chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; an unspecified patient was administered 1 dose of expired MMR II; This non-valid spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-OCT-2019, the patient was vaccinated with 1 expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), rHA, lot # N025891, expiration date 19-SEP-2019 (exact dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. There was no adverse event reported.  This case is non-valid due to lack of the patient's identifiers.
Left Eye pain; Headache; This is a spontaneous report from a contactable pharmacist. A 54-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 03Apr2021 at 11:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus and allergy to sulfa. Concomitant medications included insulin lispro (HUMALOG) for type 1 diabetes mellitus and acetylsalicylic acid (ASPIRIN) 81 mg daily for an unknown indication, both taken from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 13:15, within 2 hours of receiving vaccination, the patient experienced headache. On 03Apr2021 around 19:00, the patient experienced left eye pain which was ongoing. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache and left eye pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Blood spots on my chest, dizziness, migrane, felt like my knees were stung by bees
Temperature as high as 105.7 (despite treatment with Tylenol and Motrin) for over 24 hours.  Lethargic. Unable to perform work duties.  Menstruation cycle and characteristics have been permanently changed.  IBS-D episodes have increased in frequency and duration.
Left side Bell?s palsy, large ecchymotic, deep swelling, weakness left side, joint and muscle aches, headache, fatigue.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing), notes: Herpes. There were no concomitant medications, also reported as patient not received any other medications/products within 2 weeks of starting COVID-19 treatment. Past drug history included: Fenergan, reaction(s): "Known allergies: Fenergan", notes: Fenergan. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: 3 days in a row. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started on 05May2022 and stopped on 10May2022. Clinical course was reported as, patient tested positive using Binax rapid antigen tests 3 days in a row. Mild symptoms returned on 19May2022 08:30. No Treatment Received for symptoms and patient not recovered from symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling at insertion point that was sore on day one of this 2nd shot. On the 2nd day there was a bump the size of a half dollar that began to itch.  On the 3rd day, this morning the bump has grown in size and is itching uncontrollably.  I have really bad allergies and take Zyrtec daily but have been taking Benadryl for the itching without any relief.  I rubbed 70% alcohol on it this morning.  Still itching.
it started to itch, was feeling feverish, next day i woke up with a big round red patch on right arm where injection was given. i went today to doctor and was given antibotics for infection of site.
DAY 5 HAD GENEREALIZED ERYTHEMATOUS RASH AND PRURITIS; MACULAR RASH OVER THIGHS, BACK, CHEST, ARMS, FACE. ACHES AND COUGH/CONGESTION AND CHILLS DAYS FOR 4 DAYS. RASH LASTED APROX 4 DAYS. SEEN BY DERMATOLOGY AND GIVEN TOPICAL TREATMENT (PT WAS LAREADY ON ALLEGRA AND MOTRIN SINCE IMMUNIZATION
Patient was given flu vaccine on 10/10/11. Patient called on the evening of 10/19 and spoke with pharmacist on duty. Said arm was sore and red near injection site. Pharmacist told her to call MD in the morning. Patient was seen by PCP and said it was staph infection and was given antibiotics for 5 days.
Developed dizziness and headache immediately post vaccine . Patient without other symptoms . Patient noted to have good oxygenation.  Symptoms almost completely resolved after 20 . ER precautions given.
Body aches/joint pain, chills, nausea, fatigue, injection site muscle soreness
I had a very sore arm for 3 days. For over 24 hours, I had the worst full body pain that I have had in my life. I didn't feel feverish, but felt the aches like having a fever would induce. The headache that came along with the day could not be helped with medication. The body "aches" were horrendous.
heart rate went down to 50 and 49/heart rate was consistently in the low 50s or even below 50; A spontaneous report  was received from a consumer concerning a 71 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low heart rate/bradycardia.  The patient's medical history included allergy to sulfa and latex.  The patient was taking baby aspirin 81 mg, Simvastatin 20 mg, Ethacrynic acid 25 mg, Benicar 20 mg, Synthroid 100 mcg, Potassium, Ciprofloxacin 500 mg as concomitant medication  On 23-Jan-2021, prior to the onset of the events, the patient received their first dose of  planned two doses of mRNA-12 intamuscularly for prophylaxis of COVID-19 infection.   On 23-Jan-2021, the patient got the shot where my heart rate was consistently in the low 50s or even below 50.  No treatment information was given.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event low heart was resolved on 23-Jan-2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
reports getting the vaccine on Friday and then tested positive for for covid infection on the following Monday; reports getting the vaccine on Friday and then tested positive for for covid infection on the following Monday; This is a spontaneous report from a contactable other healthcare professional (HCP) reported for herself. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 (Friday) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine on Friday (18Dec2020) and then tested positive for covid infection on the following Monday (21Dec2020). She asked if this would interfere with getting the second dose and if she should or could get the second dose of the covid vaccine after testing positive for covid infection. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product to the development of Drug ineffective and COVID-19 cannot be excluded.  The case will be reassessed if additional information becomes available.
