chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-May-2021. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) to be not applicable.    No Concomitant medication were provided No treatment were provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 33-year-old female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
This spontaneous report was received from a registered nurse and refers to multiple unknown patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # reported as L000433 with expiration date 09-JUL-2016 and lot # L006181 with expiration date 13-DEC-2016, orally (dose not reported). The vaccine underwent a temperature excursions below 36 degrees Fahrenheit for unknown time (reported as "more than 25 times"). It was reported that Data logger was used. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sore arm, prolonged headache (possibly from the migraine I had the day I got the vaccine)  Pregnant; due date June 16 2021. First pregnancy at the age of 40.
Local immunization reaction at site of injection with hives on 11/3/16. Patient was diagnosed with strep and is now on antibiotics.
Swelling at Injection site 8 days after first dose of Vaccine; Itching at the injection site 8 days after first dose of Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at Injection site 8 days after first dose of Vaccine) and VACCINATION SITE PRURITUS (Itching at the injection site 8 days after first dose of Vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypertension and Anemia. Concomitant products included IRON for Anemia, SALBUTAMOL (VENTOLINE [SALBUTAMOL]) and BECLOMETASONE DIPROPIONATE (QVAR) for Asthma, TRIAMTERENE for Blood pressure high.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at Injection site 8 days after first dose of Vaccine) and VACCINATION SITE PRURITUS (Itching at the injection site 8 days after first dose of Vaccine). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling at Injection site 8 days after first dose of Vaccine) and VACCINATION SITE PRURITUS (Itching at the injection site 8 days after first dose of Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Dx- Chicken pox - <20 lesions, itching. Tx- Acyclovir.
Redness, warmth, swelling, pain around vaccination site right shoulder. Fever, malaise, aches, fatigue.
Had a blood blister from injury on stationery bike {cardio rehab} which was aggravated by the vaccine.,,,,occured on January 30 2021 and had my injection on 02/06/2021 which  compromised my immune system and the injury is not healing.  Had an x ray which did not show fracture.
DIFFICULTY BREATHING. ALOT OF PAIN IN THE LUNG AREA AND SEVERE DIZZINESS. SYMPTOMS LASTED 24 HOURS.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-MAY-2016 the patient was vaccinated with ROTATEQ (lot #L008054; expiry date: 30-NOV-2016), at an unspecified dose, orally that had been improperly stored (incorrect product storage). The vaccines were exposed to temperature of 58.8 F for 3.75 hours and the data logger was involved. No previous temperature excursion was reported. No adverse effect was reported. Additional information has been requested.
No additional AE reported; TE on frozen vaccines reports one dose of PROQUAD was administered to one patient 17-NOV-2022; This spontaneous report was received from  a medical assistant and refers to a patient of a not reported age or gender.  The patient's medical history, concurrent conditions and previous drugs reaction or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 17-NOV-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  lot #U039955, expiration date: 14-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided following a temperature excursion of -14 degree Celsius (C) up to -10 C (-13C) for 1 hour (product storage error), it was mentioned that previous temperature excursion did occurred of -14C up to -10c (-14.2C). No additional adverse event was reported.
Patient experienced dizziness after receiving the shot. She also stated she felt  tingling in her arms
UPON A BOARD OF PHARMACY INSPECTION, OUR AGENT POINTED OUT THAT SINCE WE ARE CLOSED ON SUNDAYS, NO TEMPERATURE MONITORING WAS TAKING PLACE ON SUNDAYS.  THUS ALL OF OUR VACCINES WERE QUARANTEED AND WE WERE INSTRUCTED TO NOTIFY OUR PATIENTS.  WE HAVE SINCE INSTALLED A DIGITAL TEMPERATURED TRACKING SYSTEM TO MONITOR TEMPS ON THE WEEKEND.  NO ALARMS HAVE EVER SOUNDED ON THE PREVIOUS SYSTEM AND ALL VACCINES APPEARED TO REMAIN WITHIN THE DESIRED TEMP RANGE.
Patient complained of chest pain, shortness of breath . MD notified 911. IV fluid started, Benadryl 50 mg ivp on 3LO2
DVT; PE; This is a spontaneous report from a contactable physician. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm, on 28Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and fibroids. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medication included amlodipine besilate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm, on 07Jan2021 (at the age of 42-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced deep vein thrombosis (DVT) and pulmonary embolism (PE) on 29Jan2021, which caused hospitalization for 5 days from an unspecified date to an unspecified date. Therapeutic measures were taken as a result of the events, which included direct oral anticoagulants (DOAC). The clinical outcome of DVT and PE was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Deepvein thrombosis,pulmonary embolism cannot be excluded.But also consider relevant medical history of hypertension and fibroids tendency to form blood clots and concomitant medications also have possible contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Multiple seizures lasting longer than 30 minutes. This happened after the second dose on 6/18/2021. Happened approximately 7 hours post vaccination. Required ambulance transport to emergency room and overnight hospitalization at a hospital.
