chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Nausea; Vomiting; Diarrhea; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration, in right arm on 22Apr2021 at 10:30 (at the age of 57-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination has not been tested for COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient experienced fatigue, nausea, vomiting, diarrhea and swollen glands on 23Apr2021 at 11:00. The events resulted in Emergency room visit and were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Son received oral vaccine on Friday morning and started to get really fussy on Saturday afternoon. He wasn't sleeping well during the day, wouldn't let you put him down, stomach was working overtime (gassy sounds), and he was having very loud and stinky farts. It's now Tuesday and he is still experiencing these symptoms.
Headache, Myalgia, Arthralgia, Nausea Vomiting, chills, fatigue
Fever 101.8  18 inch after immunization, relieved with Tylenol.  Slight irritability, no other symptoms.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with doses of improperly stored ZOSTAVAX (dosage, strength, route and lot # unknown). There was no concomitant medication reported. No adverse effects was reported. Additional information has been requested.
Patient was given expired COVID-19 vaccine lot number FL2757, expired and thawed on 09/30/2022, given on 10/5/2022. No adverse events reported.
This case is linked with case # 2012-11392 (reported by same reporter for FLUZONE ID vaccine). Initial information received from a consumer4 on 22 NOVEMBER 2012. An 84-year-old male patient had received an intradermal dose of FLUZONE ID vaccine (batch number and site of vaccination were not reported) on 29 SEPTEMER 2012. The patient's medical history included COPD (Chronic Obstructive Pulmonary Disease) and had a pacemaker. Concomitant medication included COZAAR (Losartan) and ZOCOR (Simvastatin). On unspecified date, after vaccination, the patient's spot of vaccination itched and the patient was achy and fatigued. The patient was 84-year old at the time of vaccination thus the patient received the vaccination with FLUZONE ID at an inappropriate age. The laboratory investigations and corrective treatment were not reported. At the time of this report, the patient was feeling better. Documents held by sender: none.
Information has been received from a physician concerning an 8 year old male who on 23-OCT-2002 was vaccinated with the first dose of MMR II. On 09-MAY-2007, the patient was vaccinated with the second dose of MMR II. On 07-JAN-2010 the patient experienced mumps. Date of mumps diagnosed was reported as 08-JAN-2010. The patient had right parotitis. The patient experienced pain under both ears. At the time of this report, the patient's outcome was not reported. No further information is available.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
10/9/18-Evening-face felt itchy and warm. 10/10/18-AM facial swelling, red and warm.
The patient experienced redness/bruising along the inside of her inner arm all the way down to her inner elbow. It was red to the touch and she blistered at the site of the injection. The patient went to urgent care and she received cetirizine and cephalexin for treatment.
1404 Pt reports increases of palpitations and chest pain.  Pt with hx of POTS, depression anxiety and asthma.  Pt reports did not take beta blocker today because she had a spirometry testing today and was told not to take medication.  Pt also reports she does not have medication with her today.   Pt has fitness watch and records and shows HR of 147.  CP is in center of chest-no radiation or numbness noted.  Pt is alone and is driving.   Pt given water to drink--tolerated without complications.  1416 Pt reports feeling  better but sill with tach and anxiety continues.  Pt asst to medical examination-minimal assistance. 1419 EMS activated per pt request-report given to EMS and NP completed handoff.  Completed by, FNP
patient was administered both shots by pharmacy technician. He seemed fine and walked out to the waiting area for his wait time. He passed out but remained in his chair briefly about ten minutes later. EMTs came and checked him out, he seemed fine and his parents picked him up.
PT C/O TINGLING IN THE L HAND AFTER VACCINATION. VS CHECKED. BP ELEVATED @ 155/45. PT WAS OBSERVED AND INSTRUCTED TO FOLLOW UP WITH HIS PCP FOR ELEVATED BP. PT WAS SENT HOME. VS  SpO2 98% HR 78
Normal Variant of cellulitic local reaction with satellite lesions, also with generalized vaccinia, approximately 30 lesions located on the trunk, primarily on back and left shoulder.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (lot # K012457, expiry date 04-JUN-2017, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
On 3/23 I noticed a Red bump on my stomach that I thought looked like a bug bite.  On 3/24 I woke up with red bumps scattered on my arms, legs, stomach, chest, back and a couple on the tops of my feet. The bumps became very red, had a pimple like spot on them and they itched. I called my Doctor's office and it was recommended that I take Zirtec twice a day for 7 days and hold off on taking the 2nd shot.  It is now 3/29 and the spots are starting to fade but still itch.  Is it your recommendation not to get the 2nd vaccine?