pain in the body; INAPPROPRIATE DRUG SCHEDULE; fever; A spontaneous report was received from Consumer concerning herself 26 years old Female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced pain in the body, fever and inappropriate drug schedule.  The patient's medical history was not provided. Concomitant products Rosal as contraceptive pill and omeprazol for reflux.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) by intramuscular route for prophylaxis of COVID-19 infection and on 19 Feb 2021 the patient received the second of two planned doses of mRNA-1273 (Batch Number: 300042722,) by intramuscular route for prophylaxis of COVID-19 infection.   After the vaccination got fever and body aches after 24 hours. Already 19th evening she experienced little fever and pain.  Treatment was Alvedon and Ipren for her symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event pain in the body was resolved on 21 Feb 2021, fever was resolved on 20 Feb 2021 and inappropriate drug schedule was resolved on 19 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # 300042722. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 65-year-old female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX. On 20th March 2019, 1 days after receiving SHINGRIX, the patient experienced feeling cold, tiredness, shivering, muscle pain, erythema of extremities, swelling arm, pain in arm and feeling bad. On an unknown date, the outcome of the feeling cold, tiredness, shivering, muscle pain, erythema of extremities, swelling arm, pain in arm and feeling bad were not recovered/not resolved. It was unknown if the reporter considered the feeling cold, tiredness, shivering, muscle pain, erythema of extremities, swelling arm, pain in arm and feeling bad to be related to SHINGRIX. Additional details were provided as follows: On 19th March 2019, 2 days ago (from the date of reporting), the patient got her 1st dose of SHINGRIX. On 20th March 2019, the patient did not feel too bad, but on 21st March 2019, she felt worse. The patient felt cold, tired, shivering and muscles aches. Her arm was also red and swollen and hurts when she touched it. The patient gave consent to follow up. Note: The patient felt bad on 20th March 2019 (on the next day), and on the date of reporting she felt worse. Therefore, we have considered time to onset for all reported events as 1 days, as it starts on next day and was worse on the day of reporting.
chills, malaise, flu like sxs, cough, nausea feeling, frequent urination
Very sore injection site on left arm approximately 12 hours after injection.  Fever, chills, nausea, vomiting, headache ending approximately  24 hours after injection
Covid positive with moderate symptoms within my 90 day vaccination period; Covid positive with moderate symptoms within my 90 day vaccination period; This is a spontaneous report from a contactable other health care professional (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot numbers and expiration dates were not reported), first dose on 18Dec2020 18:00 and second dose on 08Jan2021, both via unspecified routes of administration, in Left arm (at the age of 32-years-old) at single doses for COVID-19 immunization at a hospital. Medical history included clotting disorder. Patient had no known allergies. Concomitant medication included unspecified medications within two weeks of vaccination. Prior to vaccination, the patient was not pregnant, was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. The patient tested positive for COVID with moderate symptoms within 90-day vaccination period on 04Apr2021. Her family was also positive for COVID hence wanted to know if it was due to constant exposure. The patient underwent lab tests and procedures which included Nasal Swab/ PCR COVID test: positive on 07Apr2021. No treatment was given for the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure / COVID-19 cannot be ruled out.
He had a vaccine but he subsequently had COVID/was diagnosed with COVID; He had a vaccine but he subsequently had COVID/was diagnosed with COVID; he slipped out of bed, he said that he had balance problems and he couldn't get off or something; he slipped out of bed, he said that he had balance problems and he couldn't get off or something; This is a spontaneous report from a contactable consumer who reported for a patient. A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203, Expiry Date: unknown), dose 1 via an unspecified route of administration on 11Mar2021 as dose 1, single and dose 2 via an unspecified route of administration on 01Apr2021 (Batch/Lot Number: EN6198, Expiry Date: Unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced "he had a vaccine but he subsequently had covid/was diagnosed with covid", he slipped out of bed, he said that he had balance problems and he couldn't get off or something in 2021. Reporter (Pfizer Employee) stated that a cousin who had the Pfizer vaccine, he is in his 80s and it was the Pfizer COVID 19 Vaccine, and he had a breakthrough case. So, he had a vaccine, but he subsequently had COVID. Reporter was informed about role of Pfizer Drug Safety. Reporter stated patient was diagnosed with COVID on 24Aug2021. His wife was not vaccinated but he said that he meets with another individual who was vaccinated. He gave that person's name but that was the only information that he has about the other person. So, he went to breakfast with someone else who was vaccinated. That person got COVID. So, in other words he got it from someone else who had COVID, but that person was also vaccinated (further details unknown). Reporter stated it was after he was diagnosed, it was around the time of diagnosis. So, it was around on 24Aug2021, but exact date was unknown. He said that he (patient) slipped out of bed, he had balance problems and he could not get off or something. So, he had balance problem. He was discharged and he was ok now, was at home. When confirmed reason of hospitalization as diagnosis of COVID, the reporter stated Yes. Reporter stated the patient got COVID he has the Regeneron, he was actually hospitalized after he got COVID, and he had to receive the Regeneron treatment.  He may be on other medication, not known. The patient underwent lab test and procedure which included COVID-19: Positive on 24Aug2021. The outcome of events was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
