chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 64-year-old patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) via an unspecified route of administration on an unspecified date at single dose for immunization; and MOTRIN, BACTRIM, CYMBALTA, MACRODANTIN all via unspecified routes of administration on an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that on unspecified date, the patient experienced allergic to BACTRIM, CYMBALTA, MACRODANTIN, MOTRIN and pneumococcal vaccine. The action taken in response to the event for ibuprofen, sulfamethoxazole, trimethoprim, duloxetine hydrochloride, and nitrofurantoin was unknown. Outcome of the event was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Headache; Pain in arms; Vomiting; Nausea; This is a spontaneous report from a Pfizer-sponsored Program. A non-contactable female consumer (patient) of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 22Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation and experienced hypersensitivity and pain arm. The patient experienced side effect after getting the second dose. The side effect that she experiences was headache, pain in arms, vomiting and nausea on unspecified date in Jul2021. The patient just wants to know something that something she need to ask. The patient's concern was if she needs to go to the doctors about it or if she needs to like go to the hospital. Patient was informed about the role of Pfizer drug safety department and was also informed about the role of Medical information department. As per patient's request, call was transferred to MI department however it was unsuccessful. The outcome of clinical events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Joint pain; This is a spontaneous report from a contactable consumer, the patient.  A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9263; Expiration Date: 31May2021), via an unspecified route of administration, administered in Left arm on 27Jan2021 at 15:30 as dose 1, single (at the age of 72 years), for covid-19 immunization at Hospital. The reported verbatim indication was reported as Protection from Covid. History of all previous immunization with the Pfizer vaccine considered as suspect and Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Medical history included ongoing blood pressure (blood pressure high); car accident in 2006, it knocked him unconscious, and he was wearing his seat belt, he was hit and had pain in the neck and shoulder that radiated to both arms and knees. It was better than it was. Patient's Medical History (including any illness at time of vaccination) was reported as None. He was pretty healthy. Sometimes he walks pretty good. Concomitant medication included ongoing valsartan (VALSARTAN, 80 mg, 2x/day) taken for blood pressure since unknown date in 2018. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient stated that, on 30Jan2021, he had been having joint pain and he thought that he had arthritis. The joint pain comes and goes. The adverse event resulted in physician office visit. He saw his doctor yesterday and had X-rays yesterday, but he did not have the results. He had called the doctor office and was waiting for a call back. It was reported that It is better than it was. Caller adds that his wife is a nurse. She told him to not take Tylenol before he gets he second dose. His doctor told him that he should take Tylenol 30 minutes to an hour before he gets the second dose. He had been using heat and cold compresses as a corrective treatment. He was scheduled to get the second dose. There was no more information. The outcome for the event was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a physician assistant refers to a 15 year old female patient. Physician Assistant reported that on 02-JUL-2010, the patient received the first (1st) dose of GARDASIL injection (lot number, strength, dose, route and site of administration were not reported). The second dose of GARDASIL (lot number, dose, route and site of administration not reported) was administered on 06-JUN-2011. No adverse effect was reported. Additonal information has been requested.
On 6/18/99, the pt experienced a macular rash on the trunk and face with approximately 20-30 lesions and presented to an ER. The pt was afebrile. Additional information has been requested.
I received the 1st dose of my covid vaccine on Thursday 1/7 at 4pm and during my 15 min observation I started to not feel well, light headed, spacey, eyes blurry. I sat and was observed til approx. 1715 at which time I thought I was ready to head back to my department. After the elevator to the LL I really wasn't feeling well. I ended up going to the ER which they diagnosed me with Vertigo. I have never had vertigo in the past. I remained in the ER until approx. 2220 until my symptoms were managed with medication and I felt well enough to leave.The lightheaded and dizziness lasted a few days while the headaches lasted about a week.
Baby threw-up all night day of administration.  Continued to vomit, did not retain any feeds.  Pt was taken to ER on the 20th.  No h/o excessive crying.  Temp T max 100.4.  Mom kept baby home.  He recovered in 1.5 days.  He had mild diarrhea also.
Pain at injection sites, soreness, headache, muscle aches, chills, fatigue.
Headaches, muscle aches, fatigue that began the night of vaccine administration. Ongoing since then. No other symptoms
Several hours after vaccination-she fainted and hit face on floor nausea/chills/shaking/arm hurting/sweats.
Approximately 8-9 hours after receiving the dose, developed really BAD throbbing/hurting in entire arm, from neck to fingertips, and fingers became numb. This lasted approximately 8 hours, then disappeared, leaving only a sore arm, which resolved over the next 48 hours. Also ran a low-grade fever (approximately 2-degrees) for about 48 hours.
Patient was incorrectly given Moderna Bivalent Covid vaccine instead of Pfizer Bivalent Covid vaccine.  Patient started feeling ill the morning after receiving the vaccines.  He experienced a fever of 101.6, flu-like symptoms, upset stomach, headache, felt lethargic and had body aches.  His mother consulted with their pediatrician who advised them to monitor the patient and if his symptoms became worse,  to transport him to the emergency room.  On Monday afternoon, the mom stated that the patient was starting to feel some better, but was not completely recovered.
