chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weak; beginning of flu; coughing little on Sunday and it was worst on Monday (18Jan2021); shoulder was sore and painful; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients (himself and his wife). This is the 1st of two reports.  A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (reported as "shot left shoulder") on 18Jan2021 07:00 at single dose for Covid-19 immunization. The patient's medical history included cough (Sunday) 17Jan2021. There were no concomitant medications. The patient reported that yesterday morning (18Jan2021) he had first vaccine shot, then last night and this morning that he had fever during the night. The patient stated that this morning (19Jan2021) he was weak and anxious. He further stated that he is better now. He does not know if it is related to the vaccine. He added that he went to take a Covid test (unspecified date) and will receive the results in three days. He stated that he does not think that he has Covid. The patient added that his temperature was normal when he saw the doctor at 10:00 this morning (19Jan2021). He took two Tylenol every four hours. The last time that he took some was at 2:00-3:00 this morning. He recovered but not totally at this time. He further stated that because of Covid in the air was because he said that he was anxious. He stated he recovered from being anxious at noon today, completely and with lasting effects. He also stated that he was weak and had to lay down on 19Jan2021. His wife gave him a cold towel and he was better and had breakfast. He added that he was coughing little on Sunday and it was worst on Monday (18Jan2021). He added that his shoulder was sore and painful on 18Jan2021 and that this morning it is almost okay. He stated that he still have pain when he moves his shoulder. He put an ice on his shoulder. The doctor checked lungs and thinks that he may have the beginning of the flu (19Jan2021). The outcome of event beginning of flu was not recovered; outcome of event cough was unknown; while the outcome of other events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021064803 same reporter and product, similar event, different patients
COVID-19 Vaccine EUA; Fatigue, headache, muscle pain, joint pain, chills, nausea, and fever. Symptoms appeared right when I went to bed. Still have symptoms the next day at 3pm.
Morning after vaccination patient noticed swelling and redness in the area of the injection site.  Red area became the diameter of a baseball 3-4 inches around. Red area still apparent 4 days after vaccination although patient reports it has gotten better. Patient reported normal reaction: Malaise/muscle aches the day after but that didn't persist beyond 24 hours.
Information has been received from a health professional concerning a 10 year old female with no medical history and no known allergies who on 08/16/00 was vaccinated with a dose of varicella virus vaccine live. On 08/16/00 the pt was also vaccinated with a first dose of hepatitis A vaccine (inactive)(manufacturer unknown). On 05/07/03 the pt started to develop a rash. On 05/14/03 the pt was seen in the office and the physician diagnosed a mild varicella rash on the stomach and legs and itching.  There was no known recent exposure to varicella. Promethazine hydrochloride (Phenergan) was prescribed and the pt was to be seen again in a week for follow up. It was noted that there was no information on the original administration since it was administered at another location. No product quality complaint was involved. It was also noted that one other pt was vaccinated with a dose of varicella virus vaccine live and developed chickenpox (WAES # 0305USA01248).  Additional information has been requested.
This spontaneous report was received from a physician refers to a patient od unknown age and gender. On 27-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter,. Additional information has been requested.
Patient got flu shot and pneumonia shot on the same arm per patient's request. Her arm was sore, red and was painful for a couple days. She saw MD and was prescribed for antibiotics and improved. Do not know if that is caused by flu shot or pneumonia shot.
1-4-2012 started with red papules on rt- shoulder. Seen in office 1-9-12 with papules over torso head, arms with one on lower rt eyelid. Treated with KEFLEX for cellulitis of one area.
Received Hep B on 6/5/06. Late evening, started to itch. Next morning 6/6, red, big bump, very painful and numbness in her fingers. Did not receive treatment yet.
This is a spontaneous report from a contactable nurse (patient, self-reported). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration in Arm left, on 12Mar2021 at 5:45 PM, as dose 1, single for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient medical history included COVID-19. The patient was diagnosed with COVID prior vaccination. The patient did not had known allergies. Concomitant medication included sertraline hydrochloride ( ZOLOFT). The patient did not receive any other vaccine in four weeks. On 13Mar2021 at 8:00 AM, the patient experienced Fever, muscle aches, stomach upset and weak. The patient was not tested for COVID post vaccination. The AE did not resulted in physician office visit or emergency room. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
I did not submit a report for the first dose, but had the exact same adverse symptoms.  Within a five hours started to feel very fatigued and week.  Overnight developed chills and sweats.  By morning had a fever of 102 degrees, extreme body aches, some nausea, and difficulty moving.  Very ill for another 6 hours or so and then gradually started to improve.
Chills; Very high fever (several hours each day at 104F); Pain in the body; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as unknown, a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes. Concomitant medications were not reported. It was unknown if the patient received any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The reporter reported that on an unspecified date in Mar2021, the patient experienced chills, very high fever (several hours each day at 104F) and pain in the body. The reporter became aware of the adverse event on Saturday evening, sometime around 8 PM after reading friends message on a group chat. The patient did not receive treatment for the adverse event. The patient underwent lab test and procedure Body temperature with fever 104F on an unspecified date in Mar2021. Outcome of the events was re-covered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number can-not be obtained.
