chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She's on 2 different antibiotics and caller is wondering if the antibiotics will affect the vaccine; just had a sore arm; mild headache after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: Caller (retired nurse) stated her daughter is immunocompromised. The patient's concomitant medications were not reported. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "She's on 2 different antibiotics and caller is wondering if the antibiotics will affect the vaccine"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "just had a sore arm"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "mild headache after receiving the vaccine".  Additional information. Reporter was reporting for her daughter (patient) received the COVID-19 Vaccine first dose on 13Mar2021.  Reporter was asking if it would be okay to continue her daughter's antibiotic regimen. and mentioned that the last time patient took the antibiotic was on 12Mar2021. Reporter (retired nurse) stated that her daughter was immunocompromised and had the 1st dose of Pfizer's COVID vaccine on 13Mar2021 and she's on 2 different antibiotics. Reporter was wondering if the antibiotics will affect the vaccine, if her daughter can take antibiotics. Reporter also asked if there is any contraindication between the vaccine and the antibiotic.  Follow-up attempts completed. No further information expected.
Pt came into clinic for appt, wanted booster dose of moderna. Pt was given 0.25ml of moderna in the left deltoid at 1300. Pt was given expired vaccine. dose expired on 3/28/2022, administered 3/30/22.
Information has been received from a physician concerning a 2-month-old patient who was vaccinated PO with a 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccinations included "all other required 2 month vaccines".  Other concomitant therapy included acetaminophen (TYLENOL) which was administered before the office visit.  The physician reported that the patient was taken to the hospital (unknown if admitted) in an ambulance.  At some point, it was noted that the patient was not breathing.  It was believed that the patient aspirated some of the vaccine into his lungs.  The patient subsequently recovered.  Upon internal review, not breathing was determined to be an important medical event.  Additional information has been requested. (OMIC)
Red spot; Warm; Itchy; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 20Apr2021 at 10:15 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient received unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 30Mar2021 at 10:15 as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced red spot, warm and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red spot, warm and itchy was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a licensed Practical Nurse regarding multiple (unspecified) patients. Patient demographics were not provided. Information on their concurrent conditions, medical history and drug allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX from either lot # L019999, expiry date 02-JUN-2017 or lot# L034367, expiry date 08-SEP-2017 (route, anatomical location dose number, dose and units were unspecified). Concomitant medication were not reported. No adverse events were reported. There was no Product Quality Complaint (PQC) involved. Varicella virus vaccine (Oka/Merck) VARIVAX-L034367, expiry date- 08-SEP-2017 was stored at temperature: -8.9C, Time frame: multiple excursions totaling 4h 10 minutes between 07-JAN-2016 to 21-JAN-2016, no previous temperature excursion were performed. Varicella virus vaccine live (Oka/Merck) VARIVAX-Lo019999 expiry date-02-JUN-2017 was stored at temperature: -8.1C, Time frame: multiple excursions totaling 36h 42 minutes between 29-NOV-2015 to 21-JAN-2016, no previous temperature excursion were performed. Additional information has been requested.
TONGUE TINGLING; FEVER; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUN-2021, the subject experienced tongue tingling. On 23-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and tongue tingling was not reported. This report was non-serious.
After booster, pt experienced frequent shortness of breath. Lasted 4-5 months. Still experiencing but not as frequent.
More dizzy lost appetite don't want to eat nothing and much more dizzy or lost balance to walk step.
Case number PHEH2012US010286 is an initial spontaneous report received from medical assistant on 15 May 2012: This report refers to an 11-year-old male patient. He was given only the CYW-135 liquid component of MENVEO (batch number: X10053) intramuscularly on 15 May 2012. No other adverse reaction was reported following this administration error.
This spontaneous report as received from a 65 year old female retired nurse refers to herself. On 04-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). There was no concomitant therapy. On 06-APR-2013 after receiving ZOSTAVAX she developed a small reddened area on her arm. Patient did not seek medical attention. Patient received treatment by coverning the area with Band-Aid. The outcome of developed small reddened area on her arm was unknown. Additional information has been requested.
