chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5:10PM- Pt s/p H1N1#1 about 10 mins, rash on face, chest, back and arms, pt was seen by Dr., Benadryl 2.5ml (12.5mg/5ml) po given  5:50PM- pt was observed for 30mins, rash resolved
Moderna vaccine was administered outside of our facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------------- I26.99 ACUTE PULMONARY EMBOLISM 1/14/2022 ACUTE PULMONARY EMBOLISM
Generalized tonic-clonic. Seizure activity- brief less than 2 mins.
No additional AE reported; Patient was administered expired GARDASIL 9 on 09/06/2022.; This spontaneous report has been received from a pharmacist, concerning to a patient of an unknown age and gender. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dosage, strength, vaccination scheme frequency, anatomical site of application and route of administration were not provided; lot number T007035 that was verified to be valid for syringe formulation with expiration date reported and established as 01-MAY-2022) for prophylaxis (expired product administered).   No additional adverse event (AE) (no adverse event) was reported.
I had a very heavy period on May 17th after my first vaccine. I did my blood test on June 17th. I was diagnosed with Anemia as I lost a lot of blood.
Swelling on the arm; 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 PERIPHERAL SWELLING (Swelling on the arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling on the arm). At the time of the report, PERIPHERAL SWELLING (Swelling on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
within 24 hours spiked fever,chills........48 hours stomach nausea......9 days post of 2nd vaccination started itching from neck down, chest sides, stomach.   Severe  itching  abdomen and sides with no rash.  Had to go seek medical treatment. steroids and antihistime.  Doctor diagnosis as unknown or  allergic response to possible covid moderna vaccine.
After the second dose, I developed Bell's Palsy.  Remedied in two weeks  After the third dose (booster), I developed severe vertigo, dizziness and nausea. Dizziness and nausea are still ongoing
POSITIVE COVID-19 TEST; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced positive covid-19 test. Laboratory data (dates unspecified) included: COVID-19 virus test (not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive covid-19 test was not reported. This report was non-serious. This case, from the same reporter is linked to 20211203852.
rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
Injection site is hot; Injection site is a bit blotchy; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE DISCOLOURATION (Injection site is a bit blotchy) and FEELING ABNORMAL (Felt terrible) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced FEELING ABNORMAL (Felt terrible). On 14-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE DISCOLOURATION (Injection site is a bit blotchy). At the time of the report, VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE DISCOLOURATION (Injection site is a bit blotchy) outcome was unknown and FEELING ABNORMAL (Felt terrible) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.    Reporter did not allow further contact
Our son was babbling constantly beginning at 3 months of age. Immediately after receiving the vaccine at 4 months, he stopped babbling for an entire month. I was panicked, but when he began babbling at 5 months of age again, I felt relieved. I was too sleep deprived, exhausted and uneducated about vaccine safety at the time.
A week after first dose in left arm, a dime sized lump appeared. I first noticed it after a shower around 11PM, and immediately called my doctor.  - I went and got it checked by my doctor who assumed it was a sebaceous cyst. Had it removed and sent to pathology and results showed it to be a reactive lymph node. After having blood tests to make sure I did not have lymphoma, everything came back clear leading my doctor and I to believe it would be related to the vaccine.
Hands, around eyes red and edematous. Scattered rash on back. Was given Kenalog 40mg IM once, Prednisone 20mg 3x day for 4 days. Zyrtec 10 mg 1 tab daily for 30 days.
PATIENT HAS A RAISED RED SPOT AT THE SITE OF INJECTION THAT IS 3 INCHES BY 2 INCHES IN SIZE. THIS WAS MEASURED 2 DAYS AFTER THE VACCINE WAS GIVEN. PATIENT WAS TOLD TO TAKE 50 MG OF BENADRYL EVERY 4-6 HOURS AND MEASURE THE SIZE OF THE SPOT AT HOME. IF THE SPOT HAS GROWN, THE PATIENT WAS INSTRUCTED TO GO TO THE HOSPITAL.
peripheral neuropathy; had a burning sensation in dorsal aspect of her hands and feet; dilation of her veins; This is a spontaneous report from a contactable physician.   A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. As medical history was reported: patient had an iron deficiency, due to anemia she received IV iron infusion maybe 4-6 weeks before the vaccine, pre-diabetes, family history of hypothyroidism in parents and brother. The patient's concomitant medications were not reported. The physician reported that patient was experiencing peripheral neuropathy on an unspecified date. She also had a burning sensation in dorsal aspect of her hands and feet associated with dilation of her veins on an unspecified date. These symptoms were intermittent initially, but now they are more persistent. The physician is curious if this had been reported and what to expect about it in terms of a prognosis. The outcome of the events was unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. The physician confirmed that the patient was the physician's sister. Information on the lot/batch number has been requested.; Sender's Comments: Based on implied chronological connection to the vaccine, causality between event peripheral neuropathy and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. 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.
