chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache,GI upset, Fever and Chills,general malaise. Neck rash appear on day #2 post injection.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 16-NOV-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R005865 with expiration date in 22-OCT-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Rec'd flu shot right upper arm at 1 pm Saturday. Complained of pain about 5 minutes afterwards. Noticed redness and some swelling with pain Sunday. Went to pediatrician Monday am who advised Benadryl and Motrin. After swelling continued to increase called Pediatrician who called in oral steroid which was started Monday late afternoon. Pain, redness, swelling persisted after 2 doses of steroid and continued use of Benadryl/Motrin and Pediatrician started Amoxicillin.
Developed Bell's Palsy after their first dose of Pfizer/BioNTech vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter asked if a patient developed Bell's Palsy after their first dose of Pfizer/BioNTech vaccine, should they receive their second dose; if there was any evidence that another episode of Bell's Palsy or any other adverse neurological outcome may recur if a patient receives their 2nd dose; if Should this patient receive an alternative mRNA based vaccine for their booster dose. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bells palsy cannot be excluded, considering the plausible temporal relationship. 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.
One month after the second dose of the vaccine I started to get a lot of headaches. It happened two or three times a week. I was also getting joint pain in my elbows, wrists and knees. The headaches were there when I woke up in the morning and I had to take Tylenol to be able to work. They would last all day each time they come. I still get them twice a week and it has been six months. The joint pain comes and goes and it comes on a couple of times a week. The joint pain seems to go with the headaches. It does not seem to have improved or moved further apart.
Patient's left arm is red and swollen. She believes this is from her ZOSTAVAX vaccination on 5/25/17 administered about noon. She went to the walk-in this morning and was prescribed cefadroxil 500 mg bid for 10 days.
Dec 31 Itching began on lower legs/ankle, then on Jan 4 swelling, redness, itchiness at injection site; headache began 3rd and 4th.
Herpes flare; Infammation of groin area; Testicle swollen to orange size; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (Herpes flare), SWELLING (Infammation of groin area) and ORCHITIS (Testicle swollen to orange size) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 40A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Genital herpes. Concomitant products included ACYCLOVIR [ACICLOVIR] for Genital herpes.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GENITAL HERPES (Herpes flare), SWELLING (Infammation of groin area) and ORCHITIS (Testicle swollen to orange size). At the time of the report, GENITAL HERPES (Herpes flare), SWELLING (Infammation of groin area) and ORCHITIS (Testicle swollen to orange size) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Diuretics and Heart medications. No treatment information was provided.   This case was linked to MOD-2021-046431 (Patient Link).
Swelling, erythema and red streaks from right upper deltoid area to right elbow, "hot" to touch. Measurement mid-right upper arm is 8" and mid-left upper arm is 6 3/4". Treated with Augmentin.
Pt was to receive 0.25 ml booster dose Sars-2-COVID, instead received 0.50ml dose. Arm was sore for a couple of days. Fine now.
Shake; Chills; Fever; Arm pain; Heart beating fast.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 12:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. The patient did not have allergies to medications, food, or other products. The patient did not receive any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 13:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 01:00, the patient experienced shake, chill, fever, arm pain and heart beating fast. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shake, chill, fever, arm pain and heart beating fast was recovering at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I had the RSV vaccine at a pharmacy on Sept 9, and I think it was given too high on my right shoulder.   It also bled and bruised afterwards and I took some pictures of this.  Since then I've had right shoulder pain and now a few weeks later the bruise is starting to go away, but I'm still having the shoulder pain.   Today on Sept 30th, I received the new Covid vaccine at a different pharmacy, also on my right shoulder since I read the Covid vaccine may be more effective in the same arm as previous Covid vaccines.  The pharmacist  said she could still see the shoulder bruise from my vaccine of Sept 9th, and it looked like it was high on my shoulder.   The vaccine today was given lower on my right shoulder.  I messaged my primary care today about next steps to evaluate and treat any injury related to the RSV vaccine given on Sept 9th.
Right eye and cheek area swelling; Right eye and cheek area swelling; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Sep2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included crohn's disease, cardiomyopathy, multiple sclerosis, thyroid disorder and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included carvedilol (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN) and spironolactone (SPIRONOLACTON); all from unknown date for unknown indication and unknown if ongoing. On 17Sep2021 at 17:00, the patient experienced right eye and cheek area swelling. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with short course of 40 mg prednisone for 5 days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right eye and cheek area swelling was not resolved at the time of report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Second dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st September 2018, batch number G933B).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, the patient did not return for second dose within dosing window. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist did not have expiration date information. The reporter consented to follow up.