stinging @ L Deltoid injection site @ time of injection followed by soreness/aching in L deltoid region which has not resolved. Movement does not aggravate. no weakness, numbness or tingling. no radiation of pain. no better, no worse - no mass, redness or swelling. no shock type pain
Patient tested positive for COVID after completing the Pfizer vaccine series > 14 days prior to illness
Headache, Myalgia, Fever, fever 102.1, fatigue, Arm soreness on Left, tender axilla, lasted 3 days Narrative:
Extreme diarrhea during the night along with difficulty in moving both legs and difficulty concentrating.  The difficulty in walking lasted for 2 days.  The problems with concentration lasted 3 days.
Day 1-after immunization covid 19 moderna vaccine-headache, sneezing, low grade temp 99 when she arrived home Day 2-102F-took tylenol as needed, she continue to experience headaches, body aches Day 3- No signs or symptoms, temp 97.6F with out tylenol
runny nose; slight cough; COVID-19; A spontaneous report  was received from a nurse concerning a 90-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced COVID-19, runny nose and slight cough.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, approximately 9 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch unknown)  for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient tested positive for COVID-19 by polymerase chain reaction (PCR) analysis. She was experiencing a runny nose and slight cough. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events of COVID-19, runny nose and slight cough was unknown.; Reporter's Comments: Based on the known causative agent of COVID-19 infection, the event COVID-19 is assessed as unlikely related to mRNA-1273. It is likely that the patient was already infected with the virus but asymptomatic before being administered with the mRNA-1273 vaccine.A causal relationship cannot be excluded between the vaccine and the events rhinorrhea and cough.
Patient given 2nd dose of Moderna vaccine in accordance with instruction after giving first dose to 16 year old in error previously
Child's right arm has area about 3-4" in diameter- red, hot, swollen following 3rd Hep B injection, area hard and non tender- ice applied, recommended Tylenol/ ibuprofren.
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Reason for takings: COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that very pleased with paxlovid. 3 pills twice a day for 5 days. Symptoms were reduced by 2/3 the next day the patient had the Pfizer vaccine and booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 22DEC98 4PM was tense & c/o dizziness just p/vax;had a tender abd; later devel severe h/a;rt upper arm became painful;AM rt cheek was swollen, pain rt arm cont;rt perioral area swollen;extreme dysesthesia;peripheral neuropathy;
Dizziness/ light-headed; Confusion; Numbness in hands; Muscle spasms in right leg calf/ almost cramping muscle pain in arms, shoulders, neck and legs; Very scary; Chills; Continued muscle pain full body through night; Red injection site; Sore injection site; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO171) via an unspecified route of administration in the left arm on 11May2021 at 16:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks prior to the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 11May2021 at 16:15, about 25 minutes after the injection (as reported), the patient experienced dizziness, lightheaded, confusion, numbness in hands, muscle spasms in right leg calf, almost cramping muscle pain in arms, shoulders, neck and legs. The patient reported that it was very scary and she had chills and continued muscle pain in full body through the night. She also experienced a red sore injection site. The patient was not sure if she should receive second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, light-headed, confusion, numbness in hands, muscle spasms in right leg calf, almost cramping muscle pain in arms, shoulders, neck and legs, very scary, chills, muscle pain in full body and red sore injection site were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
I began to feel fluish at  10am and within an hour I had a climbing fever, head to toe pain, exhaustion to the point of immobility, was unable to sleep for any amount of time or eat because of the pain and symptoms were not helped by Tylenol.  Around 3:30pm I was finally able to sit up, but the pain and fever lasted until at least 3am, which was the last time I woke up from what felt like bone pain across my entire body. When I awoke today at 9am, I felt completely back to normal. So that was fun. I?m still glad I got the vaccine.
This patient had an increased heartbeat 2:00 - 4:00, nausea 2:00 - 10:00 PM, dizziness 2:00 - 10:00 PM most severe 5:00 PM to 10:00, and hot flashes 2:00 PM - 10:00 AM, on 01/25/01.