flu like symptoms; light headache; soreness; not a bad cough; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (light headache), PAIN (soreness) and COUGH (not a bad cough) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026A21A) for an unknown indication.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (light headache), PAIN (soreness) and COUGH (not a bad cough). At the time of the report, HEADACHE (light headache), PAIN (soreness) and COUGH (not a bad cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment included cough drops
my  daughter and I had itchy eyes; This is a spontaneous report from a contactable physician. This physician reported for two patients. This is 2 of 2 report. A 38-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Jan2021 09:00 (Batch/Lot Number: EL9263) as SINGLE DOSE for covid-19 immunization. The patient is small, not overweight, a little on the skinny side. Patient medical history was none. Family medical history was none. There were no concomitant medications. The patient did not receive any prior vaccinations within 4 weeks. AEs follow prior vaccinations was none. Additional vaccines administered on same date of pfizer suspect was none. History of all previous immunizations was not provided. It was reported that caller, her daughter, and her husband, all received the first dose of the Pfizer COVID vaccine on 26Jan2021. Caller and her daughter experienced very itchy eyes on 27Jan2021-28Jan2021. It then subsided. Asked if this is an allergic reaction and would it interfere with getting the second dose. If it is an allergic reaction, would there be a worse allergic reaction to the second dose, which is scheduled for 26Feb2021. Has the same question for her daughter too. The reporter was concerned if it plays an relevance to the second COVID shot. The patient frequently takes care of the caller, who is 79, and caller's husband, who is 84. On that basis was offered the COVID Vaccine. The AEs did not require visit. Relevant tests was none. Investigation Assessment was none. The event was assessed as insignificant. Relatedness assessment of drug to event by unspecified company was unknown. Outcome of the event was recovered on 28Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116744 same reporter/drug/AE, different patient.
12/08/03: Mother came to office reported infant has large red whelps over body.  Started breaking out Saturday 12/06/03.  Was fussy, whiny, no temperature.  Had been giving Benadryl liquid-PHN observed infant-large red area over body, extremities blanched redness.  Told her to take child to PMD or ER as Benadryl was not helping.  Not typical reaction to vaccine.  12/15/03, mother states given liquid Prednisone to take for 1 week.  To have allergy test done to determine what caused reaction.
This case was reported by a nurse via call center representative and described the occurrence of passed out in a 76-year-old male patient who received SHINGRIX (batch number 273BZ, expiry date 25th June 2021) for prophylaxis. On 19th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), headache, feeling cold, fatigue and loose stools. On an unknown date, the outcome of the passed out, headache, feeling cold, fatigue and loose stools were recovered/resolved. It was unknown if the reporter considered the passed out, headache, feeling cold, fatigue and loose stools to be related to SHINGRIX. Additional details were provided as follows: The patient experienced headache, feeling very cold, feeling very fatigued, loose stools, passed out while in the toilet. The patient was not seen by doctor of medicine (MD) or hospitalized for the events.
SKIN SENSITIVITY; LIGHT SENSITIVE; BODY ACHE; CHILLS; NAUSEA; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 27 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:30 at left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced skin sensitivity. On MAR-2021, the subject experienced light sensitive. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the skin sensitivity, nausea, chills, headache, light sensitive and tiredness was not reported. This report was non-serious.
Pt stated she had reaction 3 hrs after the vaccine. Pt stated the area became red and a fever of 103. The red area increased in size.
This spontaneous report was received from a nurse refers to a 9 month old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On an unknown date in February 2018 (reported as "some time last week" 12-FEB-2018 to 16-FEB-2018), the patient inadvertently received a dose of PNEUMOVAX 23 lot number N014188, expiration date 22-JAN-2019 (exact dose and route of administration were not provided). No adverse effects were reported.
Information has been received from medical assistant via Pfizer concerning a female patient of unknown age. The patient's medical conditions, other medications and investigations were unknown. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose and route unknown) for prophylaxis. On approximately 05-MAY-2017 (reported as two weeks ago from Pfizer awareness date of 19-MAY-2017), the patient experienced injection site swelling. The outcome of injection site swelling was unknown. The causality between injection site swelling and PNEUMOVAX 23) was not provided. Additional information has been requested.
Minimal issues after 1st vaccine. After 2nd vaccine, about 8 hours later my arm hurt so bad I could not sleep (2:30am) and taking Tylenol only cut the pain 50%. As time progressed that day about 12hours after injection I started to get the chills, achiness even after Tylenol which didn't do much. By 16 hours after injection I got hot/damp, shaky, nausea but once able to cool down nausea resolved. By 18 hours thru 28 hours I had difficulty walking due to achiness and extreme fatigue. Chills going on most of the time throughout and some looser stools. The next day 40h post injection I felt better-no chills. At 48h I was tired- no achiness, some looser stools. Day 3- I had some blood blowing my nose, resolved by day 4.
Abdominal pain coming from the right testicle, starting at 5:30 AM, ~14 hours after vaccination.   The pain made it difficult to just to lay in bed. 5/10 pain. I took Tylenol later in the morning and the pain subsided.
this is much more likely to be covid than the flu; this is much more likely to be covid than the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ5342) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre-cancer" (unspecified if ongoing), notes: I have a pre-cancer diagnosis; "mitral valve prolapse" (unspecified if ongoing); "TB exposure" (unspecified if ongoing), notes: recent TB exposure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "this is much more likely to be covid than the flu".  Clinical course: Patient had a second Pfizer vaccine - COVID-19 mRNA LNP-S, bivalent PF 12yrs-adult booster (Pfizer), 30mcg/0.3mL, Lot #: GJ5342 (withheld) - just 3 days after a double flu vaccine (asthma); immediately became ill, was diagnosed with severe bronchitis, and doctors have been back & forth on whether it is bronchitis or covid. Test results variable. Patient started coughing up blood (slightly) yesterday. Patient was fine before the vaccine. (withheld) said this is much more likely to be covid than the flu. Patient had a pre-cancer diagnosis, mitral valve prolapse, recent TB exposure due to County malfeasance - second hand smoke by people after a brief hotel state, which a county nurse later reached out to guests to advise of TB exposure - and severe asthma. patient did not get any warnings for ANY of these conditions prior to the vaccine  Follow-up attempts are completed. No further information is expected.