Child developed varicella disease after exposure to shingles. Given Acyclovir 200/5 1 1/4 tsp qid x 5 days.
small itchy rash on lower back approx 2 days after vax; 2nd vax heavy fatigue; arm pain for a week-1/2 and about the 4th week; having difficulty breathing/getting a full breath which has continued to this point; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0164), dose 2 via an unspecified route of administration, in the right arm on 16Apr2021 08:45 (at the age of 57 years old) as 2nd dose, single dose for COVID-19 immunization. The patient medical history included fibromyalgia and the patient was allergic to codeine, levaquin, cipro [ciprofloxacin], sulfa antibiotics, and Shrimp allergy. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, in the left arm on 25Mar2021 08:45 as 1st dose, single dose for COVID-19 immunization. On 11May2021, the patient experienced heavy fatigue, arm pain for a half week and about the 4th week, she had been having difficulty breathing/getting a full breath which was continued to this point. The patient reported that she can get full breath when leaning forward. This comes and goes throughout the day. It was also improved if she walks or workout but returns. The patient went to emergency room on 21May2021, workup came back negative for cardiac, looked good, lungs looked good. The patient reported that she saw pulmonologist -PFT on June 1st. The patient had small itchy rash on lower back approximately 2 days after vaccine and cleared up after a few days. Fatigue had lessened and breathing issues still at same level. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
SENSATION OF TINGLING ON RIGHT KNEE; MILD PAIN BEHIND HER RIGHT KNEE; TIREDNESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have any known drug allergies and no known ongoing conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-JUN-2021, the subject experienced tiredness. On 15-JUN-2021, the subject experienced sensation of tingling on right knee. On 15-JUN-2021, the subject experienced mild pain behind her right knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness on 14-JUN-2021, and had not recovered from sensation of tingling on right knee, and mild pain behind her right knee. This report was non-serious.; Sender's Comments: V0: 20210634511-covid-19 vaccine ad26.cov2.s-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
pain in left arm; redness in left arm; swelling in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm), ERYTHEMA (redness in left arm) and PERIPHERAL SWELLING (swelling in left arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (aspirin ), Drug allergy (ibuprofen ), Drug allergy (hydrocloroquine ), Drug allergy (chloroquine ) and Drug allergy (hydroxychloroquine ). Concomitant products included VITAMIN D [VITAMIN D NOS] and IRON for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in left arm), ERYTHEMA (redness in left arm) and PERIPHERAL SWELLING (swelling in left arm). At the time of the report, PAIN IN EXTREMITY (pain in left arm), ERYTHEMA (redness in left arm) and PERIPHERAL SWELLING (swelling in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient applied ice to alleviate the events.   This case was linked to MOD-2021-313202 (Patient Link).
small sample given in lt arm to test poss allergic react devel 1 1/2 circumfrance-raised 1/4 in reddened-itches, sl temp, nausea;
Developed cough about 5 hours after the vaccine - became dry, hacking cough that lasted several hours, some joint achiness.
DIFFICULTY BREATHING; SWOLLEN ANKLES ON BOTH SIDES (MORE NOTICEABLY AFTER THE VACCINE); LEAKAGE/GOING TO THE BATHROOM CONSISTENTLY; HEADACHE; TIRED; HARDLY SLEPT; DEHYDRATED (THIRSTY/DRY MOUTH); DRY RIGHT DOWN IN THE THROAT; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, kidney infection, headache, swollen ankles, difficulty breathing, and leakage, and concurrent conditions included neuropathy, diabetic, and high blood pressure, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient's all medications were held at the time of vaccination. The patient was previously treated with oxygen for difficulty in breathing; and experienced drug allergy when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with naproxen sodium, chlortalidone, carvedilol, lisinopril, losartan, morphine, prednisone, tiotropium bromide, and rashes when treated with cobalt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headache. On MAY-2021, Laboratory data included: Allergy test (NR: not provided) Not reported. On 09-JUL-2021, the subject experienced dehydrated (thirsty/dry mouth). On 09-JUL-2021, the subject experienced dry right down in the throat. On 09-JUL-2021, the subject experienced hardly slept. On 10-JUL-2021, the subject experienced difficulty breathing. On 10-JUL-2021, the subject experienced swollen ankles on both sides (more noticeably after the vaccine). On 10-JUL-2021, the subject experienced leakage/going to the bathroom consistently. On 10-JUL-2021, the subject experienced headache. On 10-JUL-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dehydrated (thirsty/dry mouth), swollen ankles on both sides (more noticeably after the vaccine), leakage/going to the bathroom consistently, difficulty breathing, hardly slept, headache, tired, and dry right down in the throat. This report was non-serious.
