chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immediately after vaccine: pre-syncope symptoms (lightheaded, perspiring, felt cold).  15 minutes later pulse 60 bpm (normal for pt). 30 minutes post vaccination pt reported feeling normal. called pt 5/12 to check in and he reported normal fatigue, and having experienced nausea for 2 hours
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: She had no problems with the first dose, there was a bit of sore arm. Event did not require a visit to Emergency Room or Physician Office. No additional Vaccine was administered on Same Date of the Pfizer Suspect. Patient had no prior Vaccinations (within 4 weeks). Patient had no other Conditions. No Investigation or relevant tests were conducted. The report was not related to a study or programme.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241797 same reporter/patient/event, different dose;
L arm throbbing, numbness and sensitivity from shoulder to elbow, dizziness. Home with mom.
RPh administered the vaccine, and the patient passed out 10 minutes afterwards and hit his head. Patient felt very faint even after sat up with feet up. Patient was given orange juice and he drank it all. Paramedics arrived and checked him out. 45 minutes after him passing out, patient felt fine and went back to work. He had gashed his head open on the fall.
Patient started fainting a few minutes after getting vaccine. started having jerking/seizure like movements. after she came out of that, patient said she had chest pain and 911 was called. was stable until paramedics came and paramedics took her with them to hospital
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age. Initial information was processed with additional information received on 08-JUN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was very sick with covid (coronavirus disease) (thus experienced suspected clinical vaccination failure and suspected covid-19 infection). As per reporter, "our son-in-law was forced to get the vaccine or be fired. He chose j and j and it did not work too well for him. He is now very sick with covid". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0: 20220610790-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Very sore arm; Saw black spots night of, saw neon green spots morning after; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unknown age and gender 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 10Apr2021 at 12:30 (at an unknown age) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamins from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 19:00,  the patient experienced very sore arm and "saw black spots night of, saw neon green spots morning after". Therapeutic measures were not taken as a result of the event(s). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore arm and "saw black spots night of, saw neon green spots morning after" were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Mother case: Case number PHHY2015US146922 is an initial literature report received on 02 Nov 2015. The author described 3 cases of Respiratory Syncytial Virus (RSV) infection diagnosed at a center during winter 2014. This report refers to a 21 year old female patient who was pregnant (primigravida). She had no history of asthma or smoking. Her medical history was complicated by mild aortic coarctation and a cognitive delay. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) when she was pregnant. She sought treatment at the outpatient clinic at week 32 of gestation with a three day history of sore throat, congestion and fever. At her initial visit, she was afebrile with stable vital signs and was therefore discharged to her home with empiric oseltamivir. A throat culture specimen was positive for group A streptococcus and a nasopharyngeal aspirate was positive for RSV by viral Polymerase Chain Reaction (PCR). The patient was treated with penicillin 500 mg twice a day for 10 days for the group A streptococcus infection without any further complications. At 39 weeks of gestation, she underwent an uncomplicated primary cesarean delivery of a 2,855 grams female infant with Apgar scores of 9 at 1 and 5 minutes. The infant was admitted to the newborn nursery and was discharged home with the mother on postoperative day 4. Action taken with empiric oseltamivir and penicillin were not known. The events outcome was not reported. The events RSV infection and streptococcal Group A infection was upgraded as medically significant based on the information available in the source documents. The author concluded the article stating that RSV infection might pose a substantial risk for hospitalization and further complications in pregnant women and the infection was likely worsened in the setting of baseline pulmonary disease such as asthma and tobacco use. The author also stated that the cases presented demonstrated the wide spectrum of maternal disease and emphasized the potential for maternal benefit of an RSV vaccine administered during pregnancy.
started less than 48hrs from time of shot redness, temp, sleeping more, trouble/latching on to bottle, coughing, jerking of neck, staring like a trance, head trimmers, no talking or seizing, called MD office, saw neurologist, EEG
A seizure activity/Shaking uncontrollably that happened on and off; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient (age at vaccination: 33-year-old) received bnt162b2 (COMIRNATY, lot 301358A), via an unspecified route of administration in right arm, on 29Sep2021 (also reported as 01Oct2021) around like 6-7 pm as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included allergy to penicillin; diabetes in family history. There were no concomitant medications. The patient had the dose 1 of the Pfizer Covid vaccine last 29Sep2021 and 3 days later (01Oct2021), he started shaking uncontrollably that happened on and off and was told that this was a seizure activity. He felt like it was worsening because he doesn't know what was going on. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Rash all over the body Loratadine & prednisolone Sent to ER.