Pain in arm, swelling at injection site, chills, feverish feeling (like flu or severe cold)
IPV given to left deltoid. 9 cm x 9 cm warm erythematous area. Blanchable. Diphenhydramine, ibuprofen and cephalexin prescribed.
Received TDAP/ADACEL injection 6-28-10 6:30 PM.  On 6-30-10 10AM arm sore, red, swollen at injection site size of 50 cent piece.  On 7-1-10 rash on top of left breast.
Patient is a 85 y.o. male patient of a, MD with history of recently diagnosed lung cancer, atrial fibrillation, T2DM, DJD, HLD, HTN, vitamin D deficiency presented to a local Hospital with worsening shortness of breath.   S/p palliative extubation 7/30 Cosnult hospice   Sepsis Septic shock Acute respiratory failure with hypoxia secondry to Covid Pneumonia Present on admission: yes Etiology: Respiratory Pallative extubation on 7/30   Persistent fevers Follow cultures   Atrial fibrillation Not currently on anticoagulation due to bleeding Holding  home diltiazem and metoprolol while on pressor support PRN lopressor pushes    Pulmonary vascular congestion Elevated BNP One time dose of lasix 40 7/26  Covid-19 Virus Infection Date of onset of symptoms: 7/18 Symptoms present on admission: Cough, shortness of breath Date of covid positive test: 7/25 Vaccination status: vaccinated Squamous cell carcinoma of the left lung Follows with Dr. at a HCF Completed radiation therapy July 5 Not currently on chemotherapy   Hypertension Hold home hypertensives as patient is hypotensive and requiring Levophed
Numbness in hands and feet, progressed to weakness in arms and legs, inability to walk, gamma globulin treatment at hospital.
Systemic: Abdominal Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
about 5 to 10 minutes after getting the vaccination patient started to have trouble seeing "blacked out"  was unable to see and was having trouble hearing for about 3 to 5 minutes.  He then came through and felt nauseous and threw up.
p/ pt recv vax approx 10 days later pt exp 2 lesions @ inject site, on 7/28 the area became vesicular
Flu-like symptoms: fever, chills, body aches.  (I know these are common side-effects.  I'm filling out form for more accurate statistical data on incidence.)
Pt was ok after i have him his third dose. I asked him if he was ok he stated yes, then he looked a bit pale, pt rolled his eyes back then he said he felt dizzy then he fainted I caught him mom grabbed his feet we both laid him down. Pt said did I just faint? I left the room to go get help, then the NP came in we gave him an ice pack. I took his BP it was 110/68 his color came back slowly.
After get DT patient felt weak, fatigue, fever, body ache, L arm pain, limited motion of arm due to vaccines.  No cough, no rhinorrhea, no vomit/diarrhea, no redness at site, no rash, no shortness of breath.
This case was reported by a nurse via call center representative and described the occurrence of shingles in a 71-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 7th August 2018, the patient received SHINGRIX. On 17th August 2018, 10 days after receiving SHINGRIX, the patient experienced shingles, pain of skin and itchy skin. On 20th August 2018, the patient experienced rash. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the shingles, rash, pain of skin and itchy skin were unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the shingles, pain in arm, rash, pain of skin and itchy skin to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that after receiving SHINGRIX, the patient experienced painful arm (less than a month after vaccination) for greater than 7 days. The patient's skin on her back became painful. Ten days after receiving SHINGRIX, the patient experienced shingles and the patient's skin on her back was itchy. Thirteen days after receiving SHINGRIX, the patient's skin on her back had rash. Less than a month after receiving SHINGRIX, the patient's skin on her back had rash.
Injection site pain; Injection site swelling; Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient had the pain, redness and swelling with the 2nd shot. The reporter was asked to speak with the healthcare provider regarding the events and the healthcare provider will determine the right treatment plan. This case has been linked with US2019AMR131555, reported by the same reporter.
Pt c/o not feeling well - head dropped, color was pale, was sweaty and arms became rigid for short time (syncopal episode).
Pityriasis rosea; This is a spontaneous report from a 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: EW0170) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medications included cod-liver oil (COD LIVER OIL), unspecified probiotic and prenatal vitamins; all for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 11May2021, the patient experienced pityriasis rosea. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with prednisone. The clinical outcome of the event pityriasis rosea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.