chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each; diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each; This is a spontaneous report received from contactable reporter(s) (Physician).  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Information: The reporter reported that his neighbors were diagnosed with Covid-19 after receiving a total of 4 Pfizer vaccines each. The date of vaccination was not known. It was also reported that the treatment prescribed was Paxlovid to them.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200722911 same reporter/drug/event, different patient
Patient received TDAP & flu on 01/19/12. It ached somewhat but last week, 01/26/12, it started aching more. When she would lift with the arm (L) she would have "pain all the way to the palm of her hand." She's using pain med (ASA 325 mg) at HS but nothing during the day. It doesn't hurt while working but only hurts when she relaxes.
Facial swelling and Rash on neck and chest. MMR given in MD office under direct care of MD due to her Topical Neosporin allergies.
Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 12-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on an unknown date; no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA007655: US-009507513-2108USA007711: US-009507513-2109USA006020: US-009507513-2109USA006021: US-009507513-2109USA006022: US-009507513-2109USA006023:
PT WAS VERY NERVOUS,  DIAPHORETIC, PALE, PARAMEDICS ON SITE, BP 99/64, HR 63, SX RESOLVED, REFUSED TRANSPORT, AMA SIGNED.
Temp 103.5, rigors, chills, headache, nausea, extreme joint pain and body aches. Alternated Advil and Tylenol and all night and day and temp only came down to 102.1. Still experiencing 103.4 temp at this time and all other above symptoms as well.
CHILLS AT NIGHT; FEVER OF 101.6 DEGREES FAHRENHEIT; TIRED; BODY ACHES; SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced sore arm. On 21-MAR-2021, the subject experienced body aches. On 21-MAR-2021, the subject experienced tired. On an unspecified date, the subject experienced chills at night, and fever of 101.6 degrees fahrenheit. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, chills at night, fever of 101.6 degrees fahrenheit, body aches and tired was not reported. This report was non-serious.
12-13 hours after injection: muscle aches, headache, extreme fatigue, chills & upset stomach. 30 hours after injection: muscle aches, headache, extreme fatigue, chills, upset stomach & fever of 101. Symptoms are subsiding 40 hours after injection.
A 5 year old well child received routine IPV and DTAP on right upper arm on 9/6/01. On 9/7/01 evening, mother noted hot violaceous, edematous reaction from right shoulder to elbow. Pt had no fever. He received Augmentin for probable cellulitis with improvement.
MY PERIOD GOT COMPLETELY MESSED UP.  BRAIN FOG. SWOLLEN LYMPH NODES . NAUSEA, HEADACHES
The evening of the 17th I had a running nose, I had lower back pain and pain in my knee joints and a sore throat. I also got a headache. Sore throat became intense, I went to Urgent care center, I got tested for covid. I started coughing and was getting restless sleep. Urgent care gave me steroid for 10 days and an albuterol inhaler. I still had a horrible cough that was keeping me up, I did a follow up tele health and they give me a Zpack and come medicine cough. The cough continued to linger. I do notice my heart rate is elevated still and I'm easily fatigued.
Left leg swollen, hot to tough, difficult for child to waok on it. Lasted about a day. Treatment was Benadryl and ice packs.
I got break through COVID-19. It seems like the vaccination is wearing off, I did have cough, ache, and congestion. I got the vaccination back in April and 6 months later I got COVID-19.
Pt developed pain, then redness and induration at site. Area was 2 cm diameter. No SOB, wheals, urticaria or systemic symptoms. Symptoms resolved completely by 5/10/16 exam.
Left Deltoid erythema swollen and warm 5cm x 5cm; Right deltoid erythema swollen and warm 4cm x 2.5 cm.
