chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 11-SEP-2018, the patient received a partial dose of Oka-Merck PROQUAD (rHa) lot # R012413 with expiration date of 28-OCT-2019, for prophylaxis; it was reconstituted with MERCK STERILE DILUENT (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). No adverse effect was reported. No additional information was provided.
Severe headache, chills, sweats, body aches, lightheadedness, nausea
Failure to thrive, suck on nipple, inconsolable screaming, crying, diarrhea, yellow skin, enlarged liver, urinary tract infection, metabolic acidosis  2/20/09 Received PCP medical records of 10/28/05-12/1/2005. FINAL DX: UTI, hepatomegaly, direct hyperbilirubinemia, all resolved Records reveal patient experienced hepatomegaly & increased bilirubin of 15 on 10/28/05.  RTC 10/29 & bili 13.6.  RTC 11/6/05 w/feeding difficulties & crying.  Dx w/GERD & formula changed.  RTC 11/15 w/continued poor feeding, poor suck & excessive crying, jaundice.  Dx w/FTT, formula changed again.  WBC increased & referred to hospital.  RTC 11/26 w/irritability & oral intake reduced.  Had been hospitalized for E. coli UTI & skin infection on buttock.  Was on oral antibiotics.  Was to f/u w/ GI & metabolic clinic.
Information has been received from a physician concerning a patient who at 12 months of age, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed shingles at a later time. Additional information has been requested.
This spontaneous report was received from a consumer regarding a 12 year old male patient. The patient's medical history was not reported. On 16-AUG-2016, the patient was vaccinated with PEDVAXHIB (strength, dose, frequency and  batch# were not reported) of lot # L051122 with an expiry date of 12-OCT-2018, intramuscularly for prophylaxis. The other suspect therapy included PREVNAR 13 (strength, dose, frequency and batch # were not reported) of lot # L99270 with an expiry date in March 2017 intramuscularly for prophylaxis. There were no concomitant therapies reported. On 16-AUG-2016, 1 month 18 days after onset of therapy the patient was administered PEDVAXHIB at the age of 12 instead of getting the vaccine administered before being 18 months. The reporter wanted to know if the patient needed to be revaccinated and what would be the next procedure to do. The outcome of the event was unknown. Additional information has been requested.
Rash 6-8 spots.  2-4 mm Erythema 1 with fluid collection. 2-3 unroofed.  (varicella vaccine known reaction).
Feb. 3, 2021 within first 4 hours of receiving injection I began to experience restless legs.  February 6, 2021 I experienced an out of the ordinary nosebleed.  February 21, I found a bruise on my right leg.  February 26, 2021 my PCP did lab work and determine on March 2, 2021 that my platelet count was 73,000.  Repeated lab test on March 3 with results returning March 5 with 33,000 platelets.  Had a nosebleed on March 4, 2021.  Admitted to Hospital March 5 with 30,000 platelets that fell to 29,000 after being admitted.  Throughout February 3-March 5, continued to experienced leg pain that included weakness and tingling in legs.
Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, INJECTION SITE PAIN (Injection site pain) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2020, SARS-CoV-2 test: positive (Positive) Tested Positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-381124 (Patient Link).
