chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hand shaking, chills, rash, nausea, lightheadedness ? reports hard to take a deep breath, given diphenhydramine 50 mg PO x 1 @ 10:15 in clinic and an additional 25 mg PO x 1 @ 10:30 in the clinic.  Symptoms persisted - pt anxious - taken to ED for evaluation.  After 10-15 minutes in ED, her symptoms subsided ? she only had mild tingling in the left hand along with two red spots on the back of her neck.  Given prednisone 50 mg PO x 1 in ED.  observed in ED for 2 hours ? pt feels much better ? pt felt comfortable going home ? told to continue to take Benadryl and prednisone for next 3 days.  Instructions given to return to ED for any worsening of symptoms.  Rx with Prednisone 50 mg daily x 3
Exhausted,  feeling unwell, fever then a herpes or shingles breakout in my nose, mouth, gums, lips,scalp. Lidocaine for mouth rinse Lidocaine ointment lotion Vaseline  Prescribed Valtrex Still suffering symptoms of sores, burning and nerve pain
patient's friend's alerted me that he was feeling dizzy about 2:10pm. I went over to patient just as he was passing out. small muscle jerk was noted. I obtained assistance to place patient on the floor. He regained consciousness before we could put him on the floor. He was out only 5-10 seconds. he was given some water and proceeded to sit for 20 more minutes. Patient was feeling fine. He did state he had fainted receiving flu shot previously. Patient walked home and called to inform us he made it home safely and was feeling fine. He was instructed to hydrate and take it easy for the day. He refused offer to call the squad
pt recvd vax;went to sleep & woke up crying for 10 mins;turned grey & went limp;911 called but pt was ok before amb arrived; to er; Allergic rxn to pertussis;
A non-serious spontaneous report of full dose of FLUMIST in one nostril has been received from a registered nurse concerning a seven year-old male. The patient received FLUMIST on 02-DEC-2008. The reporter stated that the patient received a full dose of FLUMIST in one nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB lot # L014878 with expiry date on 17-JAN-2018, (strength, dose, route and anatomical location were not reported). No product quality complaint was involved and no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Report 2000035560-1 describes Bell's palsy in a 40-year-old female who received an injection of hepatitis B vaccine.  Concurrent conditions were not provided;  however, the vaccine has no known allergies. Concurrent medications were not provided. The vaccinee received an injection of the hepatitis-B vaccine at the place of employment that she developed Bell's palsy on 20 November 200, 24 days post immunization. The vaccinee reported that the diagnosis had been made by her physician. The Bell's palsy persisted as of 11 December 2000.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 11:45 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive; (06Jul2022) Positive; (12Jul2022) Negative; (15Jul2022) Positive; (16Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received my 2nd dose of Moderna Covid-19 vaccine on 5/14/21. 12 hours later I developed a hard lump rash over the injection site. The rash has progressed severely since 5/15/21 (today is 5/18/21). Rash is red, swollen/inflamed, hot to the touch, painful and has spread from the size of a golf ball to almost covering my entire upper right arm in the course of 4 days. It continues to spread and grow each day, although it is not as red.  I've tried Benadryl cream (at the advisement of the pharmacist who administered the vaccine), ice packs, cool compress, Motrin and aloe Vera. The rash has not responded to any treatment listed above.
Difficult swallowing, tightness in my throat for several minutes. I waiting in parking lot before I drove home . I took 1 Benadryl and it helped. The feeling in my throat was similar to my reaction to aspirin but not as severe.  I still feel tired and have some muscle soreness in back but hopefully in a few more days, I will return to normal.  Tired, weak feeling, no appetite, continued for several days Fasted to clear my body of toxins for 2 days. Drank lots of water to flush my body
Not feeling good / General malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. Reporter claimd that she has heard from random friends that have received the Shingrix vaccine and experienced not feeling good and general malaise after receiving the vaccination.   No specific individual comes to mind but just general feedback she received from others. The reporter did not consented to follow up.  No follow-up approved.
Raised bump at injection site / golf ball size; Swollen tongue; Cough; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 28th August 2019, the patient received Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, swollen tongue and cough. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the injection site swelling, swollen tongue and cough were unknown.   It was unknown if the reporter considered the injection site swelling, swollen tongue and cough to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. On the reporting date, the patient informed the pharmacist that after an unspecified time after the injection, she experienced a raised bump on the injection site that turned into golf ball size, which led to extensive swelling of vaccinated limb. The patient also experienced a swollen tongue and cough. The patient went to an emergency department and was given Benadryl and prednisone, monitored for 2 hours, and sent home. The reporter consented to follow up. The emergency room visit required.
High fever (102) beginning 6 hours after vaccination and continuing for 2 days. Also some lethargy. I know it was a result of the vaccine, because the vaccination was given during a well-child check-up. There were no other symptoms.
