chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My friend is in the hospital and is on the ventilator; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received BNT162B2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEPENDENCE ON RESPIRATOR (hospitalization, medically significant) with onset Dec2021, outcome "unknown", described as "My friend is in the hospital and is on the ventilator". It was reported that, the patient was on the ventilator after receiving a Pfizer Covid Vaccine. The reporter was emotional about the covid vaccine mandating being push by the government. It was reported that, the reporter had never seen so many people have heart attacks as the reporter had in the last year. The reporter states that this was a genocide and it was happening right now. Pfizer, Moderna and Johnson & Johnson were all involved in this. The reporter also stated that, this vaccine has only be around a year please take it off the market because it was harming and killing many people.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immunization site of right arm red, swollen and warm to touch. Warm compress to right arm and Tylenol every 4 hours given.
woke up with a red ,large ,round mark like being hit with a baseball; woke up with a red ,large ,round mark like being hit with a baseball; sored left arm; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sored left arm), INJECTION SITE SWELLING (woke up with a red ,large ,round mark like being hit with a baseball) and INJECTION SITE ERYTHEMA (woke up with a red ,large ,round mark like being hit with a baseball) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. oK6L2017) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency (start/stop date, ongoing not provided) and Polychondritis (start/stop date, ongoing not provided).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (sored left arm). On 27-Jan-2021, the patient experienced INJECTION SITE SWELLING (woke up with a red ,large ,round mark like being hit with a baseball) and INJECTION SITE ERYTHEMA (woke up with a red ,large ,round mark like being hit with a baseball). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA) (subcutaneous) ongoing since an unknown date for Immunocompromised, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sored left arm), INJECTION SITE SWELLING (woke up with a red ,large ,round mark like being hit with a baseball) and INJECTION SITE ERYTHEMA (woke up with a red ,large ,round mark like being hit with a baseball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included immunocompromised medication ( every day with different medications), steroid medication for outbreak and Hizentra infusion SC.   This case was linked to MOD-2021-106521 (Patient Link).   Reporter did not allow further contact
Fever 100, malaise, fatigue, muscle joint aches 24 hrs. Took Tylenol.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant therapies included sterile diluent (lot # R022280, expiration date: 6-OCT-2019). On 09-OCT-2018, the patient was vaccinated with M-M-R II (lot # M027637, expiration date: 02-JUN-2018) dose 1 for prophylaxis (strength, dose, route of administration and site of administration were not reported). The patient reported that, on 09-OCT-2018, the patient was vaccinated with an expired dose of M-M-R II (lot # M027637, expiration date: 02-JUN-2018) dose 1 for prophylaxis (strength, dose, route of administration and site of administration were not reported) and the patient was supposed to receive PROQUAD (lot number, albumin status and expiration date were not reported) (expired product administered) (wrong vaccine administered).  No adverse effects were reported.
This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 46-year-old female patient who received RABAVERT. Co-suspect products included immunoglobulin human anti-rabies (HRIG) and prednisone for an unknown indication. The patient's past medical history included cat bite. Previously administered products included HRIG (received approximately 20 years ago) and Rabies vaccine (received approximately 20 years ago). Concurrent medical conditions included animal bite and asthma. Concomitant products included Influenza vaccine unspecified. On 27th October 2016, the patient received the 1st dose of RABAVERT (intramuscular) 1 ml and HRIG. In September 2016, the patient started prednisone at an unknown dose and frequency. On 27th October 2016, less than a day after receiving RABAVERT and an unknown time after starting prednisone, the patient experienced muscle soreness. On an unknown date, the patient experienced drug interaction. On an unknown date, the outcome of the muscle soreness was recovering/resolving and the outcome of the drug interaction was unknown. It was unknown if the reporter considered the muscle soreness and drug interaction to be related to RABAVERT. Additional details were provided as follows: The patient recently started a 4 dose series of RABAVERT after she thought had a bat bite, but never saw it so was not sure and received 1st dose of RABAVERT on Left deltoid. She explained that they injected medicine into the wound as well as injections in the deltoid so she assumed that she received HRIG as well as all 4 injections of the vaccine. She read that the immunoglobulin received this last time can make the vaccine ineffective. The patient had massive anxiety because thought that the recent HRIG injection was preventing the protection against rabies. On an unknown date, less than a week after receiving all vaccination, the patient experienced drug interaction. This case has been linked with case US2016GSK161876 as reported by same reporter.