Day after shot pain in elbow unable to hold drill. Soreness within elbow non superficial soreness to turn steering wheel, soreness in moving arm in certain positions.
May treat fevers and body aches with Tylenol or Motrin Please keep well hydrated May use hot tea with lemon and honey or gargle warm salt water for sore throat if desired for symptomatic relief May use saline nasal spray for congestion
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients), PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered after 25-35 days interval) in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033H21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered after 25-35 days interval). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients), PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered after 25-35 days interval) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. Vial was initially stored in refrigerator on 26 Mar 2022. Vial did not undergone any temperature excursions. No treatment information was reported. This case was linked to MOD-2022-528520 (Patient Link).
24FEB92 pt recvd APAP; pt exp 1/2 hr periods of high pitched crying on & off all night; 25FEB limp all morning-wouldn't stand up in AM; mild coordination problem, sl diffiulty swallowing; Seen by MD; given APAP & DPH;
Legs felt strange, Laid down because she felt like throwing up. She had joint cramps and Charley horse in her legs. Dizzy which is still continuing through today, Thursday 9/24, spent all day Wed in bed sleeping. Stomach still does not feel well.
Case number PHEH2014US019964 is an initial spontaneous report received from a nurse on 03 Oct 2014, and with a follow up report received from nurse on 11 Nov 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. Concomitant vaccines included tetanus diphtheria acellular pertussis vaccine (other manufacturer, batch number: 4EK53) 0.5 ml IM; Varicella (other manufacturer, batch number: 5007727) 0.5 ml subcutaneous; human papilloma vaccine (other manufacturer, batch number: K006095) 0.5 ml IM and hepatitis A vaccine (other manufacturer, batch number: GX2LA) 0.5 ml IM on 02 Oct 2014. She was vaccinated with MENVEO (batch number: M13046) 0.5 ml intramuscularly, into right deltoid on 02 Oct 2014. It was reported that she received Men A lyophilized component reconstituted with sterile diluent instead of MenCYW-135 liquid component. She was advised to repeat vaccination with MENVEO. No adverse event was reported following the maladministration. Follow up report received from nurse on 11 Nov 2014. Updated patient details (height and weight), site of MENVEO and all concomitant vaccines.
administered this vaccine to patients after this 30-day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) All the patient's antibody numbers were in the 800-900 range..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that they got 10 vials Moderna vaccine (037C21A) delivered on 24-May-2021 and immediately placed the vaccine into refrigerated storage. Then stated that the doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator and they administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use. Reporter reported that the vaccine was given unknown amount to patient past 30-day beyond use date (BUD). Patient did not report any adverse events or symptoms.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-415889 (Patient Link).
scratchy throat; allergy sx serial sneezing; allergy sx serial sneezing; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 27-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer , Prev dose brand unknown: False, Prev dose lot number: FF2589, Prev dose lot unknown: False, Prev dose administration date: 23Nov2021, Prev dose dose number: 1), administration date: 23Nov2021, when the patient was 27-year-old, for COVID-19 immunization; Covid-19 vaccine (Prev dose product: COVID 19, Prev dose brand unknown: True, Prev dose brand name unknown: COVID19 Vaccine,, Prev dose lot unknown: True, Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose dose number: 2), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), SNEEZING (non-serious) all with onset 22May2022, outcome "unknown" and all described as "allergy sx serial sneezing"; THROAT IRRITATION (non-serious) with onset 22May2022, outcome "unknown", described as "scratchy throat". It was unknown if therapeutic measures were taken as a result of throat irritation, hypersensitivity, sneezing.  Additional information: Other vaccine in four weeks were Unknown. Treatment reported as unknown. Patient covid prior vaccination was unknown but tested covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
up most of the night; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and methylprednisolone (MEDROL), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient took a Medrol dosepak and she was up most of the night with 4 pillows. The action taken in response to the event for methylprednisolone and event outcome were unknown.  Information on the lot/batch number has been requested.
Congestion; Elevated blood pressure; nausea; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, NASAL CONGESTION (Congestion), HYPERTENSION (Elevated blood pressure), NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure increased: elevated (High) elevated blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes use of blood pressure medications (not further specified).
