chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Disease Recurrence; Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 27May2021 as dose 1, single (Lot number: EW0178), on 17Jun2021 as dose 2, single (Lot number: EW0181), on 14Mar2022 as dose 3 (booster), single (Lot number: FK9895) and on 30Jul2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "breast cancer", start date: 2017 (unspecified if ongoing); "bladder cancer", start date: 2017 (unspecified if ongoing); "COVID-19 infection", start date: Feb2021 (unspecified if ongoing); "asthma" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing); "chemo therapy" (unspecified if ongoing); "issues with her memory" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE oral taken for rheumatoid arthritis (ongoing); FOLIC ACID oral taken for rheumatoid arthritis (ongoing); VITAMIN D3. The following information was reported: COVID-19 (medically significant) with onset Dec2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Dec2022, outcome "unknown"; DISEASE RECURRENCE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: She tested positive for covid in Dec2022; (2023) Positive, notes: She also tested positive for covid in Feb2023 or Mar2023. Clinical course: Patient reports she developed severe covid 19 infection for the first time in Feb2021 prior to receipt of any covid 19 vaccines; states almost died, it was bad. Then she developed covid 19 infection again in Dec2022 and then either Feb or Mar2023 while she was in rehab. States she was in a car accident and was in rehab 04Jan2023 to Mar2023. Stated she was immunocompromised. She was diagnosed with breast and bladder cancer in 2017 and had to had chemo therapy. Stated she also developed rheumatoid arthritis at that time as well (prior to any receipt of covid 19 vaccines). Stated she was currently taking Methotrexate (started taking a year before getting covid, the bad covid. Clarifies she thought she started taking in 2020 or the end of 2019). Reports she had asthma (timeline unclear); also comments that she had issues with her memory. She was asking if she could get another Pfizer covid vaccine at the end of Oct. She was hyperactive.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021738674 same patient, different drug/event;
Had a TWINRIX injection at the pharmacy. I had swelling of the lips, fingers, arms and legs with severe itching. BENADRYL did not help the situation. I had the injection on 6/9/15 at 5 pm and as of today, 6/10/15 at 912pm, I still have the symptoms of swelling in the lips, fingers and itching of the extremities.
Mother called at clinic, after 1 hour post vax, said that child had vomited once, a large amount. Mother states it might be the cookies that she ate at lunchtime. Checked on the child at 17:00 and mother stated she feels better. On 10/17/00, rechecked the child and she had no problems, per mom.
under the weather; had a sore left injection site arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site arm) and FATIGUE (tired) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site arm) and FATIGUE (tired). At the time of the report, MALAISE (under the weather), VACCINATION SITE PAIN (had a sore left injection site arm) and FATIGUE (tired) 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 were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-369380, MOD-2021-369222 (Patient Link).
This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-OCT-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
no adverse effect; improperly stored dose inadvertantly administered; This spontaneous report as received from a Healthcare business professional refers to a 12-year-old male patient.    The patient's pertinent medical history, concurrent condition and drug reactions/allergies were not reported.  On 12-JUL-2019, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1602283, expiry date: 18-AUG-2021) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis (product storage error).  It was reported that the vaccine was exposed to a temperature below2 degree Celsius (-0.6 degree Celsius) for a time frame of 50 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effect was reported. No additional information provided. No product quality complaint (PQC) was reported. The outcome of product storage error and no adverse event was unknown.
Eight days after the first injection, I noticed for the first time a reddish blotch near the site of the injection.  The day after it had spread downward, the next day the redness seems to have diminished some, but it still covers the same area.   The redness was warm to the touch, and hard,  but not painful.  The area felt like the size of the palm of my hand.  I did not run a fever.  I realize that redness is one of the side effects, but my concern is that it didn't occur immediately; rather, one week later.
