chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She knows of people who have received the Moderna COVID-19 vaccine and have had breakthrough infections; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (She knows of people who have received the Moderna COVID-19 vaccine and have had breakthrough infections) 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 BREAKTHROUGH COVID-19 (She knows of people who have received the Moderna COVID-19 vaccine and have had breakthrough infections). At the time of the report, BREAKTHROUGH COVID-19 (She knows of people who have received the Moderna COVID-19 vaccine and have had breakthrough infections) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2023: Live significant follow up appended: Additional reporter added
This spontaneous report as received from a physician via company representative refers to a 16 year old female patient. The patient pertinent medical history included diabetes. On an unknown date, the patient was vaccinated with GARDASIL. On an unknown date, the patient sugar was uncontrollable (blood glucose abnormal). The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Mother reports child is unusually sleepy was give tylenol with shots, and at 9pm went to sleep at 9:30 woke up and 5 am drank a little but slept until 12 pm and when mother called us child was still asleep.  Seen by Dr. 2/20 - dx'd ear infection started on Zithromax Seen by Dr. on 2/22 and no ear infection.
About three minutes after the shot was injected, I started getting cold sweats.  About two minutes after that I started to hear a ringing in my ears.  This ringing got louder over the course of a minute and eventually my hearing was completely gone and I could only hear the ringing loudly.  As the ringing was at it's loudest, My peripheral vision started to go black and I nearly feinted.  Over about two minutes, I slowly had my normal hearing and vision return and the ringing in my ears got quiet.
pt recvd 3rd dose of vax & devel lump & swelling @ inject site; shortly p/devel sx of diarrhea, fatigue, muscle ache; MD discovered rise in liver enzymes; pt had Hep A unrelated to vax;
15-20 min - left arm discomfort from shoulder to elbow. 30 min. - aching increased; moved to forearm and hand. 40 min. - pain/dull/throbbing throughout arm from shoulder to hand. 40-1hr1/2 - continued throbbing. 1hr 1/2 took 2 ibuprofen. 1hr 45-2 hr, pain decreased.
Pins and needles on tongue started mins after the vaccine was administered . Swollen tongue a few mins after and had to take benadryl for the allergic reaction. Fever for 3 days 102.3 being the highest. Pain on the left arm where vaccine was placed, pain on the left underarm and left breast. Shortness of breath and headaches.
Pt received DtaP #5 in right thigh and Hep A #1 in left thigh on 8/12/03. Parents contacted our office 8/14/03 with pt cc. Right thigh swollen, warm to touch. Pt seen 8/15/03 in our office and treated with Benadryl and Keflex.
No adverse event; Patient received an expired dose of VARIVAX; This spontaneous report was received from a nurse prescriber concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and previous drugs reactions or allergies were not provided.  On 17-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliter, once, lot # T000343, with an expiration of 05-JAN-2022, for prophylaxis (strength, anatomical site of vaccination, schedule of vaccination, and route of administration were not reported) (expired product administered). No additional information was obtained regarding the patient and no additional adverse event.
EXTREME BODY ACHE; JOINT PAIN; CHILLS; BAD FEVER; EXTREME HEADACHE; TIRED; This spontaneous report received from a consumer concerned a 21 year old female. 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:1821286 and expiry: UNKNOWN) dose was not reported, administered on 04-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUL-2021, the subject experienced extreme headache. On 04-JUL-2021, the subject experienced tired. On 05-JUL-2021, the subject experienced extreme body ache. On 05-JUL-2021, the subject experienced joint pain. On 05-JUL-2021, the subject experienced chills. On 05-JUL-2021, the subject experienced bad fever. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad fever, extreme body ache, joint pain, chills, extreme headache, and tired. This report was non-serious.
Large red patch at injection site with no pain, swelling, itching or any other symptoms. Showed up about a week and a half after vaccine administration.
Patient was inadvertently administered the Moderna vaccine before her 18th birthday.  She and her parent reported no adverse reactions following vaccination.
This spontaneous report as received from a physician refers to an approximately 19 year old male patient with allergy to iodine. There was a genetic component to the patient's psoriasis since patient's father had psoriasis. The patient's medical history included unspecified warts which he had as a child. The patient was not sexually active prior to receiving the GARDASIL. On 06-SEP-2012, the patient was vaccinated with the first dose of GARDASIL. On 20-FEB-2013, the patient received the second dose and on 12-JUN-2013 the patient was vaccinated with the third dose of GARDASIL (dose, route and lot number were not reported). On an unknown date, reported as after receiving GARDASIL, the patient developed psoriasis. The patient developed lesions from his neck down to his ankles due to the psoriasis. The patient sought medical attention. The patient had the lesions removed from an unspecified area on his body on an unspecified date but a psoriasis plaque developed on an unspecified date after the lesions were removed. The patient was placed on ENBREL (also reported as a concomitant medication) for the psoriasis on an unspecified date and did very well with the ENBREL. On 18-JUN-2014 and 05-AUG-2014, the patient tested positive through surgical biopsies for HPV types 6, 11, 16, 18, 30, and 32. On 22-JUL-2014, the patient had a polymerase chain reaction (PCR) DNA test done, but the results showed that there was no damage to oropharyngeal cells. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Left arm on the injection site got inflamed and continued to get worse after 24 hours. The inflammation was the size of my palm, red, very hot (temp in that spot was 102), raised, tenderness. Over 48 hours later it is still there but slightly cooler (temp is 100 on the spot). It is no longer just red, it has white spots and purple tones.
