chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developing a left facial droop; Bell's palsy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable physician reported that a female patient of an unspecified age received the first dose of bnt162b2 (COVID-19 Vaccine) via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the patient received the COVID-19 vaccine roughly two weeks ago (Dec2020) and is developing a left facial droop, they are concerned if that is a sign of facial Bell's palsy. It's left side and it's a facial droop. The physician was concerned if patient is developing Bell's palsy and they are wondering if she should get the second dose or not. The physician further stated that her patient got the vaccine like about 2 weeks ago and developed Bell's palsy three days after the administration of the vaccine (Dec2020) and of course she won't be able to get to see because we are all booked up until yesterday and that is like about a week ago, after the onset of Bell's palsy. Outcome of the event was unknown.   Information about lot and batch has been requested.; Sender's Comments: The event is considered possibly related to the suspect product based on the assumed positive temporal association. The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular the following relevant information is not available: patient's medical history and concomitant medications, exact vaccination date, event outcome. 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.
I tested positive for COVID-19. I felt like I had a cold. My symptoms include congestion, coughing, headache, fatigue, throat irritation & my throat tickles a lot. I am also dealing with a loss of smell. I have a fever 99 F temperature.
Sore testicles lasting from 9am and still existing at 10pm while I fill this out. Flu like symptoms also starting at 9am and existing still. Headache, chills and soreness.
"Itching" "@ about (1700) 5 clock" and the area "started getting big" - per employee
Fever 101.5. Chills, Heavy Sweating, Debilitating headache and, Covid like symptoms. Weakness.
abnormal menstrual cycle with heavy clotting 10 days early after both doses, heavy reoccurring nosebleed with clots , new loss of smell after second dose
Bp 220/190. Profuse sweating at rest. Short of breath. Severe chest pain. No cardiac history. Taken to ER. Given 70 micrograms Nitro drip. Oxy sat of 84.
pt recvd vax 23JAN96-first 24hrs no problems;no fever;eating nl; then 24JAN96 3PM woke w/crying-off/on crying till 630AM next day-& crying in daytime;last 31hrs slept 5-6hrs usual feeds 36oz, took 18oz;
erythema mult treated by pvt MD w/corticosteroid, antihistamine;pt recv vax & c/o skin rash & seen by MD who told pt had hives;pt has geographic erythematous & purpuric lesions over palms, distal forearms & rt ankle;
Information has been received from a female patient with no drug allergies/reactions and arthritis who on 18-MAR-2009 was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included ARMOUR, LIPITOR and alprazolam. After getting ZOSTAVAX (Merck) on 23-MAR-2009 the patient experienced muscle pain from the knees down on both legs. The patient reported that she had not had muscle pain on the leg up to this point. The patient had soreness inside the knees and on the sides of the knees. It was really bad on 21-MAR-2009. The patient found it difficult to get up from a sitting position. The patient "felt like" she was "crippled". Once she was on her feet, it was manageable. The symptoms had improved but she was still having muscle aches. The patient was seen by an orthopedic and she could not find a cause. The patient also experienced swelling at the injection site for about 2-3 days. At the time of reporting, the patient had not recovered from the adverse events. This is one of several reports from the same source. Additional information has been requested.
FLUBLOK have been administered since the excursion with no reported adverse event; Initial information received  on 14-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 48 years old female patient whom influenza quadrivalent recombinant vaccine [Flublok QIV] have been administered since the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine strength, dose: not reported lot U8058AA expiry date: 31-May-2024 via unknown route in unknown administration site for immunization.  On an unknown date flublok have been administered since the excursion with no reported adverse event (poor quality product administered) on the same day following the administration of Influenza Quadrivalent Recombinant Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event flublok have been administered since the excursion with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No problem with injection. Injection was given high on arm and may have gone into bursa or tendon. Pt complained of sore arm. Slightly better after 5 days.
Weak after Second Shot; Itchy on the Injection Site after Second Shot; Tired after Second Shot; Headache after Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak after Second Shot), VACCINATION SITE PRURITUS (Itchy on the Injection Site after Second Shot), FATIGUE (Tired after Second Shot) and HEADACHE (Headache after Second Shot) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced ASTHENIA (Weak after Second Shot), VACCINATION SITE PRURITUS (Itchy on the Injection Site after Second Shot), FATIGUE (Tired after Second Shot) and HEADACHE (Headache after Second Shot). On 21-Jun-2021, ASTHENIA (Weak after Second Shot) and VACCINATION SITE PRURITUS (Itchy on the Injection Site after Second Shot) had resolved. At the time of the report, FATIGUE (Tired after Second Shot) and HEADACHE (Headache after Second Shot) had not resolved.            Concomitant product details was not reported. No treatment medication reported by the reporter   This case was linked to MOD-2021-231441 (Patient Link).
Moderate to severe headaches lasting several days. Headaches still present as of 4/22, but getting better. No other symptoms.
I had a blood transfusion before the moderna booster vaccination and despite that I had to have another one a few weeks later because my counts dropped. Just like it did with the Jansen version I took last May.
