chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got Covid after your vaccine; I got Covid after your vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got Covid after your vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
About 12 hours post vax the pt developed urticaria and had resolved by morning. The pt was given Benadryl every 4 hours.
Pneumonia; Positive for COVID; Had a lot of mucous; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (Positive for COVID) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and COVID-19 (Positive for COVID) (seriousness criterion hospitalization). On an unknown date, the patient experienced SECRETION DISCHARGE (Had a lot of mucous). The patient was hospitalized from 17-Apr-2021 to 19-Apr-2021 due to COVID-19 and PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (Positive for COVID) and SECRETION DISCHARGE (Had a lot of mucous) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no treatment information provided.  Company comment: Limited information regarding the pneumonia and mucus secretion has been provided at this time and a causal relationship cannot be excluded.  Positive Covid test unlikely related to vaccine administration; Sender's Comments: Limited information regarding the pneumonia and mucus secretion has been provided at this time and a causal relationship cannot be excluded.  Positive Covid test unlikely related to vaccine administration
mom noted swelling of hands & feet the morning p/vax had been given;@ approx 39hr p/vax tops of hands & feet & toes are puffy;
Healthy, with 10 minutes of being vaccinated - started with facial swelling, red eyes, cough, vomited - then started wheezing - returned to clinic - given IM Epi, IM Solunedrol, Albuterol - improved. Admitted for observation - no further sequelae - D/C home next day - oral steroid x 24 hours - c/w anaphylaxsis.
pt noticed a developing red spot below the site of injection, not on more medial rather than on the lateral arm, closer to the bicep. pt had no other reaction (fever, pain, vomiting, etc.). red spot was addressed by an urgent care doctor. she was prescribed prednisone and doxycycline. she said doxycycline was prescribed as a precaution in case cellulitis emerged. pt seen today at the pharmacy. pt reports redness has decreased significantly.
Yellow patch on upper arm and hard lumps under arm x 2 days. Lumps have subsided.
Mother of child called on 07/28/2003 to report that for the past 4 days child has had a sore neck, sore muscles, headache and chills.  For the past 3 days (starting 07/26) has had temperature of 104 degrees.  She has notified their family physician.
Presented for covid 19 vaccine, vaccinated at 1010 at left deltoid. Patient denied any allergies. Patient reported having lip/facial fillers in May 2020 with a touch up in June 2020.  1024-patient first felt lip warmth  1030- notified staff of lips slightly swelling, warmth and "smoothness"; denied itching  1032- consult with pharmacy, med with diphenhydramine 50 mg PO: VS: 154/103  HR90  p.ox 99%  1040- patient reports no change, 133/90 HR82 97%  1045- patient reported decreased warmth and swelling 142/81  hr93 99%  1100- patient reported feeling back to baseline;  recommended that patient follows up with primary care provider to establish plan prior to next dose
PATIENT PRESENTED TO PHARMACY ON 11/30/19 COMPLAINING OF REDNESS AT THE SITE AND WARMNESS OF AREA TO THE TOUCH. PATIENT PRESENTED WITH FAIRLY LARGE NON RAISED RED SPOT COVERING BACK PORTION OF DELTOID. PHARMACIST SUGGESTED SHE CALL IF CONTINUES OR DOESN'T IMPROVE OR BEGINS TO RUN SIGNS OF INFECTION (FEVER).
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-FEB-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. Digital data logger was involved. There was no involvement of Product quality complaint (PQC). This is one of the several reports received from the same reporter.
Information has been received from a Physician concerning an unspecified number of patients of unknown ages and genders. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with ROTATEQ lot number L008059 with an expiration date of 18-DEC-2016 (strength, dosage schedule, route of administration and anatomical location were not provided) which were involved in a temperature excursion. Concomitant therapies were not provided. It was unknown whether laboratory diagnostics studies were performed. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
No adverse event; Greater than 35 days between Primary Series Doses of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Primary Series Doses of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Primary Series Doses of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Primary Series Doses of the Moderna Covid-19 vaccine) 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 (Greater than 35 days between Primary Series Doses of the Moderna Covid-19 vaccine).    No concomitant medication details was reported. No treatment medication details was reported.
Pain at site of injection & down arm for at least 1 mo. (still continues at 1 mo. since injection).
The day after I received the shot I had a headache body aches cold chills fever lower back pain exhaustion the next day I felt better still had a headache and lower back pain
Pt recv vax on 1/21/99; on 1/23/99 pt exp fever (105), amnesia, hallucinations, yelling for help x 2 min
A report has been received from a Pharmacist concerning a 47 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 02-Sep-2013. The reporter stated that revaccination after vaccine dripped out of nose of the patient which started on 02-Sep-2013. The outcome of the event of REVACCINATION AFTER VACCINE DRIPPED OUT OF NOSE is unknown. The report was considered to be non-serious.
