chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; severe headache; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID vaccine. On an unknown date in 2021, the patient experienced injection site pain, severe headache and fatigue. The clinical outcome of the events injection site pain, severe headache and fatigue were recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a  healthcare worker concerning an unspecified number of patients (demographics unknown). On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K023863; expiration date: 03-ARP-2016. No adverse experiences reported for any patients. This is one of several reports received from the same source. Additional information has been requested.
Narrative:  41yo male with recent mental health inpatient admission & substance abuse died on 7/24/2021 from self inflicted gun shot wound. Pt had received covid vaccinations on 5/10/21 & 6/3/21. Vaccines were not related to death.
Information has been received on 14-JUN-2017 from a medical assistant via a company representative regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (lot number and expiration not reported) subcutaneous for prophylaxis. Concomitant therapy included sterile diluent. The medical assistant reported that on an unknown date, the patient had a reaction of extreme itching all over her entire body. The patient sought treatment by contacting the office. No further information was provided. Additional information was received on 15-JUN-2017 from a company representative. The patient has been itching for 4 months. The patient has been referred to a dermatologist and an allergist. The patient is still itching as of the date of this report. The patient was not vaccinated in the reporting office and the location of the vaccination could not be confirmed. The patient is between 50 and 60 years old. The patient is attributing the itching to the ZOSTAVAX as the itching was first experienced right after the ZOSTAVAX. The patient was being seen by a primary care physician in the office. The physician did not provide a causality assessment. The outcome of extreme itching all over her entire body was reported as not recovered/not resolved. Additional information has been requested.
Ever since my child has had those 3 vaccines her behavior is like night and day. A drastic change in behavior almost bipolar it seems. Normally she is a happy upbeat child, suddenly she literally goes from Angry, to sad, to outbursts every few minutes, it is weird and scary. This is an absolute drastic turn in her behavior. She will just walk around and out of nowhere stop and get angry, or she will stop and cry, I mean literally every few minutes. She cries for no reason or gets angry. This is NOT her normal behavior at all, she does it as if she is confused. Then she will just have a random outburst of rolling around and twisting her body all over like she is very frustrated and irritated at random points. And when I hold her and look at her trying to understand what is going on to hug her and kiss her, she has this confused look at me and doesn't want to be bothered. This is very scary and this is not how my child behaves, this literally occurred once she got those vaccines. I tried to capture her sporadic behavior on video but it is literally so random that I can't catch it right when it begins! Please, please have this looked into something is really not right with the vaccines for it to cause this side effect. She has also had on and off fever and running nose, serious congestion & cough, up until today she had a fever, so I have called her doctor today and made an appointment for her to be seen tomorrow since the fever and cold symptoms should've worn off by now.
Pt developed a small erythema area the day after the rash. Rash increased in size to approximately 10 cm around injection site. Pt initially started on KEFLEX due to concern over cellulitis since it had been approximately 48 hours since injection. Pt improved over the weekend.
Mild general body aches; Mild fever, 101F; Mild/moderate headache; Tiredness; This is a spontaneous report from a Non contactable consumer (Patient). A 29-Years old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247) via unspecified route of administration, administered in left arm on 16Feb2021 03:45 PM (age at vaccination was 29) as DOSE 2, SINGLE for COVID 19 immunisation at workplace clinic. The patient had covid prior vaccination. The patient's concomitant medications were not reported. Patient had no known allergies. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on 26Jan2021 03:30 PM as DOSE 1, SINGLE for COVID-19 Immunization. Patient had not been tested post vaccination. The patient experienced Mild fever, 101F, Mild/moderate headache, Tiredness, Mild general body aches on 17Feb2021 03:00 AM. The patient also underwent the lab test and procedures included body temperature and resulted into 101F. The outcome of events was recovering.  No follow up attempts were possible. No further information was expected.
