chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 26-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jan-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 26-Jan-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
Patient presented to hospital on 6/20/21 with complaints of substernal chest pain, nausea and vomiting 6 days after his second dose of Moderna Vaccine. His symptoms had started on the day of his second vaccine dose ( 6/14/21). He had initially presented to another hospital on the day his symptoms began and was discharged home after observation overnight. He presented to healthcare facility on 6/20 because his symptoms of chest pain, nausea and vomiting had not resolved.  On presentation, his HR was 39. EKG showed sinus bradycardia, Left axis deviation and T wave inversions in II, III and aVF. His COVID and Flu RT PCR was negative. HS Troponin was elevated to 168 and peaked at 283. There were no previous values to compare with from his prior admission.  Cardiac MRI was done but did not show LGE. He was diagnosed with clinical myocarditis after Moderna vaccine administration.
Headache and body aches, rated a 3 to 4 out of 10; Headache and body aches, rated a 3 to 4 out of 10; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Headache and body aches, rated a 3 to 4 out of 10) and HEADACHE (Headache and body aches, rated a 3 to 4 out of 10) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from April 2019 to May 2019, Back pain (Treatment took steroids around June 2019 which helped.) in May 2019, Loss of smell from April 2019 to May 2019 and Loss of taste from April 2019 to May 2019.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN (Headache and body aches, rated a 3 to 4 out of 10) and HEADACHE (Headache and body aches, rated a 3 to 4 out of 10). On 08-Mar-2021, PAIN (Headache and body aches, rated a 3 to 4 out of 10) and HEADACHE (Headache and body aches, rated a 3 to 4 out of 10) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Reporter informed that after receiving the first dose of the Moderna covid-19 vaccine he had headache, and body aches, rated a 3 to 4 out of 10. He did not take any medications or treatments with these symptoms.   This case was linked to MOD-2021-402864 (Patient Link).
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 53-year-old female patient received the 4th (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. Vaccination history included the 3rd (booster) dose of COVID-19 vaccine, (batch/lot# unknown), the 2nd dose of COVID-19 vaccine (batch/lot# unknown), and the 1st of COVID-19 vaccine, (batch/lot# unknown); all single dose, for COVID-19 immunization. Medical history included penicillin (unspecified if ongoing); sulfonamide(unspecified if ongoing); connective tissue disorder NOS (unspecified if ongoing); gastroparesis (unspecified if ongoing) and GERD (unspecified if ongoing). Concomitant medication not reported. The patient experienced COVID-19/COVID-19 treatment (medically significant) and ineffective drug (medically significant), with outcome of unknown. Therapeutic measures were taken as a result of COVID-19 and ineffective drug. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Fever, chills, body aches, lethargy; strong onset approximately 11 hours after injection.   Minor pain/redness at injection.  Symptoms lasted 3 days, gradually improving after first day.  Highest recorded fever ~101F via forehead scanner, but suspect higher the first night (did not record it) based on very strong chills and shivering.  Multiple Fever Blisters/Cold sores after 2 days, treated with Abreva.  Note there were no symptoms/side effects after first dose (Lot# EL3302, administered 01/08/2021).
fatigue; sinus and chest congestion; sinus and chest congestion; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: not reported), dose 1 via an unspecified route of administration on 13Apr2021 as 1st dose, single for COVID-19 immunisation. The patient medical history included COVID-19 from Jan2020 to an unknown date (she had the corona virus in Jan2020, she tested positive then). The patient's concomitant medications were not reported. On 18Apr2021, the patient experienced fatigue, sinus and chest congestion. On an unknown date, the patient underwent a COVID test, but results were still pending. The patient asked if that could be side effects to vaccine. Her second vaccine was due for May2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
pt recv vax 28MAY97 & 29MAY97 pt devel a fever of 101 which by the 8th day post vax was 103.9;31MAY97 pt exp cough;on 5JUN97 pt exp minimal bleeding on the oral mucosa;6JUN97 pt devel SC erythematous rash on chest & cheeks;10JUN97 T100.6;
LMP 05/29/2004, EDC 03/06/2004 EGA @ time of injection 3 weeks. Delivered baby at 39 weeks, mom and baby healthy. Information from missing data report states: I have no further information. Immunization were administred by the military.
Neuropathy Tingling in my legs and feet and face Severe joint pain  Constant headaches that turned into constant migraines Phantom smells- started smelling bleach POTS- inability to even sit up Severe fatigue, brain fog, sensitivity to sound, light, and touch Severe chest pain Esophageal spasms Internal tremors Dizziness, legs give out Inability to eat, as a result, lost about 20 pounds.
I was feverish. I was achy and had bad chills. Symptoms lasted about a day and a half. I Think I may have taken Motrin. Symptoms completely subsided after a day and a half. Chills were just overnight. Fever, chills and tiredness went over into the next day.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster with complications. On an unknown date later in 2016, the patient was treated by a physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
At approx 12 hrs after vaccine given pt had 102 deg fever and had 10 min seizure. WBC 14,000 nl diff. Ears red but previously well at time given. Full recovery. The follow up received on 1/14/04 states febrile seizure, bilateral otitis media and tachypneic. The discharge summaries for 12/03 states RSV and bronchiolitis.
