chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I've had both shots. I had shingles a few years ago, but a mild case! / suspected vaccination failure; had shingles a few years ago, but a mild case!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated he/she had both Shingles shots and had shingles a few years ago but was mild case. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with Flulaval for prophylaxis. On an unspecified date on or prior to 05 February 2007, the subject received an unspecified dose of Flulaval. At an unspecified time after vaccination with Flulaval, the subject experienced severe pain at injection site, nausea, fever, aches and pain, and pharmaceutical product complaint. The reporter indicated that there were approximately six other patients who received the same lot of Flulaval who experienced the same adverse events. The reporter requested a credit for the remaining 86 Flulaval vials he had in stock, which were from the same lot. At the time of reporting the outcome of the events were was unspecified.
Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and soreness around injection site.  On 1/9- had a severe migraine was unable to get out of bed due to migraine and extreme light sensitivity. Experienced severe muscle aches and chills.  1/10- started experiencing facial swelling especially of the left side. Extreme left eye swelling. With headache. Went to ER. Was given Benadryl to reduce swelling fluids and Prilosec for throat irritation.  1/11-started experiencing left arm numbness and tingling radiating down to fingertips.  Experience left side facial numbness and tingling. 1/12- symptoms have begun to improve.
Pt came in to receive a PPD but was given Polio 0.1 ML ID into the left forearm by accident. Once staff realized what happened we checked with the provider in office who stated to keep an eye on the patient and report any reactions by giving our a call or proceeding to the ER but the patient should be okay. Patient's wife was notified of incident and aware of directions and stated understanding. Pt is rescheduled to come back for correct injection 1 week after incident per providers discretion.
Patient stated that about one week after her first dose of Moderna, she experienced a sore arm and pain in the lymph nodes under her arm pit and near her clavicle. She said they were inflamed.
Just after getting the shot, I walked away from the area feeling normal. Then suddenly an enormously intense pain occurred at the site and I began to feel faint. I steadied myself holding onto a nearby counter and considered making my way back to a chair. But then it cleared up, within a minute or so, and I went on home. Then I read up on how this shot should be administered in the upper arm and I figured out that this particular shot was given very high up in the dorsal muscle. I have never had a shot given that high in my arm  before. Possibly that caused a problem. If possibly so, then  should educate its staff as to where to locate an injection into the upper arm. Now I am ok.
One week after Rotateq 6-8 watery stool 1 time a day for 15 days, vomited 2 times at onset (1 wk after). Breast fed infant, full recovery, no dehydration.
Information has been received from a registered nurse concerning a female healthcare worker who in approximately 1997 (about 10 years ago) was vaccinated with RECOMBIVAX HB.  Recently (date not specified) an antibody titer was drawn and showed the patient's titer was low.  The patient sought medical attention via an office visit.  A product quality complaint was not involved.  No further information is available.
Minor shivering; Muscle pain; This case was reported by a consumer and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020 10:00, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced shivering and muscle pain. On an unknown date, the outcome of the shivering and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the shivering and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced shivering and muscle pain. Till the time of reporting (8PM) small traces of the side effects.
sore throat; puffy eyes; wheezing; adverse reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PERIORBITAL SWELLING (puffy eyes), WHEEZING (wheezing) and ADVERSE REACTION (adverse reaction) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (when she was 9 yr old but could not determine why she had that.) since an unknown date. Concurrent medical conditions included Seasonal allergy and Asthma.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PERIORBITAL SWELLING (puffy eyes), WHEEZING (wheezing) and ADVERSE REACTION (adverse reaction). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), PERIORBITAL SWELLING (puffy eyes), WHEEZING (wheezing) and ADVERSE REACTION (adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, weakness, pain throughout body, loss of appetite, pain at injection site, nausea, headache, glassy eyes.
Cellulitis-type reaction. Vaccine site hot, red. Resolved with oral antibiotic. No sequelea.
Shingles started on 03/04/2021 and was given acyclovir, after a couple of weeks the issue cleared up.
