chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blistered, itchy, raised rash to both forearms; Blistered, itchy, raised rash to both forearms; generalized body itching including scalp, face, neck, trunk, extremities; Eyelids moderately swollen; This is a spontaneous report from a contactable other hcp (Patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL3248) via an unspecified route of administration (Age at vaccination 55-year) in left arm on 29Jan2021 at 11:00 AM as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism, calcium citrate kidney stones, Mastcell Activation Disorder/Mastocytosis, Elevated Tryptase level, all from an unknown date and unknown if ongoing; history of allergic reactions to medications, On Montelukast and Levocetirizine allergy medications for Elevated Tryptase level vs. Mastcell Activation Disorder/Mastocytosis, hypothyroidism, calcium citrate kidney stones. Concomitant medications included levothyroxine sodium (SYNTHROID); hydrochlorothiazide; amiloride hcl; potassium; taken in two weeks of COVID-19 vaccination, for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (lot Number: EK9231) administered in left arm on 07Jan2021 at 04:00 PM for COVID-19 immunization. The patient previously took Mobic, Hydrocodone, Codeine, and experienced allergies. Reported facility type vaccine was hospital. The patient received no COVID prior vaccination. The patient not tested COVID post vaccination. The patient received no other vaccine in four weeks. On 02Feb2021 the patient experienced blistered, itchy, raised rash to both forearms; generalized body itching including scalp, face, neck, trunk, extremities; eyelids moderately swollen. AE resulted in doctor or other healthcare professional office/clinic visit. The patient received no treatment for the adverse events. The clinical outcome of the events was resolving.   No follow-up attempts are possible. No further information is expected.
Patient's daughter called MD office to report patient had a seizure at midnight same dates of Flu shot on 09/22/10. Has had falls and weakness, problems with balance and ambulation. Also experienced a stroke afterwards. No prior history of seizures although he has had history of seizures. Taken to hospital.
COVID vax#1 (MODERNA) given on Jan 23, 2021.  COVID vax#2 (MODERNA) given on 2/23/2021.  Started having waxing and waning L axillary adenopathy after 2nd vax.  6/8/2021 Biopsy is consistent with an aggressive lymphoma.
This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number, expiry date, route, site unspecified). On an unknown date 'within the last month" approximately in April 2013, the patient experienced had syncope on both first and second dose of GARDASIL vaccination. The outcome of syncope was unknown. This is one of several patients from the same source. Additional information has been requested.
Severe Headaches Severe joint aches Severe back pain Fatigue  Symptoms lasted 7 days
2 day post vax experienced local tenderness @ site of inject which extended down arm & lasted for 2 wks. Had a pruritic blister-like lesion @ the site of inject. Experienced fatigue, UTI, & fever which cleared p/antibiotics.
Feeling a little tingling; I'm about to get sick, but not bad; This case was reported by a consumer via interactive digital media and described the occurrence of tingling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On 10th May 2022, the patient received Shingles vaccine and COVID-19 VACCINE. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced tingling and malaise. On an unknown date, the outcome of the tingling and malaise were unknown.   It was unknown if the reporter considered the tingling and malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingles vaccine on the day before the date of reporting. The patient had Covid booster dose on same time. In May 2022, less than a week after receiving covid 19 vaccine, the patient felt a little tingling like was about to get sick, but not bad. The patient asked if anyone had any side effects and if so how long did it last. It was unknown if the reporter considered the tingling and malaise to be related to COVID-19 VACCINE.
Patient was given 0.3 ml of vaccine, which is the dosage given to people ages 12 and up. Child has not had any adverse reaction as of the time of this report.  Patient's mother notified that child was given higher dosage. Although it is not expected, she plans to watch for any concerning signs or symptoms beyond normal immune reaction to the vaccine.
About 12 hours after vaccine #2: - Hives on left back, arm, face. Resolved with Benadryl within 4 hours.  - Headache for about 30 hours - body aches for about 30 hours
one dose in january 2021; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2021).   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. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: pt has been complaining of joint pain in multiple areas of the body since receiving her booster. Main complaints include shoulder (right and left shoulder at different times through the last few months), right elbow, left wrist, right knee, hands/fingers.
