chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Given SQ instead of IM leading to: hospital visit due to elevated blood pressure, hand numbness, extreme soreness of vaccinated arm.
Occular shingles reactivation; Slight rash; Keratitis; This case was reported by a physician via call center representative and described the occurrence of ophthalmic herpes zoster in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date unknown) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had once before in the past).   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2019, 30 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), rash and keratitis. On an unknown date, the outcome of the ophthalmic herpes zoster, rash and keratitis were recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, rash and keratitis to be related to Shingrix.  Additional details were provided as follows:  The patient received Shingrix in the left deltoid. The reporter did not have expiry date of Shingrix vaccine. A month after vaccination, the patient had re-activation of ocular shingles. The ophthalmologist was the one that felt it was re-activation with a slight rash and the patient experienced keratitis. It had now resolved, but it took quite a few weeks, exact time was not known. The reporter consented to follow up.
patient was 17 years 6 months old and was given Moderna vaccine instead of Pfizer Vaccine
I had inflammation at the injection site, headache, stomach cramping, fever and chills for three days. I was exposed to COVID-19 from my husband when he returned from a business trip. I tested positive for COVID-19 on 09/17/2022. I had a headache, fever, stomach cramps and I was nauseated. I contacted my provider via telehealth and got a prescription PAXLOVID. I tolerated the medication without any complications. As of today, I feel better with not lingering symptoms.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of ROTATEQ (dose, lot # and expiration date were not reported) orally for prophylaxis. The vaccines were reconstituted whit a properly stored sterile diluent (DILUENT MRK) (lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 56 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA015115: US-009507513-1704USA015114: US-009507513-1704USA015112: US-009507513-1704USA010748:
Patient start having high fever 104 per mother on 07/10/2018 and had a seizure at home. Parents took patient to ER.
muscle ache; low grade fever; chills; headache; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 04Mar2021 as dose 2, single for COVID-19 immunisation (Age at vaccination: 33 years). The patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient did not had allergies to medications, food, or other products. It was unknown that the facility where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The day after the vaccine was administered, on 05Mar2021, the patient experienced low grade fever, chills, headache, and muscle ache. The patient did not receive any treatment for the events. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Woke up with symptoms 15 hours after 2nd Pfizer dose.  Fever of 101.2F sustained for approximately 12 hours after onset.  Accompanied by chills, shivering, sweating, pain at injection site, and headache.  1g oral acetaminophen used as treatment every 6 hours from onset (4 doses total).  All symptoms alleviated approximately 24 hours after onset.
Dec 8th 2009 3 hrs after receiving the injectable H1N1 vaccine, pt experienced twitching (muscle movement) on Rt side extending from the outer side of the eye up to the chin- symptoms off and on.
recently diagnosed with pericarditis/ thickening of the heart muscle/ tachycardia/ chest pain on the left side where heart it/ shortness of breath; cholesterol doubled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient 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, Batch/ Lot number not reported), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/ Lot number not reported), for COVID-19 immunization. The following information was reported: PERICARDITIS (hospitalization, medically significant), outcome "unknown", described as "recently diagnosed with pericarditis/ thickening of the heart muscle/ tachycardia/ chest pain on the left side where heart it/ shortness of breath"; BLOOD CHOLESTEROL INCREASED (hospitalization), outcome "unknown", described as "cholesterol doubled". The patient underwent the following laboratory tests and procedures: Blood cholesterol: doubled.  Clinical Course: The patient reported that she was having heart issues after getting the Pfizer COVID-19 vaccine and had no heart issues prior to that. She got two doses and then a booster. Patient was recently diagnosed with Pericarditis, also found with thickening of the heart muscle, tachycardia, cholesterol doubled and experienced chest pain on the left side where the heart is. Patient wanted to know if there have been previous reports of these symptoms. The patient further asked what was Pfizer doing about that and asked if they were going to pay the hospital bills. Also liked to know if Pfizer had information regarding the health status of those patients who developed pericarditis after they got the COVID-19 vaccine.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300224481 same patient, different doses and events;
6 days of heavy headache, chills, 102 fever, nausea, body ache .
On 11/20/99, pt reported w/4cm area, LUA, mild erythema & tenderness. No induration, no significant swelling. Rx: Tylenol & ice to LUA PRN.