Colitis ulcerative aggravated; Hair loss; Fever; Headache; Ache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4525073-00.  A 35-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 21Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 04Apr2012 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg, citrate free), subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Ache"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021); COLITIS ULCERATIVE (medically significant), outcome "not recovered", described as "Colitis ulcerative aggravated"; ALOPECIA (non-serious), outcome "not recovered", described as "Hair loss". The action taken for adalimumab was dosage not changed.  The reporter considered "colitis ulcerative aggravated", "hair loss", "fever", "headache" and "ache" related to BNT162b2.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of hair loss, fever, headache and achiness with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of ulcerative colitis flare up with Humira (Adalimumab) was a reasonable possibility.  Clinical course: Solicited report from the USA by a consumer of an adult female with events of non-serious hair loss, ulcerative colitis flare up, fever, headache and achiness with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced hair loss and ulcerative colitis flare up. In 2021, the patient experienced fever, headache and achiness. In 2021, the fever, headache and achiness resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was reported that duration of the events fever, headache and ache was 36 hours. It was unknown if patient was enrolled in a covid-19 vaccine trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.   The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
After 2nd shot on 2/22, pt reported onset of muscle pain, joint pain, stiffness, fatigue, decreased mobility, back pain, slight chills, that persisted for months.  Initially tried OTC NSAIDS (Aleve, Ibuprofen) without relief.   After inflammation seen on lab testing & MRI of spine in May, started on Prednisone x 6 wks (15 mg initially, then tapered).   Symptoms significantly improved.
Information has been received from a nurse concerning a 5 year old male with no pertinent medical history and no drug reaction and allergies who on 02-NOV-2010 was vaccinated subcutaneously with MMR II (Lot number 667247/0576Z, expiration date unknown). There was no concomitant medication. On 04-NOV-2010 the patient presented to the physician office with a red and raised rash that was warm to touch at the injection site on his right leg. The nurse reported that the patient stated it had gotten larger since the reaction started. Nurse practitioner prescribed the patient antibiotics. There was no lab diagnostics studies performed. At the time of reporting, the patient was not recovered. Follow up information was received from an advanced registered nurse practitioner (ARNP) concerning the 5 year old boy student who with no known illness at the time of vaccination or adverse event following prior vaccination on 02-NOV-2010 was vaccinated with the second dose of MMR II (Lot number 667247/0576Z) in his right leg. On 02-NOV-2010 the patient was also vaccinated with the second dose of VARIVAX (MSD) (lot number 668458/0968Z) in his left leg. On the same day, concomitant therapy included the first dose of FLUMIST intranasal (lot number 501045P) nasal inhalation, TRIPEDIA (lot number U3470CA) in his right leg and IPOL (lot number EB204) in his left leg. On 04-NOV-2010 the patient developed a raised red warm erythematous area of entire lateral and medial right upper thigh. Left upper thigh had second circle of light red and warm eruption but much less than right. On 06-NOV-2010 the patient recovered from all events. No further information is available.
Vax 1; One week later red, hot, itchy rash on upper left arm that lasted Approx 3 days.   Vax 2; Evening of vaccine red, hot, itchy upper arm, fever, chills, heart racing, severe headache, dizziness, blurred vision.
Pt.'s 1st dose was on 9/7/21. Pt arrived today (9/21/21) to get 2nd dose. Pt was administered 2nd dose. It wasn't until after the 2nd dose was administered that we noticed he was early. Pt stayed for the observation period. No adverse signs were noticed. No adverse symptoms were reported. Pt was called at 1717 hrs to check on status. No adverse signs or symptoms were reported.
COUGH; COULD NOT SLEEP; BODY HURTS; FEELS TERRIBLE; HEADACHE; TEMPERATURE KEEPS  GOING UP AND DOWN; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included recently diagnosed with metastatic breast cancer which has spread to the lymph nodes, and smoker.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced temperature keeps going up and down. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced could not sleep. On 10-APR-2021, the subject experienced body hurts. On 10-APR-2021, the subject experienced feels terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, had not recovered from cough, could not sleep, and body hurts, and the outcome of temperature keeps going up and down and feels terrible was not reported. This report was non-serious.
On set of Tinnitus on 5/9/2021 continually 24/7
Within a few minutes of receiving the vaccine, patient said she felt like she was going to faint. She appeared in distress and said she felt lightheadedness and very anxious. Denied trouble breathing, shortness of breath, swelling of lips or tongue, closing of throat. Used 2 different pulse oximeters: one said 88%, the other said 79%. Patient did not appear to be in respiratory distress, but she was started on 2L oxygen via face mask and emergency medical services was called. Paramedics came and evaluated her. Once oxygen was stopped, their pulse oximeter read 98%. They took the patient away via ambulance.
Sweating and numbness in his (L) leg to the point where he fell 2x.
Had redness at injection site. Developed rash, itching, cellulitis, joint pain, stiffness, fever and chills.
Pt had syncope x 1 postvaccination followed by seizure x 2. Pt recovered spontaneously after 3-5 seconds. No labored breathing. Alert and oriented x 3. Pt brought to ER.
