chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This solicited case was received from the investigator in a trial on 22 May 2015. A 20-year-old male subject, with no significant medical history, had received the following vaccines on 15 April 2015: a dose of ACAM2000 (lot number, route and site of administration not reported) and a dose of Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). The subject was diagnosed with acute idiopathic pericarditis on 24 April 2015 and unspecified disease of pericardium on 25 April 2015 i.e. 9 days and 10 days respectively post-vaccination. On 24 April 2015, the subject's Troponin I result was abnormal, the highest value was 00.80 and electrocardiogram (ECG) was abnormal. Echocardiogram performed on 25 April 2015 was normal. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Company causality is associated. Documents held by sender: None.
Sores in mouth. Mostly on roof of mouth. Very painful, lasted about 10 days and caused indents in the roof of my mouth like scars. Frequent severe headaches, happening 3-4 times a weeks, this is still on going.
Rash at the injection site; Itching at the injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and CHILLS (Chills). At the time of the report, VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Information has been received from a registered nurse concerning a patient who on 27-APR-2000 was vaccinated with a dose of Varivax. Subsequently, on 20-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
no fever; day p/vax 2" area on lt deltoid warm, tender to touch warm & swollen;
Redness, swelling, pain in same arm as vaccination. Some subjective chest tightness on R side of chest without vital sign changes or abnormalities on chest x-ray.
Client was vaccinated with 2 doses of Moderna vaccine for Covid in January 2021 (beginning and end of January).  Developed Covid symptoms on 10/13/2021 - nasal congestion, cough, fever at night x 3 days. Tested rapid positive for Covid on 10/25. Has not yet received booster dose of Moderna.
Patient stated she developed Cellulitis in her arm at the injection site.  It became hot with fever, very swollen, and rock hard.  She went to an  clinic and was given a course of antibiotics, which resolved the infection.
Guillain-Barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Lot Number: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Lot Number: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, Lot Number: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE, Lot Number: Unknown), for COVID-19 Immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown".  Clinical course: Consumer stated, "I am doctor in the (city-withheld) area. I have two questions. I currently have Guillain-Barre syndrome following the COVID-19 Pfizer vaccination number 5. RSV virus vaccination, the average dose, is that an mRNA? When paraphrased the concern, Consumer stated, "Guillain-Barre syndrome, it is a known side effect of the COVID-19 vaccine. It is not the question. My question is, whatever studies is mentioned on your website, 3 patients receiving the RSV vaccine got the Guillain-Barre syndrome. My question is, is the RSV vaccine an mRNA product and if already having the Guillain-Barre syndrome from one vaccine is contraindication in getting another vaccine that has the side effect of the Guillain-Barre syndrome." Consumer was informed about the role of the Pfizer Drug Safety and to contact Pfizer Medical Information for the concern and was provided with the contact# as (phone number-withheld), Option #, and was informed that the department is open from Monday to Friday from 8 am to 7 pm. When asked for permission for further probing, Consumer stated, "I don't have the time right now. I am sorry." When probed the LOT# (COVID vaccine), Consumer stated, "No, I don't have the LOT# handy. I am not able to talk to you anymore." Consumer was unwilling to complete the report. Thus, further probing could not be done. Hence, limited information was available over the call.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295135 Same reporter, patient, different product and events;
chills; body aches for 12 hours after second dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PAIN (body aches for 12 hours after second dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE (LAMICTAL) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PAIN (body aches for 12 hours after second dose). At the time of the report, CHILLS (chills) outcome was unknown and PAIN (body aches for 12 hours after second dose) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-406877 (Patient Link).
I woke up with chills- I shook the bed, slight fever and achy also. My bad leg that I normally have felt worse (achy as if I ran a marathon). This lasted for 36 hours. Shaking stopped though after 24 hours.
Period was legit a couple dots of blood that lasted a half of a day.; This is a spontaneous report from a contactable consumer or other non healthcare professional (Patient). A 25-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2593), via an unspecified route, administered in Arm Left on 16Oct2021 (Age at vaccination 25-years-old), as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. Patient took birth control medications within 2 weeks of vaccination. The patient did not 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 has not been tested for COVID-19. Patient did not have any known allergies. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0217), via an unspecified route, administered in Arm Left on 11Sep2021 (Age at vaccination 25-years-old), as DOSE 1, SINGLE for covid-19 immunization. The patient experienced period was legit a couple dots of blood that lasted a half of a day on 17Oct2021. Reporter seriousness for event reported as congenital anomaly. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event was not recovered.
