chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jul2022 at 09:30 as dose 4 (booster), single (Lot number: FR2588) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; SERTRALINE HCL; HYDROCHLOROTHIAZIDE; VIT E [TOCOPHEROL]. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 3, unknown manufacturer), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 27Jul2022 at 19:00, outcome "recovering", described as "felt extremely tired"; HEADACHE (non-serious) with onset 27Jul2022 at 19:00, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 27Jul2022 at 19:00, outcome "recovering", described as "the injection side on my left arm became very sore". Therapeutic measures were not taken as a result of headache, fatigue, vaccination site pain. Additional information: The patient stated, at approximately 7 pm, 9.5 hours post receiving my final booster (2), She developed a headache, felt extremely tired and the injection side on her left arm became very sore. AE was not resulted in physician office or emergency room visit. If covid prior vaccination reported as No. If covid tested post vaccination reported as No. Known allergies reported as No. Facility type vaccine reported as Workplace clinic. If other vaccine in four weeks reported as No.
16MAR99 pt recv vax & 22MAR99 devel diarrhea, vomiting, fever lasted for 7 days also had severe diaper rash & mild dehydration;29MAR99-1APR99 seemed to be getting better & back to eating;2APR99 chickenpox blisters 25-50;
Nurse gave dose from the Moderna 6 year to 11 year old COVID vaccine vial instead of the correct vial for Moderna 6 months -5 years old. Dose given was correct at 0.25 mL. Parent was attempted to be contacted but does not answer the phone and does not have a voicemail box which has been set up.
Patient's arm was sore for day or so before he developed flu like symptoms (Bone aches, cough) with swollen lymph nodes. Patient developed "blistery pimple like hives on right underarm and right chest Feels fine now but still has hives. Patient may see MD in day or two if not resolved.
mild nausea and dizziness starting day 3 after 2nd vaccination.  Nausea mostly gone but dizziness persisting 1 week after the vaccination.
Seriousness Criteria: Other-Medically Significant Initial report received from a healthcare professional on 12 November 2007. A female patient (age not reported) received a flu vaccine (trade name, manufacturer, lot number, route/site of administration not reported) approximately five years ago and within a week developed Guillain-Barre Syndrome (GBS). The patient also develped flu during that same week (time frame for vaccination and development of flu vaccination or of the flu. The patient had not fully recovered. No additional information was provided at the time of this report.
total pain 24/7 non stop / Was a uncommon side effect / the pain was so bad; could not sleep at night; lost 60 to70 % of muscle tissue in my left arm; Torment; regained feeling in most of my left hand except 2 fingers little & ring finger; This case was reported by a consumer via media and described the occurrence of pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain, insomnia, muscle atrophy, stress and numbness in fingers. On an unknown date, the outcome of the pain was recovering/resolving and the outcome of the insomnia, muscle atrophy, stress and numbness in fingers were unknown.   It was unknown if the reporter considered the pain, insomnia, muscle atrophy, stress and numbness in fingers to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself or himself. The patient reported that, he or she was told he/she had no choice because of his or her age by the patient's doctor and 3 years ago from reporting date, the patient received Shingrix in left arm.  The patient stated that from the moment the Shingrix vaccine was plunged into the patient's left arm, it was total pain 24/7 nonstop.  The patient stated that was an uncommon side effect from this drug that you would not get told about. Less than a day after receiving Shingrix, the patient could not sleep at night because the pain was so bad.  Less than a year after receiving Shingrix, the patient lost 60 to70 percent of muscle tissue in his or her left arm that would never come back.  The patient stated after 1 year of torment, he/she was sent to a Neurologist. The patient regained feeling in most of his or her left hand except two fingers little and ring finger but help the pain tremendously.  The patient reported that before you make the decision, find out what drug would be given to you, and google uncommon side effects.  The patient said, it was worst decision in his or her life was the shingle shot. The follow-up would not possible as no contact details were available.
After patient received vaccine, she had itching at site. On 01/01/2014 patient noted redness, warmth, swelling of left medial aspect of biceps not where injection was. Patient was treated with Rocephin 1 gram x 1 dose IM in clnic on 01/02/2014 and will follow up for exam again 01/03/2014.
PT SITTING IN OBSERVATION AREA, POST INJECTION AND COMPLAINT OF SCRATCHY THROAT AND HEADACHE ABOUT 15 MINUTES INTO MONITORING. PT DENIED ANY CHEST PAIN, OR SOB, PT WHEELCHAIRED TO URGENT CARE BY RN AND SECURITY.
Donor states inj site began to itch on 7/17/06. Upon scratching site, induration began, reaching size of 4 deg in diameter centered concentrically around inj site. Site was red and warm to the touch but no tender, no painful. Donor denies HA, N/V, fever, malaise. Donor presented to center on 7/19/06, induration had reduced to 1 1/2 in diameter but rubor and color remained. Donor advised to call if induration persists without signs of reducing.
