chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the first covax 2 weeks ago and is still feeling bad; Fatigue; fever; body aches; dry cough; runny nose; diarrhea; vomiting; This is a spontaneous report received from a contactable female consumer (patient) via Pfizer sponsored program . A female patient of unspecified age received BNT162B2 (BNT162B2, formulation: solution for injection, lot no: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date, the patient had received covax 2 weeks ago and was still feeling bad. she had Fatigue, fever, body aches and dry cough with runny nose and diarrhea and vomiting. She was scheduled for the second covax on 06 Apr 2021 and was asking whether to take second dose if she is still feeling this bad. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax; fever & pain at inject site; T of 101.8 R;
Received Influenza (GlaxoSmithKline-AFLLA187AA) 10/27/2008 afternoon.  Couldn't sleep at night.  Woke up dizzy.  Vomited 3-4 times all day. Lasted all 10/28/2008.  10/29/2008 resolved.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: known allergies: Codeine. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Reported fever of:       and rash on neck; resolved spontaneously within 24 hours without treatment.
I broke out with hives on my neck and arms inside the elbow crease.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 13Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), pre-diabetic and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks of vaccination included levothyroxine sodium (LEVOTHYROXIN), ezetimibe (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN) amlodipine (MANUFACTURER UNKNOWN) and unspecified B (as reported); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received levofloxacin (MANUFACTURER UNKNOWN) and experienced possible drug allergy. On 14Mar2021, the patient broke out with hives on neck and arms inside the elbow crease. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with unspecified oral medication. Since the vaccination, the patient had been tested for COVID-19. On 31Jul2021 and on 18Oct2021, the patient underwent COVID-19 test via nasal swab and the results of both the test were found to be negative. The clinical outcome of the event broke out with hives on neck and arms inside the elbow crease was resolved on an unknown date in 2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation.
I started having on August 13, I had sore throat and dry cough. On August 14, I had fever, chills, body aches, runny nose and congestion. The next day I went to a clinic to get tested after taking a home test I was positive for COVID-19. I was given a prescription for PAXLOVID. The medicine helped but it didn't, the symptoms did subside but as soon as the script was completely gone the symptoms came right back. On August 28, I tested again and was negative.
A non-serious, spontaneous report of administration of FLUMIST to a eleven-month-old female infant was received from a health professional. There was no adverse event associated with this medication error; treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post marketing. Commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Patient is complaining of muscle fatigue ever since the immunization.  He lacks energy.  He had itching that is now resolved.  He had headaches that are better.  He has a sore throat.
Given history of anaphylaxis with flu and shingles shot, premedicated w/10 mg Pred x 2 days, Benadryl 100 mg night before, 50 mg 1 hour before injection, Pepcid 40 mg night before, 40 mg 1 hour before injection as well as albuterol 2 puffs prior to walking into site. Received injection, within 2 minutes had moderate itching of right hand progressing to right arm.  That lasted most of the day. Also had some itching of trunk and left arm. Waited required 30 mins without breathing issues, only itching. Notified RN on way out that only had itching. Took more benadryl, Pepcid, and albuterol that evening as well as another 5 mg Pred. Next morning had some chest tightness and difficulty getting deep breath, took benadryl 50 mg, Pepcid 40 mg, Pred 5 mg and albuterol 2 puffs with relief in about 30 mins. Took remainder of usual medications as well.  Had to use albuterol q 4 hours remainder of day. Benadryl 50 mg and Pepcid 40 mg taken again at QHS. Awakened 8/21 again with some difficulty breathing deeply, repeated same regimen as day before. Pred again at 5 mg this day. Again relief within about 30 mins, took albuterol about q 4-6 hours.  Awakened this morning 8/22/21 with swollen tongue that had teeth indentations, tight throat, no difficulty breathing or swallowing.  Immediately took 50 mg benadryl, Pepcid 40 mg, albuterol 2 puffs with swelling starting to decrease within 15 mins, down to able to close teeth without biting tongue in 1.5 hours, and  completely back to normal within 2.5 hours. Vital signs remained stable, did not go to ER since symptoms decreased within 15 mins of taking Benadryl, Pepcid, Albuterol. Pred 5 mg taken in afternoon.  Continuing to take medications to prevent further issues.
muscle aches, fatigue, runny stool, slight cough, abdominal cramps, eye pain
Developed high fever and severe body ache within 18 hours.  Attempted control with 1 gm acetaminophen every four hours.  After thre (3) doses changed to 400 mg ibuprofen every six (6) hours.  Fever subsided in 24 hours. Aches persisted for two (2) sufficient to warrant continued medication.
