chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on arms and torso; This is a spontaneous report received from a contactable healthcare professional (patient) via regulatory authority.   A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 50-year-old) as a single dose for COVID-19 immunization. Medical history included covid-19, thyroid goiter, hypothyroidism, Hashimoto's disease, food allergy to honey all from unknown dates. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. Concomitant medications included levothyroxine sodium (SYNTHROID), and  unspecified vitamins (MANUFACTURER UNKNOWN), both taken from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 03Apr2021 at 08:00, the patient experienced rash on arms and torso. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received any treatment for the event. The clinical outcome of rash on arms and torso was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected
During the 15 minutes waiting after the vaccine was given, patient stated he was extremely dizzy. He just went to the bathroom prior to this.   Vitals taken with b/p 146/76, pulse 76 and regular, R16 pulse ox 96%.  Patients eyes were dilated.  He continued the whole time to be coherent.  He was given apple juice but denied wanting to eat anything.   EMS was called.  He was taken to the bathroom to his request where he then became nauseated and started to vomit several times. Continued to c/o dizziness.  The EMS arrived at approximately 11:00.   Was evaluated and  decided to go to E.R .At the time EMS was here his b/p was 160/90  P-84 and Pulse ox 96%
arm aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient in his 70's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, DOSE NUMBER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm aches".  Additional Information: It was reported that (Name withheld) called in regarding the invasion and she mentioned that they had already received the booster shot of the vaccine with her husband. She said that she had a fever for 2 days and her lymph nodes were aching so bad. She also mentioned that her husband had arm aches.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Within 15- 20 minutes experienced itching/ uncomfortable feeling in throat. Within 24 hours had hives, facial swelling, itching, hoarseness, and headache. Also passed out. Received a DEPO-MEDROL injection and 2 rounds of prednisone. As of today still experiencing hives, facial swelling, itching, hoarseness, and headache.
Patient noted different vaccine names on his vaccination card (first dose, Moderna vaccine on 1/25/21). Second dose of vaccine was Pfizer EN6201. No new/abnormal side effects or reactions.
p/2nd vax pt had pain, rash, urticaria, pruritus, erythema @ inj site & irritability, fatigue, malaise, bedwetting & wheezing;
Five days after receiving dose 1 of the Moderna COVID vaccine, this 20 year old man developed a spontaneous coronary artery dissection affecting his LAD and left circumflex arteries. This caused a ST elevation myocardial infarction. Pt received prompt stenting.  His troponin peaked at 16,083 ng/L (high sensitivity test). He recovered well.
104 degree temperature, EXTREME headache, chest pain, heartburn, chills, heart palpitations, restless leg that still has not subsided. I had covid in December and this was 100 times worse and I had pretty tough symptoms then. The headache is still affecting me now.
Four days after the booster, I was not feeling well due to booster - aches and pains and tired - initial reaction.  Then I noticed I had hives on my abdomen and upper chest and upper thighs between my legs - but not itchy.  This lasted about 4 days.  Within about another 10 days my aches and fatigue lessoned and I was back to normal.   I have had two more boosters, Moderna, and still had the same rash with both of these vaccines.  The symptoms very similar, but perhaps a bit less.
A week after vaccine developed rash upper right arm. Arm is slightly swollen and warm to touch
soreness in left arm; achy muscles over body; 100.8 fever after 24 hours.
pt recvd vax;6 hrs later turned very pale, broke out in cold sweat; went limp; v; hives on face; t 94; eyes rolled back;
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 11-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # N016185 for prophylaxis.  Concomitant therapies included sterile diluent (STERILE DILUENT). On 11-AUG-2017, 1 day after onset of therapy the patient experienced poor quality drug administered and product colour issue. On an unknown date the patient experienced no adverse event.
PATIENT STATED THE VACCINE BURNED GOING IN AND THEN WITHIN 4 HOURS, PATIENT EXPERIENCED FEVER OF 103, VOMITING AND CHILLS. FEVER WENT AWAY THE NEXT MORNING AND FINALLY FELT BETTER ON 10/26/17.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In August 2021, the patient experienced COVID-19 (COVID-19). In September 2021, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 62 year old female patient, with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days (however, in the same month) after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event recovered. Co suspect adalimumab could be a risk factor for the event. COVID-19 pandemia could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62 year old female patient, with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days (however, in the same month) after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event recovered. Co suspect adalimumab could be a risk factor for the event. COVID-19 pandemia could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Rapidly developed tumors on thyroid 6.8cm within 6 months.  Severe reduction in memory, mental capacity, energy and muscle mass beginning within days and still present. .
No adverse event; Patient had dose 1 on 16 May 2021 and had dose 2 on 13 Jul 2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 16 May 2021 and had dose 2 on 13 Jul 2021) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 093D21A and 3002331) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 16 May 2021 and had dose 2 on 13 Jul 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 16 May 2021 and had dose 2 on 13 Jul 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 on 16 May 2021 and had dose 2 on 13 Jul 2021).    No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-717838 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717838:Bivalent case
In July, 3 months after finishing the Covid-19 vaccination series, I had a week long headache and sinus pressure with both congestion and runny nose.  No fever or loss of taste, or smell. My son felt the same way as me during the same week as me, and my husband felt the same way 2 weeks prior to my symptoms.   7/8/2021 I called the clinic (through my work's insurance) and they scheduled me and my son (5) to come in for a checkup on 7/12/2021  7/12/2021 the nurse who saw us determined that we were experiencing a common summer cold.  She prescribed me nasal spray to help drain my ears and clear my nose and sinus.