A 2 year old male patient had received on 23 October 2006 Fluzone (lot number U2204AA), intramuscular, into the left deltoid (dose not provided). Within 24 hours, on 24 October 2006, the patient developed swollen and reddened area of the entire upper arm. The patient was seen by a physician on 24 October 2006 and treated with oral paracetamol (Tylenol) and Diphenhydramine hydrochloride (Benadryl). At the time of this report (26 October 2006) the patient had not recovered. The patient did not received any concomitant medications. The patient experienced fever, swollen face, hands and feet post vaccination with MMR and Varicella vaccines. Denies any illness at the time of vaccination. Denies concomitant medications. Possible allergy neomycin, denies other allergies. The patient had received Fluzone vaccine last year (2005). Follow-up information received on 12 December 2006. The Fluzone vaccine administered on 23 October 2006 was a 0.5 mL dose, and it was the third dose the patient had received. The patient had not received any other vaccinations within four weeks of that vaccination. Per the reporter the patient fully recovered from these adverse events. The patient experienced rash, not fever as previously reported with MMR and Varicella vaccines. No further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I was with the covid virus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "very sick"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "fatigued"; PAIN (non-serious), outcome "unknown", described as "aches and pains"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "couldn't put one foot in front of the other"; BEDRIDDEN (non-serious), outcome "unknown", described as "I was in bed for two days". Additional information: This AE was reported by caller's friend, earlier today and he left her phone number for a callback. Caller states that she got the Pfizer covid shot on 26Feb and for 5 days, she was very sick with chills, fatigued, couldn't put one foot in front of the other and had aches and pains out of this world. she was sicker after the shot than when she was with the covid virus. she was in bed for two days, and concerned about the 2nd shot. she didn't have any immediate reactions, at first and thought this isn't bad and tough. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
63 year old vaccinated male was admitted for severe fluid overload and renal failure. He required high dose IV diuresis and paracentesis. He also tested (+) for Covid-19 infection and received Remdesivir therapy. He was admitted with Shingles in the LLE and given Acyclovir. Paracentesis removed 10400 cc. Renal function improved dramatically afterwards. D dimer was severely elevated. VQ scan showed intermediate possibility. He was discharged on Xarelto. Cr today is 1.5. He will be discharged back on higher dose of oral Lasix.
Chills, fever, muscle/body ache, headache, pain at injection point.   Took Ibuprofen
10/06/2010 Afternoon received PNEUMOVAX. 10/08/2010 AM fever 101, erythema, mild induration, myalgia and limping of Rt lower ext. Fever decreased with IBUPROFEN. Decreased appetite, decreased oral intake decreased UOP. Rec. TYLENOL, IBUPROFEN, cool packs push fluids.
Stabbing pain in muscle 4 days post flu vaccination. Unsure of exact time.
Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06Apr2022; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06Apr2022) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known allergies.  The patient's past medical history included Torticollis. Concomitant products included ESZOPICLONE (LUNESTA), VILAZODONE HYDROCHLORIDE (VIIBRYD), PREGABALIN (LYRICA), ALBUTEROL SULFATE, CETIRIZINE HCL, NAPROXEN and CYCLOBENZAPRINE for an unknown indication.    On 06-Apr-2022 at 2:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not undergo any temperature excursions. The patient had not experienced any side effects yet. Treatment medications were not reported
This spontaneous report was received from a consumer, referring to several  "an influx of boys" of unknown ages. The patients had not historical conditions, concurrent conditions and concomitant medications reported. On an unspecified date, once the vaccine was approved for males, the patients received the vaccination series with GARDASIL for prophylaxis (dosage, route of administration anatomical location, lot number and expiration date were not reported). On an unknown date, the patients were diagnosed with Complex Regional Pain Syndrome after vaccination and were treated in a rehabilitation facility. At the time of this report, the outcome of Complex Regional Pain Syndrome was ongoing. The reporter did not provide the causality assessment for the events. The reporter considered the event of, Complex Regional Pain Syndrome, to be disabling. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1901USA012217:
1 week after receiving the flu shot in my left arm, I developed a mild throbbing intermediate pain radiating from area of shot down outer lateral arm to elbow. Occasional slightly painful to touch. I also had a mild outbreak of my cold sore require use of acyclovir ointment on my lip. The following week 9/24-9/30 it continued to bother me. I am left handed and had no change in ROM or difficult moving my arm but it bothered me while awake and more in a sitting position. I did take some sick time on Friday due to the discomfort in my arm not improving. See next page.
Hives started on face 1 hr. after vaccine administration, hives spread to arms, abdom. and legs. Took BENADRYL 4/5/11. Hives come and go. Hives today on lower back, thighs, and arms. Continue BENADRYL.
On 1/11/21 At 4:30pm I started with Chills/Shivers. At 7:30pm the body pains and headache started with fever. That lasted through the night.  On 1/12/21 the fever stopped but body pains and headache still persists all day. On 1/13/21 woke up at 7am. No headache but still a bit of body pain till about 8pm. After 8pm I was about to get out of bed and move freely.
Patient reported swelling 24 hours post vaccination with progressive swelling 48 hours post vaccination.
