chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she is getting a hard chill and fever; she is getting a hard chill and fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), 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: PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "she is getting a hard chill and fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She wants to know if the chills and fever are normal because all of her Covid shots have been Pfizer and it always happens.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315379 Same patient/vaccine, different dose/events (dose 2);US-PFIZER INC-202300314657 Same patient/vaccine, different dose/events (dose 3);
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 12-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Developed urticaria - cold induced - new 4 days after the Tdap and Influenza Vaccinations.
I started feeling itchy all over an hour or so after the injection. My arm was extremely sore and hot. I iced it by 4:00 pm and felt dizzy. I threw up for the next three days. I had 99 - 100 degree fever 4 days. Flu-like symptoms still have dizziness and chills, sensitive to light.
Mom states that child was never anxious or have OCD symptoms until two weeks after getting GARDASIL. Since that time has seen our psychologist. Also developed abdominal pain 1 month after vaccine.
1st vaccine and then became ill; it was a cold and not allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "1st vaccine and then became ill"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "it was a cold and not allergies".  Additional information: She wanted to know what she should she do about her 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After a few hours after receiving vaccine, patient felt his right eye and eyelid feeling itchy and slowly swelling.  Then it got worst the next few days and he experienced some paint.  Patient reported to take "a store brand allergy med not Benadryl," possibly 2nd generati-histamine.  Patient is in between insurance so did not want to see a provider.  He will take Benadryl in immediate future.
Patient had her 4 immunization given on both arms.  Passed out right after (sitting on chair) for few seconds, recovered right away.  VS taken, kept in bed for observation.  MD notified & evaluated, later discharged to mother.
Initial report received on 17 October 2007 from an investigator participating in the above-mentioned trial under the reference number MTA48. A nine-month-old female subject experienced respiratory distress 7.5 hours after receiving an intramuscular right thigh injection of Menactra (lot number U2359AA). On 05 October 2007 the subject was seen by her pediatrician, at which time her mother noted that she had been experiencing vomiting "on an off for two weeks", since the subject had advanced to stage three foods. In addition, the subject had one episode of vomiting in the pediatrician's office prior to vaccine administration. The pediatrician also noted intercostal retractions on exam, which her mother stated were "normal" for her. The doctor completed the exam and determined the subject to be a "healthy infant". Study vaccine was administered at 14:50, with no observed reaction. At 17:30, her mother noted that the subject "felt warm," and she gave the subject 0.4 mL of Tylenol orally. The subject then took a nap. At 22:30, she awoke crying; she then vomited, and subsequently became "limp" and "white as a ghost". Emergency medical services were called to the subject's home, and upon arrival it was noted that her oxygen saturation was 88 - 90% on room air. She was given oxygen at 10 liters, and transported to the emergency room. At 23:00, upon arrival at the emergency room, her rectal temperature was 101.7 degrees Fahrenheit, and oxygen saturation on room air was 96 - 100%. At 00.33 on 06 October 2007, the subject was given 120 mg acetaminophen rectally. Exam revealed a pulse of 170, respiratory rate of 36, and weight 8.5 kg. She was alert, with tears and a normal amount of wet diapers, had no diarrhea, and was eating well. Tympanic membranes were pearly bilaterally, and nasal crusting was noted. Lungs were clear to auscultation, skin clear with no rash. The subject was noted to be teething. Chest x-ray, urinalysis, and urine culture were all normal. At 02:15 the subject was given oral ibuprofen 20 mg/mL, and she was discharged at 02:53. The parents were instructed to follow-up with the pediatrician in two days; per the investigator, no other contact had been made despite several attempts. The investigator considered the respiratory distress to be an important medical event, "yielding a trip to the emergency room". The event was considered to be resolved on 06 October 2007, and the subject was not discontinued from the study. According to the investigator, the event was related to the study vaccine. Documents held by sender: ER record
Pt. received varicella vaccine on 2/11/04, on 2/25/04 the pt. experienced URI symptoms, headache, sore throat. On 2/29/04 she awakened during the night with itching and noticed red, raised lesions on her arms, back and abdomen and stiff neck along with the headache. She was evaluated on 3/01/04 and thought to be experiencing side effects from the varicella vaccine.
Patient is an 82-year-old male who came to clinic on 1/9/20 for Shingrix vaccine. Vaccine given at approximately 1030. Later that day, patient returned to clinic c/o left arm and deltoid pain after Shingrix shot starting at approximately 1400. Patient unable to elevate arm and rated pain 9/10. MD prescribed ibuprofen 600 mg BID with food and hydrocodone/APAP 7.5/325 mg PO TID PRN for pain. clinic called patient on 1/10/20 to f/u; wife stated that pain had improved with increased movement of left arm. F/u'd again on 1/13/20; wife stated that patient able to drive. Final f/u 1/21/20; wife stated that patient is back to baseline before receiving Shingrix vaccine.  Myalgia IBUPROFEN 1 TAB BID WITH FOOD ,ACETAMINOPHEN/HYDROCODONE 1 TAB TID PRN FOR PAIN
I got the shot walking to the waiting area and as soon as I sat down my hands started to tingle and felt nub. The knobbiness was very strange, so I raised my hand left arm. I nearby EMT notices me raising my hand and asked was I okay. I figured I should move it around to help with the circulation and the feeling started spread from the injection sight through my hand and to my torso. The EMT told me to keep checking in and thin it went through my torso, and I stood up and I felt lightheaded. This lasted for 45 minutes, and I was still in the waiting area this entire time. At 45 min  It wasn?t so bad, so I told the volunteers I was tired and wanted to go home. Nobody wanted me to drive because of the side effects. A 15 mins later  I was still very tired but not as weak as I was before. I told them I would text as soon as I made it home which 5 miles away from the site.  Upon making it home all the normal side effects set in. The very next day  I was exhausted tired but couldn?t sleep so I sat around and rested and hydrated. Fever sat in and for the next few days I just took it easy. I had fever and body aches, but I couldn?t sleep but I was so tired. I didn?t take any medication for the fever because It was a low grade fever. I did reach out to doctor about switching manufactures for the booster and he said there wasn?t enough research to support or not to. They also told me some staff had did that and didn?t see too many reactions.