Nonspecific ST and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 11Feb2022, this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s): "CARDIOVASCULAR MANIFESTATIONS in ADOLESCENT MALES AFTER THE PFIZER COVID-19 VACCINE", Journal of Investigative Medicine, 2021; Vol:70, pgs:226, DOI:10.1136/jim-2022-WRMC.226; "CARDIOVASCULAR MANIFESTATIONS in ADOLESCENT MALES AFTER THE PFIZER COVID-19 VACCINE", Journal of Investigative Medicine, 2022; Vol:70, pgs:226, DOI:10.1136/jim-2022-WRMC.226.  A 16 year-old male patient received bnt162b2 (BNT162B2) (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: PERICARDITIS (medically significant), outcome "unknown", described as "Nonspecific ST and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6". The patient underwent the following laboratory tests and procedures: blood test: negative; brain natriuretic peptide: 53 pg/mL; c-reactive protein: 4.06 mg/dl; 4.06 mg/dl, notes: on admission; 1.45 mg/dl, notes: on discharge; cytomegalovirus test: negative; electrocardiogram: nonspecific st, notes: and T wave abnormality and minimal ST elevation in the inferior leads V5 and V6; epstein-barr virus test: negative; influenza a virus test: negative; influenza b virus test: negative; investigation: negative; parvovirus b19 test: negative; polymerase chain reaction: negative; respiratory syncytial virus test: negative; troponin i: 4.76 ng/dL; 4.07 ng/dL, notes: on admission; 1.45 ng/dL, notes: on discharge.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Pericarditis" and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200283445 same patient/article/drug and different event;US-PFIZER INC-202200283444 same drug/article and different patient/event
temp of 102.4. that was about 11 hrs after the vaccine was administered. Took Tylenol and temp came down to normal and have not had a temp since. Nausea without any vomiting and poor appetite on and off 4 days. Very Tired and lethargy at times. Difficult time waking up would fall asleep at the drop of an hat. Extremely tired and sleepy. This lasted about 7 days.
Both times I have received the Moderna vaccination it has a caused a left clavicular lymph node enlargement. The knot is very prominent and tender.
About 2 weeks after receiving the Shingrix and flu shots, the patient began to have weakness in his legs and fell several times over the next few days before going to the hospital.  He was transferred to Clinic and an MRI was taken.  He had some degenerative changes, but no other nerve involvement.  He had trouble breathing and was intubated.  He was diagnosed with Guillain-Barre Syndrome and received treatment with immune globulin gamma.
Admitted to the ED with acute hypoxemic respiratory failure from covid on 6/26/22-6/29/22. Treated with Lasix drip, Remdesivir, steroids, antibiotics, and breathing treatments.
Pt received this vaccination on 02/06/2015 at her provider's office and then received another one on 05/13/2015 at the pharmacy.
not received the second dose, even though she had been given a date for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not received the second dose, even though she had been given a date for the second dose) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not received the second dose, even though she had been given a date for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not received the second dose, even though she had been given a date for the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided  Treatment information was not provided
pain in injection site ( few hours after injection, all day), muscle aches( 12/24/2020 in the evening into the next day, 12/25/2020, all day), numbness on entire left side (12/25/2020, few mins)
This spontaneous report as received from a pharmacist refers to an unspecified number (reported as few) of child patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these patients' were inadvertently vaccinated with ZOSTAVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown), instead of (Oka/Merck) VARIVAX. Additional information has been requested.
Patient received her second dose of the SHINGRIX on 3/20/19 in the afternoon. She reports she woke up the next morning in a cold sweat and her husband states she "blacked out." When she came to again she had chills for almost one hour and remained in bed for the remainder of the day. She reported the reaction on 3/23/19 and said she's been feeling herself and good since the morning of 3/22/19.
After shot on 24th,  tightness in left side of face and can't blink left eye normally, cornea drying out.
Three weeks after my second shot, I developed Bells palsy, and virus attacked right side of my face; virus attacked right side of my face; This is a spontaneous report received from a contactable consumer (patient).  A 60-years-old male patient received second dose bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 15:15 (Batch/Lot number was not reported) at single dose for COVID-19 immunization.  Medical history included meniere's disease from Oct2020 to an unknown date. There was no known allergy. The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER COVID-19 VACCINE), on 13Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization and experienced vertigo. Three weeks after his second shot, the patient developed Bells palsy, and virus attacked right side of his face at 27Apr2021 07:30 AM. These events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. This event did not result in death, cause/prolonged hospitalization, was not life threatening, disabling/incapacitating, congenital anomaly/birth defect. Treatment for the events included Zaltrex - antivirus, Prednisone. The patient did not have covid prior vaccination. The patient was covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Herpes-Like Rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Herpes-Like Rash) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: VACCINES (shingles vaccine).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Herpes-Like Rash). At the time of the report, VACCINATION SITE RASH (Herpes-Like Rash) outcome was unknown. Not Provided      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.
very scary reaction 12/1 210 PM Shot #1 Received Shingrex shot - left upper arm - starting day 2 (12/2/2020) arm became red, hot (but did not swell) and continued for 5 days. Starting day 3, pain continued in upper arm and also under arm and down the muscle from under arm to side along to middle of my body. This continued until 12/5/2020. Arm was sore for 9+ days. Day 10 - arm still sore but not red. Scared to take second shot scheduled for two months from now.