No adverse effects.; Patient was administered the 1st dose on 19-OCT-2014. Patient was administered the 2nd dose of VAQTA 30-APR-2019.; This spontaneous report was received from a pharmacist referring to an approximately 48 year-old patient of unknown gender.   The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant medications were unot reported.  On 19-OCT-2014, the patient was vaccinated with the first dose of  hepatitis a vaccine, inactivated (VAQTA) (strength, route of administration, anatomical location, lot number and expiration date were not provided). On 30-APR-2019, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (strength, route of administration and anatomical location were not provided), lot number S001485 and expiration date 12-MAY-2020; as prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Pt was adm for hyperpyrexia & thigh edema, r/o cellulitis s/p HIBTITER vax; pt exp 3x2 cm local rxn w/edema; the area was incised for drainage; no evidence of abcess or hematoma-persistence of firm, well defined SQ nodule;
Cramp on l lower leg lasting for 5 seconds, on the second day, cramp lasting for 2 minutes after a run on l lower leg. Felt little nauseous this am.
Expired Dose Administered; Administered second dose 7 months after first dose; Initial Report Received on 11-APR-2023.  A pharmacist reported that a 38 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization second dose 7 months after first dose and that the second dose was expired.  Medical history included no allergies or previous reactions to other vaccines.  No relevant concomitant medications were reported.    On 27-AUG-2022, the patient received the first dose of HEPLISAV-B (Lot number, expiration date, NDC number, route, site not reported). On 01-APR-2023, approximately 7 months after the first dose, the patient received the second dose of HEPLISAV-B (Lot number 937233, expiration date 11-MAR-2023, and NDC number 43528-003-05) in the left arm from a pharmacist.   On 01-APR-2023 the patient was vaccinated with dose 2 of  HEPLISAV-B that had expired on 11-MAR-2023.  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Patient developed a bruise at the injection site that started the day after her vaccine. It was about 1-2" in diameter, and a purple/brown color. She said it was sore. She also said it had improved since it originated.
hives; This is a spontaneous report from a contactable Other HCP (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: EL1283 and EL9261) via an unspecified route of administration on 14Jan2021, 02:45 AM and 04Feb2021, 02:45 AM at single dose in the left arm for COVID-19 immunization. The patient's medical history included allergy of Bac-trim. Concomitant medications was not reported. It was reported that the patient had not received other vaccine in four weeks and had received other medications in two weeks. The patient was not tested for Covid prior vaccination. The patient was not tested for Covid-19 post vaccination. The patient experienced hives for 24 hours 10 days after the first dose and hives for 48 hours, 3 days after the second dose which was on 07Feb2021. Treatment medications included loratadine and hydrocortizone cream. The outcome of the event was recovering.
large red, swollen area noted to posterior upper arm w/smaller, darker, red area in center
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX injection, 4 doses of lot # K021936; expiration Date: 10-NOV-2016 and 2 doses of lot # L018001; expiration Date: 19-MAY-2017 (strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Urinary tract infection treated with Ciprofloxacin for 7 days Symptoms: Pain and frequent urgency while urinating, low-grade fever, diarrhea.
arm swelling; This spontaneous report was received from a pharmacist and refers to a male patient of an unknown age. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On an unspecified date, the patient received unspecified Coronavirus disease (COVID) vaccine (exact dose, route of administration, lot number and expiration date were not provided) and on an unknown date (reported as at least a month later), the patient had a pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided).   On an unknown date, the patient experienced arm swelling after his pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown).  The outcome of the event was unknown. The causality assessment was not provided.  This is one of three reports from the same reporter.; Sender's Comments:  US-009507513-2110USA006332: US-009507513-2110USA006333:
The next day, my right arm was very sore and swollen to the point I could not lift it without severe pain.  Uncontrollable sweating, pain in every part of the body..  Body aches and chills, yet no fever.   Feeling extremely hot yet my feet are ice cold.  Inability to get warm.  Diarrhea, nausea. Unable to sleep more than 4 hours at a time.  Taking frequent naps during the day, still feel exhausted.  Head in a fog.    I took a 500mg Naproxen and the pain was relieved about 5%.  My PCP called me  and told me to take Tylenol which doesn't help at all.    Today is day 4 and the side-effect symptoms are progressing.
Shortness of breath, Left arm pain, Numbness and tingling, " Unable to move my body".
Quarter size Herpes zoster rash on left buttock. Itchy,  pain, bumpy. Have had shingles many times in the past. Received  Zostavax vaccine in 2017.  Started Acyclovir 400 mg 5 times a day
Fever, chills, temp, headache, dry cough, anorexia, weight loss.
