chrisvoncsefalvay/vaers-outcomes huggingface dataset:
II have received both doses of your vaccine and after the second dose, my long Covid symptoms subsided; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history included COVID-19 (several months) from Nov2020 to an unknown date and was hospitalized for 5 nights and 6 days and multiple sclerosis. The concomitant medication included Ocrevus for multiple Sclerosis. The patient past drug event included Ocrevus for multiple Sclerosis that depletes patient B cells and select T cells. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient received both doses of vaccine and after the second dose, her long COVID symptoms subsided. The patient firmly believe her Ocrevus infusion every 6 months will repeatedly wipe out COVID vaccine. The patient wanted COVID booster or the two shot series every 6 month and asked that was that possible. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Moderna was given 5 days post expiration date.  no treatment needed. Contacted moderna and was advice no additional shot needed within 30 days of expiration. Family was contacted and patient tolerated vaccination well with no adverse effect.
Pt having increasing shortness of breath and found to be COVID positive. She was admitted with sepsis with acute on chronic hypoxic respiratory failure secondary to multifocal COVID-19 pneumonia.
Significant mental impacts: Depression (to the point of suicidal ideation); Neuropathy in Face, Arms, Legs; Sensation of coldness in bones; Extreme sudden fatigue; Significant mental impacts: Depression (to the point of suicidal ideation); Inability to concentrate; Light sensitivity; low grade headache in center of brain; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Apr2021 10:30 (Batch/Lot Number: ER8732) as single dose for COVID-19 immunization, in the hospital. Medical history included nonalcoholic fatty liver disease (NAFLD), now almost gone, from an unknown date. The patient has no history of COVID prior vaccination. The patient was not COVID tested post vaccination. There were no concomitant medications. The patient experienced neuropathy in face, arms, legs, sensation of coldness in bones, extreme sudden fatigue, significant mental impacts: depression (to the point of suicidal ideation), inability to concentrate, light sensitivity, and low grade headache in center of brain, all experienced on 04Apr2021 12:00 AM. No treatment was given for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
A 5/8" needle was used to deliver and IM injection with no noticeable side effects noted by the patient.
Shortly after injection patient felt light headed and stood up. He fainted and fell forward. He was unsure if he had a seizure although he does have a history of seizures. EMS was called and checked his BP, BS, and pulse ox.
fever; chills; pain; tenderness; swelling; redness; fatigue; headache; loss of appetite; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (pain), VACCINATION SITE PAIN (tenderness) and VACCINATION SITE SWELLING (swelling) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TILACTASE (LACTAID), METFORMIN, align                                                          for his stomach and LISINOPRIL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (pain), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness), FATIGUE (fatigue), HEADACHE (headache), DECREASED APPETITE (loss of appetite) and MYALGIA (muscle pain). At the time of the report, PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (pain), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness), FATIGUE (fatigue), HEADACHE (headache), DECREASED APPETITE (loss of appetite) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Patient has been taking tylenol every 3-4 hrs for the fever.   Reporter did not allow further contact
Tender left shoulder, with a cyst or lump on collar bone. very tender to touch.
Got seriously injured by that vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of injury in a patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced injury (serious criteria other: Serious as per reporter.). On an unknown date, the outcome of the injury was unknown.   The reporter considered the injury to be related to HPV vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, he/she knew someone got seriously injured by the HPV vaccine.
no additional AE's; An HBP who is also a medical assistance is reporting an AE on behalf of a patient. The HBP reports that a patient was administered an expired dose of ROTATEQ today. No additional clarifying statements or AE details were provided and no additional AE; This spontaneous report has been received from a health business professional (HBP) who is also a medical assistance, referring to an identified patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On 10-MAR-2023, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters (mL) administered orally for prophylaxis (strength was not provided; lot #1742418 confirmed as valid, expiration date reported and stablished as 14-OCT-2022). No adverse events (AE).
At approximately 49 hours after the first dose, patient experienced unusual sudden tiredness, soreness at the injection site, visibly flushed face and sensation of heat emanating from the face. No treatment was given. All symptoms were resolved within 8 hours from onset.
patient presented with a large red spot on her upper left arm, about 2 inches in diameter . she said the main symptom was itching, followed by pain and redness. the area felt hard underneath.
Headache, Myalgia, CoughWheeze, NauseaVomiting, congestion Narrative:
Rash. Started on the lower back within 12 hours of the shot. Rash spread to both thighs, front and back with 24 hours.
zoster related immune inflammatory disease; zoster related immune inflammatory disease; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On or about 11-DEC-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for zoster related immune inflammatory disease. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was unknown. The causality was related.