Info has been received from a physician concerning a pt who was vaccinated with varicella virus vaccine live. Subsequently, the pt appeared to have chicken pox. No additional info regarding the adverse event or pt's outcome was not available at the time of this report. Additional info has been requested.
pt recvd vax; immediately after vax pt found to be anti HBs pos; also anti HBc pos;
he has got hives all over his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A 14-year-old male patient received BNT162b2 (BNT162B2), on 10Jun2022 as dose 2, single (Lot number: FM0173) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Jun2022, outcome "unknown", described as "he has got hives all over his body". Therapeutic measures were taken as a result of urticaria. Additional information Reporter stated, my son got, he is 14, he got a second dose of the Covid vaccination on Friday and Saturday he has got hives all over his body. If wants to report or have any question: Reporter stated, I want to report. I was told to report it. My doctor told me to report it to you. Reporter stated, No I am the mother of my child. Medical conditions or Concomitant medications: Reporter stated, "Nothing (Further not appropriately clarified, hence tab left uncheckered). Treatment: Reporter stated, "Just Claritin like a you know, (voice overlapped).  No follow-up attempts are needed. No further information is expected.
FLU SYMPTOMS; BROKE FOOT; HEADACHE; This spontaneous report received from a patient via AbbVie concerned a 38 year old of an unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. On 13-MAY-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The age at time of vaccination was 38 years. On an unspecified date, the patient received non-company suspect drug adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) citrate free, 40 mg/0.4 ml, 1 time every 2 weeks for psoriatic arthritis. On an unspecified date, the patient experienced flu symptoms (dose number in series: 1). On an unspecified date in 2021, the patient experienced headache for a duration of four days (dose number in series: 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 2021, and the outcome of flu symptoms was not reported. On 20-SEP-2021, the patient received non-company suspect vaccine elasomeran (Moderna covid-19 vaccine) (dose number in series: 2) (form of admin was not reported, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, administered for covid-19 prophylaxis. No concomitant medications were reported. On MAR-2022, the patient experienced broke foot (dose number in series: 2). The action taken with elasomeran was not applicable; and action taken with adalimumab was not reported. The outcome of broke foot was not reported. On 30-APR-2022, the patient received booster of non-company vaccine elasomeran (Moderna covid-19 vaccine) (dose number in series: 3) (form of admin was not reported, subcutaneous, batch number was not reported, expiry: unknown) dose was not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following elasomeran (Moderna covid-19 vaccine) (dose number in series: 3). This report was non-serious.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M041084, expiration date 04-APR-2018) for prophylaxis (dose and route of administration were not reported). A sterile diluent (manufacturer unknown) was used. The vaccine was stored at 6°F-14°F for 1 hour. There were no previous temperature excursions and the call was because of a digital data logger. No product quality complaint was involved.
Lower extremity weakness, associated with areflexia in an ascending pattern - admitted to  Hospital on 11/6/16 with diagnosis of Guillain-Barre Syndrome and being with treated with IVIG, Neurontin and Motrin Remains inpatient to date.
Myalgia, Fever, NauseaVomiting, chills, knot in right arm Narrative:
Information has been received from a consumer concerning her 9 year old son (one of twins) who was vaccinated on 09/26/00, with one dose of Hepatitis B vaccine. On 09/27/00, when the patient returned from swimming his mother noted a 10 cm x 4 cm bump going down his left arm. Unspecified medical attention was sought. Follow up info from a consumer indicated that her son was given this "shot series as a toddler". Conflicting follow up info from a member of the physician's staff indicated that on 08/31/00, the patient was vaccinated with his 1st dose of Hepatitis B vaccine. On 08/31/00 the patient experienced a 3 inch red, raised, warm, local reaction at the site of the injection lasting 48 hours. The reporting healthcare provider indicated that the patient had recovered on 09/02/00. No further info is available.
Following her 6 mo. round of shots fever and lethargic.  Doctor sent her to emergency room.  Soft spot was full.  Overnight stay to observe.    Large patches of  HAIR fell out following illness.
