chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at the injection site; Injection site with welts; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site pain and injection site wheal. On an unknown date, the outcome of the injection site pain and injection site wheal were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site wheal to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter was nurse at the pediatric office. The reporter stated that multiple pediatric patients had soreness at the injection site with welts which lasted for more than 24 hours.  No additional information was provided. Fax and email details were not available. The reporter consented to follow-up.
Back to back periods; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161), via an unspecified route of administration in the left arm on 14Apr2021 at 15:30(at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN), Crohn's disease and ulcerative colitis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vedolizumab (ENTYVIO), mesalazine (MESALAMINE), amlodipine (AMLODIPINE) and olmesartan (OLMESARTAN) all taken from unknown dates for unknown indications. The patient previously received REMICADE for an unknown indication. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination.  The patient reported that on 16Apr2021, two days after the vaccination she had her period which lasted for four days and it was a normal cycle, then again on 23Apr2021, the patient experienced another period which lasted for four days and it was a normal cycle (irregular periods). The patient reported that the back-to-back periods were completely out of normal. The clinical outcome of the event back-to-back periods (irregular periods) was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Pain in my shoulder; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in my shoulder) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced ARTHRALGIA (Pain in my shoulder). At the time of the report, ARTHRALGIA (Pain in my shoulder) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  Action taken with respect to mRNA-1273 was not applicable.
Tachycardia; Rash; This case was reported by a physician via sales rep and described the occurrence of tachycardia in a child female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included GARDASIL for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and GARDASIL. On an unknown date, 15 min after receiving Bexsero, the patient experienced tachycardia (serious criteria hospitalization) and rash (serious criteria hospitalization). The patient was treated with epinephrine. On an unknown date, the outcome of the tachycardia and rash were unknown.   It was unknown if the reporter considered the tachycardia and rash to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and Gardasil on different arm at same time. After 15 minutes, the patient had rash and was tachycardiac. The patient was brought to hospital. The reporter consented for follow up.
Muscle pain in upper arm started around 2 1/2 hours after injection. Pain got worse over the next 24 hrs then traveled to elbow. Elbow pain lasted around 2 days then traveled to upper part of lower arm. Severe pain in upper part of lower arm has lasted for 10 days so far. Took Ibuprofen on day 8 with no effect.  The pain is like a burning, knife stabbing pain when arm is used or fully extended.
I am experiencing VERY, VERY heavy menstrual bleeding and cramping. My period came 9 days early which is also HIGHLY unusual. My cycle is so regular that you could set your watch by it. I do not experience cramping or this heavy of a blood flow EVER. I am 41 years old, I have had my period since I was 10, so I know my body and my cycle pretty well by now. This is not normal and after consulting  my gynecologist, we feel this is not something that is "wrong" with me, but a side effect from the vaccine.
Patient 4yo by DOB, parent wrote age 5 on registration form. Patient given PFIZER 5-11yo formulation. Called parent to clarify patient DOB x 4 without an answer, left multiple messages requesting return phone call.
I ended up with 2 blood clots in my upper right above my elbow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "I ended up with 2 blood clots in my upper right above my elbow". The event "i ended up with 2 blood clots in my upper right above my elbow" required physician office visit. The patient underwent the following laboratory tests and procedures: Scan: One was where stated above my elbow, notes: and the 2nd had moved up and was stuck under my highest rib on my right side. Clinical course: After taking the first 2 shots, a booster was available and patient had that also. In a short period of time patient ended up with 2 blood clots in upper right above elbow. Knew the symptoms of a possible blood clot and made an appointment with doctor. He immediately sent patient to get a scan to see their exact location. One was where stated above elbow and the 2nd had moved up and was stuck under highest rib on right side. Patient was told the clots were in an unusual area. Within a short.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Needle malfunctioned while administering injection, so pharmacist estimated that appx 0.1ml may have gone into the arm and gave a 2nd shot on the same day -- pharmacist stated she gave "slightly less" than 0.5 ml on the 2nd dose.  After administration, arm was very sore and has sensation of numbness in elbow & hand of same arm.  Called doctor, they said to watch and wait.
woke up about 2:30 am, got up and about fainted (ears ringing, tunnel vision, heavy feeling), off balance, horribly nauseated, body aches and w swollen/painful nodes under my shot arm. In general pain/miserable. Standing made symptoms worse. Vomited, which helped the nausea but other symptoms persisted. Took ibuprofen which helped the aches and eventually got back to sleep but woke up a lot, sweating/hurting. 7:30 am I'm reasonably better by still have body achy, mild nausea, fatigue, swollen/painful armpit nodes, and sweaty. No fever this morning - did not take it overnight.
