chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 minutes after receiving 1st dose of Moderna vaccine, patient slumped over in waiting area, patient aroused with contact, appeared pale, stated anxious, nausea, "not feeling right," A&O x 4, denied SOB, chest pain, swelling, itching, no redness, swelling, hives noted.  B/P: 98/60, HR: 58, BG: 98, SPO2: 99%. Per DO, MA applied 4L face mask. Patient laid supine: feet up, given water, removed O2. After 15 minutes: B/P 105/66, HR: 59 supine, SPO2 99%RA. After 30 minutes: B/P 97/67, HR 59 sitting, SPO2 100%RA. Patient stated "feeling better" another 30 minutes later. B/P: 110/67 HR: 58. Patient stated all symptoms resolved, had been anxious about vaccine, has had syncope prior at dental appts. Patient denied SOB, chest pain, swelling, itching. Patient advised to call EMS if develops any above symptoms. Patient monitored for 1 hour total.
Seizure 16 hours after shots (PENTACEL, PREVNAR and rotavirus). Jerking episode with protuding tongue then became lump for 10-15 minutes. Associated pallor no cyanosis/apnea.
Patient received first dose Pfizer covid without incident. Upon sitting in waiting area post vaccination, patient experienced syncope and fell off chair to floor. Patient regained consciousness within moments and was verbally conversing with staff. EMS was called and responded. Patient was given blood pressure check. patient declined any other medical treatment. Patient left without further incident.
Nausea; Vomiting; Congestion; Low energy; Headache; Cough; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the right arm on 13Apr2021 at 15:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid condition and iron deficiency anemia. 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 vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 15Apr2021 at 12:00, the patient experienced nausea, vomiting, congestion, low energy, headache and cough. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, congestion, low energy, headache and cough were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
End up getting BioThrax (anthrax vaccine) but it was after the 28 days of the vial being opened; Spontaneous report received on 08FEB2022.  A healthcare professional reported that the patient (patient 1) (unknown age and gender) "end up getting BioThrax (anthrax vaccine) but it was after the 28 days of the vial being opened" (PT: Poor quality product administered). It was reported that over the weekend the patient got BioThrax vaccine (lot number unknown) after the 28 days of the vial being opened. Reportedly, the patient did not experience any side effects after taking the vaccine. Action taken with BioThrax with respect to the reported event was not applicable. Outcome of the reported event was unknown.  No additional information was reported.  Based on the information available in the document two individual case safety reports (patient 1) and (patient 2) were created and cross linked in the database.  Company comment: It was reported that a consumer was administered with BioThrax but it was after the 28 days of the vial being opened (poor quality product administered). BioThrax vial is to be used within 28 days after first opening. Considering the case information, the causality of poor quality product administered is assessed as not related with BioThrax due to the nature of the event.; Sender's Comments: It was reported that a consumer was administered with BioThrax but it was after the 28 days of the vial being opened (poor quality product administered). BioThrax vial is to be used within 28 days after first opening. Considering the case information, the causality of poor quality product administered is assessed as not related with BioThrax due to the nature of the event.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 at 13:00 as dose 1, single (Lot number: EL8982), in right arm, on 11Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in right arm, on 22Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 20Mar2022 at 14:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: Tested positive 11 days previous. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 07Jan2023.
I developed shingles; muscle twitching; This is a spontaneous report from a contactable Pharmacist (patient herself). A 69-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6199) via an unspecified route of administration in left arm on 04Mar2021 08:30 as 2nd dose, single dose for COVID-19 immunization. Patient was 69-years-old and was not pregnant at the time of vaccination. Patient did not had COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. Vaccination facility type was reported as Health Clinic/Administration facility. Patient did not receive any vaccines within 4 weeks. Patient medical history included diabetic arthritis, heart problems, fibromyalgia and known allergies to versed, hydrocodone. Concomitant medications included atorvastatin calcium, losartan, metformin, ASA, dexamethasone sodium phosphate (DEXALAB [DEXAMETHASONE SODIUM PHOSPHATE]), metoprolol succinate (TOPROL). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Pfizer 6199) via an unspecified route of administration on 04Mar2020 08:30 (as reported) as 1st dose single dose for COVID-19 immunization. On 26Mar2021, patient developed shingles and had muscle twitching. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. Patient did not receive any treatments for the adverse events. The outcome of the events was not resolved.   No follow-up attempts are possible. No further information is expected.