Massive diarrhea, spitting up, fever of 100.4, fussy, tired, pink cheeks and sweating
This report describes joint pain in a 30 year old male who received Lyme disease vaccine recombinant OspA (Lymerix). This was received from the vaccinee and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions and concurrent medications were not specified. Reportedly, in April, 1999, the vaccinee received his first injection of Lymerix without adverse event. In October, 1999,the vaccinee reportedly received his second dose of Lymerix. He reported subsequently, in October, 1999, he experienced painful joints and knee pain and flu-like symptoms The flu-like symptoms reportedly resolved in Octoiber, 1999. Lymerix was discontinued. As of 04/02/02, the painful joints and knee pain were reportedly persisting. The adverse events 'joint pain' does not meet ICH serious criteria, but is being submitted as an expedited report by special FDa request per the 06/28/00 letter.
Developed Shingles you know it is a second form of chicken pox in adult life; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (COVID Vaccine, Solution for injection) via an unspecified route of administration on 17Mar2021 (Lot number: EN6204, NDC/UPC number: Unknown, Expiry Date: Unknown) as single dose for Covid-19 immunization. Expiration date: Consumer stated, 6/2021 she guessed. The patient's medical history was not reported. Concomitant medications included metoprolol (Strength: 50 mg) at 50 mg once daily, ondansetron at 8 mg once daily, atorvastatin (Strength: 80 mg) at 80 mg once daily, gabapentin (Strength: 600 mg) at 600 mg, hydrocodone bitartrate/paracetamol (NORCO) at an unknown dose thrice daily and duloxetine hydrochloride (CYMBALTA, 600 mg) at 600 mg once daily. Concomitant Products: Topiramate 100 mg and Zantac 50 mg twice a day (Not appropriately clarified, hence not captured in tab). On 19Mar2021, the patient experienced developed shingles which was a second form of chicken pox in adult life. Consumer stated, she took the Pfizer vaccination the first one on 17Mar2021 and two days after she took it developed shingles which was a second form of chicken pox in adult life. She contacted her Primary Care Physician who bought her in and confirmed it and was given Prednisone and Acyclovir (Treatment), and she was just recently reading the document which was given when she got first COVID Vaccination. She was due for second one on 07Apr2021 at 3 o clock. It said if she had any side effect to give CDC a call. Outcome of the event was unknown.  Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are needed. No further information is expected.
The COVID booster was left out overnight and 2 patients were given  expired COVID boosters.
Injection site soreness; tiredness; muscle pain; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 14Jan2021 at 09:00 at a single dose in the hospital for COVID-19 immunization. Medical history included autoimmunity of unknown origin and seafood allergy. The patient is not pregnant at the time of vaccination. Concomitant medication included folic acid, methotrexate, multivitamins (vitamins nos), and fluoxetine hydrochloride (PROZAC). The patient experienced injection site soreness, tiredness, muscle pain, feeling unwell for 30 hours on 14Jan2021 at 12:00. The patient did not receive treatment for the events. Outcome of the events was recovered on 15Jan2021.  Information on batch/lot number was requested.
Confirmed Breakthrough Case  COVID-19 (Moderna) 1 09/02/2021 Clinic Moderna 037B21A   COVID-19 (Moderna) 2 02/10/2022 Clinic Moderna 046L21A
pt recv vax;area became red, swollen & feverish;applied ice x 2 days;
Headache, fatigue, malaise and arthralgia-of neck and back. Bed rest x 2 days.
This retrospective pregnancy case was reported by a consumer and described the occurrence of death nos in a female neonate subject who was exposed to BOOSTRIX (GlaxoSmithKline), ADACEL (non-gsk) during pregnancy. A physician or other health care professional has not verified this report. On 6 September 2011, the 31-year-old mother of the subject received unspecified dose of BOOSTRIX (.5 ml, transplacentary) and unspecified dose of ADACEL (transplacentary). The mother's last menstrual period was on an unknown date and estimated date the delivery was 01 May 2012. The neonate was exposed to BOOSTRIX during an unknown trimester. Examination results of an "ultrasound 7" showed no evidence of a defect. On 1 May 2012, at an unspecified gestation age, the neonate was delivered by unknown method and weight 3.9 kilograms. Apgar score was not provided. The neonate was diagnosed with pulmonary hypertension and arterial venous malformation. The neonate remained hospitalized and died on 17 May 2012, cause of death was not provided. It was unknown whether an autopsy was performed. The outcome of pulmonary hypertension and arterial venous malformation were not specified. Please see report A0984491A for details regarding the mother case. Follow-up information received via the consumer on 17 July 2012 indicated the lot number for BOOSTRIX as C3947BA with expiration date 03 February 2014.