Legs are numb/numbness in legs from knees down/ Fingers were also numb on both hands./tingling in hands; both legs swelled some; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in right arm on 03Feb2021 as single dose for COVID-19 immunisation. The patient had no medial history or concomitant medications. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via an unspecified route of administration on 13Jan2021 as 1st dose, single dose for COVID-19 immunisation. On 04Feb2021, the patient's both legs became numb from the knee down, they swelled some, but numb as they can be and experienced tingling in her hands. The numbness in her legs got real bad in the night of 04Feb2021. On the morning of 05Feb2021, the legs were still partially numb but not as numb as in the night of 04Feb2021. The fingers were also numb on both hands. The tingling was just in her fingers. The patient was wondering if these were after effects of the vaccine. She didn't have a prescribing doctor and was advised by her doctors to get it though. She wanted to know if this was one of the side effects. She stated that she know no other reason other than this that she would get this reaction. Outcome of the events Legs are numb/numbness in legs from knees down/ Fingers were also numb on both hands/tingling in hands was not recovered while that of the event both legs swelled some was recovering.  Follow-up attempts are completed. No further information is expected.
On Monday, 09/19/2022 I began to have mild aches. I took one gram of acetaminophen. AT 02:05AM I had really bad muscle and joint pain. My temperature at that time was 98.6. At 02:50AM. The muscle and joint pain was not as bad but my temperature was 99.8. At 03:15AM I no longer had any muscle or joint pain and my temperature was 99.3. At 08:30AM my temperature was 100.9 and I took 650 milligrams of aspirin. I re checked my temperature at 09:30AM and it was 101.4. At 10:00AM I started getting a mild headache and my temperature was 101.9. I took one gram of acetaminophen. At 01:00PM I was getting a headache again and my temperature was 99.4 and I took 650 milligrams of aspirin. At 06:00PM I had a really bad headache and I had pain behind my eyes along with tooth pain. At 06:15 my temperature was 101.5. I took one gram of acetaminophen, 30 milligrams of SUDAFED, and 50 milligrams of BENADRYL. I was also experiencing pain, redness, and swelling at the injection site of my Moderna COVID-19 shot. The swelling was around golf ball sized. At 11:00PM my temperature was 100. At 01:30AM, I took 1 gram of TYLENOL, 30 milligrams of SUDAFED, and 50 milligrams of BENADRYL. At 07:45AM I woke up with an excruciating headache, my temperature was 98.6. I took 975 milligrams of aspirin. At 07:25PM I had bad nasal congestion, a bad headache, my temperature was 100.1. I took 30 milligrams of SUDAFED, 1 gram of TYLENOL. At 02:00PM I took 50 milligrams of BENADRYL. On Wednesday at 08:00AM I had a bad headache. My temperature was at 98.6. I believe I took TYLENOL at that point for the headache. I have not had a fever since then. I went to urgent care on Monday. They did a COVID-19 and a Flu test which were both negative. I let my doctor know on Wednesday that I was having really bad headaches. She mentioned sending me for a CT scan and to test for meningitis. I declined since I did not have any other signs of meningitis. I had a telehealth appointment where they prescribed medication if I needed it. However, all of my symptoms have basically gone away with the exception of the swelling in my arm which is now tennis ball sized. It reminds me of a reaction I used to experience with allergy shots.
I developed severe recurrent dizziness, vertigo/unsteadiness, ear fullness, worsening headache.
My face turned red and an onset of hives.  We left and about 20 minutes later started to get hives.  We went back to the facility.  Was given Benadryl and it knocked it down.
SICKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sickness. This report was non-serious.
body aches; wheezing; Dry cough; coughed up a plug of thick yellow mucus once; nose was running; swollen glands under her right arm and throat; face felt slightly swollen (tight); bone aches; nasal congestion; chills; fever up to 101.5 F; nausea; muscle aches; low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (body aches), WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once) and RHINORRHOEA (nose was running) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Lyme disease, Seasonal allergy, Food allergy and Nasal congestion. Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (body aches), WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once), RHINORRHOEA (nose was running), LYMPHADENOPATHY (swollen glands under her right arm and throat), SWELLING FACE (face felt slightly swollen (tight)), PAIN (bone aches), NASAL CONGESTION (nasal congestion), CHILLS (chills), PYREXIA (fever up to 101.5 F), NAUSEA (nausea), MYALGIA (muscle aches) and PYREXIA (low grade fever). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Pain, at a dose of 1000 mg; ALBUTEROL [SALBUTAMOL] for Wheezing, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Rhinitis, at an unspecified dose and frequency. On 25-Mar-2021, WHEEZING (wheezing), COUGH (Dry cough), COUGH (coughed up a plug of thick yellow mucus once), CHILLS (chills) and NAUSEA (nausea) had resolved. At the time of the report, PAIN (body aches), RHINORRHOEA (nose was running) and PYREXIA (fever up to 101.5 F) outcome was unknown and LYMPHADENOPATHY (swollen glands under her right arm and throat), SWELLING FACE (face felt slightly swollen (tight)), PAIN (bone aches), NASAL CONGESTION (nasal congestion), MYALGIA (muscle aches) and PYREXIA (low grade fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Pyrexia: 38.6 celsius (High) 101.5 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.