1/15/21 afternoon-fatigue soreness 3 inches below vaccination red/hot swollen (between shoulder/chest area)
Shortly after receiving the vaccine, my arm began to hurt at the injection site and continues to this day.   It is difficult to lift items with my left arm due to pain.
5 hours after vaccine given became irriatable, diaphoretic, pale. Seen in office and noticed to have decrease HR to 90 and pulse ox to 94% with pale episode. Temp 99.8. Sent to hospital and admitted over night for observation. Dx of hypotonic-hyperresponsive reaction 10/18/07-records received for DOS 10/8/07-Hypotensive, hyporesponsive episode secondary to DPT vaccination. Prior to admission became diaphoretic and turned very white. Observed overnight.
arm hurt a lot; had a fever with chills; had a fever with chills; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary immunization series complete unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurt a lot"; PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "had a fever with chills".  Additional information: Patient stated arm hurt a lot and had a fever with chills after booster.  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.
Woke up at 1AM lightheaded, dizzy & nauseated. Then she passed out. Husband helped her up & she passed out. She went back to bed, woke up at 7am & passed out again.
Pt had swelling to Lt arm. C/o weakness, fatigue, & muscle pains.
Patient was due for Moderna Bi-Valent and was given Moderna Monovalent
This case was reported by a physician via a sales representative and described the occurrence of febrile seizure in a subject of unspecified age and gender who was vaccinated with HIBERIX (GlaxoSmithKline). On an unspecified date the subject received a booster dose of HIBERIX (unknown). At an unspecified time after vaccination with HIBERIX, the subject experienced febrile seizure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
swollen, red, hot, tender arm on third day p/vax;increasing not decreasing twenty five cents size reddened indurated raised area on lt upper arm;
Approx. 2 weeks after vaccine, sore spots on toes appeared. Sores became itchy, swelled, and then turned purple. Purple discoloration never cleared, and new spots with itch and swelling continued to appear for 3 more weeks. Now in 6th week from first dose and toes still purple and splotchy as though they have poor circulation. New spots appearing on heel. Mouth sores/cold sores continued for 5 weeks despite being treated with Valtrex.
Developed and itchy rash on thighs, stomach and upper arms on 1/12/21. Took 24 hour non-drowsy allergy medicine for 5 days and rash is gone.
t105 ax @ 51 hrs post inject; no previous reactins, APAP given @ home, not much relief in fever; seen by MD on 6AUG92 evening; MD felt may also have a virus, given PCN;
Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red large hives all over my body including my face/head; numbness to my hands/feet/chest area; the SOB started; This is a spontaneous report from a contactable nurse, the patient.  A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU9231), via an unspecified route of administration in the left arm on 30Dec2020 at 08:30 as a single dose for COVID-19 immunization.  Medical history included hypothyroidism and chronic low back pain.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), and etodolac (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took miconazole nitrate (MONISTAT) on unknown dates for an unknown indication and experienced drug allergy. On 31Dec2020 at 10:00, the patient started with a red raised rash under her arms and waistline and as the day progressed the rash turned hot to touch with raised red large hives all over her body including her face/head. By 23:00 on 31Dec2020, the patient had already taken 3 doses of diphenhydramine (BENADRYL) which was not effective. Then, later on 31Dec2020, shortness of breath started with numbness in the hands/feet/chest area. Her daughter took her to the emergency room. She was started on intravenous diphenhydramine, dexamethasone, and famotidine (PEPCID). The medications took time to work but they did resolve her shortness of breath and the hives subsided to mild redness.  She was sent home and given the following medications to take: diphenhydramine 50 mg every 4 hours, methylprednisolone (MEDROL DOSE PAK), cetirizine (ZYRTEC) daily, and famotidine (PEPCID) daily. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of the red rash, rash was hot to touch, shortness of breath, and numbness, were reported as recovered with lasting effects; while that of the hives was recovering as they still flared up if she did not take the medications every 4 hours. The reporter assessed all the events as non-serious.; Sender's Comments: The reported shortness of breath together with red rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE together with rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), due to temporal relationship and clinical course.  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.
Swollen and pale arm of injection (and pain in same arm).  flushing on face and neck and hives on neck.  Puffy eyes and face. Feeling like something is stuck in my throat.
Patient stated that she had rash/redness from injection site down to forearm. She also suffered from hypothyroidism
Within hours of vaccine, patient reports dizziness, fatigue, neck and shoulder pain radiating down arm, headache. Symptoms have persisited since immunization 5/10/21.
Have a swollen lymph node under my left arm. Got the shot in this arm. This started yesterday. Other symptoms I got were: very sore arm through Friday, second day nausea, fatigue, aches.
