chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient took the PCR COVID test for the purpose of travelling  and it was positive; patient took the PCR COVID test for the purpose of travelling  and it was positive; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable physician (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on  unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported the patient was antibody-antigen negative before taking the vaccine. Then the patient took the PCR COVID test for the purpose of travelling  and it was positive on an unknown date. Outcome of the events was unknown.    Information about Lot/Batch number is requested.; Sender's Comments: Based on the time association, the lack of efficacy cannot be excluded for vaccine BNT162B2.
Dizziness; Swelling underneath eyes, eye swelling; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2023, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th February 2023, 4 days after receiving Shingrix, the patient experienced dizziness and eye swelling. On an unknown date, the outcome of the dizziness was recovering/resolving and the outcome of the eye swelling was not recovered/not resolved.   It was unknown if the reporter considered the dizziness and eye swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-Feb-2023: Reporter comment: This case was self reported by the patient. The patient received first Shingrix vaccine on the left arm.  On 6th February 2023, the patient woke up dizzy and swelling underneath eyes.  The patient reported on the day of reporting the dizziness had gotten better but not completely resolved and the eye swelling appeared to be worse.  The patient would contact the healthcare professional who administered the Shingrix vaccine.  The reporter consented to follow up.  The patient reported a nurse gave her the Shingrix vaccine.  The patient did not have a specific healthcare professional that she saw. Additional supportive information: The outcome of the event dizziness was captured as recovering as per information given in the narrative.
Spontaneous report received on 29MAY2015 from a nurse practitioner. A 31 year old male received dose 3 of BioThrax vaccine on an unpecified date and experienced a 1 inch area of localized erythema and tenderness at the injection site. On 27MAY2015, he was administered dose 4 'deep intramuscular' in the left arm (Lot FAV440). Approximately 24 hours later, the male called the clinic due to itchiness and redness at the injection site. He was advised to take Benadryl 25mg every 4-6 hours, which helped the itchiness. The following day (48 hours post dose), he was seen at the clinic and observed to have a 4 inch are of mild erythema, induration accompanied by tenderness. The symptoms resolved in several days.
Recieved Varicella and Hepatitis A vaccine. While waiting in the lobby left arm (varicella) began to swell and became inflammed and hot to touch. Ice and Antibiotic ointment applied.  Inflammation and edema improved @ 11:15
Rashes all over the body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes all over the body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 RASH (Rashes all over the body). At the time of the report, RASH (Rashes all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter. The patient consulted doctor and was prescribed antihistamine (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non-significant follow up
On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced DRY MOUTH (Dry mouth). On 29-Jan-2021, the patient experienced PYREXIA (slight fever). The patient was treated with IBUPROFEN for Fever and Chills, at an unspecified dose and frequency and ALKA SELTZER PLUS COLD & COUGH FORMULA for Cold and Flu, at an unspecified dose and frequency. On 31-Jan-2021, PYREXIA (slight fever) had resolved. At the time of the report, DRY MOUTH (Dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-013712 (Patient Link).
HAD SX 1/2022; TESTED + FOR COVID 1-19-22;  ADMITTED TO HOSPITAL  2-6-22  WITH WEAKNESS, SHORTNESS OF BREATH, DECREASED APPETITE ;  ADMITTED AGAIN 3-3-22 TO 3-9-22 WITH DX OF PNEUMONIA UNSPECIFIED ORGANISM, ACUTE ON CHRONIC CHF; ACUTE KIDNEY FAILURE, ANEMIA, PAROXYSMAL AFIB, TYPE 2 DIABETES MELLITUS, PALLIATIVE CARE, DISORIENTATION; DECEASED 4-18-22