Facial paralysis 22 days following 2nd covid vaccination - Bells Palsy diagnosed
Had severe tingling and muscle tightening in left arm; Had severe tingling and muscle tightening in left arm; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. This 51-year-old female patient received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0172) via an unspecified route of administration on 28Apr2021 at 08:45 (at the age of 51-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies, anxiety disorder, gastroesophageal reflux disease (GERD), hysterectomy, and allergy to sulfa drugs. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included omeprazole, estradiol patch, fexofenadine hydrochloride, and duloxetine hydrochloride (CYMBALTA) from unknown dates for unknown indications. The patient previously received bupropion (WELLBUTRIN) and clarithromycin (BIAXIN) from unknown dates for unknown indications and experienced allergy and "shingles" on an unknown date and had a similar experience. The patient previously received dose 1 of BNT162B2 on 07Apr2021 at 09:00 (lot number EW0150) as a single dose in the right arm for COVID-19 immunization. On 30Apr2021 at 00:30 the patient experienced severe tingling and muscle tightening in her left arm which felt like possible heart attack. The event was reported as non-serious. The patient visited the emergency room (ER) as a result of the events and it was confirmed negative for thus but discussed that it felt similar to her "shingles experience" which was also in her left arm. The patient did not receive any treatment for the events. The outcomes of tingling and muscle tightening were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Red, welts/hives all on her sides, hips, lower back, upper arms, and shoulders. NO angioedema or hives on the face. Airway is fine, employee at home recovering. Employee took Benadryl and had Cortisone cream on hand for the hives. Employee health will call employee tomorrow for assessment
Information has been received from a physician concerning his 26 year old daughter  with no known allergies and no pertinent medical history, who on 15-JUL-1996 and 20-AUG-1996 was vaccinated SC with first (lot # "03893") and second (lot # 612222/0241D) doses of varicella virus live vaccine live (Oka/Merck) respectively. There was no concomitant medication. Routine lab work was done by the patient's OB/GYN physician in January 2005 in which it was found that she had no immunity. It was reported that the patient has not gotten the chickenpox since receiving the two doses of varicella virus vaccine live (Oka/Merck). the patient suffered no ill effect. No further information was available. There was no product quality complaint involved. Additional information is not expected.
Tooth pain; soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Tooth pain), PAIN (soreness) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TOOTHACHE (Tooth pain), PAIN (soreness) and FATIGUE (Fatigue). At the time of the report, TOOTHACHE (Tooth pain), PAIN (soreness) and FATIGUE (Fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of tooth pain, soreness and fatigue was not provided. The reporter assessed events of tooth pain, soreness and fatigue as possibly related to Moderna Covid-19 vaccine.  No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623061, MOD-2022-623065.
A TON OF PHLEGM; FELT SO LETHARGIC THAT COULD  BARELY MOVE; RUNNY NOSE; BODY ACHES.; DIARRHEA; HYSTERICAL COUGH TO THE POINT IT HURTS AND HURTS TO TALK; FEVER; This spontaneous report received from a patient concerned a 51 year old female. 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced a ton of phlegm. On 30-MAR-2021, the subject experienced felt so lethargic that could barely move. On 30-MAR-2021, the subject experienced runny nose. On 30-MAR-2021, the subject experienced body aches. On 30-MAR-2021, the subject experienced diarrhea. On 30-MAR-2021, the subject experienced hysterical cough to the point it hurts and hurts to talk. On 30-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a ton of phlegm, felt so lethargic that could barely move, runny nose, fever, body aches., diarrhea, and hysterical cough to the point it hurts and hurts to talk. This report was non-serious.
Started as muscle tiks. Now progressing to full blown spasms and yesterday contractions began throughout body. I cannot get in to see a neurologist for months and I?m terrified it will progress into something more extreme. I cannot work or take my children to school.
After receiving the vaccine, patient felt nauseous. After waiting a while patient patient attempted to walk and had a dizzy spell and had to be lowered to the floor to rest.
Mother reported patient had a reaction to the immunizations. Had a migraine headache and was feeling some throat swelling. Was given a Claritin and this helped with throat swelling. Went to medical provider PA-C. Was given a shot of Toradol for the headache. Took Benadryl later that evening and the next day with relief.
Large swelling at point of injection.  Swelling is hard and approximately size of a softball.  It is painful when pressed.  Started as size of a golf ball and grew significantly over two days.
The pt experienced swelling to injection site. Fever of 101.5 for one day post injection. A rash was experienced for  2-3 days.
Patient came to Hospital ED on 01/31/2021 for chills, temp 99.0, tachycardia (HR 110) and intermittent palpitations following receipt of the Pfizer COVID-19 vaccination earlier that date in a ED encounter. Pt was seen by Doctor. Patient was ordered NS 1500 mL IV, diphenhydramine 25 mg IV, and methylprednisolone 125 mg IV while in ED. Patient improved and was discharged with an outpatient script for prednisone 20 mg tablets (two tablets PO daily for two days).
fever to 103 R evening p/ & day p/inject of DTP; APAP effectively reduces fever;
I was coughing a lot, fever 101, sore throat, tired, congestion, mucus, and drainage. I took Tylenol to get rid of fever. I tested positive for COVID-19 at home. I called my doctor and she prescribed me Paxlovid and I got better. I still have  a cough and my voice isn't how it used to be. My voice is a little horse and I can't scream.
