chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A serious, spontaneous report of received H1N1 and found out pregnant, pulmonary embolism, the umbilical cord was short and when the doctor tugged on it the cord snapped, heartburn and itching was received from a 27-year-old registered nurse/healthcare professional concerning herself, subsequent to H1N1 vaccine, Intranasal. This case is linked to MEDI-0011469. Neither relevant medical and obstetrical history nor concomitant medications have been reported for this patient. The expected delivery date was 30-Jul-2010. On 05-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. On 15-Nov-2009, the patient found out that she was pregnant. The patient started taking prenatal vitamins. From the middle of the 2nd trimester, the patient was taking diphenhydramine for itching and ranitidine hydrochloride for heartburn, both on a daily basis. On 24-Jun-2010, she delivered a baby girl at 35 weeks and six days gestation. The birth weight of the baby was 6 lbs and 4 ounces; apgar score at both one and five minutes was nine. The delivery was vaginal, the only complication was the umbilical cord was short and when the doctor tugged on it, the cord snapped. The doctor therefore had to deliver the placenta manually. The baby was perfectly healthy at birth. Four weeks after delivery, the patient had a pulmonary embolism, she was unsure if that was related to the H1N1 vaccine. The patient was hospitalised on 26-Jul-2010 and treated with intravenous heparin and was discharged on 31-Jul-2010 and was on warfarin sodium at the time of report. The outcome of 'vaccine exposure during pregnancy' and 'the umbilical cord was short and when the doctor tugged on it the cord snapped' was considered recovered. The outcome of pulmonary embolism, heartburn and itching was unknown at the time of report. Additional information was received on 09-Aug-2010 and incorporated into the narrative: Case upgraded from AESI to 15-day, since information of two serious events received. Serious events experienced by the patient are "pulmonary embolism" and 'the umbilical cord was short and when the doctor tugged on it the cord snapped" and two non-serious events are "heartburn" and "itching". Medications during pregnancy, newborn information, treatment medications.
second dose: arm pain; second dose: headache; They both received an email that the vaccine was invalid due to freezer storage beyond recommended date; They both received an email that the vaccine was invalid due to freezer storage beyond recommended date; This is a spontaneous report form a contactable consumer. This 36-year-old female consumer reported for a 32-year-old male patient (reporter's boyfriend) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EW0186, expiration date: 31Aug2021) via an unspecified route of administration, administered in left arm on 07Jun2021 at 14:58 as single dose for COVID-19 immunization. Patient's medical history (including any illness at time of vaccination) was none. There was no family medical history relevant to AE but cancer runs in his family but there has not been any scares or anything with him. The patient had no prior vaccinations (within 4 weeks). There were no AE following prior vaccinations. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EW0167, expiration date: 31Aug2021) via an unspecified route of administration, administered in left arm (upper) on 16May2021 at as dose 1, single for COVID-19 immunization and experienced headache and pain the arm. It was reported that patient received an email that the vaccine was invalid due to freezer storage beyond recommended date and administered on 07Jun2021 at 14:58. The email indicated that the facility had reached out to the center and it was recommended that they take a third dose. The reporter stated that her boyfriend had taken the first and second dose at the same exact date and time. The reporter stated that, when the patient had the second dose, the patient had pain in the arm and a little headache. The patient not visited to emergency room and physician office. No treatment medications were received for the adverse events. The outcome of the events was unknown.  Follow up information has been requested.; Sender's Comments: Linked Report(s) : 2021814858 same reporter, dose, drug and event, different patient.
Received vaccine at local health department clinic on 02/18/2021-presents to this reporters facility ED on 02/23 with worsening shortness of breath x 24 hours.  patient currently off warfarin for afib x 72 hours due to upcoming outpatient scheduled carpal tunnel surgery 2/25.  afib with RVR in ED.  Afib treated in ED, anticoagulation therapy resumed, surgery delayed
Patient reported had not received booster dose of COVID vaccine, checked our EHR and noted patient due for vaccine, gave vaccine. Charted vaccine in our EHR and in State immunization system. State immunization system showed booster dose given at another facility on 12/6/2021. Reported adverse event to provider, supervisor and our pharmacy.