1/4 inch to 1/2 inch size rashes on torso; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 08:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medication included tetanus vaccine (MANUFACTURER UNKNOWN) in the left arm on 05Mar2021 for an unknown indication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received other vaccine within 4 weeks prior to the COVID-19 vaccine. On 02Apr2021, the patient experienced 1/4-inch to 1/2-inch size rashes on torso. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event  rashes on torso was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
headaches. has been under treatment for headaches, parent feels headaches were under more control before vaccine, headaches started to get intensified after receiving vaccine
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA272032 and 2018SA271924 (same reporter). This case involves patients (unknown demographics) who received DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to incorrect product storage. It was unknown if the patient had any 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 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. List of documents held by sender: none.
Began with itching and redness at injection site; by noon, small red, itchy eruptions on skin on left arm; by evening, eruptions on right arm; by bedtime, eruptions had spread to legs. The itching is constant.
Information has been received from a health professional concerning a 44 month old male pt who on 09/21/1998 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that on 05/12/2001 the pt was diagnosed with "a mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Fatigue, headache, muscle pain, joint pain, nausea, vomiting, and fever 100.8 F
Patient had rash around lower bicep area. It occurred below the injection site. Approximately 4x5".
pt recv vax;flu like sx;lasted 2 days p/ vax;3 wk later to er;probable exacerbation of existing alveolar proteinosis condition;
Patient received both doses of a World Health Org approved vaccine (SinoVac). No known adverse reactions occurred.
Pfizer-BioNTech COVID-19 Vaccine: patient presented to clinic for follow-up reporting syncope and emergency department (ED) evaluation immediately after immunization and bruising and bleeding where the vaccine was administered. Patient was discharged from the ED stable and the provider documented the injection site as a healing bruise with no intervention necessary.
Feverish, hot flashes, excessive sweating, chills, headache, cough
pt recv vax AUG95 & 10MAY96 pt devel a breakthrough case of chickenpox w/vesicular lesions & a fever of 102 x 3 days;
spot behind his head then hives broke out on his legs and arms around 5 and 6 in the evening; spot behind his head then hives broke out on his legs and arms around 5 and 6 in the evening; Initial information received on 08-Sep-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 7 months old male patient who had experienced spot behind his head then hives broke out on his legs and arms around 5 and 6 in the evening after receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Sep-2023, the patient received a dose 1 of suspect Influenza Quadrival A-B Vaccine at a dose of 0.5 ml  (Frequency: once, strength: standard and lot UT8076KA) (expiry date :unknown) via intramuscular route in the left thigh as Immunization.  On 06-Sep-2023 the patient developed spot behind his head then hives broke out on his legs and arms around 5 and 6 in the evening (rash macular) and (urticaria) (latency: same day).  Action taken: not applicable.  The patient was treated with Diphenhydramine Hydrochloride (Benadryl [Diphenhydramine Hydrochloride]) for Hives and rash macular.  At time of reporting, the outcome was Recovering / Resolving for the event (urticaria) and was Unknown for the event (rash macular).
Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a female patient of unknown age who on an unspecified date was vaccinated with 0.5 ml of PNEUMOVAX 23, intramuscularly (lot number 1851AA). The L.P.N. reported that the patient called the office after developing redness, soreness and warmth at the injection site after receiving a dose of PNEUMOVAX 23. It was reported that the patient sought medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested. This is one of three reports from the same source.
no longer able to use a throwing motion without pain; no longer able to use a throwing motion without pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: ew0183) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 2, single, Batch/Lot No: el3249), administration date: 18Jan2021, for COVID-19 immunization; BNT162b2 (Dose 1, single, Batch/Lot No: ek9231), administration date: 28Dec2020, for COVID-19 immunization. The following information was reported: VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 06Oct2021, outcome "not recovered" and all described as "no longer able to use a throwing motion without pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site joint movement impairment, vaccination site pain.  Additional Information: It was reported that the patient received other vaccine in four weeks of BNT162B2. The patient was not tested to covid prior vaccination and the patient was tested positive post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician via company representative refers to a female patient, not pregnant, of unknown age. On an unknown date the patient was vaccinated intramuscularly with a first dose of GARDASIL (dose and lot # were not reported). On an unknown date, while on therapy with GARDASIL, the patient fainted. The patient sought unspecified medical attention. No treatment was given for reported adverse event. The outcome of the fainted was reported as recovered (date unspecified). It was also the that adverse event improved on therapy. Additional information is not expected.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Ten minutes after getting vaccination for her 2nd dosage she reported feeling tightness in her chest and back. Her blood pressure was 145/88. Husband stated it subsided with water. Out of cautiousness, EMS was called. They evaluated her and determined she did not need to go to the hospital. They did not need to administer any medications. They told her if anything changed to go to ER right away.