Thursday 6/15/06 slept late tired and slightly weak. 5:20 pm temp 100.9, 6:10pm temp 101.1 gave Ibuprofen, 6:60 pm temp 100.8. 8:05 pm temp 100.4, 11:00 pm 99.5.  6/6/10 8:00am temp 97.7 gave Ibuprofen 9:30 am temp 98.4, 8:30pm temp 100.8 gave Ibuprofen, 10:00 pm temp 100.4, 11:30pm temp 99.9.Felt a slight weakness, tiredness generalized achiness when temp elevated, arm sore and red until 6/19/06. No temp 6/17/06.
the morning after the vaccine injection, my lips started to itch & swollen. it's been itching & burning around the lips ever since i took Claritin for 7 days and also tried Benadryl for another week but the condition still not improved.
- Received vaccine #2 on Friday, 26 Feb, 1100, at health center - On Sunday, 28 Feb, around 1100, I noticed the arm where I received the vaccine was starting to swell and turn red across the bottom of the affected area, measuring 2? above the injection site, 5.5? below and 4.75? across - Sunday evening, my arm was obviously swollen with 3 rash-like areas across the bottom of the affected area, was warm and painful to touch and was itchy; no limited range of motion  - I also had a low grade fever starting Sunday evening, which lasted through yesterday afternoon, Mon, 1 March - Today, 2 March, most of the swelling gone and the redness is gone; minimal discomfort
I felt the vaccination spreading through my body as I got really heavy and lost consciousness. I woke up to my husband holding my head and yelling my name. I had been seizing and had bitten my tongue. I was very white and nauseous and cold and shaky. They gave me water and a cold pack. The seizure probably only lasted for 5 seconds but it's hard to say. I felt very fatigued afterwards. I stayed for 10 more min and drank water and then they sent me on my way.
pains around left chest area; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Aug2021 at 14:30 (at the age of 38-year-old) (Batch/Lot Number: FC3184) as dose 1, single for COVID-19 immunization. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior to vaccinations received within 4 weeks. No AE(s) following prior vaccinations. Family Medical History Relevant to AE(s) the only thing that he can say was probably blood pressure for his parents. The patient medical history and concomitant medications were none. Patient was calling to report a side effect from the vaccine he took five days ago. Caller clarified vaccine as COVID19 Vaccine. The side effect he felt was pains around left chest area. He doesn't know if it had anything to do with it. He took the shot in his left arm. He had shot and pain in left chest area. It was intense. He first felt it two days after he took the shot and thought it would pass away. It started to get intense. He went to the pharmacy where he got it and they said it could be side effect and for him to go to the emergency room. The Emergency room ran test and gave him Aspirin and some kind of medication that he doesn't know. The next day he felt more better. The shot was given in his left arm. Aspirin: they gave it in the Emergency Room. It was one tablet. He doesn't have the product to provide strength and lot number. He was not currently taking Aspirin and was not on any current medications. Investigations: they did test in the Emergency Room. No further details provided. Event was resulted in emergency room visit. Therapeutic measures were taken for pains around left chest area. The outcome of the event was resolving.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Developed fever up to 101, along with body aches about 14 hours after receiving 2nd dose shot.  No appetite.  Symptoms resolved within 24 hours of onset.  Made sure to rest and drink fluids.  I did NOT take tylenol based on guidance from the health department.
pt states her face was swollen and then she developed red blisters on her face that started to peel.  These lasted about 2 to 3 days.
pt recv vax 22OCT96 & pt felt like was getting a rxn & lips felt funny;appeared very flushed;pt laid down;VS 147/88-96-18;no SOB;knot @ inj site;
Patient became hot and sweaty immediately and felt dizzy. The patient was given a glucose tablet has he said he had not eaten for the day yet. He felt slightly better and upon arriving home the patient had troubles breathing and explained it as a panic attack without actually having any anxiety. The patient consulted with a physician at a local clinic and was instructed to go to the emergency room. I have not had contact with the patient since arriving at the emergency room.
None. No adverse reactions. Gave immunization to 3yr old (only indicated for 4yr and older).