Presented to ED w/ stroke-like symptoms dx w/sub acute CVA; tested positive for COVID-19 pna; admitted for COVID-19 pna w/ acute hypoxemic resp failure; tx w/abx, remdesivir, steroids, pepcid, zinc; prolonged hospital stay requiring trach and peg; tx to a HCF
Hoarseness - 1 day after. Fatigue, chills, sweating, slight PM cough.  General malaise and slow reaction time.
Patient suffered a seizure (unknown date) and was admitted and discharged.  Presented on 11/17 with complaint of severe headache.  CT revealed a large R intracranial hemorrhage necessitating emergency surgery. Admitted to ICU.  Discharged to SNF on 11/24/21.  Brought by ambulance to ED on 11/25/21 with worsening headache.  Evaluated overnight and returned after Keppra increased.
Day after receiving Hepatitis B vaccine had rash/hives to chin, neck area. No shortness of breath. No treatment.
90 minutes after the shot my tongue started to get numb and swell a bit, then quickly following my throat started swelling and then my hands started to tingle, get hot and go numb.  I called 911.  The squad came and took me to the hospital.  In the squad my BP was 209/110.  I was given Benedryl in the squad and prednisone and pepcid in the ER.
Severe erythema, warmth, tenderness, slightly raised- "like skin was burning off", Fever.  8/27/08 Hospital records received DOS 8/5/09 8/6/09. Assessment: Localized inflammatory reaction/vaccine reaction. Patient presents with area of erythema, pain, and induration at vaccine in the left shoulder. Fever/Chills. Anxious  ICD-9 Codes; 999.9 Compic Med Care NEC/NOS, 999.39 Infection Follow Oth Infusion, Inject, Transfusion, or Vacc, 311 Depressive Disorder NEC, 710.0 Syst Lupus Erythematosis, E948.8 Adv Eff Bact Vac NEC/NOS  9/3/09 Received ER medical records of 8/3/2009. FINAL DX: cellulitis, fever Records reveal patient experienced: fever of 102.1; myalgias; pneumovax injection site redness, warmth & swelling x 1 day.  Tx w/oral antibiotics & d/c to home w/PCP followup.
I took my child into for a Flu Shot but she was administered a COVID Shot Booster which is not FDA approved for her age of pediatric patients.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 22-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-071431, US-MODERNATX, INC.-MOD-2021-071492 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071492: US-MODERNATX, INC.-MOD-2021-071431:Crosslinked case
Rash on neck, back, arms, within 18 hours. Then progressed to torso and thighs within 5 days. 12/04 shows mild rash.
It was determined that the patient's booster dose of Moderna COVID19 vaccine had been given early.  His vaccination dates were 4/30, 6/4, and 11/11.  The patient stated that he may have had some symptoms of increased heart rate (but that he had also been consuming more caffeinated beverages than usual).   Otherwise he felt normal.
Information has been received regarding a 17 year old female who is an eyeglasses wearer and hearing aid user in the right ear, who over the past year experienced amenorrhoea, thought to be secondary to athletic participant. On unspecified dates the patient was vaccinated with the first two doses of GARDASIL (Lot #s not provided). Concomitant therapy included aspirin and unspecified calcium supplements. On 25-DEC-2007 the patient developed a rash in two areas on her sternum. The rash was reported to be less than the size of a quarter and was being treated with an unspecified steroid cream. At the time of the report the rash was reported to be resolving. On 28-DEC-2007 the patient was vaccinated with a third dose of GARDASIL (Lot # not reported). No further information is available. 02/10/2010 Follow up information was received which stated that the patient's original rash under the left axilla resolved on an unspecificed date with the use of an unspecified topical steroid cream. On an unspecified date the patient developed two new additional areas of rash plus itching on her sternum. It was also reported that the patient had "been feeling tired" which continued with the onset of the rash. On 19-FEB-2008 it was reported that the patient appeared pale. The patient was scheduled to be evaluated by a pediatrician on 05-MAR-2008. Additional follow up information was received which stated that the two new areas of rash the patient had developed were improving with the use of the unpsecified topical steriod cream which the patient was applyig ot the areas twice a day over a two week period. It was reported that the patient will follow up her pediatrician in another week and if the rash has not resolved at that time the patient will see a dermatologist. No futher information is available.  02/12/2010 Additional follow up information was received indicating that the patient's rash had resolved. It was reported that the skin is slightly discolored and that the patient also experienced fatigue, malaise and lethargy. Additional information is expected.