Injection site, L deltoid, reddened, swollen and painful to touch.  Patient reported feeling generalized achiness.
Systemic: temporary loss of vision in the right eye-Mild, Systemic: Visual Changes/Disturbances-Mild
Patient inadvertently received a dose of VAXELIS, nurse accidentally pulled and administered VAXELIS, instead of the ordered FLUZONE HIGH DOSE QIV, with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 73-year-old male patient who inadvertently received a dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE (Vaxelis), nurse accidentally pulled and administered vaxelis, instead of the ordered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Immunization and suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE produced by unknown manufacturer (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination (Immunisation) and patient inadvertently received a dose of vaxelis, nurse accidentally pulled and administered vaxelis, instead of the ordered fluzone high dose qiv, with no reported adverse event (wrong product administered) (unknown latency).  It was reported, ordering physicians ordered FLUZONE HIGH DOSE QIV for both patients. This situation is reported as a medication error due to a missed dose of FLUZONE HIGH DOSE QIV.  As patient did not receive dose of ordered FLUZONE HIGH DOSE QIV on 07NOV2022. No further information provided by the reporter.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) and DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE (DIPHTHERIA, TETANUS, AC PERTUSSIS, HEP B, IPV AND HIB VACCINE) was not applicable.  At time of reporting, the outcome was Unknown.  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 the 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.
Tinnitus became extreme about a week after taking vaccine.  Day and night.  Seems like it gets better sometimes, but comes back.  Terrible!
Have pain everyday since the vaccine, can not sleep well due to pain on arm, can not lift, have had headaches.  Its been more than a month and the pain is still persistent.
Pts mother called clinic on 9/30/21 at approximately 1700.  Mother reported, right leg swelling, injection site warmth/redness, rash and crying for 3 hours with no relief.  No facial or oral swelling and no noticed shortness of breath.  Per provider advised to give  Benedryl 12.5 mg/mL dose of 2.5 mL every 4-6 hrs as needed and Tylenol 160/5mg, give 2.5 mL every 4-6 hours.  Also advised to apply cool compresses to injection site.
pt recvd vax series #1 in AM; pt had high pitched scream for over 1 hr; wouldn't eat inconsolable; lo grade temp & sore leg; didn't get "back to nl til PM";
I am a pharmacist that gave this patient 3 shots. I gave him the flu vaccine and pneumonia in the right arm and the tdap in the left arm. When I just got finished giving the tdap in the left arm, the patient became unresponsive to me and was staring into space. I tried to gain his attention for a few seconds and he finally came back around and stated he was having trouble breathing.  At this point I was thinking I needed to get him to the ground but he refused. He slowly regained his breath then had several severe back spasms that was causing him significant pain. At this point I told the other pharmacist on duty to call EMS. The patient's back spasms subsided while we were waiting on EMS to arrive. EMS checked him out thoroughly with a heart monitor and they stated everything was normal. We released the patient after getting all of his information. He was doing fine.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date between 03-AUG-2015 and 24-AUG-2015, the patient was vaccinated with the second dose in the PROQUAD (Merck) immunization series that was improperly stored (Lot # L007230, expiration date: 03-SEP-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
hives; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2E3EH, expiry date 31st October 2021) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (allergy to Cephalosporin).   On 18th October 2019, the patient received Boostrix. On 18th October 2019, less than a day after receiving Boostrix, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Boostrix on the left arm and that evening, she experienced hives.  The reporter could not confirm where the hives originated. The patient took Benadryl and she got better.  After the Benadryl medication wore off, her hives returned so she took Benadryl again and she was fine at the reporting date. The reporter consented to follow up. The age group and outcome of events reported in the database was does not match with that reported in the source document.
After 24 hours for about 6 hours and again 48 hours for about 6 hours: chills, body aches, headache, dizzy, nausea; then after 9 days (February 25), same symptoms for about 6 hours.
Information has been received from a health professional concerning a 6 year old male who on 08 February 2006, was vaccinated subcutaneously with 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot # "0829R"). On 21 February 2006, the patient presented to the school nurse with chickenpox with 40-50 lesions on his trunk, hair line and face with a temperature of 99 degrees F. Prior to visiting the school nurse the patient was being treated with benzocaine (+) resorcinol (Lanacane). Unspecified medical treatment was sought. There was no product quality complaint involved. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving covid vaccination for acute cholecystitis. Patient had second dose on 5/12/2021. On 5/17/2021 pt hospitalized for gallbladder cancer.