Patient administered vaccine after the 30 day beyond use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 13-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date) and 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 EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date).    It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No reported symptoms.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719719 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719719:2nd adult patient
Patient claimed after she received her first shot of Moderna, she developed back/kidney pain and now has weak legs (bilateral). She stated she has not followed-up with her PCP. She has been busy and they won't call her back. She did not have these symptoms prior to vaccine.
-Dec 24: received -Dec 24 evening: fatigue, sore joints  -Dec 25th: fatigue, generalized malaise, sore joints  - especially those affected by the arthritis..  Moderate symptoms.Last all day.  Bed rest. -Dec 26th. Symptoms improving. bed rest -Dec 27th: Much improved. Only symptoms remaining is sore joints (mild)  Treatment: 1000 mg Tylenol q 4 -6 hr since Dec 24th
Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE and EXPIRED PRODUCT ADMINISTERED in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE and EXPIRED PRODUCT ADMINISTERED. On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE and EXPIRED PRODUCT ADMINISTERED had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This is a spontaneous case of product temperature excursion issue and expired product administered for this 89-year-old, male patient with no relevant medical history. No adverse event was reported after administration of the third dose of the Moderna mRNA-1273. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.  No concomitant medication was provided by the reporter.  No treatment information was provided.
1st vaccine: 28 weeks pregnant-due 6/10/21.  Adverse reaction was soreness at injection site the following day only.  2nd vaccine: 31 weeks pregnant.  Adverse reaction was soreness at injection site for appx 2.5 days; low grade fever (in the 99's), fatigue, general feeling of malaise/lack of energy for the day after the injection only.
Super Heavy periods starting the first month after being fully vaccinated. Blood running down my leg, changing super tampon every hour.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Apr2021 (Lot number: EN6199) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing), notes: other medical history: Celiac disease. Concomitant medication(s) included: FLAXSEED. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin", notes: known allergies: Augmentin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318), administration date: 22Mar2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 24May2021, outcome "not recovered", described as "Super Heavy periods starting the first month after being fully vaccinated. Blood running down my leg, changing super tampon every hour.". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient received Womens daily multivitamin in two weeks. Events considered as non-serious as per the reporter. Patient did not receive other vaccine in four weeks. Patient was not diagnosed with covid-19 prior vaccination and was not tested for covid-19 post vaccination. Device Date: 15Dec2021  No follow-up attempts are possible. No further information is expected.
"sick for 4 days" ? Narrative:  Pt wife stated "He was sick for 4 days and can't take the flu vaccine." *HISTORICAL INFORMATION * (vague illness attributed to vaccine by patient ???)
-Face tingly and/or numb starting with lips before spreading to entire face about 40 minutes after injection. Felt like face was going in and out of conscienceness entire time. Sometimes felt like the sensation when a scab on a scrape is healing and the new skin is forming under the scab. Based on internet research with others having this rare side effect wanted to note that there was no swelling or change in heart rate (also I have not had any cosmetic surgery). But most reactions tended to be after the second dose and not the first as in my case. This mainly lasted about 48 hours at a pain level of medium with occasional minor occurrences after that. -Left bicep soreness (entire bicep not localized to injection). Pain intensified when touched or arm lifted above head. Pain level medium but consistent. Started about 16 hours after injection and last about 60 hours. - Overall body soreness. Felt like being hit by a freight train. Pain level fairly high starting about 18 hours after injection and lasting about 24 hours gradually decreasing in pain level over duration of that period. - About 40 hours after injection, face felt like it was hit by a frying pan, most pain localized to where nose meets face (not tip of nose) and radiated out from the bones around the nose to the rest of the face. These symptoms were high pain level for 36 hours and probably a low pain level about 24 hours after that. - About 70 hours after injection, dizziness and headache lasting for about 8 hours. Medium pain level. - Almost all high and medium level side effects are finally gone after 4 days although still minor face pain and left arm bicep pain exist.  (Sorry I didn't know I could report side effects so have been trying to keep track on paper as best as I could this week).