Imms given, immediately red area at injection site and child complained of itching. Rt arm red area 4.5 mm x 3 mm. Hydrocortisone cream & ice pack applied for 20 min. Resolved
Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an Adult patient (age and gender not reported) who received a dose of vaccine QUADRACEL lot number not reported via unknown route instead of ADACEL lot number not reported. The patient's past medical history included Wound. It was a case of actual medication error due to wrong vaccine administered. It was unknown if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
Case number PHEH2013US016004, is an initial spontaneous report received from a medical assistant on 25 Jul 2013: This case refers to a patient of unspecified age and gender. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: not reported), intramuscularly without being reconstituted with Men A component, three to four weeks ago on an unspecified date. No adverse reaction was reported following this administration error.
temperature excursion 14 degrees F to 46 degrees F (16F); This spontaneous report as received from a nurse (also reported as medical assistant) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (RHA)(PROQUAD) 0.5 ml, lot # T021301, expiration date: 19-DEC-2021 (route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine underwent the temperature excursion of 14 degrees Fahrenheit (F) to 46 degrees F (16F) for 25 minutes. Digital data logger was involved. There were no previous excursions reported. It was reported that the vaccine was administered to the patient during the excursion.
no adverse event noted. patient was administered wrong vaccine- received Peds Pfizer 5-11 years rather than Pfizer 12 years & older.
malaise; dizziness; skin rash; Severe Vomiting; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Drug allergy (Multiple drug allergies), Insect sting allergy (severe reaction), Contrast media allergy (yellow dye 5) and Anaphylactic reaction. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), EZETIMIBE (ZETIA), UPADACITINIB (RINVOQ) and HYDROMORPHONE HYDROCHLORIDE (DILAUDID) for an unknown indication.   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting), PYREXIA (fever) and HEADACHE (headache). At the time of the report, MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting), PYREXIA (fever) and HEADACHE (headache) was resolving.            No treatment medications were provided by reporter.
itches; rash, rash is spreading; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches) and RASH (rash, rash is spreading) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced RASH (rash, rash is spreading). On an unknown date, the patient experienced PRURITUS (itches). At the time of the report, PRURITUS (itches) and RASH (rash, rash is spreading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
pt recvd vax;following day exp a sore arm; approx 5 days later exp lymph nodes under lt arm;
Our daughter went from a very happy and bubbly mood to suddenly very sick within an hour after shot. She displayed persistent non-stop crying and irritability. She wouldn't play, eat, or even interact. She couldn't sleep and kept waking up crying throughout nap time. She would not quit crying for over 4 hours and when we finally calmed her down she only laid down in our lap and wouldn't sleep. She was perfectly ok before shot and only showed symptoms of being sick after shot. The symptoms cleared up after 8 hours.
Welting at site of injuection, rash on entire body, treated with cortisone
increase in absence/partial seizures after vaccine (was having one every 3 months, has had 4 since date of vaccine)
Patient went home, slept from 6-10pm. Awoke complaining "heart hurts". Mother took pulse and thought it was fast. Not aware of any temperature. Took child to Emergency Room. No treatment given. Child fine today per mother.
Then it spread to her face and lower leg; Itching on her chest, back, lower leg, arm, neck and face; It was red; Her arm started burning; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Her arm started burning), CONDITION AGGRAVATED (Then it spread to her face and lower leg), PRURITUS (Itching on her chest, back, lower leg, arm, neck and face) and ERYTHEMA (It was red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TIMOLOL, AMLODIPINE, CHLORTHALIDONE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL, CYANOCOBALAMIN (VITAMINE B12) and ASCORBIC ACID (VITAMINE C) for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SKIN BURNING SENSATION (Her arm started burning) and ERYTHEMA (It was red). On an unknown date, the patient experienced CONDITION AGGRAVATED (Then it spread to her face and lower leg) and PRURITUS (Itching on her chest, back, lower leg, arm, neck and face). At the time of the report, SKIN BURNING SENSATION (Her arm started burning), CONDITION AGGRAVATED (Then it spread to her face and lower leg) and ERYTHEMA (It was red) outcome was unknown and PRURITUS (Itching on her chest, back, lower leg, arm, neck and face) had not resolved. Not Provided          Treatment information included hydrocortisone cream.   This case was linked to MOD-2021-089102 (Patient Link).
Extreme Nausea (48 hours), Loss of appetite (48 hours), Hot & Cold Chills.