Pt received his COVID shot about 11:00 am and went to the observation area where a nurse was doing follow up observation.  Nurse informed me of a rash developing at the injection site as well as the right forearm and left temple.  I administered 50mg of Chewable Diphenhydramine and we continued to observe pt. for a further 30 minutes.  His rash improved so we discharged him to his group home.  A follow up call was made this morning, Pt rash continued to improve.
bled quite a bit (trickle of blood); Potentially did not receive full dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bled quite a bit (trickle of blood)) and INCORRECT DOSE ADMINISTERED (Potentially did not receive full dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bled quite a bit (trickle of blood)) and INCORRECT DOSE ADMINISTERED (Potentially did not receive full dose). On 14-Apr-2021, INCORRECT DOSE ADMINISTERED (Potentially did not receive full dose) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (bled quite a bit (trickle of blood)) outcome was unknown.            Concomitant medications were not reported.   Reporter did not allow further contact
My fiance  recently took our son  for his 2 month check up on March 4, 2003. He received three vaccines that day DTP, IPV and Hib. That night he was very fussy, wouldn't take his bottle and cried all night. Patient usually would go back to sleep in the middle of the night after he ate, but this night was different. It was so bad I stayed home from work to be with him. I didn't think nothing of it due to the fact he was colic.      March 7th I took him to his Doctor because he had conjunctivitis and they gave him a routine check up. The next two nights he wouldn't sleep much and a little fussy, but not as bad as when he first got the vaccines. Saturday night March 8th I put my baby down to sleep around 12:45am. Patient woke up around 6 am. His daddy tried to feed him but he wouldn't take his bottle all he did was cry. Finally patient fell asleep from exhaustion.      Around 9:30am I woke up and checked on my baby and he was all blue, he died in his sleep. He was rushed to the hospital in the matter of minutes. They worked on him for about a half hour and there was nothing they could do. My angel was gone.       The Doctors said they believed it was a case of SIDS. His tissues are still under investigation for the next 6 weeks. I really believe his death had something to do with the vaccines.    He was born December 25, 2002 and rec'd the hepatitis vaccine, and agian on Jan.29,2003. I had a healty normal full term pregnancy. The only problem was that I had to get an emergency c-section due to patients heart rate was dropping.   I was never informed of all the risks from vaccines. Please help me.       --------------------------------------------------------------------------------
No history of hypertension . After receiving 1st vaccine experienced high blood pressure 159/110.  Blood pressure has remained elevated .  continued to monitor blood pressure at home with elevation.  Seen in urgent care after 2nd vaccine blood pressure 151/109.   Started on blood pressure medication.
I did not have an adverse reaction to the vaccine. In 03/2023, my thyroid levels are out of balance. The T4 went really high and T3 went down. In the last few days, my allergies have gotten worse. I went to my doctor and got a prednisone shot. I was also tested for COVID-19, and it was negative.
Within 5 minutes of receiving immunizations (DTaP/IPV/HIB/PREVNAR); started crying/irritable, fell asleep x 1/2 hour.  20 minutes later had pink papular rash over body.  Hurts on right leg.  Temperature 99 F.  NOTE:  These 3 cases were called to state epidemiologist who seemed disinterested that we had 3 adverse reactions in 1 week in our practice.
Hypertension - 234/145 - Had vaccine 11-19-09 went to ER at local hospital with high blood pressure. I am now on medication, and have been since, before injection my blood pressure was normal.
Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The day after receiving the vaccine, mom reports patient had a fever and then a seizure Spoke with physician who had seen the child at a well check up the day before states patient had a febrile seizure no adverse affects.
The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022; HCP reported dose of Moderna vaccine administered beyond 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP reported dose of Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP reported dose of Moderna vaccine administered beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP reported dose of Moderna vaccine administered beyond 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2022 and the doses were administered on 01-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The occupation of the reporter was reported as clinic manager.  No concomitant medications were reported.  The healthcare professional (HCP) stated the total number of doses was actually 8 doses.  On 31-May-2022 4 PM, the vial went from freezer to refrigerator.  The vial was administered on 01-Jul-2022 between 9 AM and 12 noon. It was reported that, the days were miscalculated. The vial did not undergo any temperature excursions.  No treatment medications were reported.