When I got the vaccine I drove over to the parking lot waiting area. I felt strange but ok. My arm had pain at the injection site with a burning sensation. I had a brief moment of narrowing vision or blurred  about 5 minutes after the injection but it went away. It lasted approximately 1-2 minutes at the most.  I felt just fine after I waited the 15 minutes and I left. I didn't feel the need for medical care. I filled out the V-Safe questionnaires to discuss my other symptoms that started at about 1 am the same day. but it didn't ask about at the time of injection. I reported my fever 101.8, severe chills, severe headache (worst I have ever had), joint pains, muscle and body aches, nausea, injection site pain, fatigue and tiredness, and that I was unable to attend work or do normal activities.
No symptoms that day until I entered the appartement building : suddenly it was exquisitely sore and the soreness was triggered by even subtle movements.       The soreness was , to the touch, located in  a?ribbon? shape several inches long.    Time has modified the soreness to touch/ pressure but not to movements.     The shoulder remains extremely sensitive to movements that, perhaps, stretch the structures involved.
On 8/10/00, the pt developed a fever, papules and vesicles. On 8/11/00, at 3:00 PM the pt experienced a febrile seizure lasting 2-3 minutes. Temp was 102 rectally. On exam on 8/10 the pt experienced red papules and hurt.
Chills started at 8pm 1-12-21, turned into body aches and sweats, fever started middle of night and lasted until noon on 1-13-21, reaching 101.0 at the highest. Then had headache and sore eyes and fatigue. Body felt hot 1-14-21 with no fever just fatigue. Felt fine 1-15-21. Previously was dx with a positive COVID test in October of 2020.
pt recv vax 4JAN99 & 10JAN99 onset of fever 104, muscle aches, h/a, abd cramps, bloating, drowsiness, dark stool;treated w/APAP;12JAN99 reported to hlth dept tested in hosp ER all tests negative;
She said she broke out into a rash from her ear down to the side of her cheek. She said it was very mild and lasted about a week. No new lotions/detergents/makeup during this time
Pt became dizzy, pale, and lightheaded about 5 minutes after receiving his COVID-19 vaccination. He states that he feels like this every time he gets a shot. Denies shortness of breath or nausea. After drinking water pt stated he was no longer experiencing symptoms. He was observed for 20 minutes and then left after all symptoms had improved.
Moderna COVID-19 booster dose (0.25mL) administered on Oct 26, 2021 before checking expiration date of Oct 11, 2021.
child exposed to chickenpox in 1st grade classroom;13MAY98 mom noted several fluid filled lesions on neck, arms & front & back of torso;no fever noted;reddened base to blisters;
No additional AEs; VARIVAX administered to24 month old via IM route; This spontaneous report was received from a nurse referring to a 24-month-old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 04-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml intramuscularly (IM) (strength, lot #, and expiration date were not provided) for prophylaxis (incorrect route of product administration). No other information provided. No additional adverse events (AEs). The outcome of incorrect route of product administration was unknown.
Began with visual changes,  numbness on June 25th; admitted to hospital July 9-12th, 2021 w/ presumtive Guillain Barre syndrome; has had CT scan showing no lesions
Dose 1: Redness, swelling at injection site, Headache, dizzy, nauseous, fever over 100 degrees F. Everyday or every other day. Diarrhea, muscle aches, joint aches, neck pain, fatigue all lasting 2-3 weeks. Still had 100 degree fever the night before Dose 2. Told nurses at Super Station about all the side effects from first dose and they had me take a Benadryl before 2nd shot, stay 30 min. for observation, then they told me to take Tylenol when I got home, which I did. Taking 2-3 more over the next day or so. Did not get redness or swelling at shot site, did have headache, fever, fatigue, muscle and joint pain, but much more muted than with the first dose with no medication. I continue to have a fever of 100 degrees about every 2-3 days. Some days I have diarrhea or feel headachy and have to be in bed most of the day. Usually fever is first symptom on those days. It's been 3 weeks since last dose and my fever was 100 yesterday and spent 15 hours in bed.
Pt. fainted when leaving office. Noted on floor by nurse.  No notification of changes in feeling to staff or visitors prior to fainting. Jerking movements , eye roll, sweating, disorientation noted.  Duration less than one minute.