Within 10 mins of injection, site was swollen and painful. Unable to walk for 30 mins. Leg painful more than other vaccines x 2 days. On 7/15/2003 sudden onset of intense "stabbing" nerve-like pain in face, neck, and head for 45 seconds. One week later, same pain in shoulder area. Multiple episodes of this same pain in shoulder, upper arm, hands, and wrist since this time, sometimes multiple times a day, not experienced everyday.
12 hours after first dose, swelling in right ankle.  12 hours after 2nd dose, swelling got worse, tightness in chest, cough.  medrol dose pack alleviated symptoms, came back 24 hours after last dose.  inflammation came back worse, now in both ankles and feet, toe joints, tightness behind knees, hard to bend knees and toes.  all indication per MD is that this is response to vaccine.
diarrheal x 2 days, fever x 2 days, weak last 3 days;APAP for adult & diarrheal med-bed rest for 3 days
local rxn;swelling, movement of arm limited, feverish @ shot site;pt mom states pt had both flu & pneumovax same day;
rash on the arm of injection; delayed hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash on the arm of injection) and TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE RASH (rash on the arm of injection) and TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity reaction). At the time of the report, INJECTION SITE RASH (rash on the arm of injection) and TYPE IV HYPERSENSITIVITY REACTION (delayed hypersensitivity reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
SkinRash  Pain and tenderness with 3-4 hours of injection. Redness induration  Narrative:
At approx. 5pm I started to have severe dry mouth and my heart rate was elevated.  I decided to check my BP and it was 211/110.  I called my doc and she had me take Benedryl and then waited about an hour.  My BP was still 200/100 so she had me go to the ER.  They gave me some Ativan to help my BP and heart rate and after around 3 hours my BP was down to 155/96.  It has continued to run higher than normal this week.
1 of 3 pts exp a rxn following vax from the same lot;pt exp numbness & swelling in arm & hand (inj site); pt had recvd pneumococcal vax in 1988;unk if pt had any underlying conditions which would warrant re-immunization
ABOUT 1 HR P/ VAX, PT EXP H/A, HIVES, PAIN, SWELLING OF TONGUE & OTHER BODY PARTS, & RAPID HEARTBEAT. TX W/ SOLU-MEDROL & BENADRYL. ALSO ER W/NAUSEA, DIFFUSE PRURITUS, ERYTHEMA, TEMP. D/C'D STILL EXP SXS; READM 12OCT90 W/ DELAYED ALLERG RXN
report by phone from MD office; pt came to office 10AM w/hx of immun given 21JUN93; w/temp about 104 @ time of office visit t012;
This spontaneous prospective pregnancy report as received from a pharmacist refers to herself an approximately 31 year old female patient. None pertinent medical history, drug reactions or allergies were reported. On unknown dates, the patient administered multiple ZOSTAVAX subcutaneous injections to anonymous patients. The patient did not take concomitant medication. The patient became pregnant with LMP of 18-FEB-2014 and EDD of 25-NOV-2014. In May 2014, after administering multiple ZOSTAVAX injection, the patient developed a mild case of shingles. The patient stated that she had not received ZOSTAVAX. The patient was 12 weeks pregnant. Treatment was not given for the adverse events. None lab studies were performed. The patient sought medical attention. The outcome of after administering multiple ZOSTAVAX injections to patients she developed a mild case of shingles was reported as recovering. The pregnancy outcome was pending. Causality was not reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker regarding unspecified patients of unknown age. The patients concurrent conditions, medical history and concomitant medications were not reported. Since 06-MAY-2015, unspecified number of patients were vaccinated with a dose of GARDASIL (Lot # K005083, expiry date 04-NOV-2016; or Lot # K006960, expiry date 19-FEB-2017) which were exposed to a temperature outside of the recommended range. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a 62 year old female consumer with fibromyalgia and "a whole list of drug allergies"who on 02-FEB-2008 was vaccinated in the left arm with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID. On the evening of 02-FEB-2008 the patient experienced really bad pain in her left arm where the vaccine was given. It was very sore and tender around the injection site. There was also redness. It was noted to be worse on 04-FEB-2008. Medical attention was sought. There were no lab studies performed. There was no product quality complaint involved. No further information was provided. No further information is available.