Rash on the arm where she received the vaccination, it's a big red blotch; Rash on the arm where she received the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Rash on the arm where she received the vaccination, it's a big red blotch) and RASH (Rash on the arm where she received the vaccination) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced RASH MACULAR (Rash on the arm where she received the vaccination, it's a big red blotch) and RASH (Rash on the arm where she received the vaccination). At the time of the report, RASH MACULAR (Rash on the arm where she received the vaccination, it's a big red blotch) and RASH (Rash on the arm where she received the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: source doc attached
Narrative: Patient reported feeling flushed, experienced diaphoresis, and had a  little bit of swelling on the right side of the throat. It was also reported that the patient experienced joint pain, headache, and a slight fever, All symptoms resolved within a few days.
June 1967 - My arm swell after vaccine shots - I was sent to Hospital I was given one white tablet. I got severe headaches and my eye became very sensitive to light. I did not know anything about nerve damage at the time. The damage may have also came from another when he grab me by the neck and pulled me to the floor and tried to assault me. Their were witness from both watching. I have sent letters to newspapers asking my story be told in hope that one of the see it and contact me so I can get a legal statement from them. Nothing was done about my eyes until I received a injury in Judo class. My sparing partner threw me and I tired to throw him at the same time and I landed on the back of my head, neck and upper back. My sparing partner feel on my head, eyes and chest. I could not see and my room mate's told me I should go the hospital because I could get up in next morning and I may not be able to open my eyes. The doctor told me my eyes were highly sensitive to light and he ordered me too pairs of very dark sunglasses. I still have one pair of the in a box. One pair was stolen. To this day they have denied that my eyes became highly sensitive to light due to the injury to my eyes in the judo class. I had forgot about the problem I had after the vaccine shot. At the time I did not know that vaccine's could do that. I also got sick when they gave Flu shots in 1968-1969 they tried to make it look like it was in my mind.
Moderna 6/25 and 7/23. Positive on 9/14;
pt recvd vax & devel  eye pain, blurred vision, & sensitivity to light; exp same react w/dose 2 of vax;
off label use; Tenderness; Vaccination adverse reaction; myalgia; pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), MYALGIA (myalgia), PAIN (pain), TENDERNESS (Tenderness) and OFF LABEL USE (off label use) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction), MYALGIA (myalgia) and PAIN (pain). On 07-Sep-2021, the patient experienced TENDERNESS (Tenderness). On an unknown date, the patient experienced OFF LABEL USE (off label use). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), MYALGIA (myalgia), PAIN (pain), TENDERNESS (Tenderness) and OFF LABEL USE (off label use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received her first dose of Moderna COVID19 Vaccine on 23Feb2021 and second dose on 24Mar2021. She received her third dose on 05Sep2021. The patient asks if getting the booster was too early. No concomitant medication was reported.  No treatment medication use was reported.
Tested positive for Covid after having both Pfizer vaccinations; Tested positive for Covid after having both Pfizer vaccinations; muscles aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome "unknown" and all described as "Tested positive for Covid after having both Pfizer vaccinations"; MYALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "muscles aches". The patient underwent the following laboratory tests and procedures: body temperature: (Dec2021) about 101.5; COVID-19: (24Dec2021) positive. Clinical course: His symptoms included fever of about 101.5 and muscles aches.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101884897 same reporter/drug/AE, different patient
Wed, 10-2-13 noticed area was warm. Thurs, 10-3-13 noticed stripe (red rash) about 2/3 of way around the arm ~ 2.5 inches wide, below injection site. Sat, 10-5-13 reported to pharmacist - could still see rash.
ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; ulcerated tongue, cheeks and gums; Painful to eat; limited taste (similar to having seriously burned your tongue and mouth); tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; tingling, painful and swollen mouth, gums, cheeks, tongue and lips; itchy throat; This is a spontaneous report from a contactable other hcp (patient). A 31-years-old non-pregnant female patient received second dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL3249 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 22Jan2021 at 10:00 AM (at the age of 31 years), as a single dose for covid-19 immunisation. The patient medical history included very minor latex irritation from an unknown date and unknown if ongoing. The patient concomitant medications received within 2 weeks included prenatal vitamin. Historical vaccine included first dose of BNT162B2 (CONMINTARY, Solution for injection, Lot No: EL1284 and Expiration date was not reported), via an unspecified route of administration, in Arm Left, on 30Dec2020, as a single dose for covid-19 immunisation. The most recent covid-19 vaccine was administered in hospital. The patient didn't receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for covid-19. On 22Jan2021, 1-5 hours after injection, the patient had experienced tingling, painful and swollen mouth, gums, cheeks, tongue and lips on, itchy throat. On 23Jan2021, the patient had experienced ulcerated tongue, cheeks and gums on, painful to eat, limited taste. There was no treatment received for adverse events. Outcome of the events were recovered. The reporter seriousness was reported as Non-serious.  Follow-up attempts are completed. No further information is expected.