Patient went to bed in his normal state of health the night he received his vaccine and was found deceased upon family waking the following morning
Causality difficult to determine, but patient history was overall unremarkable, except for admission with vision changes, and abnormal MRI a few months after vaccination from Moderna COVID-19 vaccine. Patient was diagnosed with acute disseminated encephalomyelitis, and treated over the course of stay with high dose steroids, and IVIG. Through additional work-up, patient has been diagnosed with MS.
approx 1-2 mins p/vax noted pt became unresponsive & apnea; airway was immed opened & 1 breath given; pt began to breathe spontaneously & responded to verbal stimuli
patient got her second COVID shot, her second dose yesterday and shot was around noon, she forgot and took a Tylenol at 5.00; Very little sore arm; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on 13May2021 at 12:00, as dose 2, single for COVID-19 immunization and the patient also received paracetamol (TYLENOL) via an unspecified route of administration, start and stop date, lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on unspecified date, as dose 1, single for COVID-19 immunization. Patient had very little sore arm on unspecified date in May2021. The patient stated that when patient got her second COVID shot, her second dose yesterday on 13May2021 and shot was around noon, she forgot and took a Tylenol at 5.00. The patient got one of the captions of not to take Tylenol before get the shot and that was what she did and she wondered if that was going to hurt anything. The patient reported that she had very little sore arm and that was (incomplete sentence).  No follow-up attempts are needed. No further information is expected.
suspected vaccination failure/Got the shot and in a few months got a horrible case of Shingles.; got a horrible case of Shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by friend of the patient. Age at vaccination was not reported. The patient received a shot of Shingles vaccine several years ago and few months after experienced a case of Shingles. The patient was concerned that he might need another one. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Grandmother stated that he complained of a headache at 10 p.m. and she gave him 2 teaspoons of liquid Motrin and at 11:00 p.m. he could not smile on the right side of his face and his right eye would not close all the way. Seen at ER and his blood pressure and arms/legs were checked and the ER doctor diagnosed Bell's Palsy.
joints are stiff; burning in my legs; red spot the size of a baseball; can barely move; administration date=04Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 14:30 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "sleep apnoea" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; LINZESS; LEVOTHYROXINE; FLUOXETINE; VIT D [VITAMIN D NOS]. Past drug history included: Biaxin, reaction(s): "known allergies: Biaxin"; Claritin, reaction(s): "known allergies: Claritin". Vaccination history included: Bnt162b2 (Dose number: 1, Dose administration date: May2021, Dose administration time: 07:00PM, Dose vaccine location=Right arm), administration date: May2021, for covid-19 immunization, reaction(s): "Severe itching", "rash on right arm from elbow to wrist that spread to left arm", "Blotches all over top of both legs". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Oct2021 14:30, outcome "unknown", described as "administration date=04Oct2021"; JOINT STIFFNESS (non-serious) with onset 05Oct2021 08:00, outcome "not recovered", described as "joints are stiff"; BURNING SENSATION (non-serious) with onset 05Oct2021 08:00, outcome "not recovered", described as "burning in my legs"; RASH MACULAR (non-serious) with onset 05Oct2021 08:00, outcome "not recovered", described as "red spot the size of a baseball"; GAIT DISTURBANCE (non-serious) with onset 05Oct2021 08:00, outcome "not recovered", described as "can barely move". Therapeutic measures were not taken as a result of joint stiffness, burning sensation, rash macular, gait disturbance.  Additional information: First rash on right arm from elbow to wrist that spread to left arm. Blotches all over top of both legs. Severe itching to where I wanted to tear my skin off so far, second injection, I have a red spot the size of a baseball on my left arm, burning in my legs both times and it's extremely difficult for me to get out of bed in the mornings as my joints are stiff and I can barely move. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
p/vax pt exp mild atypical chickenpox;pt sought unspecified medical attention;
Swelling of the lips & tongue, fever with chills; Swelling of the lips & tongue, fever with chills; Swelling of the lips & tongue, fever with chills; Swelling of the lips & tongue, fever with chills; This is a spontaneous report from a contactable other health care professional (patient). A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as DOSE1, SINGLE (at the age of 62-years-old) for covid-19 immunisation. The patient has no medical history. There were no concomitant medications. The patient had no known allergies. On 09Feb2021 at 02:00 PM, the patient experienced swelling of the lips and tongue, fever with chills. The patient underwent lab tests and procedures which included body temperature: fever on 09Feb2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The patient did not have COVID prior to vaccination. It was unknown whether the patient got COVID tested post vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient recovered from the events on an unspecified date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Tenderness and swelling for a few days after that injection site. Itching seven days after
Vaccine at 3 pm at 5:22 pm LEFT facial,  jaw, neck numbness and tingling. Resolved in 2 hours by 7 pm.
Left arm soreness after injection that lasted 5 days. Headache and fatigue after injection for 5 days. Left arm tingling beginning 24 hours after vaccination and then moving to right arm 1 week after injection. Tingling and discomfort in both arms for 3 weeks after vaccination. Acupuncture, chiropractic, physical therapy and massage all being used to alleviate symptoms- but with each modality symptoms only lessen or disappear for 24 hours post treatment. Neck stiffness and pain are present as well.