Dizziness , tired. Waited 15 extra mins - Checked out by EMS-Cleared
Afib-Dr said could be from flu shot and also stress etc. in her life. Episode happened in middle of night 4 day after vaccines.
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female pregnant patient (confirmed as of 14-FEB-2009, last menstrual period 22-SEP-2008) with no known drug allergies or pertinent medical history who on 19-MAR-2009 was vaccinated IM with a dose of GARDASIL by mistake instead of being vaccinated with an influenza shot. Concomitant therapy included prenatal vitamins (unspecified) and FIORICET. No known adverse effect was reported. Estimated delivery date is 29-JUN-2009. A pregnancy urine test was performed. The patient sought unspecified medical attention. Follow up information has been received via telephone call from a nurse practitioner indicating that the female patient had a normal vaginal birth on 11-JUN-2009 at 37 weeks from LMP, and delivery a healthy male who weighed 3115 grams, and had 8/9 Apgar at one and five minutes respectively. On 20-JUL-2009, the patient went back to the office for a postpartum visit, and the nurse practitioner stated that the baby did not appear to have any problems at that time either. It was reported that after that, the mother returned for contraception. Additional information is not expected.
Information has been received from a physician concerning a 11 year old patient with no pertinent medical history, allergies or drugs reactions, who on 27-JAN-1999 was vaccinated with the first dose of VARIVAX (Oka/Merck) and second dose was received on 07-NOV-2001. On 18-SEP-2008 the patient experienced chickenpox on chest and arms. Subsequently, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant medications were not reported. On 04-MAR-2016, the patient was vaccinated with an expired VARIVAX (Merck) injection (dose and route were not reported, lot # K002916 and expiry date 26-FEB-2016) (expired product administered). No adverse effects were reported. No further information was provided. Additional information has been requested.
Headache (3 hours after shot, lasted 3 days) , fever (started 20 hours after shot, lasted 24 hours), rash on arm of injection site (started 30 hours after) , rash on face(immediately following injection, went away within hour), swollen lymph nodes in armpit of arm that received injection (started 40 hours after shot), tinnitus (started 24 hours after shot)
Patient started to feel swelling in throat and neck at approx. 4:00 PM, came back into clinic at about 5:30 PM with some swallowing difficulty and visible edema in throat. Sent to ED for treatment. Treated with oral Benadryl and released. High Dose Flu Vaccine given, Sanofi Pasteur manufacter
8 days after the vaccine, I woke up with my arm hurting. The injection site was red, hot, swollen and it was itchy.
Swollen muscle at site, with redness and hot to touch. Itching also. I treated area w/cooling ointment and took 2, naproxen sodium, 220 mg every 4 hrs.
This case was reported by a healthcare professional and described the occurrence of allergy attack possibly due to latex in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine recombinant for prophylaxis.  The healthcare professional reported that, some subjects experienced an allergy attack possibly due to latex following the receipt of Engerix-B, however, subject identifiers were not provided.   The healthcare professional reported that the subject, had previously been established as being allergic to latex before the vaccine was administered. On an unspecified date on or before 09/26/2005, the subject received a dose of Engerix-B, in the 20 mcg, single-dose prefilled syringe.  The outcome of the allergic reaction was not reported.  The healthcare professional considered the allergic reaction to probably be related to vaccination with Engerix-B.
The next day I was very sick. It felt like someone had beaten me up. I spent most of the day lying down and drinking water. I tried to eat something and slept more. When I awoke, it felt like four huge needles piercing my lungs. I had to use my albuterol inhaler it was so bad. My symptoms are normally completely arrested by the use of Advair and Spiriva. The albuterol caused a dry heaving fit during which I expelled quite a bit of phlegm from my lungs. I felt better and the pain went away after that. Since then I've been suffering higher levels of chest congestion than is normal for me.
After her flu shot patient reports she noticed a bump forming.  She reports she went to urgent care on 12/4 and is being treated for a staph infection at the injection site.
Pt. c/o  moderate anxiety during vaccine.  Around 15 mons after the vaccine , she c/o mild headache and stated  she has history of HTN.  She was hypertensive and her pulse was WNL.  She was rechecked in 15 mins and her BP decreased and HR stable with continued headache.  The patient denied any other symptoms and declined going to the ED.  She left without further  complaints 45 mins after her vaccine.
Individual states felt dizzy and fainted for a quick second and recovered.  Individual states first time to have vasovagal reaction.  No injury resulted from reaction.  Individual treated for shock and monitored closely until felt better.