By 10 pm I was quite achy and sore in my neck and upper body. [My two Pfizer shots barely had any effects.  Sore arm 1st shot only.  No side effects in the 2nd shot] 7am next morning I noticed a lump under my left arm, in the armpit adjacent and to the site of my breast.  It was tender when touched, similar to a strained muscle.  All that day my heart rate was elevated when just sitting while traveling.  The heart rate lowered and the aching subsided by the end of Sunday (48 hours roughly) and the lump reduced in approximately 72 hours or more.   Strangely enough I learned my brother (all Pfizer shots) got the same lump reaction under his arm in the armpit after his booster and lasted about 3-4 days.
Loss of smell; He can confirm he also had covid; Exposed to covid-19 lately and contracted it; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), SUSPECTED COVID-19 (He can confirm he also had covid) and EXPOSURE TO SARS-COV-2 (Exposed to covid-19 lately and contracted it) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-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 ANOSMIA (Loss of smell), SUSPECTED COVID-19 (He can confirm he also had covid) and EXPOSURE TO SARS-COV-2 (Exposed to covid-19 lately and contracted it). At the time of the report, ANOSMIA (Loss of smell), SUSPECTED COVID-19 (He can confirm he also had covid) and EXPOSURE TO SARS-COV-2 (Exposed to covid-19 lately and contracted it) outcome was unknown.            No concomitant medications were provided.  No treatment medications were taken by the patient.  The patient did not get tested for covid-19.  This is a spontaneous case concerning  a  50-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event of anosmia and Suspected COVID-19, Exposure to SARS-CoV-2 as an added event. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2021-419369 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  50-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event of anosmia and Suspected COVID-19, Exposure to SARS-CoV-2 as an added event. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
The pt developed a red, swollen, tender and warm area over the site of vaccinia vaccination with drainage from primary site and 1 1/2cm tender left arm in the left axilla; treated with Ceftin 250mg BID X 5 days.
STARTED OUT LIKE A SUMMER COLD AND PROGRESSIVE FLU-LIKE SYMPTOMS.
took the booster shot on the 22nd of November and started feeling bad on Wednesday.  Just sluggish and some discomfort in upper stomach - like heart burn.  Took Pepsid and it subsided.  Did this on and off until he died.   (Had a UTI a month earlier and had heart monitor placed on him and EEG done - heart doctor said heart was beautiful and didn't need to be follow up)
tried to mix it, put adapter on it, looks like product leaked out; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 02Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received for immunisation. The patient didn't receive rsv vaccine prot.subunit pref 2v (ABRYSVO). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "tried to mix it, put adapter on it, looks like product leaked out".  The reporter considered "tried to mix it, put adapter on it, looks like product leaked out" associated to device constituent of rsv vaccine prot.subunit pref 2v. Causality for "tried to mix it, put adapter on it, looks like product leaked out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: Additional information: Initially a reporter was on the call to Pfizer, and stated they needed to report an item that was damaged, and clarified the product was the 'RSV vaccination.' The reporter was not sure why the product was defective, stating the owner was the one who gave the vaccine, and the owner would be coming onto the call to complete the report. Then the second reporter and came onto the call to complete the entire report. The second reporter had been doing a lot of these vaccines, and this one when the reporter tried to mix it, put the adapter on it, looked like the product leaked out. The powder was still there, but nothing mixed in there, and the reporter saved everything. The product "all spilled onto the table." The second reporter was going to administer the vaccine to a patient, but the product "pretty much kind of exploded", so the second reporter used another one. The suspect vaccine was not administered to a patient. RSV vaccination vial adapter: the reporter regarding the adapter, did not have the manufacturer, NDC, lot, or expiry. The adapter came in another container and peeled off the top, so maybe the information was on top of that, but the reporter threw out that part. RSV vaccination dry powder in the vial: Manufacturer: There was a sticker around that part that the reporter took off and slapped on a sheet where the patient signs their name for the vaccine. The reporter had already taken the sticker off, but usually was the same as lot, expiry, and NDC on the box. The reporter confirmed there was just one vaccine with the issue.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Developed an itchy red rash (~2-3 inches in diameter) around the injection site 8 days after the first dose was given.  It started resolving the next day.
Erythema & induration (1-1.5 in) with PCV.  Warm compresses.