PAtient had Omicron booster vaccine on 9/12/2022. Next a.m. he was driving to work- suddenly developed pins and needles in left leg and foot, at first it would come on and off, then gradually spread to another foot and both hands, became more burning, with fluctuating severity but still increasing. He saw neurologist , did EMG, blood workup (comprehensive) , MRI C spine and brain- all tests were negative or normal. Seeing me today.
One of our stores got confused with the storage parameters around the Pfizer vaccine and exceeded the 14 day freezer window.  The Vaccine was placed inside the freezer on 6/5/21 and taken out on 6/25/21 and placed into the refrigerator.   The temperature range for the days the vaccine was in the freezer was -0.9 (warmest) to -5.9 (coldest) with an avg temp of -4.9
Potential Adverse Event because of the infection and the potential relation with the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Potential Adverse Event because of the infection and the potential relation with the Moderna COVID-19 vaccine) in a male 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.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INFECTION (Potential Adverse Event because of the infection and the potential relation with the Moderna COVID-19 vaccine). At the time of the report, INFECTION (Potential Adverse Event because of the infection and the potential relation with the Moderna COVID-19 vaccine) outcome was unknown.
Patient developed headache, nausea, dizziness and clammy skin about 15 minutes after vaccination. She was assessed by the RN; pulse was 85-95 bpm, and O2 saturation was 93% on room air (normal per patient). Patient reported increased headache pain to 8/10 and increased dizziness; she was taken to the emergency department.
PT BECAME  PALE/DIZZY/LIGHTHEADED, COLLAPSED OUT OF CHAIR ONTO FLOOR WITHOUT INJURY. GRABBED HER THROAT AND STATED HER THROAT WAS CLOSING. HER EYES ROLLED BACK IN HER HEAD  THIS OCCURRED AT 12:24PM (9 MINUTES POST INJECTION) A DOSE OF 0.3MG EPINEPHRINE WAS ADMISTERED BY AUTO INJECTION INTO RIGHT THIGH AT 12:24PM.  PT WAS RESPONSIVE AND TALKING SHORTLY AFTER. EMT ARRIVED AND NO OTHER MEDICAL ACTION WAS TAKEN.
Seizure/couldn't have Harbor without having seizures she entered darkened room; had a blood clot on brain; had 2 strokes; This is a spontaneous report from a non-contactable consumer. A female patient (Age 42: Unit Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications were none. The patient had a blood clot on brain and had whole head drilled in her brain and had seizure and dying in hospital. It was declared vaccine injury from Pfizer, Is anything going to make stop these and make more safe before they get in to children. The patient was serious now. She had 2 strokes. She was 42 and an average runner and she had 2 strokes and she was coded blue twice. She couldn't have Harbor without having seizures she entered darkened room. She can't have visitors, television, light or telephone (Duration was not clarify, hence Hospitalization was not checked). She got a clot on her brain because of that and it was declared as Pfizer vaccine injury. The patient was hospitalized, but she was sent home she thought that important to the hospital but she was as of today, she was home and send with Palliative care. Outcome of the events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101335055 different  patient, same drug, different event;US-PFIZER INC-202101335052 different  patient, same drug, different event
Had severe headache and fatigue starting with first shot - 4/2/2021 Now has abnormal neutrophils - 34 - low and lymphocytes - 53 high and immature granulocytes white blood cell count 3.6 K done on 12/6/2021
pt recv vax 15OCT96 & 17OCT96 thumb began hurting;eventually involved lt arm which is where recv flu vax;MD believes nerve may be inflamed;Ibuprofen prescribed;thumb still hurts;
This spontaneous report as received from a pharmacist refers to a male patient who is less than a day. Pertinent medical history and past drug history was unknown. On 02-MAR-2013, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant)(manufacturer unknown) which may be HEPATITIS B VACCINE (RECOMBINANT)(lot number was reported as 0737AE, expiry date was 18-APR-2014 and dose was not reported) that has been out of refrigerator for 2-4 hours. The outcome was unknown and it was unknown if the patient would continued to received hepatitis b vaccine (recombinant)(manufacturer unknown). Additonal information has been requested.