Sluggishness; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggishness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025821A and 026B21A) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    The patient's past medical history included Cancer (The Patient had rare type of unrecalled cancer and it did not worsen while he was on Creon.) Previously administered products included for Product used for unknown indication: Spiriva handihaler and Oxycodone. Past adverse reactions to the above products included No adverse event with Oxycodone and Spiriva handihaler. Concurrent medical conditions included Drug allergy, Drug allergy, Non-tobacco user and Abstains from alcohol. Concomitant products included LISINOPRIL, PANTOPRAZOLE, SENNA ALEXANDRINA, METOPROLOL SUCCINATE, INSULIN LISPRO (HUMALOG) and INSULIN GLARGINE (LANTUS) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PANCREATIN (CREON) (Oral) 3 dosage form three times a day. On an unknown date, PANCREATIN (CREON) (Oral) dosage was changed to 2 dosage form three times a day, PANCREATIN (CREON) (Oral) dosage was changed to 3 dosage form three times a day and PANCREATIN (CREON) (Oral) dosage was changed to 2 dosage form three times a day. On 04-Mar-2021, the patient experienced SLUGGISHNESS (Sluggishness). On 04-Mar-2021, SLUGGISHNESS (Sluggishness) had resolved.            Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Erythematous raised rash started on the left arm 01/10/21, the following day blisters appeared and the rash became painful. Prior to that there was shock-like pain through the left arm starting on the day after the vaccination. Suspect likely shingles
Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
on 5/18/21 five minutes after  first vaccination tongue warming sensation & couldn't move arm for 2 days on 6/8/21 received second dose  at 6pm and by 9pm mouth, cheeks, and throat tingling and weird, sweet taste in mouth for one hour (patient did not inform vaccinator about side effects when coming for second dose)
pt syncopal episode 20 minutes after COVID vaccination cold, clammy, AMS, convulsions improved with supine position, leg raised BP 98/68 norm per patient STAT BG 118 likely vasovagal transported to ER by EMS
Mild soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild soreness of the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Mild soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Mild soreness of the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood glucose: high (High) Higher than normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided.
Burning, flushing sensation, throat tightness, fever, rash, lip and eyelid edema, nausea, vomiting, and diarrhea, overally body pain.
Diagnosed in ER as an allergic reaction. Released same day, given epinephrine and Benadryl.
Information has been received from a licensed practical nurse for the Merck pregnancy registry for GARDASIL concerning an 18 year old female who on 08-JUN-2007 was vaccinated intramuscularly with the third dose of GARDASIL (lot# not reported).  Per the nurse, the patient received the third dose of GARDASIL while pregnant (LMP=17-Apr-2007).  The pregnancy was confirmed by a urine pregnancy test.  The reporter did not know when the patient received the first or second dose of GARDASIL.  The patient sought unspecified medical attention in the physician's office.  The reporter requested that all correspondence take place via mail as opposed to fax and that the mailing envelope be marked "CONFIDENTIAL".  Additional information received from pregnancy questionnaire and telephone memo (27-MAY-2008): On 15-FEB-2008 the patient gave birth to a normal, female baby (7.5 pounds, 20 inches long).  The patient developed pre-eclampsia at full-term and had a long "30-hour" labor.  Both the mother and baby are doing well.  Additional information is not expected.
influenza A; Initial information received on 25-Dec-2022 regarding an unsolicited valid non-serious social media case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who experienced influenza A after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for Flu vaccination.  On an unknown date, the patient had the flu vaccine and he/she was home alone on Christmas because had Influenza A (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza A).  At time of reporting, the outcome was Unknown.
Chills, fever, headache, unable to stand without pain.  This was worse than when I had COVID.  My whole body ached really bad. Worse than when I have a flare up from my fibromyalgia.   For two days I could hardly move. Felt a little better the third day. Have had stomach issues since I had the shot.
I started out with a small lump below my left ear and along my jawline that started hurting. I went to the doctor about two weeks after noticing. The doctor told me that my ear was fine and she thought maybe it was a swollen gland. I was given Keflex, but it did not help at all. I still have the pain. Some days it hurts really bad and some days it doesn't bother me at all. I was supposed to call my doctor back, but I have not made a follow up appointment yet.
Exactly 2 weeks post-vaccination, I started experiencing itchy scalp, hairline, back of neck, and shoulders. Hives would develop in the itchy areas. The itchy skin and hives expanded to the arms, legs, torso, hands, feet, and face. Hives last around 10-15 minutes. Cortizone 10 cream helps with itchiness. Have been taking Allegra (180mg) since day one of symptoms (November 18th). Red lines and hives still develop even after taking the Allegra. Allegra seems to help more with the itchiness than the onset of the red marks.