After receiving my COVID-19 vaccination I experienced a zap of nerve pain in the right side of my butt. No treatment received.
mom brought pt in 2 days p/vax below inj site 1inch x 1inch red erythematous warm,macular patch;does not itch;MD prescribed hydroxyzine
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer program. A contactable consumer (patient herself) of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date as a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient and husband had their second dose appointment scheduled for 21Apr2021, would like to cancel appointments as both tested positive for covid. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained
Patient received first COVID 19 PFizer-BioNTech vaccine on 12/21 and her second dose on 1/9. On 2/7/21 she started experiencing covid related symptoms and tested positive on 2/8/21.
Subsequently post vax, the pt experienced terrible headaches. The pt rarely went a day without a headache. The neurologist thought it might be migraines, but they never went away; she went to bed with a headache and woke up with a headache.
fever 100.8, chills, headache, nausea, muscle aches, very sore painful arm. Symptoms lasted 12 hours
Unable to use the arm; Excruciating arm pain; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Unable to use the arm) and PAIN IN EXTREMITY (Excruciating arm pain) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0D1BL1A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced LIMB DISCOMFORT (Unable to use the arm) and PAIN IN EXTREMITY (Excruciating arm pain). At the time of the report, LIMB DISCOMFORT (Unable to use the arm) and PAIN IN EXTREMITY (Excruciating arm pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided.  Concomitant medication not provided.
This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with improperly stored doses GARDASIL 9 lot # M041990 with expiration date 28-JUN-2019, lot# N004799 with expiration date 25-NOV-2019, lot# M042853 with expiration date 27-JUL-2019, or lot# N013276 with expiration date 21-JAN-2020, (strength, dose and route of administration were not provided) for prophylaxis. Other suspect therapies included improperly stored doses of PEDVAXHIB, lot # N007751 with expiration date 30-NOV-2019, lot # N000238 with expiration date 25-OCT-2019, or lot # N003537 with expiration date 17-NOV-2019 (strength, dose and route of administration  were not provided) for prophylaxis. The reporter stated that she was not sure which lot the patient received. The doses of GARDASIL 9 and PEDVAXHIB were exposed to a temperature of 29 Fahrenheit (°F) during a time frame of 63 hours and 15 minutes, which was not detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.
Difficulty breathing 4 pm-8 pm airway limited fever 5 pm-6 am / swollen eyes 6 pm-11 am. Massive headache 5pm-9pm. Chest pain 3pm-7pm. Severe aches 5pm-6am (treatment ibuprofen only).
Crying for more than 3 hours after DTAP #4 immunization and HIB #4.
Tachycardia, Hypertension, Light headed, dizzy, hot, flushed on neck and chest.
Rxn - vomiting, paleness, fever, tachypnea. Tx - Motrin at hospital
Lymph nodes inflamed; felt fatigued; Big rash; Lumps/lumps under the neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Lumps/lumps under the neck), FATIGUE (felt fatigued), VACCINATION SITE RASH (Big rash) and VACCINATION SITE LYMPHADENOPATHY (Lymph nodes inflamed) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] and POTASSIUM for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced NECK MASS (Lumps/lumps under the neck) and VACCINATION SITE RASH (Big rash). On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (felt fatigued). On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Lymph nodes inflamed). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, NECK MASS (Lumps/lumps under the neck), FATIGUE (felt fatigued), VACCINATION SITE RASH (Big rash) and VACCINATION SITE LYMPHADENOPATHY (Lymph nodes inflamed) outcome was unknown.            This case was linked to MOD-2021-378325 (Patient Link).
Has been experiencing a dull headache since receiving the first dose; This is a spontaneous report from a contactable Other HCP.  A patient (demographics unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. She has been experiencing a dull headache since receiving the first dose vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient experienced an outbreak of herpes zoster two days after vaccine was administered.  Patient was seen by Dr. four days after outbreak.  Patient was experiencing multiple erythematous plaques to right mid abd and right oblique at T9-10.  Patient also reported pain at site of lesions.  Patient was prescribed Valtrex 1000mg TID for five days.