Patient was given Pfizer Booster at age 15 years . Attempted to notify father, left message on voicemail. No return phone call at this time.
Chills; dehydration; dryness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient 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: CHILLS (non-serious), outcome "unknown"; DEHYDRATION (non-serious), outcome "unknown"; DRY MOUTH (non-serious), outcome "unknown", described as "dryness".  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.
tingling sensation in both arm; muscle spasm; body aches/sharp needle like pain; headache; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 04Apr2021 at 14:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the left arm on 15Mar2021 at 11:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 04Apr2021 at 16:00 about 2 hours after the second dose, patient started having headaches and body aches, muscles spam, sharp needle like pain. On 09Apr2021, 5 days later, patient begin to feel tingling sensation in both arms particularly in the palms. He did not think much of these since they were not severed. But now he was concerning that the symptoms were not going away even 3 weeks later(at the time of reporting). The tingling sensations, the needle like pain and occasional headache. He was asking whether this Could be a sign that he was developing a blood clot? He was praying that he will be well. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, body aches/sharp needle like pain, muscle spasm and tingling sensation in both arm were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning her 24 month old nephew who was vaccinated with MMR II when he was 18 months old. Sometime after receiving the vaccine the patient started spacing. The patient had to have something in each hand. The patient did not have verbal skills. When the patient was 2 years old the physician's thought was that the patient was deaf. But then the physician diagnosed the patient with autism. It was reported that the patient was improved by doing therapy but was not 100%. At the time of reporting the 4 years old patient was having seizures at night time. The outcome of the patient's autism and seizure at night time were not reported. Upon internal review, autism and seizures were considered to be other important medical events. Additional information has been requested.
Injection administered too high on arm.  Pt experienced pain and limited mobility begining the day after recieving the flu shot. She visited her primary care who diagnosed her with brutitis and prescribed physical therapy.  Pt called today to report to the pharmacy.
HCP called to report late order of VARIVAX that was administered to a patient. HCP could not provide confirmation if the product was improperly stored; No additional AE; HCP called to report late order of VARIVAX that was administered to a patient. HCP could not provide confirmation if the product was improperly stored; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      The healthcare professional reported a late order (product distribution issue) of varicella virus vaccine live (oka/merck) (VARIVAX) that was administered to the patient on 07-MAR-2023, for first time with an expiration date reported as on 05-OCT-2024 (Strength, route of administration, anatomical location and lot # were not reported). Additionally, the healthcare professional could not provide confirmation if the product was improperly stored (product storage error). No additional Adverse Event (AE) was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002607:
One day p/receiving a dose of Td, pt devel induration @ inject site, which encompassed the entire deltoid region;
3 hours after vaccine pt said she was red all over and felt "out of it". Sent pt to the ER.
I got cold sores in my mouth after each vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2022 (Lot number: FM0698) at the age of 60 years as dose 3 (booster), single, administration date 27Aug2021 (Lot number: FC3180) as dose 2, single and administration date 06Aug2021 (Lot number: PC3180) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: ORAL HERPES (non-serious) with onset 07Aug2021, outcome "recovering", described as "I got cold sores in my mouth after each vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oral herpes.  additional information: the patient did not received other vaccine in four weeks and received Other medications in two weeks. no Covid prior vaccination, covid tested post vaccination and Known patient had no know allergies  Follow-up attempts are completed. No further information is expected.
After mixing vile, and administering two 0.3ml doses there was not enough vaccine left in the vile to administer anymore doses.
Had kidney stones before/Developed kidney stone; Had kidney stones before/Developed kidney stone; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included kidney stones. Concomitant medications were not reported. The patient developed kidney stones. She had kidney stones before. Outcome of the event was unknown.  Information on batch/lot number was requested.
Second vaccine given at day 47; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given at day 47) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given at day 47). On 20-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine given at day 47) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided by the reporter. No treatment information was provided.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: ep6965), in right arm, on 06Apr2021 as dose 2, single (Lot number: ER2789), in right arm and on 20Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 50 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30May2022 at 13:00, outcome "recovered" (2022) and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Course: Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
head pressure; feet hands prick pins; itching; Tight cough; Feverish; Pain chest; ringing ears; weakness; Eyes watering; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering) and HEAD DISCOMFORT (head pressure) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rash and Chest pain.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering), PAIN (feet hands prick pins), PRURITUS (itching), COUGH (Tight cough) and PYREXIA (Feverish). On an unknown date, the patient experienced HEAD DISCOMFORT (head pressure). On 03-Sep-2021, CHEST PAIN (Pain chest), TINNITUS (ringing ears), ASTHENIA (weakness), LACRIMATION INCREASED (Eyes watering), PAIN (feet hands prick pins), PRURITUS (itching), COUGH (Tight cough) and PYREXIA (Feverish) had resolved. At the time of the report, HEAD DISCOMFORT (head pressure) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Patient's medical history included Nerves. The patient had ear dizzy.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.