Nausea; Passed out; Felt a little dizzy; Mumbling, slurred speech; Developed a "static" feeling in her head; Eye shutting; Weakness in her left arm and leg; This is a spontaneous report from a contactable physician. A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), intramuscular on 23Mar2021 as single dose for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. Concomitant medication included fluoxetine 60 mg taken for an unspecified indication, and an unspecified oral contraceptive. It was reported that on 23Mar2021, the patient received Pfizer Covid vaccine and felt a little dizzy on 11:00. She also started noting mumbling, slurred speech, passed out for about 15 (unspecified) after using the bathroom, developed a "static" feeling in her head and then noted her left eye shutting and then weakness in her left arm and leg. She was taken to the Emergency Room (ER) for evaluation. Symptoms lasted about 5 hours. She fell asleep in the ER. Symptoms seemed to clear by about 8:30 PM. She had lab and head CT at the hospital which were essentially normal. She felt okay the next day, but had some nausea for a couple days starting on the 3rd day on 25Mar2021. She stated she feels fine at the time of report in the Student Health Clinic and asked whether she should receive her second Pfizer dose scheduled on 20Apr2021. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was received for the adverse events. The outcome of the event nausea was recovered in Mar2021, and for other events was recovered on 23Mar2021 20:30.   Information about lot/batch number was requested.; Sender's Comments: Based on the information currently available and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported event Passed out. 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.
Sore Itchy Bruising. About 2 dozen random sore to the touch bruises from dime size to quarter size and a little bigger all over body areas like top of shoulders, shoulder blades, mid back, lower back, sides, hips, thighs, knees, calves, etc.  Noticed them about 4 days after the shot.
Patient woke up on 10-5-18 with a rash under both breasts. The rash did not hurt or itch. The injection site was not red or sore. The rash went away by the end of 10-5-18 per the patient with no treatment needed.
Sore arm began on 9/25/21, 9/26/21 rash started, hot to touch with rash and itching. Taking Tylenol and applying cold compress .9/29/21 redness and rash resolved. All symptoms resolved 9/30/21
Patient received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received wrong doses of the Moderna COVID 19 vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Patient received wrong doses of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that seven patients received wrong doses of the Moderna COVID 19 vaccine. Five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.  No treatment information was provided.
Extreme swelling, hot, pain,  fever, change in color of arm,...size of area  and described symptoms, enlarged down arm, around inside of arm, traveling to inside bend  of arm.  The size of my arm did NOT even resemble the normal size of my other arm!!! The  main discoloration lasted two weeks and I still have some noticeable discoloration on affected arm.
3 days after Td, patient developed cellulitis at vaccine site; warm, red, inflamed. Treated with oral Cephalexin successfully. (F/U call on 2/19/03).
local itching; local / bruising; was in bed all day; tingling in his arm/ tingling sensation all over; joints are sore; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number TP943, expiry date 28th January 2023) for prophylaxis.   On 20th July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2021, less than a week after receiving Shingrix, the patient experienced tingling of extremity and soreness of joint. On 21st July 2021, the patient experienced movements reduced. On 22nd July 2021, the patient experienced localized itching and contusion. On an unknown date, the outcome of the tingling of extremity, soreness of joint, localized itching and contusion were not recovered/not resolved and the outcome of the movements reduced was unknown.   It was unknown if the reporter considered the tingling of extremity, soreness of joint, localized itching, contusion and movements reduced to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient had received 2nd dose of Shingrix vaccine in the right arm and had tingling in his arm, tingling sensation all over, his joints are sore and he was in bed all day on next day of vaccination and 2 day after receiving Shingrix, he had local itching and bruising. The reporter consented to follow up.
hallucinations; strong flu symptoms; This is a spontaneous report received from a contactable other HCP (patient). A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), second dose via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 (at the age of 40 years old, not pregnant), single dose for covid-19 immunisation. Medical history included chronic migraines secondary to an old neck injury. The patient previously took tetracycline, minocycline, experienced allergies. The patient had her first dose of bnt162b2 (lot_number=EM9809)for covid-19 immunisation on 13Feb2021 11:00, left arm. On 07Mar2021 0100, patient woke up at 1 am with strong flu symptoms and hallucinations. She saw a gigantic bunny standing next to her, and three clowns who were talking to her. The clowns and bunny were not concerning to her, but very real, and she vividly remembers having a conversation with them for hours. Later, she found it funny, but they were just so real. Again, it wasn't a problem since she was lying in bed anyway, so was interesting and so real. The bunny and clown stayed with her until 5am when she fell back asleep and were gone when she awoke at 9am. The outcome of the events was recovered on 07Mar2021 0900. No treatment received for the events.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument to suggest a causal relationship for BNT162B2 in development of serious Hallucination and non-serious Influenza. 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.