Right arm red,swollen,warm to touch from shoulder to Right elbow. Vet states the pain kept him up all night.  Instructed vet to use warm compresses to arm 15 min QID, take Motrin 400 mg po q6h prn, take Benadryl 50 mg po as soon as he gets home, then Q6H prn. Written and verbal instructions given to vet.  Allergy to Pneumovax charted in CPRS. Instructed vet he can no longer get  Pneumovax injections. Instructed to call Green Team in 1 week if no improvement.  Vet verbalizes understanding of instructions.  Patient did not contact the clinic again regarding this issue.
On day 9 after first dose vaccine, upper left arm began to be painful/itchy similar to first day after vaccine. This progressed to exhibit a growing red blotchy area only in the area of the injection.  This peaked at around day 11, with the area being about  7 in. X  4 in. The symptoms were mild and did not require any pain medication. The visible symptoms at day 15 were mostly gone.
This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales presentative. A patient of an unspecified age and ethnicity received, on 16Oct2014, PREVNAR 13, Lot. H86680, Expiration Date: Oct2015, NDC: 0005-1971-02) single dose, for immunization. Anatomical location of vaccination was left arm. Flu shot was given at the same time but in a separate arm. Relevant medical history was unknown. On an unspecified date, the patient experienced swelling and redness at the injection site and it seemed outside of the normal expected reactions according to the pharmacist. Clinical outcome of the events was unknown at time of this report. Follow-up (29Nov2014): Follow-up attempts completed. No further information expected.
Patient developed an itchy rash on her arms, legs and chest about 20 minutes after receiving the vaccine. She was given 50mg of diphenhydramine IM at that time. She was observed for an additional 30 minutes and the rash resolved during that time. After confirming she did have a driver and would not be home alone, she left the pharmacy. We spoke with her a few hours later and confirmed the rash had not returned and there were no additional symptoms.
3 patients received a dose that was exposed to low temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number AE2J4, expiry date 30th March 2023) for prophylaxis.   On 1st April 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.       Additional Information: GSK Receipt Date: 5th April 2022 Reporter's Comments: The pharmacist reported the patient received a dose of Shingrix that was exposed to low temperature excursion of 31.5 degree F. The reporter did not consent to follow-up. Additional Supportive Information: As the Shingrix was exposed to low temperature excursion, which led to incorrect storage of drug. The case has been linked with the case US2022060314 and US2022060313 reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022060313:same reporter US-GLAXOSMITHKLINE-US2022060314:same reporter
1/27 at approx 11:30 Patient started with chills and muscle cramping during dialysis.  After returning home took 2 -500mg acetaminophen and  approx 2:30pm had more chills, body shakes, muscle/leg cramping, all over muscle aches, headache, weakness, arm numbness and tingling.  Temp taken and was afebrile.  Temp taken at 6pm and afebrile and symptoms of chills,  weakness, headache, muscle aches, tingling in fingers.
@ site of inj-pt exp severe swelling, hard, 4 or 5cm in size, itching & hot;24hr post vax MD suggested no further Td vax in future generally did not feel well-swollen glands;
Area is red and swollen. Patient states was 3 days on bed taking Ibuprofen 800 mg .
Hospitalized 1/6/2022; COVID-19 positive 1/6/2022; fully vaccinated plus booster  BRIEF OVERVIEW: Admission Date: 1/6/2022 Discharge Date: Jan 7, 2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Syncope and collapse  Syncope, unspecified syncope type    HOSPITAL COURSE: This patient was admitted for evaluation of syncope and collapse having had 2 episodes of getting dizzy and lightheaded 1st on 1/04 and again on 1/06.  Patient had been using some codeine cough syrup on the day of admission and had previously experienced some symptoms from narcotics in the past.  She was evaluated in the emergency room and demonstrated orthostatic blood pressure drop.  She is admitted for further evaluation.  In the course of her admission, a COVID-19 study was obtained which was positive.  Over the month prior to admission the patient has had 2 episodes of head congestion and nasal drainage thought to be related to a sinus infection and treated with 2 courses of antibiotics without significant improvement.  At the time of admission the patient continued to have some head congestion, sore throat, but no significant respiratory symptoms.  Her initial orthostatic blood pressure drop was treated with IV fluids with improvement in her blood pressure and resolution of her orthostatics symptoms.  A CT of her sinuses was obtained which showed evidence of mucosal thickening but otherwise was unremarkable.  Because of her age the patient was felt to be at increased risk for possible complications from COVID and was felt to be a candidate for monoclonal antibody therapy.  (patient had previously been immunized for COVID).  This infusion was on the day of discharge.  In light of the CT findings of the sinuses does not felt that additional antibiotic therapy was necessary and the patient was instructed on use of nasal irrigation for treatment of her sinus congestion symptoms.  Patient had a previous multidisciplinary chest mass appointment scheduled for the week following discharge.  This was also discussed with the patient and she will attempt to have this appointment virtually.