Narrative:  91 yo male with with age-related debility, COPD on O2, CAD died at home on 9/9/2021. Pt had received covid vaccines on 1/11/21 & 2/8/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Patient received first dose Moderna 4/24/21, second dose Pfizer 5/22/2021. Troubleshooting: Scribe and vaccinator did not look at card to see what was given prior; he did not present card until after vaccine; first vaccine at different location so no clear record. Counseled by staff that he had received two doses of mRNA vaccine and there was no need for a third dose. Possible language barrier, but pt checked Moderna in the computer and was served by provider.
Information has been received from a physician concerning a 19 year old female patient who on an unspecified date was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot # 662842/1296X). On an unknown date the patient experienced nausea, malaise, aching, an arm swollen to 2x its normal size, fever and headache. The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
3 hrs after the injection - ache in the whole arm Low grade fever - 99-100F and chills over night Extreme fatigue and headache in the morning
Symptoms: 8/08/2021 Sudden onset of chest pain, savior sharp pain localized to left upper chest that radiated to left shoulder blade.  Pain was made worse by taking a breath in and when leaning forward. Rapid heat rate 100+. Treatment: 8/09/2021 Went to  Urgent care and was tested for COVID-19, test came back negative, they did a EKG that came back with abnormal results (depressed ST segment). They then referred me to another emergency department due to the abnormal EKG results. While at  ED the following tests were conducted - chest x-ray, EKG, and blood work.
DIFFICULTY BREATHING. PAIN IN LEGS AND AT INJECTION SITE. EMERGENCY ROOM VISIT.
Extremely painful migraine on left side temple; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 14Apr2021 at 19:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 24Mar2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to 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 COVID vaccine. On 15Apr2021 at 08:00, the patient experienced extremely painful migraine on left side temple. No therapeutic measures were taken as a result of these events. The clinical outcome of the event migraine was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-JUN-2015, the patient received their first dose of RECOMBIVAX HB (concentration, dose and lot#, expiration date were not provided), for prophylaxis. Then, on 08-JAN-2016, the patient received their second dose of RECOMBIVAX HB (concentration, dose and lot#, expiration date were not provided), for prophylaxis and on 23-FEB-2016, the patient received their third dose of RECOMBIVAX HB (concentration, dose and lot#, expiration date were not provided), for prophylaxis, instead of the recommended schedule (0-, 1-, and 6-month schedule). No adverse effect reported. Additional information has been requested.
Student became very hot, pale, had ringing in her ears, and passed out for a few seconds, approximately 3 minutes after vaccine was given, student's BP decreased 68/40 P 50, ammonia inhalant used to arouse, cool cloths placed on nape of neck and forehead. Student came to quickly and VS as follows 11:55 - BP - 98/50 P -16 R -16 respirations easy and unlabored. student given PO snack of ginger ale and crackers. Feel better after interventions. VS at 12:05 - BP 103/71 P 72 R -16. Mother notified.
Booster; the joint pain cause we have a third back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1), administration date: 06Mar2021, for COVID-19 immunization, reaction(s): "they kind of pinch your skin"; Covid-19 vaccine (Dose no: 2), for COVID-19 immunization, reaction(s): "they kind of pinch your skin". The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021, outcome "unknown", described as "Booster"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "the joint pain cause we have a third back".  Additional information: Received call from consumer. She and her husband both got Pfizer COVID booster shot today. He got arm pain and it shot down to his leg on right side and that is the side he got the vaccine on. She wanted to find out if that has been reported or not. While reporting for her husband, she mentioned that while getting the other two vaccines, they kind of pinch your skin and this one here, she just put it straight through. This report completed for her injection going straight through. Caller said, we have that anyway, the joint pain cause we have a third back, or very bad back, and we've had them before, the day we got shot, he got back pain and pain shooting on his legs after we got them. The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient Miscarried; vaccine exposure during pregnancy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030m20a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) (seriousness criterion medically significant). On 30-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Patient Miscarried) (seriousness criterion medically significant). At the time of the report, ABORTION SPONTANEOUS (Patient Miscarried) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Company Comment:  This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use.  Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking.  Additional information has been requested.; Sender's Comments: This case concerns a 25-year-old who experienced vaccine exposure during pregnancy and abortion. Abortion occurred 1 month 8 days post mRNA-1273 use. Although a temporal association exist, there is still not enough information to assess the causal association with the product use.  Critical details such as the obstetric history including the duration of pregnancy, antenatal history and condition at the time of abortion is lacking.  Additional information has been requested.
nausea; vomiting; stomach pains; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history included 'gallbladder our' and migraines. The patient's concomitant medication included galcanezumab gnlm (EMGALITY) for migraines. On an unspecified date on the day of the shot, the patient had fish and chips which she hadn't had since getting her 'gallbladder our' and she started her period the same day. On an unspecified date that night, she had a lot of nausea, vomiting and stomach pains. The outcome of events, nausea, vomiting and stomach pains was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.