Muscle aching and sometimes twitching. Dizziness of the head and stomach. Extreme nausea of head and stomach. Vomiting. Suppressed appetite. Great pain in head and stomach. Extreme fatigue and weakness. Symptoms peaked 24-36 hours after injection and were mostly gone after 3 days. Fatigue and weakness took a week to fully disappear.  Seemingly no lasting symptoms.
headache, chills, fever got as high as 100.5, body aches, nausea - this all occurred the day after vaccine.  Now 48 hours have gone by...  headache is still there but not as intense,  body temp down to 99.5., nausea gone, muscle pain not as severe.  Arm still hurts and now there is swelling and redness at site of injection.
pt recv vax 15MAR96 & 19MAR96 pt devel chicken pox w/open lesion;no further details were provided;
h/a, arthralgias & myalgias p/2nd & 3rd dos post exposure to a skunk bite;
Patient was vaccinated with Moderna vaccine.  Form was marked as first dose however when I went to enter into Impactsiis I discovered the resident had received 1 dose of Pfizer in Jan. 2021.  I contacted the home to inform them .
pt  stated they were short of breath, brought them back into vaccine room and asked them to lay down, but they didn't want to.  called 911 and pt spontaneously began feeling better within a couple minutes, she asked for water, she asked to cancel ambulance.  she sat w/ me in room and person who was with her sat with us. she was feeling completely better and insisted she needed nothing else.  I asked her to at least stay in the pharmacy area for a while to observe her.  She stayed about 15 extra minutes and left.
Breakthrough case admission after 2 vaccines Moderna 5/19/21 lot# 041C21A  Moderna 6/6/21 lot# 053C21A
The nurse reported that the patient did not experience any type of adverse reactions; twins were given an "extra dose" of "varicella" due to receiving the PROQUAD vaccine; This spontaneous report was received from a nurse, referring to a 4-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapy and drug reactions/allergies were not reported.  On 24-JAN-2023, the patient was vaccinated with an "extra dose" of "varicella" due to receiving the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number W029547 has been verified to be a valid lot number, expiration date was reported as 14-MAR-2024, 0.5 milliliter (ml), route and anatomical location were not provided) for prophylaxis (extra dose administered). The patient was on a "catch up" schedule and was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) that resulted in them receiving a dose of "varicella" that was not needed. It is unknown what the "catch up" schedule was in reference to and how many doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) that patient had received in the past. The patient did not experience any type of adverse reactions (no adverse event).  This was one of two reports from the same reporter.; Sender's Comments:  US-009507513-2301USA009662:
This spontaneous report was received from a Registered Nurse, referring to a 2 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not provided. On 08-FEB-2016, the patient was vaccinated with the first dose of PROQUAD lot # L040415 with expiration date on 13-APR-2017 for prophylaxis.  Other suspect therapies included sterile diluent (STERILE DILUENT). It was reported that the patient was vaccinated at a inappropriate age, however, no adverse events were reported.
Chills; Headache; Muscle pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single 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", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain".  Additional Information: The patient reported that she took acetaminophen (TYLENOL) or something on an unspecified date (not specified if taken as treatment or as concomitant medication).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Delayed cutaneous hypersensitivity in are which received vaccination, 3 days following vaccination. Had minimal soreness, I At the site of vaccination prior to that. Began with intense itching, followed by erythema, insulation extending down to lower arm. Resolved after  8-9 days
Massive hematuria noticed approximately 10 hr after dosing (10 pm); This is a spontaneous report from a contactable other (patient). A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 11:30 AM (Lot Number: EN6204) as 2nd dose, single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included diabetes, heart disease, kidney stone, Pine pollens only. Concomitant medications included Clopidogrel bisulfate (PLAVIX); acetylsalicylic acid (ASPIRIN (E.C.)); metoprolol succinate (METOPROLOL); metformin; glimepiride. Historical Vaccine included the first dose of BNT162B2 on 05Mar2021 11:30 AM (Anatomical Location: Left arm, Lot Number: EN6202) for COVID-19 immunization. The patient experienced massive hematuria noticed approximately 10 hr after dosing (10 pm) on 26Mar2021 22:00. Urine was clear immediately before vaccination.  Hematuria resolved by next morning (8 am). No pain or other symptoms. Past history of kidney stones, but event was completely absent severe pain associated with past stone passage. Hematuria not observed after first vaccination, only after 2nd shot. Called doctor but have not done any follow-up given rapid resolution. Just checking to see if the patient should have additional follow up on kidney function, disease etc, and/or if acceptable to get Pfizer vax at some future time. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was resolved without treatment on 27Mar2021 08:00.
next day achy, fever, n/v, diarrhea felt sick for 3 days;now 1wk later has achy joints, sore throat;
My daughter received a flu shot about an hour and half or so after getting the injection her nose started bleeding.  She was not in the heat or doing anyting that would cause er nose to bleed. Today 11/04/12 she experienced nose bleed again.