Red patch about 4 inches long and 3 inches wide, swollen and hard, render to touch, and itchy.  No fever.  Noticed on about the 12th day after shot and it cleared up in about 7 days after the symptoms appeared.
Tiredness; Headache; Shivering; Fever; Upset stomach; runs every day but has been unable to since the vaccination; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd September 2020, 6 hrs after receiving Shingrix, the patient experienced tiredness, headache, shivering, fever, upset stomach and mobility decreased. On an unknown date, the outcome of the tiredness, headache, shivering, fever, upset stomach and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, headache, shivering, fever, upset stomach and mobility decreased to be related to Shingrix.  Additional information was provided as follows: The patient experienced  tiredness, headache, shivering, fever, upset stomach and mobility decreased after receiving 2nd dose of Shingrix. The reporter mentioned that the patient was still experiencing all the events and they had not gone away. The reporter consented to follow up.
Narrative:  Covid infection after completion of COVID vaccine series 02/18 COVID vaccine dose #1 03/11 COVID vaccine dose #2 03/28 Non-ED visit, c/o viral symptoms, "nasal congestion, runny nose, dry cough x 1 day, declined testing or treatment 05/23 Non-COVID test positive, pt go tested due to symptoms of diarrhea, fatigue, runny nose, fever x 2 days; reports recent travel to another country
Patient reported dyspnea that began about 1 week post 2nd shot in Covid vaccination series.  Patient deceased on 3/18/2021
Numbness in lips; Numbness in fingers; Numbness in toes; This is a spontaneous report from a contactable Consumer. A non-pregnant female patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) 2nd dose (lot/batch no: not available/provided to reporter at the time of report completion) for covid-19 immunization, administered in right arm on 11Mar2021 at 16:15pm. Medical history included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (lot/batch no: not available/provided to reporter at the time of report completion) for covid-19 immunization, administered on left arm on 18Feb2021 at 16:15 hours. Concomitant medication included Sertraline. The patient had taken sertraline within 2 weeks of covid-19 vaccination. The patient had no allergies of food, medications and other products. The patient experienced numbness in fingers, lips and toes on 16March2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient had not been tested COVID-19 since the vaccination. No therapeutic measures were taken. The patient was not pregnant at the time of vaccination. The patient had not recovered from the events at the time of reporting. No follow-up attempts are possible. information about lot/batch number cannot be obtained. No further information is expected.
Headache, nausea, vomiting x 2, tiredness.  Phenagran 25mg IM.
pt recvd vax;devel fever 103;area of erythema & sl swelling 5x3 cm at site of inject on lt leg; irritability;
Starting 2/7/2022, roughly around 10:00 am, I felt odd and scary sensations on the left side of my face. It was a tingly and bubbly sensation, especially on the left cheek area. It came and went throughout the day, including at various times before 11:30pm. I have NEVER felt these sensations before, especially to this degree. I felt ABSOLUTELY AWFUL during the first few days after taking the Johnson and Johnson shot, but these new sensations were scary because it was unexpected. I welcome a phone call or email about this. As of now I feel okay but I fear this will happen again. I would go to the doctor but I trust doctors less than ever after this. I further emphasize I have NEVER felt this way, before taking the vaccine. This is a new and BIZARRE occurrence! Please investigate!!!!
Information has been received from a 61 year old female consumer with allergy to azithromycin, DILANTIN and amoxicillin and a history of chicken pox (at the age of 6 years old), who "over 6 months ago" (in approximately May 2010), was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported) SQ. Concomitant therapy included acyclovir, prednisone and ibuprofen. The consumer stated that her symptoms started about a week ago (on 10-NOV-2010). She had pain shooting down her leg then the pain went into her chin. The patient could not feel the space from her knee to her ankle. It was numb. She then developed into blisters on her lower back. Two doctors have diagnosed her with shingles. There were no lab diagnosis/studies performed. The consumer indicated that the doctors wanted to take a sample of her lesion but due to the incorrect spelling of her name and incorrect date of birth that was reported, by the time the doctors found out who she was, the lesions had crusted up and it was too late to take a sample of them. She stated that she had lesions on both sides of her calves and on her lower leg. She now had nerve problems in her legs and she had no feeling from her knees on down. She had no reflex in her legs, she could not sleep and she was now limping. The doctors had put her on codeine and LYRICA. At the time of the report the consumer had not recovered. Follow up information was received from the patient stated that she was admitted to the hospital on 06-DEC-2010 and diagnosed open fracture tibia and fibula of the left leg, where the shingles were located. The patient went to a neurologist who confirmed all of the issues were caused as a result of the shingles. The consumer had a cast and could not walk. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Corneal Ulcer left eye Foreign body sensation, redness, light sensitivity, upper lid swelling, severe pain This is Day 2. Saw optometrist and started erythromycin ointment and besivance drops. Hydrocodone and oxycodone for pain. Recheck tomorrow
Patient was administered Flu shot by writer of this report with father present in room. She was then dismissed to go to Check-out. At checkout patient stated to her father that she was feeling dizzy. Per dad he told her to sit on the floor. Staff seen her sitting on the floor and intervened to help. She was placed in a nearby room where she remained until she was feeling better. Given ice pack, and obtained vitals.  Pulse-82 B/p-92/60 O2 Sat-99%
Approximately 10 minutes after I gave the patient her Moderna vaccine, she got my attention and said her cheeks felt flushed. I went out to her and 1 cheek was definitely red and the other slightly pink. She took a couple of drinks of water that she had and said she felt ok, just flushed. She said her tongue and lips did not feel funny, but she had her dentures in and said it was hard to "sense" anything. I asked her to stay in the store longer than the 15 minutes just to make sure everything was ok. The patient stayed for around 40 minutes and her cheeks returned to normal while she was here. She said she felt fine. I asked the patient to call me after she got home and let me know how she was feeling. She called me at 8:05pm and said she was feeling fine.