swelling of my lymph node under my armpit on the same arm as my shot; chest started to tighten a bit; body aches; chills; fever persisted for 24 hours and surpassed 100.4; lymph node pain; headache; fatigue; This is a spontaneous report from a non-contactable consumer.   A 23-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 10:45 (Batch/Lot number was not reported) (at the age of 23) as single dose for covid-19 immunisation. Medical history was none. No known allergies. There were no concomitant medications. The patient experienced swelling of my lymph node under my armpit on the same arm as my shot on 17Feb2021 22:00, chest started to tighten a bit on 17Feb2021 22:00 with, body aches on 17Feb2021 22:00, chills on 17Feb2021 22:00, fever persisted for 24 hours and surpassed 100.4 on 17Feb2021 22:00, lymph node pain on 17Feb2021 22:00, headache on 17Feb2021 22:00, fatigue on 17Feb2021 22:00. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Most symptoms subsided after 36 hours, but lymph node pain, headache, and fatigue persisted for a bit longer. The outcome of fever was unknown, of the other events was recovered on an unknown date  No follow-up attempts are possible; information about lot/batch number cannot be obtained
pain in my kidneys on both sides; Fever of 103, usually averages around 96.7 to 97 degrees; Chills; body aches; horrible headache; vomiting; diarrhea; nausea; The arm that received the shot was extremely sore; Still feeling weak and exhausted after day 5; Still feeling weak and exhausted after day 5; Kidney infection; This is a spontaneous report from a non-contactable consumer. A 39-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER2613) via an unspecified route of administration on 26Mar2021 at 09:00 (at the age of 39-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism, gastroesophageal reflux disease (GERD), generalized anxiety disorder (GAD), atrial fibrillation, and psoriasis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included levothyroxine, birth control, propranolol, escitalopram oxalate (LEXAPRO), naproxen (naproxen sodium), and loratadine (CLARITIN) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EN6198) on 08Mar2021 at 11:30 as a single dose in the left arm for COVID-19. The patient previously received oxycodone hydrochloride, paracetamol (PERCOCET) from an unknown date and experienced allergy. On 26Mar2021 at 09:00 (as reported), the patient experienced fever of 103, usually averages around 96.7 to 97 degrees, chills, body aches, horrible headache, vomiting, diarrhea, nausea, the arm that received the shot was extremely sore. These symptoms lasted over 3 days. The patient was still feeling weak and exhausted after day 5 (30Mar2021). The patient had pain in her kidneys on both sides that started on day 4 after getting the vaccine (29Mar2021). The patient visited a doctor as a result of the event. The patient received treatment for a kidney infection. The patient's symptoms started within 3 hours of the second shot and continued for over 3 full days. The outcomes of fever, chills, body aches, horrible headache, vomiting, diarrhea, nausea, the arm that received the shot was extremely sore, weak, exhausted, kidney infection, and kidney pain were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
1/9-had body aches and fatigue. ibuprofen helped. 1/10-fatigue 1/11-fatigue stuffy nose. headache. 1/12-fatigue, runny nose, headache, diminished taste and smell 1/13 -fatigue, runny nose, headache, diminished taste and smell -PCR tested today.
About halfway through the patient's 15-minute waiting period after receiving the Janssen vaccine, she let me know that she felt a numbing feeling in her upper shoulder on the side she received the shot.  She said it feels like when you get novocaine at the dentist's and it starts wearing off.  She said it traveled up to the same side of her face/jaw and the side of her mouth.  She could move her arm fine and raise it above her head.  No signs of drooping in the face when asked to smile.  No other symptoms such as trouble breathing or swallowing, dizziness, or pain.  When she touched herself in the numbing areas, she could still feel the touch.  I called 911 to be safe.  While talking to the dispatcher, she said she thinks it's not as bad in her face but now thinks she feels it in her legs.  While still on the phone, PD arrived. Shortly paramedics came and said her vitals were fine and evaluated her for signs of anaphylaxis.  Since she had no immediate symptoms,  the patient decided to go home instead of in the ambulance to the hospital.  Her friend was with her who drove them.  She was instructed to call 911 or go to the ER if symptoms worsened or new symptoms began
got the shot, got them anyway; got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot, got them anyway) (serious criteria GSK medically significant) and shingles (Verbatim: got them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-Mar-2023 The reporter reported the case via interactive digital media. The reporter's friend got the shot, got them anyway. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
I experienced the following symptoms. Pain in the right shoulder at the injection site for 3 days. The injection site was red for three days. Tingling from right shoulder, extending to my finger tips of my right hand.  Hives on my face and neck. Extreme fatigue and body aches. Diarrhea and loss of appetite. Headache, and fever. Persistent coughing. Significant amount of mucus and congestion, which materialized into  Pneumonia.
