: in the past; "Afib" (unspecified if ongoing), notes: She had had Afib treated in the past. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN (non-serious), outcome "recovered"; DIZZINESS (non-serious), outcome "recovered", described as "lightheaded"; TACHYCARDIA (non-serious), outcome "recovered". The events "abdominal pain", "lightheaded" and "tachycardia" required emergency room visit.  Additional information: The reactions were on the same day of vaccinations. Event took place after use of product. The patient recovered and got her 2nd dose administered on 29Jan2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : PFIZER INC-202201347159 same patient, different dose and different event.
This spontaneous report was received from a consumer reporting about her friend who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on an unknown date, her friend experienced the shingles after receiving the vaccine. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The relatedness for patient experienced shingles was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.