The pt experienced bloody diarrhea and a fever of 102.2 following the Prevnar vaccination on the same day. No treatment received. The symptoms resolved spontaneously.
he didn't feel good; felt like he had to burp; vomiting; feels groggy; Always freaked out when he feels pain; This is a spontaneous report received from a contactable consumer, the patient (reported for himself). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173; Expiration Date: 31Aug2021) via an unspecified route of administration, administered in Arm Left on 11Jun2021 09:15 as 2nd dose, single for covid-19 immunization. The patient medical history was reported as none. Concomitant medications were not reported. Family history was reported as no. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no: EW0175) received on 20MAY2021 08:05 AM in right side upper arm and experienced arm pain. Patient reported that he was the only one in the family that got the vaccinated. On 11Jun2021, patient didn't feel good, experienced vomiting, felt groggy, he always freaked out when he feels pain. The first dose was on 20th of May and the second dose was on this morning around 09:15 AM. Patient received second dose today at 9:15am and an hour and a half later he didn't feel good, felt like he had to burp and ended up vomiting once, and feels groggy but not tired. He dint had headache, fever, or chills. His temperature was 98.6. He had to leave work today. He stated he always "freaked out" when he feels pain or something that was not normal in his body. He asked, should he just wait it out for a couple of days and then go to the ER. No treatment was received to treat events. The outcome was unknown.  Follow-up actions are needed. Further information has been requested.
stiff neck, headache, closed sinuses, injection site pain, fever, body aches, chills, sweats.  Fever as high as 102  CIDP Neuromuscular symptoms WAY WORSE with 2nd shot.  Hands very numb and tingling  Hand tremors exaggerated.     Pinky fingers keep pulling away.  No grip, no movement control.  Balance WAY WORSE.  Leg muscle trembling & weakness, collapsing.  Had to use walker CAUTIOUSLY.  Burning painful feet and legs.  Dizzy and odd head feelings.  Eyesight weird, like it was faded.
Immediate rash with persistent rash months later, itching and warmth. biopsy done 4/19/21
some hearing loss; Developed tinnitus; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Developed tinnitus) and DEAFNESS (some hearing loss) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 13-Apr-2021, the patient experienced TINNITUS (Developed tinnitus) (seriousness criterion medically significant). On an unknown date, the patient experienced DEAFNESS (some hearing loss) (seriousness criterion medically significant). At the time of the report, TINNITUS (Developed tinnitus) had not resolved and DEAFNESS (some hearing loss) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications was not reported. The treatment details was not reported. Patient experienced with developed tinnitus 2/3 weeks after 1st shot. Met with an audiologist and ENT doctor on 06-Apr-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-255352 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: significant follow up document: height, weight, ethnicity added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vertigo lasting over 10 days; This is a spontaneous report from a non contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 17:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included Idiopathic low Complete Blood Count (CBC) (white blood cell count <2.0). The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left  arm on 26Mar2021 at 18:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 17Apr2021 at 03:00, the patient experienced vertigo lasting over 10 days. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event vertigo  was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT VACCINATED W/ENGERIX-B DEVELOPED 70% DEAF RT EAR.
not feeling good; shoulder of the injection site down to the elbows and wrist became sore; like whole brain was being shorted out; shoulder of injection site down to elbows and wrist became sore; electrical current running through head,felt like whole brain was being shorted out; pain in left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good), PAIN IN EXTREMITY (shoulder of the injection site down to the elbows and wrist became sore), FEELING ABNORMAL (like whole brain was being shorted out), VACCINATION SITE PAIN (shoulder of injection site down to elbows and wrist became sore) and HEADACHE (electrical current running through head,felt like whole brain was being shorted out) in a 74-year-old female patient who received mRNA-1273 (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis and Parkinson's disease.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (not feeling good), PAIN IN EXTREMITY (shoulder of the injection site down to the elbows and wrist became sore), FEELING ABNORMAL (like whole brain was being shorted out), VACCINATION SITE PAIN (shoulder of injection site down to elbows and wrist became sore), HEADACHE (electrical current running through head,felt like whole brain was being shorted out) and ARTHRALGIA (pain in left shoulder). At the time of the report, MALAISE (not feeling good), PAIN IN EXTREMITY (shoulder of the injection site down to the elbows and wrist became sore), FEELING ABNORMAL (like whole brain was being shorted out), VACCINATION SITE PAIN (shoulder of injection site down to elbows and wrist became sore), HEADACHE (electrical current running through head,felt like whole brain was being shorted out) and ARTHRALGIA (pain in left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Patient stated that the pain is on-going and does cause her to wake up in the middle of the night with pain in the left shoulder and left arm. Treatment was reported as Tylenol extra strength and ibuprofen. No concomitant medications were reported.; Sender's Comments:  MOD-2021-100608:Husband's case
RMA took out MenB vaccine instead of Menactra vaccine for patient. Pt will still need to received Menactra or MCV4 vaccine. RMA retrieved it out of the AccuVac machine by accident and someone else administered it.