About the site and some burning and pressed the area to find the injection site/ typical symptoms of pain that developed hours later; Tiredness; Feeling lousy; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A 74-year-old male patient received unknown dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. It was reported that per caller the pharmacist who injected him with Pfizer covid 19 vaccines went what he thought was fairly low with a 1-inch needle. He had amazing pain reaction when she pushed the plunger. He experienced the typical symptoms of pain that developed hours later, tiredness and feeling lousy. The next day he was concerned about the site, some burning and pressed the area to find the injection site about 1-2 days later. Caller voiced that he hoped he didn't cause any damage with the vaccine by pressing the site. He asked how long it takes the Pfizer covid 19 vaccines to disperse from the deltoid muscle. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had the same reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (had the same reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (had the same reaction). At the time of the report, SKIN REACTION (had the same reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
My son developed acute swelling and erythema in his penis and partially circumcised foreskin on 12/17/21. He complained of pain. We took him to the ER and he was diagnosed with  Balanitis on 12/18/21. He was prescribed topical steroids and anti-fungal cream.
Narrative: 34 y/o F received 2nd dose of Moderna COVID-19 Vaccine on 4/29/21 and developed upper lip swelling 15-20 min after. Patient was observed for 30min and provided with 1 dose of diphenhydramine 25mg. As of 4/30/21 airways intact, no lower lip symptoms, and upper lip still swollen, but coming down.
This spontaneous report was received from a male consumer referring to his wife of unknown age. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # and expiry date not reported). One month later the patient became pregnant. The last menstrual period (LMP) and estimate due date (EDD) was not known. The pregnancy outcome was pending. The reporter asked if it got any effect for the baby. Additional information is not expected.
Headache, Myalgia, NauseaVomiting, chills, cognitive slowing Narrative: onset of flu like s/s with cognitive slowing about 12 hours after injection
This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's concomitant therapies, pertinent medical history, drug reactions and allergies were not reported. On 14-NOV-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # N028258 with an expiration date 30-MAY-2019), orally for prophylaxis (dose was not reported). Administered dose of ROTATEQ, was stored in the temperature of 47.8 degrees Fahrenheit for 23 hours and 8 minutes. Previous excursions were not reported. Temperature excursion was detected by digital data logger. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1812USA003003: US-009507513-1811USA009031:
No adverse effects reported; expired dose of PROQUAD was inadvertently administered; Information has been received from a medical assistant referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (STERILE DILUENT) (lot number R032352 and expiration date was on 04-JUN-2021). The patient's pertinent medical history, drug reactions/allergies and current condition were not provided.    On 21-MAR-2019 the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: recombinant human albumin(rHA); lot # N025927 and expiration date was on 18-MAR-2019) subcutaneously for prophylaxis (expired product administered). No adverse effects were reported.
Within 15 mins of vaccine administration mother noticed rash on chest & back. Injection sites ck'd redness & warmth noted bil - mottled rash. BENADRYL 25/5ml 2.5ml PO given. Rash resolved dc'd home with inst to give BENADRYL q6 & ZYRTEC 2.5ml for next 3 days. To go to ER if reoccurs.
arm was "hot"; very itchy; rash at the injection site; red sport at site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (arm was "hot"), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red sport at site of injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Status is controlled.) since 1985, Breast cancer (Status is controlled.) since 2015, Breast cancer (Status is controlled.) in 2017 and Bypass surgery (Status is controlled.) in 2017. Concurrent medical conditions included Diabetes (Status is controlled.) since 2002, Penicillin allergy, Drug allergy (Codeine allergy), Food allergy (Citrus allergy) and Drug allergy (Sulfa allergy). Concomitant products included CLOPIDOGREL for Anticoagulant therapy, EXEMESTANE for Cancer, DULAGLUTIDE (TRULICITY) for Diabetes, LOSARTAN, CLONIDINE and METOPROLOL for Heart disease, unspecified, DEXLANSOPRAZOLE (DEXILANT) for Reflux gastritis, LEVOTHYROXINE for Thyroid disorder, METHENAMINE for UTI.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm was "hot"), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red sport at site of injection). At the time of the report, VACCINATION SITE WARMTH (arm was "hot"), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE ERYTHEMA (red sport at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient started to get a rash at the injection site. The rash was larger and very itchy. Cannot reach any of the doctors. Otherwise patient feels ok. Patient does not feel sick or have a fever. Due for second injection 02 Feb 2021 and does not know what to do. Treatment included antihistamine and cortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: New events added, Patient demographics added, Concomitant medications added