Second dose not administered with 35 days interval; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not administered with 35 days interval) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history provided by the reporter. .     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not administered with 35 days interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not administered with 35 days interval) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No other concomitant medical  provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up received on 25-MAY-2021 and contain no new information
Swollen gland on right collarbone near shoulder (Still present).  Moderate to severe joint pain in right elbow (reduced pain but still slightly present).  Hives at injection site - lasted one evening (3/23)
3/17   Headache  -- heart racing -- contact doctor's office and took some meds
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # K023157, expiration date 23-JUL-2016. No adverse effects were reported. Additional information has been requested.
CHILLS FOR 7 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills for 7 hours. The action taken with covid-19 vaccine was not applicable. The outcome of chills for 7 hours was not reported. This report was non-serious.
20 minutes after receiving flu vaccine employee developed hives on her neck & face. No chest pain no S.O.B. Took BENADRYL 25mg P.O in work. Took another 25mg 2 hours later at home. 4 hours later hives subsided. Employee's first flu shot.
Swelling/pain at injection site and moved into the shoulder also intermittent numbness and weakness with tingling sensation. These symptoms developed  the evening of the shot  and did not resolve, Patient sought medical attention 5-6-2022 and was prescribed an NSAID
Numbness in face and hands.  This lasted off and on for the 21 days between shots
Paraesthesia (numbness and tingling) started in upper back, arms and hands.  Numbness was worse at night particularly in right arm.  As weeks since first dose of COVID-19 vaccine, numbness and tingling experienced over entire body.   The numbness and tingling waxes and wanes.  Neurology consult on 7 April and started on gabapentin 300 mg nightly.  MRI was conducted on 21 April and was normal.  Blood work on 7 April and immunoglobulin G, A, and M and all were normal.  Methlymalonic acid was normal.
Patients got her period 2 days after receiving her second COVID vaccine. She had not had her period since Feb2021; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her period 2 days after receiving her second vaccine. She has not had her period since Feb2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 2/22/2021, started to feel numbing sensation in mouth. On 2/26/2021, left side of face started to become paralyzed. On 2/28/2021, left side of face became totally paralyzed and went to ER because worried it was a sign of a stroke.
Injection site swelling; Redness; Fatigue extreme; Nausea; Vomiting; Low grade fever; Cough; Appetite lost; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 15Apr2021 at 15:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes, and hypertension. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 00:00, the patient experienced injection site swelling, redness, fatigue extreme, nausea, vomiting, low grade fever, cough and appetite lost. The event did not result in doctor or other healthcare professional office/clinic visit, and 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 injection site swelling, redness, fatigue extreme, nausea, vomiting, low grade fever, cough and appetite lost was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Had both vaccines in afternoon, had reaction of hives by that PM - body hives, irritation/burning in vaginal area
Symptomatic with covid 12/22-started with just sinus congestion and fatigue. Progressed to fever, chills and body aches 12/25, coughing shortness of breath 12/26,loss of taste and smell 12/27
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient is in hospital with continued nausea, vomiting, diarrhea, fever, headaches, body aches, and hyponatremia. These symptoms have been occurring since the after receiving the vaccine.
EXTREMELY EXHAUSTED, HEADACHE FOR 36 HOURS, NO FEVER, COUGH, CONGESTION, LACK OF APPETITE TREATMENT: REST FOR 3 WEEKS, PLENT OF FLUID (HOT TEA)
This is a spontaneous report from a Pfizer sponsored program Patient Testimonial Recruitment. A non-contactable consumer reported that a male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 02Oct2017 at a single dose for pneumonia. The patient's medical history and concomitant medications were not reported. On Oct2017, couple days after vaccination, the patient experienced dizzy and vertigo. The outcome of the events was unknown. The patient wasn't sure if it was a side effect from the medicine. No follow up attempts are possible. No further information is expected.
Seizure lasting >1 minute 6:45 AM while sleeping w/ Mom; witnessed by Mom. Vomited x 1 45 min after seizure. appeared normal in office
Initial report was received 19 August 2009 from another manufacturer (doc number 45223759), who received the report from a health care professional. A patient (demographics not reported) had received an Influenza vaccine (manufacturer and lot number not reported) in 2002 and an unspecified amount of time later, the patient may have developed Guillain Barre Syndrome. According to the reporter, "the patient was treated at the hospital at that time". No additional information was provided at the time of the report. Documents held by sender: None.
first dose in 2020, only first was administrated; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd September 2020, no lot number and expiration date provided).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments: The pharmacist reported that the patient was late for the second dose of Shingrix. No adverse event was reported. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Moderna COVID-19 Vaccine EUA Itchy red rash on upper left arm in area of injection.  Only itched for a few minutes.  Red area about 1.5 wide  x 3 inches long visible but did not itch that faded away after 5 days.
headache, arm soreness at site of injection, itchiness at site of injection, chills, fatigue, body aches, general malaise
Patient received flu shot on 9/22/08.  When she went home, she developed vomiting, nausea and dark colored diarrhea.  No treatment given as yet.