Sore, lump, and minor rash at injection site.  No treatment Body aches, fatigue, abdominal cramps, dry lips, dry mouth and throat, sinus pressure, nasal passage closed on one side and closing on the other, pale white skin on back of throat on the right side, chest tightness while laying face-down,  minor nausea, and very tired but unable to stay asleep all night.  Self treatment with previous prescriptions: Azelastine, Albuterol, ibuprofen, multi vitamin, lots of alternating cool and warm drinks.  Day 2 after the vaccine was the worse for abdominal pains. Had constipation since.  Day 3 was the start of the symptoms that mirror cold or flu like ones.  Current prescriptions seem not to be working. Especially the Azelastine for opening up the nasal passage.
Getting sick from flu shot; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2016-2017 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (dose received on an unknown date, for tolerance refer case US2021AMR072617). Concurrent medical conditions included asthma, renal insufficiency, intestinal obstruction, shellfish allergy, sulfonamide allergy and allergy to antibiotic (Allergic to bactrim). Concomitant products included simvastatin.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2016-2017 season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2016-2017 season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent 2016-2017 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Influenza vaccine Quadrivalent 2016-2017 and experienced sickness. The patient could not get infulenza vaccine because it contains egg content. The patient also took versed which made her quit breathing. The patient was allergic to Bactrim and almost died at the hospital, went to acute renal failure and partial bowel blockage.  The patient now had renal insufficiency that scared her right kidney. The patient had been taking ACE inhibitors and simvastatin which worked well and gave her lungs more protection. The patient could not have any contrast dyes that caused anaphylactic shock and could not take Doxycycline. The patient was asking if the vaccine contains iodine. The patient did not want to be contacted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR072618:Friend's case US-GLAXOSMITHKLINE-US2021AMR072617:Shingrix case
Pt states she received injection in R arm. States it didn't start hurting until 2hrs after. C/o sharp pain top of R arm into shoulder. States it hurts to raise arm.
Janssen COVID-19 Vaccine EUA.  Headache started 30 minutes after receiving shot and lasted 28 hours.  Brain fog started 1 hour after receiving shot and lasted about 5 hours.  Chills and shakes started 6 hours (6:30 pm) after receiving shot and lasted through the evening until about 1 am, then were gone.  Temperature at 7:30 pm, 7 hours after receiving shot, was 99.7.  Temperature at 7:50 pm was 101.  Temperature at 8:30 pm was 101.3.  Took 2 IBUPROFEN at 8 pm.  Still had fever 99.9 at 7 am on 4/9/21.  Took 2 IBUPROFEN at 7 am.  Fever dissipated over the next few hours.
Right arm with area of redness to upper outer area that was warm to touch, non-tender; 3" in length and 1" wide.
abdominal pain; indigestion; 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 ABDOMINAL PAIN (abdominal pain) and DYSPEPSIA (indigestion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced ABDOMINAL PAIN (abdominal pain) and DYSPEPSIA (indigestion). At the time of the report, ABDOMINAL PAIN (abdominal pain) and DYSPEPSIA (indigestion) outcome was unknown.            No other concomitant medical  provided by the reporter. patient want to know Would a second shot cause abdominal pain & indigestion after eating soup & salad?
PT CALLED SHE HAD SOME NASTY SIDE EFFECTS FROM THE VACCINE THE NEXT DAY INCLUDING rash ON OPOSITE ARM - BULLSEYE RASH ON ARM WITH SHOT -- AND THROAT SWELLED UP - AND UNDER THE LIP GOT WORSE -- AND CHEST PAIN -- NO TREATMENT
LOCALIZED REACTION AT INJECTION SITE, RED SWOLLEN VERY SORE ARMS.
1st dose moderna: entire right arm from top to finger tips were swollen, I had rotator cuff surgery years ago for three days it felt like I had had rotator cuff surgery again. 5 day migraine. Within 5 min started itching did not have an ing reaction and they said I could have second shot. Was admitted to the walk in clinic and given a shot of benedryl. To,d to take benedryl as needed. Did for two days.   2nd dose modern: told to premeditate: did with benedryl and Tylenol. Took benedryl and Tylenol from that Friday to Sunday and added ibuprofen after that. On 6th day I can now move my left arm. My lymph nodes are swollen across my chest and on both sides of my neck. The rash on my arm is as large as an adults hand.
Report 2001005254-1 describes elevation of AST and ALT in a 47 year old male who received Hep A vaccine (Havrix) for prophylaxis of Hep A. The vaccinee received Hep B vaccine (Engerix-B) on 02/02/01. On 02/02/01, the vaccinee received his first dose of Havrix. Thirteen days later, on 02/15/01, he was found to have elevated AST (719 U/L) and elevated ALT (1694 U/L). No symptoms were reported. This event is considered SmithKline Beecham medically serious. As of 02/26/01, the outcome of the adverse events is unresolved.
Vaccinated with johnson and johnson in April 2021. Has fever and body ache and sore throat.