Moderna COVID?19 Vaccine EUA  Both my daughter and I got moderna vaccine and 6 days later both got what is know as moderna-arm or covid-arm.  Not sure if you have cases were parent and daughter had the same reaction, which might give more info to this specific event and possible genetic causes.
shingles; This spontaneous report has been received on 04-OCT-2019 from a lawyer and the patient, regarding a case in litigation referring a  female patient of unknown age. Concurrent conditions, medical history and concomitant medication were not reported.   On or about 18-APR-2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (route, anatomical location, lot number and expiration date were not provided) for long-term prevention of shingles and zoster-related conditions. Subsequent, on unknown date, to patient's Zoster Vaccine Live (ZOSTAVAX) inoculation, patient was treated by a health care provider, at the clinic for shingles, requiring hospitalization.   As a direct and proximate result of patient's use of the Zoster Vaccine Live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The causality between Zoster Vaccine Live (ZOSTAVAX) and shingles was considered as related by reporters.
Nausea , dizziness, tired, sweaty, , and arm was extemely sore
2/10/03 p.m. Noted knot and soreness on left upper arm above inject site. 2/11/03 p.m. Noted redness to upper arm, also itching and slight discomfort went to see private MD - Temp. 98.8, edema, erythema, and punitis - MD's diagnosis -> insect bite, treated. 2/28/ Redness, pain, swelling, itching lasted 2 wks.
MOTHER  STATED THAT STARTING 7/28/21 SHE HAD A COUGH, HEADACHE AND FEVER OF 101 DEGREES.SHE HAD TIGHTNESS IN THE CHEST. SHE WAS TAKEN TO URGENT CARE AND HAD CHEST XRAYS TAKEN.  PA THOUGHT SHE HAD COVID-19 BASED ON HER PRESENTATION. NO RESULTS HAVE BEEN GIVEN FOR COVID TEST AS OF YET
Redness at injections site moved over to inside of arm (from middle out outside arm to inner arm).  Was hot ..
Patient received her first dose of the Pfizer Covid-19 vaccine. While waiting for observation, patient started to faint and seized. She also reported being hot and asked to take off her sweater.  Paramedic was called and patient was taking to the nearby hospital.  Patient reported black out while sitting on her chair, though by the time paramedic finish with the transportation patient reported vision recovery.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccine was stored in the freezer and they would take out one to two vials and keep in the fridge as needed each day. Concomitant product use was not provided by the reporter. Treatment information was not provided.
pain, swelling, erythema, itching, significant increase in circumference of upper outer thigh
Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report from a contactable other health professional. This reporter reported same events for three patients. This is 3rd of three reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The memory care patient received Pfizer-Biontech Covid vaccine, and then was diagnosed with Covid and had Covid symptoms on an unspecified date, the patient was scheduled to receive monoclonal antibody. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: There is limited information reported, it is possible patient would have taken only single dose,  a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : US-PFIZER INC-2021004746 same reporter/product/event, different patient;US-PFIZER INC-2021004747 same reporter/product/event, different patient
Approx 10 days p/vax recvd, 3OCT92 a high fever of 103-104 devel; also swollen glands, ?submaxillary, bilaterally; On 4OCT92 pt devel red raised rash on all of body that lasted 3 days; Pt seen by MD x 2 MD requested pt not to have MMR vax;
mom called 23JUL97 w/ c/o pt had inc temp 102.2, joint pain w/o site pain;pt has rheumatic arthritis;instructed pt to be seen by pvt MD to r/o infect;24JUL97 mom states was instructed to take antibiotics & has sore throat;
diarrhea, fatigue, head down to buttocks felt like it was burning up, felt like the flu
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 01Apr2021 at 08:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of the COVD-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 14Apr2021 at 09:30, the patient woke up with a horizontal rash along the side of the upper right torso. It stretched from just below the side of her right breast toward the center of her back. On 16Apr2021, it was diagnosed as shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with VALTREX EQ and pain medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In January 2019, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with shingles a week before the date of reporting.