Information has been received from a physician referring to an 18 years old male college student. The patient's medical history and drug reactions/allergies were unknown. Concomitant therapy included MENACTRA. In approximately 2015 (reported as about a year ago), the patient received GARDASIL (lot#, expiration date, dose and route were unknown). After the administration, the patient "passed out which happened so quickly". He turned gray, looked dead and landed on the floor with no pulse. Then the patient's legs were raised and he was given oxygen. The patient was in the hospital overnight. It was unknown if the lab diagnosis was performed. The outcome of events was unknown. The causality assessment between the events and GARDASIL was not reported. Upon internal review, passed out was determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Leg cramps; Nausea; Chills; Pounding headache; Vomiting; Tired; sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (Leg cramps), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Pounding headache) in a 31-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anemia (Stable) and Thalassemia (Stable). Concomitant products included IRON from 17-Feb-2021 to an unknown date for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Jan-2021 and the estimated date of delivery was 23-Oct-2021. On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-May-2021, the patient experienced MUSCLE SPASMS (Leg cramps), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Pounding headache), VOMITING (Vomiting) and FATIGUE (Tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred  on 08-Sep-2021.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 28-May-2021, MUSCLE SPASMS (Leg cramps), NAUSEA (Nausea), CHILLS (Chills), HEADACHE (Pounding headache), VOMITING (Vomiting) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Laboratory test: normal normal. On 08-Jun-2021, Ultrasound scan: normal normal.         Concomitant medication included Prenatal from 17-FEB-2021 once a day.    This case was linked to MOD-2021-095487, MOD-2021-095487 (Patient Link).
Body aches, headache, fever from 3/23:  12:01 am -  3/24: 7:00 am
5 minutes following the vaccination, patient's  BLE and BUE went into abnormal extension immediately followed by facial tics and shaking of the BUE.  Pt was pale, diaphoretic, and verbalized " I am OK" three times in a row without being asked. Pt stated he was unaware of what had just happened then verbalized feelings of nausea. Airway, Breathing, Circulation intact. Pt was placed on gurney, side rails up x2, and transported to ED.
Headache, Fever, neck muscle pain, hot flashes, chest tightness Narrative:
Shingles; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program XELSOURCE.   A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on an unspecified date as single dose for covid-19 immunisation and tofacitinib citrate (XELJANZ XR 11mg), via an unspecified route of administration from an unspecified date to an unspecified date at 11 mg unknown frequency for an unspecified indication. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced shingles.Patient had to go off of tofacitinib while getting the Covid Vaccine and later she came down with shingles.The outcome of the event was unknown. Action taken for tofacitinib was post-therapy.No follow-up attempts are possible, information about batch number cannot be obtained.
8X10 warm, red harden area on site of injection which is the right deltoid muscle.
Pt. received ZOSTAVAX on 11-14-12. Niece called 11-16-12 to report/ask about rxn. Woke up at 2 or 3 AM with an itchy, red area at injection site.
Moderna covid-19  vaccine: Swelling and redness at injection site developed after 2 weeks after injection.  size 4'' long x 2' wide by 1/2"
On 5/18/2021 at about 3:00 AM, I began running a fever of 101.1. I took Tylenol, which got rid of it. I then became nauseous and threw up three times. I slept a lot of the time on 5/18/2021. On 5/19/2021, I had a very bad headache, but I was okay by 5/20/2021. On about 5/27/2021, my left arm began hurting very badly from my shoulder to my fingertips. I still have pain in that arm from the shoulder to the fingertips, and it becomes numb very easily. I've tried taking Tylenol for it, but it doesn't help, and no matter what I do, I can't make that arm comfortable. I haven't been seen by a doctor for it, but I have a medical appointment in late October 2021, and I plan to bring up my arm pain to the doctor then.
Vaccine administered at 8:10PM Reported feeling dizzy and a slight tingling sensation in mouth at 8:22PM Vital Signs: BP 115/71 POx 98% HR 72  No issues swallowing, no facial swelling or other symptoms. Gave 50 mg PO Benadryl at 8:30 and continued to monitor.  At 9PM reports symptoms gone. Feeling well and wished to go home, did not want to go to ER for further evaluation. Lives with her family at home who will keep an eye on her tonight. Escorted out to her ride home.
difficulty of breathing; tightness of chest; 4-5 pumps a day for his spray (asthma); This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty of breathing), CHEST DISCOMFORT (tightness of chest) and ASTHMA (4-5 pumps a day for his spray (asthma)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (difficulty of breathing), CHEST DISCOMFORT (tightness of chest) and ASTHMA (4-5 pumps a day for his spray (asthma)). At the time of the report, DYSPNOEA (difficulty of breathing), CHEST DISCOMFORT (tightness of chest) and ASTHMA (4-5 pumps a day for his spray (asthma)) had not resolved.            Concomitant medication included using 1-2 pumps daily for Asthma.  Patient reported that now he takes 4-5 pumps of this spray daily, for the same.