CERVARIX was given a the male patient, while it should be given to the female patients, only.
Prior to by Dose 3 vaccination I was having an issue with coughing, sneezing and head aches that continued to resurface  several months August, September and October which required several rounds of antibiotics before it disappeared. 8 weeks approximately after my Dose 3 Moderna, 12/15/2021, I experienced Heart issues in late February 02/25/2022, and early March 03/03/2022. I experienced sharp pains in chest off and on for several hours and in route to getting EKC my left arm became numb. I have not had any significant pains currently; however, doctor has confirmed inflammation around the heart. Two episodes 02/25/2022 and 03/03/2022 were emergency room visit, two different hospitals.
Child received multiple injections 2/29/00. Mom put child to bed around 11:15 PM on 2/29/00 on the floor on 2 soft pillows.  Did not check on the infant until around 9:00 AM on 3/1/00.  Found child deceased.
I develop COVID. The final results came in March 26, 2022. I had respiratory infection and diarrhea. This past Monday I was back in the hospital. Tested positive for COVID-19  again.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA274204, 2018SA274203 and 2018SA274230. This case involves female patient who received doses of ADACEL stored outside the recommended range, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (from 30-Jul-2018 - 03 -Aug-2018), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. No known reports of side effect. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1" x 1" round left cellulitic at the site of vaccine.  Cover with Augmentin, warm compresses.
CVA  several weeks after 2nd shot . Ambulated to Hospital ED on 4/20/21
Herpes sore; A spontaneous report was received from a Healthcare Professional concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events herpes sore outbreak.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (unknown Batch Number) intramuscularly in his left deltoid for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the events herpes sore.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 3 Feb 2021 the outcome of events herpes sore was not reported.
Narrative:  Timing ERROR only, 2nd dose given 56 days after 1st.
12-16-09 Patient called and stated she had a H1N1 vaccine on Monday 12-14-09 at 12:15, at 1:30 she was at store and had chest pain (all across chest), throat itchy, ears felt weird. She said she had pain going down L arm and the right arm before having the chest pain. By Monday evening the chest pain left she still has uncomfortable feeling in throat and a "pluced ear". She has not been to a provider. Instructed her to see provider.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. On 30-JUL-2014, the patient was vaccinated with ZOSTAVAX lot # K000995, expiration date 16-MAR-2015, 0.65 ml, subcutaneously. Other suspect therapies included hydrocortisone (manufacturer unknown) topical cream (strength, dose, frequency and indication were not reported). In approximately 2014 (reported as some time after vaccination), the patient was seen by the pharmacist and complained of a raised, itchy rash. The pharmacist recommended to use hydrocortisone (manufacturer unknown) cream as a treatment. On 15-OCT-2014, the patient returned to the pharmacy and no longer complained of a raised rash, but did present with a flat, purple discoloration at the injection site (onset date on an unknown date in 2014) with no other symptoms present. The outcome of raised itchy rash was reported as recovered/resolved on an unknown date in 2014. The outcome of flat, purple discoloration at the injection site was unknown. The relatedness between adverse events and therapies with ZOSTAVAX and hydrocortisone (manufacturer unknown) cream was not reported. Additional information has been requested.
Red rash around the injection site; Red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash around the injection site) and VACCINATION SITE ERYTHEMA (Red rash around the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Red rash around the injection site) and VACCINATION SITE ERYTHEMA (Red rash around the injection site). At the time of the report, VACCINATION SITE RASH (Red rash around the injection site) and VACCINATION SITE ERYTHEMA (Red rash around the injection site) outcome was unknown.            Concomitant medications were not reported. Treatment details were not received.
Tired; Myocarditis; Pericarditis; Chest pain; sickness; Fever; Throwing up; This is a spontaneous report from a contactable consumer (patient parent). A 18-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EW0185 and expiration date was not reported), via unspecified route on 12May2021, as dose 2 single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included Somatropin (NORDITROPIN) and Letrozole. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, 14Apr2021 (Lot number EW0161 and expiration date was not reported), (age at vaccination 17-years-old), via unspecified route on as single dose for COVID-19 immunization.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date 2021, patient experienced chest pain and he did not know that was a side effect with the myocarditis and pericarditis, also he had normal sickness that he had fever and throwing up and tired. When He had the first shot, was 17 and he was 18 when he had the second one. The patient took Ibuprofen,  as treatment drug the next day after he had the shot. The outcome of all events were unknown   Information on Lot/Batch number was available. Additional information has been requested.
This initial spontaneous case, was received on 22-Sep-2017, from other health professional (nurse), concerning a 45-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that, the patient was administered the vaccine with a 0.5 inches needle, hence possibly received only a partial dose. It was reported that the patient, had not experienced any adverse event. At the time of the report, the outcome of the events was not reported. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that the patient had not experienced any adverse event. The narrative was amended accordingly.
in 15min local redness;in 30min whole rt arm w/itching then 45min whole body itching;DPH given;
Moderate++ pain in L arm at and below injection site, pain prevents raising L arm more than 25% of normal rom.