Subsequent to the vaccination, OB ultrasound on 10/05/2001 revealed approximately 3-4 weeks gestation at time of vaccine administration.
Pain down outside of left arm - assessed by physician- neg neurological exam. Referred to PCP for follow up.
No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 23-OCT-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012655: US-009507513-1904USA012656: US-009507513-1904USA009929: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA012654: US-009507513-1904USA012652:
No additional adverse event; the patient was 17 years old, he received first dose of GARDASIL 9 on 7/29/2016 and the second dose ofGARDASIL 9 on 8/10/2017.; This spontaneous report was received from an administrator referring to a 17 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 29-JUL-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose detail, frequency, route, lot# and expiration date were not reported) for prophylaxis. On 10-AUG-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose detail, frequency, route, lot# and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported.
Severe body aches with onset on evening of 10/06.  Also experienced transient spasms around the right knee.  Pain was not relieved by Tylenol and Ibuprofen last night.  Patient could not reach her PMD on 10/07.  Symptoms now lessened but patient still sore in vaccinated arm.  Body aches much decreased.  No knee spasms.
We had all 4 of the shots and the immunoglobulin for post exposure; This case was reported by a consumer via other manufacturer and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   Previously administered products included Rabavert (1st dose received with immunoglobulins), Rabavert (On 25th November 2016,received  2nd dose), Rabavert (On 29th November 2016,received  3rd dose) and Rabavert (On 6th december 2016,received  4th dose).   On an unknown date, the patient received the 5th dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient's wife reported they had bat in the house and the patient received 4 shots with immunoglobulins. All 4 doses received in 2016 and the patient had not received 5th dose which led to incomplete course of vaccination. This was medication error without harm. The reporter consented for follow up.   On the follow up following internal review it was determined that the initial receipt date (26th August 2020) which is earlier than initially reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163481: US-GLAXOSMITHKLINE-US2020AMR163473:
Lightheaded, dizzy, palms of hands red, elevated BP, scratchy scalp, intense all over muscle pain, nausea, feeling of impending doom, toxic feeling
Patient states that his big toenails on both fee had bruising after getting ZOSTAVAX vaccine.
Hive was developed all over body after 2 days of second shot of COVID vaccine, and it has been there for a month and half. Treatment is taking allegra, allertec, benedryl.
Dull achy pain from armpit to elbow, redness on injection site, headache.
pt recv vax & exp a significant reaction of tenderness & swelling 4-5 inches round & raised 1-2inch, which lasted 1wk;No further details were provided;
Systemic: Eyeball turned red/purple and got worse-Medium, Additional Details: eyeball turned red/purple that pt attributes to covid booster dose. Pt has a visit scheduled to eye dr. on 01/14/2022
Patient came with a Novavax prescription from her doctor because she was told that Novavax is better than any other manufacturer. Patient was asked if she ever had any covid vaccine, she said no. Novavax was given to the patient on 10/26/22. Staff (from CDC) called on 11/2/22 saying that the patient already got 4 doses of pfizers. Upon investigation, patient thought she was asked if she ever had Novavax vaccine that's why she said no. On 11/3/22, I spoke to the patient and told her that she can't be given the Novavax vaccine if she already got a Pfizer booster. Patient understand and acknowledged that a misunderstanding happen.
nasal swab covid test result positive; nasal swab covid test result positive; This is a spontaneous report from a contactable Other HCP (for herself) reported that a 38-year-old female (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EJ1685 and Expiration Date unknown) intramuscularly on 21Dec2020 01:45 PM at single dose (Left arm) for COVID-19 immunisation. The patient's medical history was known allergies: Penicillin, clindamycin, doxycycline. The concomitant medications was not reported. No other vaccine in four weeks. Patient experienced nasal swab covid test type post vaccination on 01Jan2021 was positive. The outcome was unknown with no treatment.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported nasal swab covid test positive based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Confusion, temperature over 102 degrees, chills, joint pain, muscle pain, headache, diahrea, cough, difficulty breathing, facial swelling, fatigue, slept for 24 hrs followed by additional long periods of sleep, weakness, lightheadedness, loss of voice, tingling in the extremities
Petechiae on leg. 4 small red dots, 7 days after vaccine.