Caller stated that her friend who got the the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller stated that her friend who got the the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.) and NO ADVERSE EVENT (no adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller stated that her friend who got the the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.) and NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller stated that her friend who got the the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller stated that her friend who got the the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported. Dosage text of suspect Spikevax Bivalent was reported as Additional Booster.  Patient stated that she had the bivalent 22-Sep-2022, and wanted to know when she should get the next Moderna bivalent dose. She made an appointment and it was declined, stating that they couldn't do that. Patient stated that her friend who got the vaccine at the same time as she did in September of 2022, received a second Bivalent last week.  No treatment medications was reported.
A report has been received from a Physician concerning a 34 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The medication was given to a pregnant woman. The outcome of the event of given to a pregnant woman is unknown. The reporter's description of the event(s) was as follows: This is a non-adverse event report. FLUMIST was given to a pregnant woman about 2 months ago. She is currently at week 25 of her pregnancy. The reporting doctor is not the doctor who gave the patient FLUMIST. The PI and questionnaire were sent to the reporting doctor and contact information for the doctor who gave the FLUMIST was requested. The report was considered to be non-serious by the company physician.
Red swelling at site of left thigh injection (8/19/22 @ 6:15PM. Went away after a few hours).  Fever (8/19/22 @ 6:15PM. Administered 2.5mL Infant Tylenol. Went away after 12 hours. Awake every hour or so that night. Very fussy).  Eczema (Had not seen any signs of Eczema prior to 8/19/22 vaccines. On 8/24/22, I started noticing patches on both cheeks, all over belly, inside/outside elbows, outside legs/thighs, ankles. Seemed to be itchy. Was cutting cheeks & ankles by scratching a lot. Pediatrician said that it may be why he doesn?t sleep as well now).  (Prior to 9/14/22 Sick visit: Used AVEENO Baby eczema therapy nighttime balm immediately after baths and throughout the day. Tried using Vaseline 100% pure petroleum jelly after baths and throughout the day. Tried using Lanolin Nipple Cream on areas during the day. It did not get worse, but nothing really helped).  (9/27/22 Applied light amounts of IC HYDROCORTISONE 2.5% Cream on cheeks & ankles (bad areas). This helped, but has not cured. The eczema will come back within a day if I don?t apply the cream).  Chronic Diarrhea (Exclusively breastfed. My diet had not changed at all. I tried to cut back on soft cheeses and add more leafy greens, but did not change my son?s diarrhea problem. No vomiting. He has continued to have a good appetite. Eats about 30oz of breast milk over 5-6 feedings in a 24 hour period).  (Prior to 8/19/22 vaccines: Small bowel movements 2-3 times a day. Bright mustard yellow, seedy, sweet smelling. Regularly slept through the night between 8:30/9PM-5:30/6AM).  (8/20/22-Present: Large blowout bowel movements once a day or once every 2-3 days. Dark yellow, bright yellow, or greenish, slimy, mucus, foam, or watery/runny. Smells bad, sour, rotten. Has more smelly gas. Regularly wakes up throughout the night and has to be fed between 2:30-4AM to get back to sleep).
After PENTACEL, Hep B, PREVNAR, Rotavirus given at 6 weeks old child had crying, then lethargy -> extreme for 2 d -> hardly ate then sleepy for 5 more days. Not seen by any doctor. Reported by mom now.
This spontaneous report as received from a nurse refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not reported. On unspecified dates in 2016 (reported as started on or after 09-FEB-2016), the patients were vaccinated with improperly stored doses of VAQTA (lot # l015460, expiry date: 20-JUL-2017; lot # L022259, expiry date: 06-APR-2017). Nurse stated tha the mentioned lot numbers of the vaccine underwent temperature excursion at 22.7 and -1.2 degree Celsius for 10 hours 8 minutes and 37 hours 6 minutes, respectively. She also reported the details of unsupported vaccine administered to unspecified patients: lot # L041676 (expiry date: 15-MAR-2016, lot # L041676 (temperature excursion of -1.2 degree Celsius for 18 hours 34 minutes) on 22-MAR-2016, lot # L041676 (temperature excursion at -1.2 degree Celsius for 23 hours 20 minutes) on 23-MAR-2016, lot # L041676 (temperature excursion at -1.2 degree Celsius for 24 hours 33 minutes) on 24-MAR-2016, lot # L041676 (temperature excursion at -1.2 degree Celsius for 25 hours 40 minutes) on 28-MAR-2016, lot # L015460 (temperature excursion at -1.2 degree Celsius for 26 hours 58 minutes) on 29-MAR-2016. No adverse effect was reported.  This is one of five reports received from the same reporter. Additional information has been requested.
Pt recvd vax & 01JAN90 devel inward deviation of the lt eye & was taken to the ER dx OM; 2JAN90 unable to walk w/o wobbling; PE revealed ataxia, hyporeflexia, complete ophthalmoplegia, fixed, dilated pupils; also sleepy, weakness, GBS;
pt recv vax 30AUG95 & 11APR96 pt devel chickenpox w/approx 20 lesions on body;no further details were provided;