Brachial neuritis currently being treated by her doctor. Event happen approximately 3 weeks after immunization per pt.
patient was inadvertently administered the Liquid Diluent component of Menveo without the Lyophilized component on 9/22/2023.; patient was inadvertently administered the Liquid Diluent component of Menveo without the Lyophilized component on 9/22/2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732A, expiry date 31-OCT-2023) for prophylaxis.   On 22-SEP-2023, the patient received Menveo. On 22-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient was inadvertently administered the Liquid Diluent component of Menveo without the Lyophilized component on 9/22/2023.) and inappropriate dose of vaccine administered (Verbatim: patient was inadvertently administered the Liquid Diluent component of Menveo without the Lyophilized component on 9/22/2023.).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 26-Sept-2023 Pharmacist called to inquired that how to proceed and they should revaccinate. The reporter was unable to provide patient details. Did not consent to follow-up. The patient was inadvertently administered the liquid diluent component of Menveo without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Mother of client reports client having a cold/cough 8 days prior to vaccination. At time of vaccination denies illness. 9/25/12 around midnight client way experiencing 104 degrees F temperature. Contacted doctor and was diagnosed with pneumonia. She is currently receiving treatment.
After receiving 3 shots, client became pale & "passed out in chair approx. 5 seconds.  Assisted to floor by nurse + father.  Had not eaten yet that day + was "nervous" about shots.  Given a snack + juice.  Felt fine within 10 minutes.  Left with dad.  TC 1/14 to dad.  Client is fine.  They went out to eat after leaving  Health Dept.
tired; diarrhea all day/loose stool; headache all day; patient is not 100%; extreme headache turned into a migraine headache; nausea; vomit; pain; cold; chills; achy; felt really bad; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea), FATIGUE (tired), PAIN (achy) and MIGRAINE (extreme headache turned into a migraine headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041BV1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM for Anxiety, DICLOFENAC SODIUM for Arthritis, LAMOTRIGINE (LAMICTAL) for Bipolar disorder.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea) and PAIN (achy). On 14-Apr-2021, the patient experienced MIGRAINE (extreme headache turned into a migraine headache), NAUSEA (nausea), VOMITING (vomit), PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills), HEADACHE (headache all day) and MALAISE (patient is not 100%). On an unknown date, the patient experienced FATIGUE (tired) and DIARRHOEA (diarrhea all day/loose stool). At the time of the report, FEELING ABNORMAL (felt really bad), DIARRHOEA (diarrhea), FATIGUE (tired), PAIN (achy), MIGRAINE (extreme headache turned into a migraine headache), NAUSEA (nausea), VOMITING (vomit), PAIN (pain), NASOPHARYNGITIS (cold), CHILLS (chills), DIARRHOEA (diarrhea all day/loose stool), HEADACHE (headache all day) and MALAISE (patient is not 100%) outcome was unknown.            Treatment include Tylenol, Advil sinus Pressure and Ice application.   This case was linked to US-MODERNATX, INC.-MOD-2021-076508 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076508:
Fever, irritability, fever (102 deg. F), no appetite. Seen in ER given Tylenol with Motrin, push fluids per MD.
Oval red, raised 12x12 cm at site of quadracel  warm to touch  oval red raised 6x8c, with several vesicles at site of proquad warm to touch Benadryl, Ibuprofen recheck next week
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot# reported as M003027, expiry date 27-JUN-2017 (number of doses, doses, routes and sites of administration were not reported). No adverse effect reported. Additional information has been requested.
No additional AE reported; a dose of PROQUAD was inadvertently administered to a 16 year old patient today; This spontaneous report was received from a nurse referring to a 16 years old patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reaction/allergies were not reported.  On 13-AUG-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (strength and route were not reported, lot # T030943, expiration date was 09-MAR-2022) 0.5 ml for prophylaxis; other suspect therapies included sterile diluent (start date: 13-AUG-2021, strength, frequency, indication and route were not reported; 0.5 ml, lot #  S022090, expiration date: 21-FEB-2022) ( product administered to patient of inappropriate age).      No additional information was provided. No additional adverse event was reported
Acne from eruption began about 11 days post smallpox vaccination. Had fever 8 days post vaccination, resolved with tylenol. ROS negative.