Since the 25th of October from 5 pm to now I have been experiencing high blood pressure thats goes from 185/99 to 150/89 every night and day, I also feel numbness  and tightness on my left side from the shoulder and irradiates to the neck and left ear, at night I feel a pressure on my head and warm sensation and is uncomfortable to sleep but no fever, present, also on my left injection shot im developing an abscess that it feels warm.
On 10-20-05, broke-out with hives on his chest and back, no fever, experienced vomiting as well. Has been taking zyrtec since late June after he experienced hives and edema 10 days after his last set of vaccines. On 10-21-05 Hives still present but have moved to buttocks and groin area..no vomiting today.
This spontaneous report was received from a pharmacist via a Pfizer's company representative and refers to unspecified multiple patients, all of 65 years of age or older. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with single doses of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). The patients experienced redness at the injection sites after receiving the PNEUMOVAX 23 (unspecified dates). The outcome of the events and the relatedness between the events and PNEUMOVAX 23 were not reported. Additional information has been requested.
Initial report was received from a consumer who is also the patient on 07 December 2010. A female patient (age at the time of the event was not reported) had received an Influenza vaccine (manufacturer, lot number, route and site of administration was not reported) on an unspecified date in 1984 and an unspecified amount of time later experienced "brain swelling" for three days and a four inch by seven inch "black area" on the vaccinated arm. The patient reported to have had the same reaction to an influenza vaccine administered to her in 1976. Treatments for the events were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
This spontaneous report concerning a female patient, who is currently 63 years old, was received from the patient herself. Her concurrent conditions included diabetes and cholesterol. However, information regarding her medical history and drug reactions/allergies were unspecified. On 26-SEP-2013, the patient was vaccinated with a single shot of ZOSTAVAX (the dose, dosage number, frequency, route of administration, anatomical location, lot # and expiration date were not reported). Her concomitant therapies included JANUMET, CRESTOR and LEXAPRO. Subsequently, on an unknown date the patient developed bumps on the right side of her face along with a bed head pain. Therefore, she contacted her physician and sought medical attention via an office visit. The physician recommended that she wait for a couple of days to see if the bumps went away. However, on 14-MAY-2016, she went to an urgent care and was diagnosed with shingles. As a result, she was treated with prednisone (Manufacturer unknown) for five days. Notably, no product quality complaint was involved. At the time of reporting, the shingles remained having unresolved. The patient failed to provide a causal relationship between the event and the vaccination with ZOSTAVAX. Additional information has been requested.
She got very lightheaded and fell to the side of the chair while sitting. I asked her to lay down on the floor and elevated her feet. She never lost consciousness and was alert and oriented. She was able to answer my questions. I checked her blood pressure, injection site, and skin for 30 minutes. .
severe stomach pain; diarrhea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 23Aug2022, outcome "unknown", described as "diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 23Aug2022, outcome "unknown", described as "severe stomach pain"; VOMITING (non-serious) with onset 23Aug2022, outcome "unknown".  Additional information: The reporter reported that, Dose 2 date: 24Aug2022 (Time: 7 Am - 5 Pm); Dose 3 date: 24Aug2022 (Time: 5 pm - 7 am); Dose 4 date: 25Aug2022 (Time: 7 Am - 5 Pm). Patient visited Pharmacy or drug store as a facility for administration of 1st and 2nd dose of COVID-19 vaccine. Patient received no other vaccines within 4 weeks PRIOR to the COVID-19 vaccine and stated specific relevant test for thromboembolic events with thrombocytopenia was none. Patient reported that, she started having severe stomach pain, diarrhea, Vomiting about 2hr after taking the first dose. (illegible) until at 3 days after last dose urgent care nurse stated to stop taking the meds.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On January 10, 2023, I got the first symptoms on my forehead and scalp area. I saw a provider on January 12, 2023. I was diagnosed with Shingles. I saw an eye doctor the same day. They saw the virus in my eye. I started Valacyclovir on January 12, 2023. I took it for two weeks. I returned to the eye doctor on January 18, 2023. I was given a prescription for Trifluridine and Prednisolone.  I took Trifluridine for two weeks. I took the Prednisolone for about four weeks, but I've had a reoccurrence so I'm taking it again. The virus is not in my eye currently, but I have inflammation. There is still pain in my forehead.
BODY ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 59 year old male. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021at left arm for prophylactic vaccination. Batch number was not reported and has been requested No concomitant medications were reported. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from headache, and body ache. This report was non-serious.
This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report section. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received Influenza vaccine. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with Flu shots the patient experienced Soreness (non serious, outcome: Unknown). For relevant test results see appropriate report section. Linked case: 2016060274 (same patient).