Developed ascites; It was gradual fluid buildup in the legs\ It was gradual fluid buildup in the feet; Gained about 5 to 10 pounds a month, Probably gained 30 pounds of water; Skin used to tight and it has started getting stretch marks; Lost a lot of her muscle mass in the last 20 days; This spontaneous case was reported by a consumer and describes the occurrence of ASCITES (Developed ascites) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 031620A and 002FZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASCITES (Developed ascites) (seriousness criterion medically significant), OEDEMA PERIPHERAL (It was gradual fluid buildup in the legs\ It was gradual fluid buildup in the feet), WEIGHT INCREASED (Gained about 5 to 10 pounds a month, Probably gained 30 pounds of water), SKIN STRIAE (Skin used to tight and it has started getting stretch marks) and MUSCLE ATROPHY (Lost a lot of her muscle mass in the last 20 days). At the time of the report, ASCITES (Developed ascites), OEDEMA PERIPHERAL (It was gradual fluid buildup in the legs\ It was gradual fluid buildup in the feet), WEIGHT INCREASED (Gained about 5 to 10 pounds a month, Probably gained 30 pounds of water), SKIN STRIAE (Skin used to tight and it has started getting stretch marks) and MUSCLE ATROPHY (Lost a lot of her muscle mass in the last 20 days) outcome was unknown.            Treatment information included paracentesis on 02-Sep-2021.  Company comment: This case concerns a  63 year-old female patient , who experienced the unexpected event of Ascites. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event of Ascites is Medically significant based on medical judgement and reported paracentesis.   This case was linked to MOD-2021-320732, MOD-2021-320770 (Patient Link).; Sender's Comments: This case concerns a  63 year-old female patient , who experienced the unexpected event of Ascites. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event of Ascites is Medically significant based on medical judgement and reported paracentesis.
This spontaneous report as received from a healthcare worker via company representative refers to a patient of unknown age and gender with intussusception. On an unknown date the patient was vaccinated with ROTATEQ (route, dosage, dose number and lot number unknown). It was reported that the patient experienced severe vomiting after receiving ROTATEQ. The patient was hospitalized (length of stay and hospital unspecified). The patient sought medical attention (hospitalized) and received treatment (unspecified). The patient was reported as recovered from the event (unknown date). Additional information is not expected.
Site redness, chills, fever 102.3 F, headache, dizziness, weakness, body aches, vomiting.
Felt vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received HBV (Engerix B) (batch number 7N5M5, expiry date 16th November 2020) for prophylaxis.   Concomitant products included HBV (Engerix B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, immediately after receiving Engerix B, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist administered Engerix B to the patient, and after doing so, the patient felt the shot. The patient stated that, a month ago received 1st dose of Engerix B, but did not felt the needle or medicine. The patient asked to the pharmacist was they gave the shot and the pharmacist said yes. The caller asked if they were to be safe and consider today the first dose, was there any safety information on extra doses of Engerix B. There may be a planned fourth dose based on information provided. The reporter consented to follow up.
At first he had a mild fever, complaints of discomfort where the shot was given, slight headache.  By late that evening, he had an intense migraine and a high fever of about 103.  He had an incredible headache that was making him vomit.  In the middle of the night his fever spiked to 104.5.  He was lethargic, unable to understand me when I spoke with him.  I asked him to swallow some Motrin tablets.  He chewed them.  He didn't even have a reaction that they tasted awful.  He didn't seem to understand anything I would say to him.  It was scary! He had this terrible fever, migraine headaches and EXTREME fatigue for 2 days!  I should have gone to the hospital.  It was very scary!
Provider inadvertently ordered an additional hepatitis B vaccine during the 6-month visit.  A combo vaccine was ordered containing hep b, however the smartset for 6 month visit still contained a checked box for hep b. Offering 2 orders of hep b for this visit.
One day after vaccines, patient's right arm (upper SQ area) was red with edema and warm to the touch. Area of redness and edema measuring 4 inches x 4 inches. Mother using cold compresses to relieve pain and swelling. Signs and symptoms improving today (8-9-07).
Began feeling "hot and flushed" complained of itching in her throat. 1023 - Taken to recovery room and v/s taken. PT 150/100, P 77, SaO2- 99%. No respiratory issues noted. Itching continued and at 1024  Benadryl  50 mg p.o. given per agency protocol.  Reported feeling light headed so moved to cot and legs elevated. v/s every 3-5 minutes. Pt cool and clammy and anxious. No respiratory difficulty reported or noted Resp at 20/min. 1025- BP 170/80, P=- 69, SaO2 - 100%. Pt still feeling lightheaded and cold. RN called 9-1-1. Continued to monitor v/s and resp statsu. Covered with a jackets. 1047- stated itching was gone and reported breathing  was "good". 1055-EMS arrived and evaluated pt and transported to ER for evaluation at 1103.  RN called pt on 3/25/2021 to check status. Pt stated she still has a headache today and muscle aches but "nothing" like yesterday. Reported taking Benadryl every 6 hrs as recommended per dr.
The patient was administered both M-M-R II and PROQUAD; No adverse effects reported; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant therapies.   On 13-MAY-2019, the patient was vaccinated with both vaccines Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) by subcutaneous route, lot #N025897, expiration date of 19-SEP-2019, for prophylaxis (strength, dose and anatomical site of injection were not reported) and with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) by subcutaneous route, lot #R011217, expiration date of 15-OCT-2019, for prophylaxis (strength, dose and anatomical site of injection were not reported) (inappropriate schedule of product administration). No adverse effects reported.
Increasing induration at site (12cm x 12cm); increased bicep girth; tenderness with muscle use.