soreness at the site of the injection; red patch around the area where they inserted the needle; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the site of the injection), VACCINATION SITE ERYTHEMA (red patch around the area where they inserted the needle) and HEADACHE (headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of the injection), VACCINATION SITE ERYTHEMA (red patch around the area where they inserted the needle) and HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. On 31-Mar-2021, HEADACHE (headache) had resolved. On 02-Apr-2021, VACCINATION SITE PAIN (soreness at the site of the injection) and VACCINATION SITE ERYTHEMA (red patch around the area where they inserted the needle) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment taken was Motrin  no any concomitant drug was given in SD
pt recv vax & devel fever to 102 & prolonged crying overnoc & wa seen n ER:pt exp fever & bulging fontanelle;LP was performed w/no pleocytosis;pt wa sent home;irritability & fever cont until 11PM on 26MAR97;pt was seen by MD;
This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via unspecified route of administration, in the left arm, on 04Feb2021 (at the age of 43-year-old), as single dose and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via unspecified route of administration, in the left arm, on 15Jan2021 (at the age of 43-year-old), as single dose, both for COVID-19 immunization. The patient's medical history was not provided. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination included ZOLOFT, PLEXUS, CLARITIN, and DEPO PROVERA. The patient was tested positive for COVID-19. The patient underwent the lab tests and procedure which included the Rapid test antigen. Nasal Swab SARS-CoV-2 test and result was positive 09Aug2021. No treatment received for AE. Outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Patient received the pediatric Pfizer COVID-19 vaccine for dose 1, when she should have received the adult dose of this vaccine due to her age at vaccination (12 years old).
Approximately 3 minutes after receiving HPV #2 and BEXSERO #1 patient went from talking to fainting, falling off exam table hitting mouth/head on floor.
Started menstruating more frequently - specially every 10-14 days from the end of my last period. This is still happening. It started right after I got the second shot of Pfizer. I have felt an increase in the intensity and frequency of cramping in my lower back and lower abdomen area. I have experienced heighted pms symptoms since getting the second dose, such as mood swings, sugar cravings, and tiredness surrounding my period. I have also experienced some weight gain.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient may have received an improperly stored dose of one of the following vaccines PROQUAD therapy type: rHA, lot # N009773 with expiration date on 29-NOV-2018 or N009773 with expiration date on 20-SEP-2018 (dose, route and site of administration were not reported) or VARIVAX lot # N017397 with expiration date on 07-JUN-2019, lot # N014368 with expiration date on 09-MAY-2019, lot # N009768 with expiration date on 24-MAR-2019 or lot # N008829  with expiration date on 16-MAR-2019 (dose, route and site of administration were not reported). Concomitant therapies included sterile diluent (MRK). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 25 hours and 50 minutes. Data logger was involved. There were no previous excursions reported.
At 4:30am today when I woke up and my left arm arm was a little sore. It it swollen, red, warm and itchy.  It is odd to me because I got the vaccine eight days ago.
This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 4 October 2010 the subject received a dose of FLULAVAL (details unknown). On either 4 or 5 October 2010, less than one week after vaccination with FLULAVAL, the subject experienced a 2-4 inch area of injection site tenderness, injection site redness and hotness at injection site. At the time of reporting the events were improved. The healthcare professional reported that she gave approximately 40 vaccinations to employees and has had 7 reports of a 2-4 inch area around the injection site that was tender, red and warmer than the surrounding skin. This is case 3 of 7 (see case IDs A0885121A, A0885268A, A0885270A - A0885273A for the other reports). The healthcare professional also reported an additional subject who experienced different adverse events following vaccination with FLULAVAL (see case ID A0885114A for more details). Follow-up information received on 26 October 2010 indicated that the subject was 36 years old at the time of the events. No additional information was provided.
Burning and itchiness of both eyes. Redness of both eyes. Cough and sore throat shortness of breath. Itchiness of throat.
On Friday 1/8/21 0830 Patient started to have whole body aches and  soreness to the arm where vaccine was given. Patient developed a fever of 102.0 at 1pm then took Ibuprofen 800mg  and took temperature again and it was 99.4. Patient also stated she was tired. Patient was advised to push fluids and take Tylenol 1G now . Body aches and fever went away on 1/9/21. Patient stated she was tired and had a HA until 1/11/21.Patient took Tylenol to help with these symptoms which was effective.