Approximately 10 minutes after the  immunization, patient became lightheaded and passed-out.  We helped her to the floor and called the paramedics. About 3-5 minutes later, she was conscious but was slightly disoriented. The paramedics arrived approximately 15 minutes later and took vitals. All vitals were within range. She sat in a chair for approximately 15 minutes longer, then walked out of the store with her mom.
Patient states that she woke up the next morning around 10:30, which is late for her, feeling extremely drowsy. Throughout the day she felt drained and almost impaired "drunk" feeling. It was hard for her to process thoughts and carry on conversations. States she did not drink any alcohol or take any medications she doesn't usually take.
No additional adverse events; reconstituted with expired DILUENT MRK; reconstituted with expired DILUENT MRK; This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On 04-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S018593 has been verified to be a valid lot number, expiration date was reported and upon internal validation established as 17-JUN-2021) for prophylaxis, reconstituted with expired sterile diluent(MERCK STERILE DILUENT) (Lot # M009800 and expiry date : 12-SEP-2018) (product preparation error and expired product administered). There was no additional adverse event reported.
pt recvd vax; n, abdo pain, dizziness, urticaria, fatigue, tingling sensation upper body; no tx; recovered in 12 hrs;
Pt with no history of seizure had an episode I suspect as a seizure approximately 8 hours after receiving PREVNAR-13.
Patient reports of pain all over body, fatigue, chills, dry mouth, severe pain in arms and legs, and headaches. Pain started 2 hours after vaccine was administered.
Breakthrough chickenpox rash/lesions. Extreme itching and pain at injection site.
Information has been received from a physician concerning a female who "approximately 7 weeks ago", on approximately 12-MAY-2010 was vaccinated with the first 0.5ml dose of GARDASIL in the deltoid. Subsequently the patient experienced nausea, vomiting and body aches. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
7-28-09 Vaccine admin after approp. screening. 7-29-09 Pt. arm sore. Red & warm to touch. Minimal swelling. 7-30-09 Called HD. Arms swelling. Encouraged to consult fam. dr. 7-31-09 After Dr visit, came to HD. Swelling (R) MMR measures 50mm x 100mm. (L) varicella measures 30mm x 40mm. Dr states use BENADRYL. Script to cont. vaccine admin on schedule.
Information has been received from a medical assistant referring to a 16 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Information has been received from a physician concerning a 76 year old female patient who on 05-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 662969/1206X). On 09-JAN-2009 the patient developed shingles of the right face and scalp. The patient was experiencing significant discomfort in the area of the vesicular lesions. The patient was examined in the office on 09-JAN-2009 and was prescribed VALTREX and PREDNISONE. The patient had been referred to an unspecified ophthalmologist for evaluation. The patient had visited office for medical attention. The patient had not recovered from the adverse effect. The physician felt that the events were disabling. Additional information has been requested.
Itchy; Bumps from rash on injection arm; Rash; Arm felt heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm felt heavy), INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Bumps from rash on injection arm) and INJECTION SITE RASH (Rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm felt heavy). On 31-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Bumps from rash on injection arm) and INJECTION SITE RASH (Rash). On 19-Jan-2021, LIMB DISCOMFORT (Arm felt heavy) had resolved. At the time of the report, INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Bumps from rash on injection arm) and INJECTION SITE RASH (Rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
pt recv vax 23FEB98 & 5 days p/vax devel a mosquito-bite-like rash (hives on the trunk only;
DPT was given instead of DT. No side effects. No fever. No adverse event. Advised to take Tylenol if fever occurred but not needed.
Patient witnessed slumped over in chair and unconscious. at approximately 12:52 PM.  Patient aroused with physical stimulation.  Patient immediately  regains  consciousness. Patient oriented to person, time, place and situation. Patient reveals history of syncope to a prior flu vaccine and Gardasil vaccine. Patient then loses consciousness. Patient aroused with verbal and physical stimulation. Patient regains consciousness immediately.  911 had already been activated at this point. Paramedics  assumed care  at approximately  1:00 PM.  Patient refused transport to hospital. Patient advised to have someone drive her home. Patient monitored until transportation arrived. Prior to leaving facility, patient reassessed at approximately 1:30 PM. Blood pressure was 139/102 mmHg and pulse 90 bpm. Patient left facility at approximately 1:35 PM to roommate. Patient escorted to car by paramedic. Patient left facility alert and oriented to person, time, place, and situation with steady gait and unlabored breathing.
I am physician who took the overnight call from pt's mother.  Pt had been well before 6mos shots but began with 1)fever 104'F  2)"all over body spasms and twitches" per mother over the phone.   I referred pt to local peds ER where they attributed fever/emesis to DTaP administration earlier in the day.  On the ER report it says that Neurol exam was normal.