Upon disease investigation of 8/21/21, case reported onset of symptoms on 8/15/21 which included fever, muscle aches, runny nose, new olfactory disorders, headache, fatigue, cough, diarrhea and loss of appetite.
Ectopic pregnancy within 3 months after dose #2 No other history of ectopic (2 prior term deliveries) Only risk factor otherwise is age over 35 Unsure if considered adverse event but as an OB/Gyn MD, would like to contribute to pregnancy and fertility data if it is being collected.  Thank you!
ABOUT 18 MIN AFTER DOSE PT BEGAN HAVING NUMBNESS IN TONGUE AND TIGHTNESS IN THROAT.  FEELING LIKE THROAT WAS CLOSING AND SIMILAR TO FEELING OF SOMETHING STUCK IN THROAT.   VERY SAME FEELING WHEN EATING SHELLFISH.
Narrative: mild flu like symptoms the next day after the 1st dose. Pt had  Covid in November 2020.   Other Relevant Hx:  Symptoms. Myalgia & malaise  Treatment:
Patient reports tenderness and soreness on left arm where she received the vaccine. The patient reported symptoms on 10-22-14 through 10-24-14. She then was fine but noticed symptoms again on 10-31-14. She reports no redness, swelling around injection site. This is her first flu shot.
Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection site; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 Vaccine, lot E"JI"1685 but not clarified), via an unspecified route of administration on 21Dec2020 at single dose, for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included levothyroxine. The patient got her first Covid Vaccine on 21Dec202 and got the minimal pain at the injection site which was no big deal but about 10 days later (31Dec2020), she started getting sick. She was getting sick with Covid type symptoms, so she was off of the work and get swabbed yesterday and waiting her result to come out. She had typical body aches, headaches, cough and nasal congestion everything was along with that. She does not think these were side effects of the vaccination but just "quite" (not clarified) wondering how you she felt. She was so upset. She took Ibuprofen and Alcazar. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain and headache were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully 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.
Case number PHEH2014US013554 is an initial spontaneous report from the nurse received on 02 Jul 2014 with a follow up report received from nurse on 03 Jul 2014. This report refers to a 16 year old female patient. On 02 Jul 2014, she was inadvertently vaccinated with only the liquid component MenCYW-135 of MENVEO (batch number: not reported) without reconstitution with Men A lyophilized component. No adverse event reported following this medication error (inappropriate preparation of medication). Follow up report was received from a nurse on 03 Jul 2014: The gender of the patient was updated.
High fever, pain and swelling in thigh where vaccine was administered, within a couple of hours following vaccine. Fever lasted about 3-4 days, pain and swelling lasted almost 2 weeks. Still has a bruise and pain over 2 weeks later. Behavior changes within a couple of days included severe emotional reactions to anything he didn't like. Continues to scream high pitch screams and tantrums over any dislike to a situation.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M010486, expiry date 25-MAY-2017) 0.65 ml. Excursion temperature was possibly 9F for 288 hours. No adverse effects reported. Additional information has been requested.
Paralyzed right side of face (possible Bells Palsy), predisone, right side of face will not move, eye will not close, unable to smile, condition is unchanged.
Patient presented dizziness,nausea and mild swelling at injection site. Fever of 102.No vomiting.Patient was seen by Dr. Tylenol was administered.
This case was reported by a healthcare professional and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 27 October 2010 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced nonspecific reaction. The healthcare professional reported that the subject was administered FLULAVAL vaccine and experienced a reaction, however the reporter refuse to provide any details regarding the event. At the time of reporting the nonspecific reaction was resolved. The healthcare professional reported another case regarding FLULAVAL, see case A0890085A.
Nothing major; slight redness at injection site and a sore arm for 24 hours; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6195), via an unspecified route of administration on 04Mar2021 12:30 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has not had other vaccine in four weeks. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. The patient experienced nothing major; slight redness at injection site and a sore arm for 24 hours on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Pt had swelling and redness immediately after injection. Pt presented to ED 2 weeks later with dizziness, headaches, and nausea. Pt discharged home with azithromycin, meclizine, and oxymetazoline nasal spray. Meclizine 25 mg TID.
increased (previously existing) neuropathy; continued fatigue; This is a spontaneous report from a contactable other healthcare professional reported that an elderly female patient of an unspecified age (current age: 90, unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Not available), second dose via intramuscular on 13Jan2021 at single dose for COVID-19 immunization in a nursing home/senior living facility. Medical history included ongoing neuropathy, Celiac disease, and allergies to gluten. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. No adverse events occurred with first dose. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. In Jan2021, patient was experiencing continued fatigue and increased (previously existing) neuropathy, two weeks post second dose. However, onset date of the events was reported as 13Jan2021 (pending clarification). No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the possible contribution of suspect vaccine BNT162B2 to the event neuropathy peripheral cannot be 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.