Chief Complaint: AMS   Source of Information: Available medical record   History of Present Illness:  This is a 91y.o. male with hx of HFrEF 25%, COPD, DM T2, dementia, sick sinus syndrome with pacemaker, AAA who presents to hospital with a chief complaint of decreased appetite and generalized fatigue x2 days.  Patient has also been vomiting this morning.  Facility is also noted cold toes and fingers that were blue.  Patient is nonverbal.   Per report from EMS the patient has been slowly declining over the last 2-3 days. The patient has a recent history of COVID-19 infection, unclear what treatment the patient received. The patient was reported to have received two doses of the Moderna vaccine.
About 2 hours after received PPD and TDAP, employee returns to Employee Health Clinic c/o 20 minute hx of feeling nervous, coughing, throat irritations, swollen throat & bumpy tongue. B/P 106/64, HR 68. Tongue is red and bumpy. States had anaphylactic episode at age 18 after admin of ROCEPHIN. States 1 yr ago ate something - unknown - that made her face swell. Within 20 minutes states is less nervous, tongue less bumpy. Went home.
Pt was roughly 13-14wks pregnant. Provider ordered Hep B vaccine for this patient and was given the wrong one. The patient recieved Heplisav-b instead of the boostrix hep-b that was ordered. There has been no known reactions/complications reported by the patient at this time.
ABOUT  5 MINUTES AFTER RECEIVING MODERNA (DURING THE 15 MINUTE OBSERVATION PERIOD), PATIENT REPORTED FEELING "STRANGE". SHE HAD A HARD TIME CONVEYING WHAT SHE WAS FEELING. I ASKED HER IF SHE WAS SHORT OF BREATH, FELT LIKE HER THROAT WAS CLOSING, OR IF SHE WAS GOING TO FAINT. SHE STATED NO, THAT SHE  JUST FELT A LITTLE WEAK. SHE ASKED ME TO RETRIEVE HER A COKE, I DID. SHE STATED SHE FELT BETTER AFTERWARDS. AFTER HER 15 MINUTE OBSERVATION PERIOD WAS UP, SHE STATED SHE WANTED TO WAIT LONGER TO MAKE SURE SHE FELT BETTER AND THAT SHE HAD CALLED HER HUSBAND TO COME PICK HER UP BECAUSE SHE DID NOT WANT TO DRIVE. SHE THEN STATED HE WAS NOT COMING TO PICK HER UP AND THAT SHE WANTED TO CONTINUE TO SIT JUST TO MAKE SURE SHE FELT OK AND THAT THE STRANGE "FEELING" SHE HAD WAS COMING AND GOING.  SHE DECLINED ANYTHING I ASKED HER (TO LAY DOWN, TO GET HER A COLD WASHCLOTH). SHE STATED SHE THOUGHT SHE WAS JUST NERVOUS ABOUT THE VACCINE, AS SHE WAS EXTREMELY NERVOUS TO GET IT. AFTER A FEW MORE MINUTES SHE ASKED FOR US TO CALL AND AMBULANCE. SHE STATED SHE JUST WANTED TO BE CHECKED OUT TO MAKE SURE SHE WAS OK AND THAT SHE DID NOT WANT TO DRIVE UNTIL SHE WAS. SHE STILL SAID HER BREATHING WAS FINE, AND THAT SHE DID NOT FEEL LIKE SHE WAS GOING TO PASS OUT.  SHE DID THEN TELL ME THAT HER HEART FELT LIKE IT WAS BEATING FAST BUT THAT WAS EARLIER ON AND THAT IT HAD STOPPED. EMTS ARRIVED. I CALLED HER THE SAME DAY TO FOLLOW UP  AND SHE WAS HOME AND FELT FINE. SHE HAD BEEN GIVEN ATIVAN IN THE HOSPITAL TO CALM HER DOWN.  SHE STATED THE HOSPITAL SAID THEY DID NOT KNOW IF IT WAS HER NERVES OR A REACTION TO THE VACCINE.
pt recvd vax & 3-4 hrs later, began vomiting through noc; became lethargic; ER visit-given IV meds, hosp x 1 day; dx gaestroenteritis; mild dehydrat;