This spontaneous report was received from a nurse and refers to a 4-years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-NOV-2017, the patient was vaccinated with an expired dose of PROQUAD lot# M018638 and expiration date 11-OCT-2017 (dose and route of administration were not reported), reconstituted with sterile diluent. There were no adverse effects reported.
Moderate abdominal pain beginning on Sunday evening.  The pain worsened throughout the day on Monday and became severe.  It was accompanied by nausea and vomiting  and made worse with food and water.   I went to the ER on Tuesday (2/2/21) morning.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: .closed eyes when dissy about 6 to 7min after injection. leaned on wall while sitting then went to floor. does not remember getting to floor.  nurses and pharmacist came to comfort as she came too.  pt was passed out for just a brief couple seconds from when she got to floor.  blood pressure was checked was high. then as she recovered pressure started to return to normal. also used ice pack on neck and head to feel better.** pt has history of passing out from needle.  got ears pierced at age 14.
03/12 flu like symptoms, fever (99.3), headache, vomiting, diarrhea She stated her symptoms are getting better, I recommended she follow up with her doctor just to get a check up to make sure everything is ok
knot in lt leg noted by mom day p/had shot; smaller now but still present w/darker pigmentation
discomfort under the armpit; Swelling in nose; This is a spontaneous report from a contactable consumer (patient). The 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunization, at the age of 68 years old. The patient medical history and concomitant medications were not reported. The patient experienced discomfort under the armpit, swelling in nose on an unspecified date. Reported as: Consumer stated, "I have the vaccine, the COVID, the Pfizer on Thursday about 5 or 5:30 and I experiencing the discomfort under the armpit and I got swelling in nose." The patient took Aspirin as treatment. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever of 99.9 on 5/3, 99.6 on 5/4, and 100 on 5/5. Patient started on IVF, Zosyn & Vancomycin ABT's IC for Pnuemonia, Nebulizer treatment for COPD, VS every 4 hours x 48 hours.
red spots/hives appeared all over body. They are not itchy or painful but are mildly scaly; Inappropriate schedule of vaccine administered to Dose 1:17Apr2021; Dose 2: 05May2021; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 05May2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to cephalosporin antibiotics. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 16May2021, about 10 days after 2nd dose the patient experienced red spots/hives appeared all over body. They are not itchy or painful but were mildly scaly. Patient had no other new illness, medication, vaccine, etc. or any other event (such as contact with an allergen like poison ivy) at that time period.  As of 23May2021 they had not yet healed/gone away. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event hives appeared all over the body was not resolved at the time of report.  No follow-up attempts are possible. No further information is expected.