After Patient received Vaccine immediately developed a welt at the injection site and red rash. Patient was immediately given 5 ml of Benadryl and a cold compress. Patient was observed for 30 minutes and welt and redness went down. Patient went home to rest.
Pt recvd vax 27OCT92 & on 6NOV92 devel a temp of 101, drowsiness, balance problem; was dx w/poss encephalitis; did not have rash nor was hospitalized;
couldnt open her jaw; hard to eat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 years 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: TRISMUS (non-serious), outcome "unknown", described as "couldnt open her jaw"; EATING DISORDER (non-serious), outcome "unknown", described as "hard to eat".  Additional information: The reporter who was the cousin of the patient stated that, she was unaware of how long the symptoms started and lasted. The reporter called the patient and she was talking so according to the reporter, the patient must have felt better. The reporter does not know exact birthdate of the patient and the year but reporter believed it was 14 May.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Son was given series of rabies vaccine. Approximately two months later began getting noticibly weak.  Three months later developed guillian-barre syndrome. One of the vaccines given was Rabavert. Per review of d/c summary received 7/28/05, diagnosis of GBS is confirmed. Additional symptoms include pain in extremities, staggering gait, vomiting, anorexia, pallor, cough, headache, decreased visual acuity, diminished DTRs, respiratory distress, choking, and low-grade fever.
Patient received vaccine on 3/13, initially had fatigue and myalgia the day after, which resolved, but also on 3/14 began having mild intermittent coughing, nonproductive, occurring every two hours or less. Patient began having some blood in his sputum since this morning at 4AM, and that occurred twice more with intervals of a few hours, both continuously improving and less blood. No other symptoms. No history of TB, no exposure to sick contacts, no recent travel. Unlikely a pulmonary embolus given normal vital signs and no risk factors. Patient was doing outdoor work in his yard for the past few days before the symptom onset and was working on mulch and compost. Although unlikely to have fungal infection currently, may be bacterial pneumonia
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt said she felt dizzy and lost vision when standing. When she sat down, she was temporarily unresponsive. 911 was called and pt was assessed. She left the the pharmacy on her own moments later feeling much better
Patient experienced syncope. We brought him to the immunization room and let him sit with the lights off. We gave him a snack and water, as well as a blanket and a cool towel. He recovered in about 15 minutes.
After the 2nd day I had an unexplained rash on my body and my throat was irriated and closed up.
Gave injection IM, pt became dizzy, and pale.  I propped patient's feet up on chair.  i took blood pressure of 133/85, pulse of 84. I laid patient on the floor after she became even more dizzy with feet propped up and placed icepack behind the neck. Patient blood pressure remained at 135/88 pulse 87. Patient laid for about 30 minutes while I fanned her and she returned in color. She then moved to chair where she sat for another 15 minutes and then left with her husband.  Patient has had similar reaction to vaccines in the past
Wrong Pfizer product / wrong dose. Pt is  7 yrs old and should have gotten the product for 5-12 yr olds but instead got the young child product
Our arms we can't hardly move them; Nothing but pain; I mean it hurts so bad you can hardly move your arms; Our arms we can't hardly move them; Nothing but pain; I mean it hurts so bad you can hardly move your arms; Shoulders are locking up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0158), administration date: 15Apr2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot/batch number not reported), administration date: 07May2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot/batch number not reported), administration date: 01Oct2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot/batch number not reported), administration date: 05Aug2022, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) all with onset 11Nov2022, outcome "not recovered" and all described as "Our arms we can't hardly move them; Nothing but pain; I mean it hurts so bad you can hardly move your arms"; JOINT LOCK (non-serious) with onset 11Nov2022, outcome "not recovered", described as "Shoulders are locking up". The events "our arms we can't hardly move them; nothing but pain; i mean it hurts so bad you can hardly move your arms" and "shoulders are locking up" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, vaccination site joint movement impairment, joint lock.  Additional information: Reporter and his wife had taken vaccine and could not move their arms hardly. Nothing but pain, reporter stated that it hurt so bad and could hardly move arms and the shoulders were locking up. Patient took 5 shot of Pfizer vaccine. Fifth dose was taken on 11Nov2022 and lot number reported was GT25Z4 or 24 (not clear). Patient was given Advil 200mg a piece. Patient visited hospital and had neck and arm X ray and they could not find anything. He had an MRI because he thought it had something to do with his neck but it did not. Doctor could not find anything. Both reporter and his wife could not move left arm and it hurt constantly and there was no stop for it.  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.