Tired and sore arm at injection site on day of shot.  Redness and swelling the day after the shot.  12 days post injection and site is larger (10 cm) diamter and red and itchy.
Headache, Myalgia, CoughWheeze, injection site pain, dehydrated, chills, congestion Narrative: Took OTC tylenol
shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was not reported if the reporter considered the shingles to be related to Shingles vaccine.     It was not reported if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-03-2013 The patient took the shot within a few days, he/she had shingles. He/she was told that he/she could not do anything about it.  The patient felt someone should pay him/her some money.
pt recv vax 21OCT98 & 22OCT98 pt exp fever & vomiting;23OCT98 pt exp facial & arm swelling & redness;24OCT98 facial swelling & fever had decreased however arm was still red & swollen w/3" inches of erythema & swelling;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-MAR-2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. On or about 31-OCT-2014, the patient was treated by the same physician for the onset of rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Only injected the liquid component; Only injected the liquid component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the liquid component of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked should she give the entire vaccine again. The vaccine administration facility was the same as primary reporter. The reporter stated that they could follow up with her though the patient was her colleagues but they were at same practice. No other details available. The reporter consented to follow-up.
Report 20020004361 describes joint pain in a 46 year old female who received Lyme disease vaccine recombinant OspA(LYMErix). Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee had no history of Lyme disease. In June 2000 (exact date not known), the vaccinee received her third injeciton of LYMErix. The vaccinee reported to the physician that she began to experience joint pain in her knees, neck, shoulder, and legs in December 2000, six months post-immunization. The joint pain persisted as of 01/09/2002. The adverse event 'joint pain' does not meet ICM serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
PATIENT RECEIVED 1ML OF THE JANSSEN COVID 19 VACCINE; OVERDOSE; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced subject received 1ml of the janssen covid 19 vaccine. On 08-APR-2021, the subject experienced overdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received 1ml of the janssen covid 19 vaccine and overdose was not reported. This report was non-serious.
Tingling/itching - of ears, nose, vagina Diarrhea/watery stools 7/29-7/31 Headache
Patient presented to the pharmacy with a bruise at the injection site. The patient also had a rash below the injection site. The patient stated the arm was very sore and hot to touch.
No additional adverse event; One dose of Proquad was administered after a temperature excursion; This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender.  The information about patient's concurrent condition, medical and drug history and concomitant medications was unknown.  On 21-NOV-2021, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # U010743 and expiration date: 03-OCT-2022, dose: 0.5 milliliter (route of administration and anatomical location were not provided) as prophylaxis.  On an unspecified date in November 2021, the administered doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)  had a temperature excursion (product storage error) as follows: -14°C to -10°C lasted for 45 minutes and -10°C to 8°C (-9.92°C) lasted for 15 minutes. No previous temperature excursion and no additional adverse event reported.
Still in pain; side effects getting worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Still in pain) and CONDITION AGGRAVATED (side effects getting worse) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia (At the time, MRI studies and nerve conduction studies were done.) in 2017 and Heart attack in 2019. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and METOPROLOL for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PAIN (Still in pain) and CONDITION AGGRAVATED (side effects getting worse). At the time of the report, PAIN (Still in pain) and CONDITION AGGRAVATED (side effects getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-075127 (E2B Linked Report). This case was linked to MOD-2021-031481 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: VAERS; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075127:MOD-2021-075127 (Case for dose1)
Hives like symptoms began with severe itching and swelling beginning on the back of neck and shoulders, then spread to include legs, hands and feet. Did not respond to external creams much, so after two weeks I scheduled an allergist appt. Tried to go off any antihistamines for 2-3 days before the appt, and both times on the third day it became unbearable and pt (myself) took an antihistamine. I tried zyrtec first, it only helped a little. Then tried bernadryl. Benadryl was 6 hour version, name brand. Itching and  swelling became so bad the day I saw the allergist (Premier Allergist member, FNP) that it began to affect my hands and feet, and private parts. Any friction such as washing of hands and wiping myself clean caused immediate swelling and redness, and deep painful itching that did not improve with scratching or creams (benadryl or cortisone). It caused problems with sleep, driving (due to the hands and feet), and sanitation (hard to wash hands or face, shower). Benadryl helped significantly but wore off after about 6-7 hours, so I needed to take it 3 times a day and for bed to avoid active swelling/itching. Allergist prescribed prednisone for 5 days that Wednesday, and it had no effect so I took benadryl again Saturday evening and into the weekend. Met with allergist to followup on 12/14/21 and told her I was unable to get off the anti histamines long enough to do allergy testing. She suggested continuation of the benadryl then allergy testing once the reaction has improved. I did try switching detergents etc to make sure that wasn't the issue, and it seemed to have no effect. Allergist stated she has had several patients with the same response after the Moderna booster, and to report it for the sake of documentation for the manufacturer.
pt seen by MD & had an acute ataxic episode in AM x 90min, lateral loss of control, could not sit up straight or stand up;this lack of control was of a different type than the usual that pt has w/cerebral palsy;dx ataxia episode;