Redness both arms; tingling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness both arms) and PARAESTHESIA (tingling) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ERYTHEMA (Redness both arms) and PARAESTHESIA (tingling). At the time of the report, ERYTHEMA (Redness both arms) and PARAESTHESIA (tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
A few hours after the shot my right arm felt dead and I was unable to move it.  Had to move it with my left arm. At 9 pm called PCP for advice. Scheduled a telephone visit for next day. 5/11-Dr. told me I was having an adverse reaction and to alternate ice & heat & could take Motrin. If it didn't feel better 48 hrs after vaccine I could go to urgent care. 5/12-Went to urgent care still barely able to move my arm. I thought my injection seemed high as I still had the band aid on, Dr. said placement was fine. Said to continue ice, heat, Motrin & try to move it. 5/13-My range of motion improved but still  experiencing excruciating pain-waking up 3-4 times a night. 5/15-finally able to lift my arm & take a shower, still painful but a lot less than first couple of days. 5/17-First day back at work after a week. Shoulder still painful with certain movements continuing through present 5/24
Swelling of arm; Large red circle at the injection site; Severe pain in left hip/ left wrist.; Also severe pain in left hip and left wrist; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8727) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included losartan (MANUFACTURER UNKNOWN) for blood pressure from an unknown date and unknown if ongoing. The patient previously received doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 05Apr2021, the patient experienced swelling of arm and large red circle at the injection site. The patient also had severe pain in left hip and left wrist. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with unspecified antibiotic . Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling of arm, large red circle at the injection site, also severe pain in left hip and left wrist was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Felt a little weak; Slight dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt a little weak) and DIZZINESS (Slight dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ASTHENIA (Felt a little weak) and DIZZINESS (Slight dizziness). At the time of the report, ASTHENIA (Felt a little weak) and DIZZINESS (Slight dizziness) was resolving.            No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: No new information regarding dose 1, and second dose updated.
HEART INFLAMMATION LEADING TO MILD HEART ATTACK AND PNEUMONIA.  6 DAYS IN HOSPITAL, 3 STENTS IN ARTERIES, 6 WEEKS OF CARDIAC REHAB NEEDED.
Anxiety; chills; headache; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ANXIETY (Anxiety), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). On an unknown date, the patient experienced ANXIETY (Anxiety). At the time of the report, PAIN IN EXTREMITY (sore arm), ANXIETY (Anxiety), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
chills; fatigue; nausea; aches in body; weak muscles; Fever; dizzy; sweating; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via intramuscular route of administration on 13Jan2021 at 08:30 at a single dose on the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took lamotrigine (LAMICTAL) and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 13Jan2021 at 18:00, the patient experienced chills, fatigue, nausea, aches in body, weak muscles, and fever. On the same day, patient was feeling dizzy and sweating. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history and concurrent condition were not reported. On an unknown date the unspecified number of patients received improperly stored PEDVAX HIB (dose, frequency and route were unknown, lot # K008879, expiration date 30-MAR-2017). No concomitant medication was reported. No adverse effects reported. There was no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Started 24 hours after the shot had light severe dizziness, brain frog, muscle pain, head pressure, and lightheadedness.
2nd dose administered from vial that had been in refrigerator for 32 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (2nd dose administered from vial that had been in refrigerator for 32 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (2nd dose administered from vial that had been in refrigerator for 32 days). On 16-Jun-2021, PRODUCT STORAGE ERROR (2nd dose administered from vial that had been in refrigerator for 32 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Herpes zoster diagnosis in a 2-dose varicella vaccine recipient. Diagnosed by Dr. in ED. Painful rash in one dermatome. Rx for antiviral. Had UTI one month before HZ diagnosis.
June 27th: patient reported feeling "slightly light-headed" in the evening. Patient denied any S/S immediately and 15 minutes after vaccination.   June 28th: Patient reported that she started experiencing general malaise, chills, fever (although patient stated "I never actually took my temperature"), night sweats, and dramatic increase in thirst. Patient stated "the weakness was so bad I could barely walk or hold onto a glass of water". Patient also reported frequent glucose cravings.   Patient stated that symptoms lasted several days. she woke up several nights "drenched in sweat" and "could barely get out of bed".   Patient stated that after the 1st week of symptoms, she called her PCP. Patient stated that she spoke to the triage nurse. Patient stated that the triage nurse stated "sounds like you just need to ride this out" and encouraged lots of fluids and rest.  Patient stated that over the course of 3 to 4 weeks, other symptoms she experienced included: join ache, blotchy chest, red blotches on the legs, general aching, malaise, decreased appetite, upper shoulder pains that were not long in duration, and bladder incontinence. Patient denies ever having pain at the injection site but stated the right arm felt "sensitive".   Patient reported that at the end of July symptoms have improved but she is still experiencing back aches, hot spots under the arms, itching, fatigue, weakness, and hand tremors.   Patient stated that she started taking astragalus after symptoms.   Patient called to report adverse event on 8/22/2023. Patient denied ever seeking medical attention with the exception of contacting PCP 1 week following the start of symptoms. Patient stated that she has an appointment to see a medical provider on 8/23/2023.
21Jan91 pt vax w/ MMR; exp soreness at inject site for 2 days. 28Jan91 exp gen malaise and arthralgia. 02Feb91 sx subsided.