On 11/2 pt had lesion removed on Lt chest & TDAP. Reported some redness in Rt arm where injection given but went away. 11/9 came in for stitch removal - no mention of Rt arm prob. 11/11 c/o rt arm swelling & sore, HA, nausea, aches all over T-98.3 Diagnosed - cellulitis. Pt told nurse - noticed previous evening (11-10-10).
Started vomiting 4 hrs p/HIB; vomited 1 hr p/taking bottle x 3 wks p/HIB; started crying & drawing up legs a/vomiting; p/3 wks, changed formula to similac w/low Fe & pt improved;
Sore arm: chills: fatigue: nasal drainage: cold symptoms: stuffy nose: fever: tested positive for Covid19.
I got first Pfizer dose on March 11th, and on March 31st I was diagnosed with COVID; I was told that I need to wait for 90 days; I was told that I need to wait for 90 days; I got first Pfizer dose on March 11th, and on March 31st I was diagnosed with COVID; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got first dose on 11Mar2021, and on 31Mar2021 the patient was diagnosed with COVID, the patient tested positive with COVID 19 and it had been a month since the patient got tested, and today when the patient sent to schedule appointment the patient was told that he/she need to wait for 90 days, where as his/her other doctor health care provider, family care provider said the patient can just get within 14, after 14 days of quarantine if there is no more symptom showing up. So, the patient was kind of confused which one should the patient believe, should the patient wait for 90 days as per, like when the patient calling to schedule appointment to vaccine center, they said the patient need to wait for 90 days, or should the patient wait for 14 days and then get it, that should cover it in 14 days the patient mean the patient can go to get second dose, the patient was waiting for second shot. The patient didn't have any other symptom or any other side effect except the patient got infected. Outcome of the event was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Left armpit was completely swollen for 4 days. I have been extremely dehydrated since the booster shot. I've had body aches and muscle aches, also very tired and have not wanted to do anything but sleep.
This "event" occurred 9 days after the first injection. The injection site is red, itchy and swollen. It is also painful to the touch.  Certainly not painful enough to require medical attention.
Abnormal reaction to vaccine which included a swollen area that went past injection site. painful red rash which covered most of arm area. Rash did have heat. Patient stated she had a fever for three days after injection. Patient stated her arm was sore and painful to the touch for 7 days after injection.
the patient was inadvertently given PNEUMOVAX instead of PREVNAR13; the patient was inadvertently given PNEUMOVAX instead of PREVNAR13; This spontaneous report was received from an other healthcare professional (HCP) via Pfizer and refers to a 12 months old female patient. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, lot # and expiration date were not provided) instead of her fourth dose of pneumococcal vaccine conj 13V (CRM197) (PREVNAR 13) for prophylaxis (wrong vaccine administered, inappropriate age at vaccine administration).
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Itchy arm near injection site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Tingling/numbness in left arm
EXTREME TENDERNESS IN LEFT ARM. BODY ACHES INTENSE CHILLS ON FIRST NITE 2ND DAY  - TIREDNESS, LOW GRDE FEVER  ALMOST LIKE I HAD COVID AGAIN
Varicella Information has been received from a physician and a school nurse concerning an 10 year old male who on 09-AUG-1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy that day included a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was also noted that the patient was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 17-MAY-2000.  A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesion. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. It was also noted that the patient's brother developed chickenpox after vaccination with varicella virus vaccine live (Oka/Merck) WAES#0510USA08936).  No additional information is expected.
Chest pain that feels like what people might describe an anxiety attack. It can occur with or without a stressful event. It occurs intermittently and sometimes to the degree that the chest hurts for hours afterward. My upper back also hurts at times.
9 days p/vax pt devel fever also assoc w/URi & otitis-had sz on 9th & 10th days evaluated in ER:had LP/CT scan/labs & was given Rocephin Im
After receiving the vaccine I had a headache and a fever of 101. I also had congestion and a cough along with nasal congestion.
Extreme Soreness in arm started approximately 5 hours after injection; Headache started 7 hours after injection; Body Aches and Chills (chattering teeth) started approx 9 hours after injection and persisted for four hours.  Took Tylenol.  Today (October 16) I am still experiencing some soreness in arm and a slight headache.
Constant sneezing-100+/day,  ?runny nose?, achy feeling, low grade temperature, other flu like symptoms.