Was in bed for two days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "Was in bed for two days".  Additional information: Reporter together with his wife got their first dose of the vaccine 3 weeks ago (13Apr2021). Their second dose of the vaccine is due tomorrow 04May2021. However, they were told that they will be receiving the second dose on a different facility and have to re-schedule. They did not receive a call yet regarding where to go for their second dose of the vaccine. It was stated that he is 62-year-old and wife is 65-year-old. They both received their second Pfizer Covid vaccines on 05May2021 and on 06May2021 he reports they have low grade fevers. He has no questions at this time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cellulitis, swelling, pain, redness limited use of arm for 3 days at injection site. TX: KEFLEX P.O.
Erythema and swelling around injection site starting about 24 h after injection. Has also had HA, fever and sweaty. (L) deltoid/upper arm with 8x10cm red elevated wheal, mildly tender.
some surgeries; This case was reported by a pharmacist via call center representative and described the occurrence of surgery in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced surgery. On an unknown date, the outcome of the surgery was unknown.   It was unknown if the reporter considered the surgery to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not know about those surgeries but mentioned that due to those surgeries, the patient was late for 2nd dose of Shingrix. It was 18th months over from 1st dose but the patient did not receive 2nd dose. No information about Lot number available. The reporter consent to follow up.
3 weeks after 2nd dose of vaccine, he was hospitalized for bloody diarrhea.  5 days later was diagnosed with Ulcerative colitis.
Pt recvd vax 31OCT90; On 01NOV90 pt noted edema of the triceps muscle, erythema, & warmth @ inject site; sx were treated locally w/ice & resolved;
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jan2021 at 11:00 as dose 1, single (Lot number: EL1283), in right arm, on 08Feb2021 at 15:00 as dose 2, single (Lot number: EL9265), in right arm and on 30Sep2021 at 17:00 as dose 3 (booster), single (Lot number: 301308A) at the age of 68 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 at 19:00 as dose 4 (booster), single (Lot number: AR71448) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022 at 19:00, outcome "unknown", described as "Moderna Dose Number: 4; Pfizer Dose Number: 3, 2, 1"; COVID-19 (medically significant) with onset 10Nov2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 12-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    No concomitant medications were reported.  The patient didn't received second dose of vaccine. No adverse effect noted in patient. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:MAster case
11/2000-Burning bottom of foot.  Extreme fatigue, severe joint/muscle pain, stiffness, difficulty walking and going upstairs.  Sometimes have to crawl up stairs, forgetfulness, disorientation, blurry vision, shin splints, burning sensation-hand.  When on floor I have to crawl to furniture to get up.
Urticaria-uper extremities, trunk. Rx: Benadryl 60mg now + 50mg q 6 hr prn.
Temp 102.8 F, nausea, vomiting, severe headache, dizziness, weakness, myalgias, sore throat with swollen glands.
Information has been received from a physician and a medical assistant concerning a 23 year old female patient with no medical history and reported as "free of heart murmur" who on 19-JUL-2010, was vaccinated with the first dose of GARDASIL (Lot # 0450Z). There was no concomitant medication. It was reported that after the vaccination, the patient was instructed to wait in the reception area. Then she went back to the exam area and while standing up, "about 10 minutes" after she had received GARDASIL, she felt dizzy, fell back, fainted and hit her head. The physician stated that she was not sure but the patient may have had a seizure. She also stated that she heard the patient fall and when she went to the reception area the patient was unconscious, on the floor sitting up. According to the medical assistant, the patient was unconscious for less than a minute. The patient had bruised her head (specific area not specified). The physician called the patient's name and she regained consciousness immediately and recovered. It was mentioned that the patient had a brief period of amnesia, when she stood up she was coherent. The patient was taken to the treatment room and was given water. The time from the GARDASIL to the time the patient went to the treatment room was about 15 minutes. The patient remained in the physician's office for one hour and a half, before she went home with her mother. She was sent to the emergency room to rule out head injury and had other screenings (unspecified). The patient had an electrocardiogram (EKG) performed which results were abnormal; she was not admitted to the hospital. The patient was referred to a cardiologist. Upon internal review the patient may have had a seizure was considered another important medical event. Additional information has been requested.
Headache, Myalgia, Arthralgia, Insomnia Narrative:
Approximately 5 weeks after vaccine tested positive. On 11/13 in the evening I began noticing a tightness in chest and when I breathed I could hear wheezing. On the morning of 11/14 I took at home COVID-19 test which was positive. Called a HCP and made appointment. At appointment I tested positive again. Was prescribed PAXLOVID and inhaler for wheezing. That evening still had cough and developed fever. Woke up on 11/15 feeling much better and on the mend. Still feeling better today.
No adverse reaction occurred; Patient was vaccinated for booster dose too soon (12/9/21). Six month waiting period occurs 12/29/21