Pt developed flu like symptoms within 24 hours of second dose of Pfizer COVID vaccine on 3/5/21 which included fever, body ache, headache, and chest pain.  The chest pain was severe and on 3/7/21 she sought evaluation in the Emergency Room.  She was found to have an elevated troponin test (repeated x 3), and T wave abnormalities on EKG concerning for a NSTEMI.  CRP was also elevated.  It was recommended that she be admitted to the hospital but she left the ER against medical advice.
SHE GOT HER FIRST COVID SHOT ON 7/19/21 AND I DID NOT REALIZE THAT. WHEN SHE GOT HER 2ND SHOT FROM ME IT WAS ON DAY 14. I TALKED TO PATIENT AND SHE SAID THE SHOT MADE HER FEEL POORLY FOR  A DAY JUST LIKE THE FIRST VACCINE.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 DM" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid-19 Treatment; (17May2022) negative, notes: Negative antigen test two days after stopping Paxlovid;; (19May2022) Positive, notes: positive antigen test four days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
On 2/4 I had a headache, muscle aches. I had a rash on th einjection site that was warm and tender to touch on 2/5 lasting to 2/7.
Patient reported having repeated flu symptoms every time he gets the flu vaccine on 11/29/18.
Patches in various areas over body, beginning in 7/05. 8-10 patches originating from vaccine area. Vaccination given on 2/05.
Headache- 1 day shivering, body aches, fatigue - 3 days
After 3-4 hours of getting the vaccine, patient's arm was swollen, red, and patient felt ill.
Patient reported to ER w/ 3 days of chest pain. Patient found to have segmental Pulmonary embolism and non segmental Pulmonary embolism w/ pleural effusion with evidence of right heart strain
Fever of 101.3 on the second day after receiving the vaccine.; Facial swelling on the second and third day of receiving the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Jun2021 at 14:00(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pineapple and penicillin. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC) from an unknown date for birth control. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Jun2021 at 16:00(at the age of 22-years-old) as a single dose for COVID-19 immunisation. 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 24Jun2021 the second day after receiving the vaccine, the patient experienced fever of 101.3 and facial swelling on the second and third day of receiving the vaccine. The patient reported that she did not have any dental fillers that would cause the events. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On 24Jun2021, the patient underwent body temperature test and tested with 101.3(unspecified units).  The clinical outcome of the event fever of 101.3 and facial swelling was recovering at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
The morning after the shot I had the worst headache, very painful.  I drank a lot of water and it temporarily improved.  But I've been dealing with an almost chronic migraine situation since then which required two ER visits and I'm still not well.  I have no history of migraines.  Never had one before.
marble sized lumps under her arm after the 1st shot; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date Mar2021 (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: NEOPLASM (non-serious) with onset 2021, outcome "unknown", described as "marble sized lumps under her arm after the 1st shot". The event "marble sized lumps under her arm after the 1st shot" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information:Calling about the Covid 19 Vaccine. Caller states that she got the shot last Mar and Apr. She got marble sized lumps under her arm after the 1st shot, and after the 2nd shot on 16Apr2021 she got a grapefruit sized lump and it's still there. States that she doesn't have any health insurance, but she did go to one doctor who looked at some cells under a microscope, and said that she didn't see any cancer or anything. Caller states that she has not had any blood tests done because she can't afford it. States that she has been trying to find information locally, and she has called the CDC but they just keep referring her to the internet. She has also been to the local health department, but this is the first time calling Pfizer. States that a friend of hers sent her something today talking about people that got lumps on their arms after getting the booster. It said she is 1 in 100 that got lumps after the 1st 2 shots. Caller explains that the lump got larger after the 2nd injection. Clarifies that she received both the 1st and 2nd dose in the same arm. States that the 2nd dose was significantly more painful. States that she is an anti-vaxxer, but she got the vaccine because she is a dog walker and was going to be around the children that owned the dogs and wanted to be responsible. States that when she got the 2nd dose, it started to burn and the pain went up and down her shoulder and then went over to her other shoulder and back. States that her husband got sick after his 2nd dose, but she did not.
Flu vaccine administered on 9-28-16. Pain in left arm began about 2hrs later. It continues to this date and is also in shoulder and neck. I have limited arm movement.
outcome is heart only puts out 30 % and now very ill.  ever since shot been sick
I currently have COVID and will be out of quarantine on 18Sep2023. How long do I wait until I can get my booster; I currently have COVID and will be out of quarantine on 18Sep2023. How long do I wait until I can get my booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) 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), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "I currently have COVID and will be out of quarantine on 18Sep2023. How long do I wait until I can get my booster".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.