HYPOXIA 3/1/2022,  3/8/2022,  3/24/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This is spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient  were not reported. On 12-NOV-2015 at time- 20:17, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L004754 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.6 ad 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Information has been received from a 67 year old female consumer reporting on herself with allergy to codeine and a history of epidural in her spine in January 2012 who on 19-APR-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not provided). Concomitant therapy included aspirin, oxybutynin, atenolol, baclofen, ranitidine and lovastatin (manufacturer unknown). On 19-APR-2012, the patient contracted shingles. The patient was admitted to hospital, she was transported to a different branch of the same hospital on 20-APR-2012. The patient's blood pressure was elevated and she had chest pain. Laboratory test included blood panel performed every 3 to 4 months (results were not provided), she would have the next blood panel in August 2012. At the time of the report, the patient had not recovered from the events. Additional information is not expected.
Daily tachycardia (8-20 times per day), with duration of 1 min - over an hour,  with pulse rate up to 130. Tachycardia lasted through March, April, and May. May 24th was the last episode.
patient here with mother for ppd reading,mother showed Left arm,noticed tenderness,redness and swelling on LD.mother advised to place ice pack and motrin for pain.
Pfizer dose #2 given 14 days after dose #1 (12-30-2021)
Information has been received from a pharmacist referring to a male patient of unknown age. The patient had a medical history of gout. On 25-MAY-2016 the patient was administered a dose of ZOSTAVAX (lot #, dose and route were not provided). On 26-MAY-2016 (reported as "a day later"), the patient experienced a "flare up" of his gout in his foot. It was reported that treatment would require a corticosteroid shot in unspecified foot on an unspecified date. The outcome of the event and causality were not provided. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Lot number: FP7534), in left arm, on 18Apr2021 as dose 2, single (Lot number: ER8751), in left arm and on 23Apr2022 as dose 3 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholestrol" (unspecified if ongoing). Concomitant medication(s) included: LISOPRIL; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 23Apr2023 to 27Apr2023 for COVID-19 treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300178266 same patient, different drug and event;
January 10 2003-  received first anthrax shot in left tricep.  Jan 11, 2003- upper left leg went numb and lasted three days. Jan 13, 2003- leg regained feeling but sharp pains began.  The sharp pains would last from minutes to hours.  every other week the stabbing pains would return.  Roughly in March and April the pains began to come about a week apart.  In June and July the pains would come bi-weekly and began to happen in my left arm.  In Aug-Sept the pains would come 3 to 4 times a week. Also the pains began to grow in strength.  I began to to also experience loss of feeling and a surging sensation through my left limbs.  Oct-Nov - the pains and loss of feeling would occur daily and I began to temporaily lose the ablity to move my left am and leg.  Dec-Jan2003-2004  The pains and loss of feeling began to happen in my right side as well and would occur multiple times a day up till present day.  currently my entire body aches constantly. Follow up 05/25/2004: Patient states he was diagnosed with neuropathy by EMG. He was treated for a time with Neurontin, but discontinued due to lack of effectiveness.
Received the vaccine, and had no reactions until Friday 3/12/21 and had blurred vision with a little bit of dizziness that did not last for very long, about 4-5 minutes.  He then had some other instances of shortness of breath that happened about 3 times.  He has had shortness of breath in the past, but the vaccine seemed to have worsened these and they were more frequent.  He has not had any other reactions since 3/12/21.