pt recv vax 25APR97 & 2MAY97 pt devel an inj site rash;
Information has been received from a physician concerning a 15 year old female with a family history of cancer following mononucleosis who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid arm. Concomitant therapy included CONCERTA, ZYRTEC and montelukast sodium (MSD). The physician reported that on 23-JUN-2009, was seen in the physician's office with fatigue, left shoulder pain and a lump in her neck. The patient also had nausea but a good appetite. The physician believed there was lymph involvement. Blood tests were performed, complete blood cell count (CBC), streptococcal and a mononucleosis. The results test were normal. The patient was seen at the physician's office again (date unspecified), and patient's the lump was smaller, hard but still mobile. The patient also had a sore throat, stuffy nose, red eyes and shoulder pain. The shoulder had full range of movement but the patient had such pain with movement that she cried. It was noted that the lump on her neck was still visible. On 07-JUL-2007 the patient visited the physician's office and the physician reported that the shoulder pain, sore throat and fatigue had resolved. It was reported that the enlarged supraclavicular node was still palpable at about 1 cm, but non-tender. Follow up information has been received who reported that the 16 year old female with a rash allergy to amoxicillin, seasonal allergies and no adverse events following prior vaccination a who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid (lot number: 662300/0100Y) in the afternoon. Concomitant therapy included CONCERTA 36 mg, ZYRTEC, montelukast sodium (MSD). The patient was reported as a well child. On 23-JUN-2009, the patient developed left shoulder pain and a lump in left side of her neck (supraclavicular area) with 1 day of duration, tired, sore throat, stomach ache and headache. Physical was negative except for left supraventricular lymph node. On 30-JUN-2009 the patient developed sore throat, left shoulder pain, lump was sore and felt harder. She was tired, had malaise and she could not move her left arm. And left shoulder pops and hurts. She was treated with naproxen. It was reported that on 07-JUL-2009 the lump was smaller in size and did not hurt any more. On 10-AUG-2009 the lymph node was small but still palpable. On unspecified dates the following laboratory tests were performed : two rapid streptococcal, serum antinuclear antibodies test and mononucleosis test and lyme disease test all with negative results. Complete blood cell count (CBC) was within normal limits at 8.6 (14.5/41.8), 247 erythrocyte sedimentation rate (ESR) (41), serum C-reactive protein test (CRP) low and complete metabolic panel (CMP) was within normal limits. Additional information is no expected.
Fever, chills , body aches, SEVERE headache!!!! For 14 days!!!!!!
Pruritic rash that progressed to entire torso, head, extremities and hands that started 3 days after vaccine and worsened. Seen in office 6 days after and provided steroids, antihistamines
Diarrhea  Nauseous  Headache  Fever Chills Joint pain Limited mobility in arm with injection
Case number PHHY2011US116491 is an initial literature report received on 18 Nov 2011. Authors described a case of postpartum leukocytosis and gram positive bacteremia. This case refers to a 33-year-old pregnant female patient. The patient's history included seasonal allergies, occasional migraine headaches, and no sexually transmitted diseases. Her previous pregnancy had ended at an unknown gestational age; the reason was not determined. The patient had no known history of drug allergy. The patient did not smoke, drink alcohol, or use illicit drugs. Her concomitant medications included of prenatal vitamins. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) at 20 weeks of gestation. She was also vaccinated with H1N1 vaccine (manufacturer and batch number: unknown) at 28 weeks of gestation. On an unspecified date she noticed of increased fatigue and dizziness. One week later to this, at 36 weeks of gestation her blood pressure at a routine prenatal examination was 132/80 mm Hg (increased from 108/80 mm Hg 2 weeks earlier); a spot urine sample revealed 2+ proteins. One week later, at 37.1 weeks of gestation, the blood pressure was 140/84 mm Hg, with 1+ pedal edema and urinalysis revealed 4+ proteinuria. The patient was admitted to the hospital for induction of labor because of preeclampsia. Labor was induced with a single dose of misoprostol followed by oxytocin (unknown manufacturer) (see linked case: PHHY2011US116485) and magnesium sulfate. Forty-seven hours after admission, spontaneous vertex vaginal delivery of a healthy boy occurred (weight 2910 g; 1-minute and 5-minute Apgar scores, 8 and 9, respectively). The seriousness and causality of the events were not reported.
Swelling, itching, redness, warm to touch right arm, starting 8 days after injection
have had it and took the two shots/ suspected vaccination failure; have had it and took the two shots; sick that I was in bed for a week; dizzy; headache; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, sickness, dizziness and headache. On an unknown date, the outcome of the vaccination failure, shingles, dizziness and headache were unknown and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, sickness, dizziness and headache to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she took two Shingles shot and had shingles. The 2nd Shingles shot made he/she so sick that was in bed for a week. The patient stated he/she still dizzy and headache. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient developed hoarseness of voice, sore throat, sensation of swelling of his throat and fever. No fever at time of vaccine administration.