A spontaneous report has been received from a Health Professional concerning a patient born on 17-MAR-2010, female patient. The patient's concurrent disease included seasonal allergies. The patient received FLUMIST QUADRIVALENT on 16-NOV-2014. On 17-NOV-2014, the patient developed swelling around her eyes. The patient was treated with prednisone and clindamycin. The event completely resolved on 22-NOV-2014. The reporter assessed the event of swelling around eye the day after patient received vaccine to be non serious.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium
head cold; sinus issues; congestion; mild to really bad headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (head cold), SINUS DISORDER (sinus issues), NASAL CONGESTION (congestion), HEADACHE (mild to really bad headaches) and PYREXIA (fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 002A21A and 013L20A) for COVID-19 vaccination.     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 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PYREXIA (fever). On 02-Sep-2021, the patient experienced NASOPHARYNGITIS (head cold), SINUS DISORDER (sinus issues), NASAL CONGESTION (congestion) and HEADACHE (mild to really bad headaches). The patient was treated with IBUPROFEN for Fever, at a dose of UNK, as necessary. At the time of the report, NASOPHARYNGITIS (head cold), SINUS DISORDER (sinus issues), NASAL CONGESTION (congestion), HEADACHE (mild to really bad headaches) and PYREXIA (fever) outcome was unknown.            No concomitant drug details were reported.
Cough and it is not like usual coughs; it seems odd; heaviness at top of my chest or bottom of my throat that could be when I cough; was like an attack; Cough and it is not like usual coughs; it seems odd; heaviness at top of my chest or bottom of my throat that could be when I cough; was like an attack; Cough and it is not like usual coughs; it seems odd; heaviness at top of my chest or bottom of my throat that could be when I cough; was like an attack; Aching in my body; Extreme tiredness; Never went to sleep because started aching all over my body; This morning my temperature was 99; This is a spontaneous report from a contactable consumer (patient). A 97-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. Medical history included macular degeneration, hearing problem, and COVID-19 (when patient got the injection, patient already had the virus). The patient's concomitant medications were not reported. After vaccination, patient never felt a thing, for may be 4 or 5 days and all of a sudden about 3 or 4 days ago, patient had a cough and it was not like the usual coughs that patient got where patient can blame it on anything. Well than patient was having a little aching in body. Now this was in last 3, 4 days and back and from side, it was a different thing. Now patient will get to point, last night, last evening, all around 7 o'clock, patient really noticed a lot of aching and at 9 o clock patient went to bed because patient just felt have to and tiredness, extreme tiredness and then patient never went to sleep because patient started aching all over body and patient got up about 7 times during the evening. Now when patient got up this morning, patient have definitely improved. Right now, patient could not say really say that patient was aching noticeably anywhere. Patient was almost wondering when patient got the virus do not see the symptoms for a while and patient thought what if patient got the virus and when patient went in and got the injection patient already had the virus. Temperature was 90, last night it was 98. This morning it was 99 and patient felt a little bit nothing to talk about. A little bit of heaviness at the top of chest or the bottom of throat but that could be when patient cough like this to show patient can cough. So patient thought it was better to check and see if should Ignore all this because definitely what happened last night was almost like an attack, it is gone now, aching all over body. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever of 102; Chills; Lethargy; Pain at injection site; This is a spontaneous report from a contactable Other HCP.   This female patient (age not provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at single dose for COVID-19 immunisation, administered at hospital. No relevant medical history and concomitant medications were provided. On 17Jan2021 (at 02:30 AM) she developed fever of 102, chills, lethargy and pain at injection site. She was not treated for the events. She was recovering from the events.  Information on the lot/batch number has been requested.
pt recv vax 1245PM;during observation period pt wa asymptomatic;no rxn or signs of distress noted;approx 130PM pt c/o SOB;teacher called pt mom;pt taken to MD & given epi & DPH;
patient was given the adult dose, instead of the Ped dose. No s/s of adverse reaction noted at this time
Didn't receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication was reported.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # L012034, expiration date 04-JUL-2017, Lot number: L019128, expiration date: 27-MAY-2017 and Lot number: M008172, expiration date: 16-FEB-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The VARIVAX vaccine was exposed to a temperature of >5 Fahrenheit degrees but <14 Fahrenheit degrees for 2 hours and 4 minutes. There was a previous temperature excursion of <5 Fahrenheit degrees but 14< Fahrenheit degrees for 13 hours, 26 minutes for VARIVAX vaccine. This excursion was detected due to a data logger. No adverse effects  were reported. This is one of several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008543.