Date of Admission: 10/25/2022, Date of Discharge: 10/28/2022, Admission Diagnosis: Severe persistent asthma with acute exacerbation,  Hospital Principal Problem (Discharge Diagnoses): Severe persistent asthma with acute exacerbation
Patient reports sharp pain in back starting roughly an hour after receiving vaccine.  Extreme arm weakness, to the point of difficulty lifting.  Feels extremely weak and unwell.
tachycardia to HR=150; headache; This is a spontaneous report from a contactable Physician. This Physician reported for a female patient. A female patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date 2021 as dose 1, single for COVID-19 immunization. Medical history included Covid-19 from Mar2020 to an unknown date had a nasty case of Covid in March. The patient's concomitant medications were not reported. On an unspecified date 2021, 24 hrs later after the first vaccine developed tachycardia to HR=150 and then severe headache similar to that which she had when she had Covid. She needed to go to the ER (Institution Name) and asked should she get the 2nd shot in view of her severe to the 1st vaccine. The patient underwent lab tests and procedures which included heart rate resulted as 150 on an unspecified date. The clinical outcome of the events was unknown.  Information on lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Red area at injection site, pain or discomfort in right arm. Pt had low grade temperature and was slightly nauseated. Pt here for routine TB test. Tetanus was injected instead of PPD.
dizzy; gave apple juice and cold pack; checked bp 1)93/62 2)100/34 3)110/74 ; pt improved after 20 minutes
Narrative: COVID infection following COVID vaccine series unknown date and  location of vaccine 12/29 COVID swab, result: detected 12/29 pt cc: exposure:  family 12/29 pt admit ED cc: exposure to COVID dx: COVID EXPOSURE LOS:  I day
This spontaneous case, initially received from other non-health professional (consumer) on 19-Oct-2018, concerns a male patient of unspecified age (under 65 years as reported). On an unspecified date (couple of weeks ago as reported), the patient (under 65 years of age) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250798 and expiry date: 31-May-2018] (explicitly coded as inappropriate age at vaccine administration). The patient had not experienced any adverse events after the vaccination. The reporter assessed the case as non-serious. Follow-up received from other non-health professional on 20-Nov-2018: The batch number: 250798 and expiry date: 31-May-2018 were added in product tab. It was confirmed that, patient had not experienced any adverse events after the vaccination. The narrative was amended accordingly.
Developed left arm swelling, redness, itching below injection site around (L) bicep - Given BENADRYL 25 mg  tablet every 6 hrs prn and HC 1% cream tid 7/24/09.
Unclear that it is linked to vaccine. 10/10/13 (R) deltoid IM vaccine. 10/12/13 (approx) fever/(R) arm pain x 24 hrs - treated at urgent care, no records available better then 10/20/13 - fever (R) arm/shoulder hot and limited ROM --> admitted - Xray OK, MRI showed bursitis clinda x 21 days and I and D in OR. No skin infection ever apparent.
severe swelling lymph nodes; fever; chills; bodyaches; Blurred vision; feeling sick; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 10May2021 (at the age of 24-years-old) at 2ND DOSE, single for COVID-19 immunization. Ongoing medical history included patient had glasses. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at 1ST DOSE single for COVID-19 immunization. On 11May2021 09:00, the patient started to feel really bad described as severe swelling in lymph nodes, fever, chills and body aches; and blurred vision during the day of 11May2021. The patient had glasses and had them on. Her vision would go in and out of focus during the day. She was feeling sick and fatigue in May2021 after the second dose. The doctor's nurse only said she did research for about 10 to 15 minutes and said it was recommended that the patient go to the emergency room.  With blurred vision and at night, the patient could not drive herself.  The patient did not call 911 because she knew the other ones were expected.  The patient waited it out to see how it was. She further reported that her vision was better on 12May2021 in the morning, but her lymph nodes were still swollen and tender and still feeling sick, having body aches and fatigue. The outcome of the event blurred vision was recovering, outcome of the swelling lymph nodes, feeling sick, body aches and fatigue was not recovered; outcome of the events chills and pyrexia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reported on Friday about 5:00 PM (9/11/09) he had a fever 103 degrees, achy joints, headache, and his eyes hurt. The day after he felt fine during the day and a temp of 100-101 in the evening. Two days post immunization he had no fever but an 8 inch patch of redness on the right arm lower than where shot given. No treatment, no doctor was seen.