16 cm + 11cm red area surrounding injection site. Minimal warmth, no blisters, no hives on L thigh.
Pt slumped over in chair approx. 3 seconds, post vax. His arms and legs starting jerking, his eyes were open and eyeballs rolled back. This lasted about 10 seconds. Pt sat up. Pt stated "I fell asleep, I had a dream". He was not aware of what happened. Pt was alert and oriented to person, date and day, immediately after the episode. Pt was able to leave the office, walking without assistance.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of VARIVAX (Oka/Merck). Subsequently the patient experienced redness and swelling at the injection site. The patient contacted the office to seek medical attention. This is one of 4 reports from the same source. No further information is available.
pt recv vax & became pale, lethargic, & laid on floor, cont to breath, but gave no verbal response to stimulation for 3-4sec finally responded to verbal stimuli;Saturday up then walked to mom's lap;clinic visit observed for 15-20mi;
Tired. Slept for while after shot, then a few hrs later, Pressure in chest followed by  a feeling that I must breathe deliberately for myself or I might not breathe automatically. Did deep breathing, watched and wondered when I should get help. Realized I could help myself and began using acupuncture and applied kinesiology points. After a time, breathing slowly retuned to normal.  Very, very tired.Next 2 days, balance poor. Actually fell before I realized how woozy I was. Hit head on wall, but not knocked out. After balance recovered, still very tired after 10 days, but not as bad. Memory worse.  Hoping all will improve.
Dose Leaked from the arm to the elbow; Dose Leaked from the arm to the elbow; Slight Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Dose Leaked from the arm to the elbow), DEVICE CONNECTION ISSUE (Dose Leaked from the arm to the elbow) and DISCOMFORT (Slight Discomfort) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced UNDERDOSE (Dose Leaked from the arm to the elbow), DEVICE CONNECTION ISSUE (Dose Leaked from the arm to the elbow) and DISCOMFORT (Slight Discomfort). At the time of the report, UNDERDOSE (Dose Leaked from the arm to the elbow), DEVICE CONNECTION ISSUE (Dose Leaked from the arm to the elbow) and DISCOMFORT (Slight Discomfort) outcome was unknown.            No concomitant medications reported by investigator  No treatment medications provided by the reporter.    Reporter did not allow further contact
pain near injection site; Vaccine administered a bit higher on arm; A spontaneous report was received from a male patient (unknown age) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain near injection site and vaccine administered a bit higher on arm.  The patient's medical history was not provided. No concomitant product use was reported.  ON 30-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.   The patient stated that he experienced pain near the injection site on left arm. The patient also mentioned that he believes the vaccine was administered a bit high on the arm than where it should have been administered- closer to his shoulder blade. Treatment included Tylenol (acetaminophen) and Advil (ibuprofen).  Action taken with mRNA-1273 was not applicable.  The outcome of the event, pain near injection site, was not recovered. The outcome of the event, vaccine administered a bit higher on arm, was considered recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 026L20A)  with AE reported of injection site pain.
VACCINE GIVEN 8 DAYS AFTER BEYOND USE DATE. NO ADVERSE REACTION OCCURED.
This spontaneous report as received from a nurse practitioner refers to a 17 year old female patient. In October 2013 (reported as one year ago) the patient received the first dose of GARDASIL (lot#, dose and route unspecified). On 30-OCT-2014 the patient presented to office for the second dose of GARDASIL (lot#, dose and route unspecified). No adverse effects were reported. The outcome of the event was unknown. No product quality complaint (PQC) involved. Additional information has been requested.
1/12 Pt received vaccinations 1:30pm in Rt upper arm and reported 1hr later that 10 mins after receiving vaccination she had tingling of Rt hand and pain with Rt arm between shoulder & elbow.  1/13 at 11:00 spoke with patient on phone. Reports - pain & tingling resided at about 9pm 1/12 and then she noted hive-like splotches on face & body. Took Benadryl & they are going away. Awaiting return phone call from her MD.