Headache, Neck pain, tingling in hands and feet, subjective report of "throat swollen".
Patient received Varivax vaccine/ no reaction/ checked out left clinic, in car with father, patient started shaking and sweating, nothing to eat all day, came back to clinic 02 sats 98% on Room air, Patient given orange juice.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date in July 2012, the patient was vaccinated with series consisting of 1 dose of CERVARIX and 2 doses of GARDASIL. No adverse effects reported. No further information was available. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-APR-2009, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. Later in 2009, the patient was treated by Nurse Practitioner for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient sated that she received her vaccine at the clinic that she works at. Five minutes after getting the vaccine she became dizzy and started having rapid heart beat. Patient stated that the rapid heartbeat lasted about five minutes. A few weeks after the patient said she started having a serve headache that last for a few days, congestion and hypertension.
pt recv vax 28FEB97 & pt to MD office 4AUG97 w/ 2 vesicles on abd, on arm , on leg came back in to office on 6AUG97 w/a few more vesicles already crusted over;confirmed varivax by MD;
Nausea with vomiting and dizziness; vomiting was constant when it began @ 2100. patient then came to er, received fluids dizziness and nausea decreased in ER
Information has been received from a 33 year old male with eczema, and egg allergy and a mild allergy who "sometime in 1989" was vaccinated IM with a second dose of Recombivax HB. Concomitant therapy included WESTCORT ointment. He reported that a worsening of eczema developed after this second shot. He did not receive the third shot. It was noted that allergy testing was done. The patient recovered after a couple of weeks. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
sore throat for 1 wk-hoarse, cough; called MD ATB prescribed for 10 days;
Information has been received from a registered nurse (R.N.) and a mother of a student concerning another child in elementary school who was vaccinated with a dose of Varivax. It was reported that the patient now has breakthrough chickenpox after an outbreak occurred in th elementary school. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that the index case was an unimmunized individual. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
After my second dose at 12;45pm on May 13th, 2021, I started to have large areas of itchy rashes on my neck, arms, legs, and body at 8am on May 16th, 2021. I've been applying Itch Relief Cream and taking Allergy Relief since 4pm on May 16th, 2021. There is no sign of relief or deterioration at this point (8am on May 16th, 2021).
Within 10 mins. after injection, pt lost consciousness in waiting room, briefly. Started to lose consciuosness again after finger stick to check blood sugar. Recovered quickly in wheelchair. Was transported to ER. Neuro-psychiatric eval done. Dx was vaso vagal syncope after vaccination
9/11/19 Pain, redness, swelling (golf ball size), and warm to touch at sight of injection. Itchy also. 9/12/19 Visit with provider and given Hydroxizine and Hydrocertisone topical. 9/13/19 Symptoms improving noted by nurse call.
hearing loss; tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss"; TINNITUS (non-serious), outcome "unknown".   Clinical course: He wants to know the prevalence of tinnitus and seeks recommendations to tell the patient. Caller said he does not have the information right now regarding which vaccine formulation or color of vaccine cap was administered. He wants to know the frequency of reports with tinnitus. He also wants to know if there are any reports of hearing loss. He also asked for the number of subjects for each study arm who reported hearing loss. Caller states that they have a patient who had a reaction to the vaccine. Caller states that they are curious about any guidance for this case? What is the prevalence of tinnitus with this vaccine?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt called to report an oblong lump at the injection site. Feels as though it's warm & has some redness. Treat with antihistamines & cool compresses recommended.
Initial misuse report received from a health care professional on 14 June 2013. This case is invalid as individual patient identifiers were not reported. In a VFC audit it was found that the storage temperature of vaccines as 1 degree Celsius and 2 other gauges had other readings starting from 24 December 2013 where IPOL, FLUZONE SV 2012-2013, ActHIB, MENACTRA, ADACEL and PENTACEL vaccines were stored. All products were unstable as of 24 December 2012. No adverse event was reported. Documents held by sender: none
5 minutes after receiving vaccine 12 yo male feeling "like I'm going to be sick".  Skin warm and clammy, BP = 108/62; RR = 22; HR= 86;  02 sat = 98-100%.   Laid down on cot for 10 minutes at which time male stated "I'm feeling better now"  Sat up for 10 minutes with no further symptoms. BP = 110/64  RR = 20 HR = 82.   Escorted patient and Pt parent to door. Reviewed s/s of adverse reaction and provided instructions for further action if needed.
administered SC; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 49-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4M2AZ, expiry date 30th June 2023) for prophylaxis.   On 17th November 2022, the patient received Boostrix (subcutaneous). On 17th November 2022, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's comment: A Medical Technician administered a Boostrix vaccine subcutaneously (SC) to a patient. The reporter consented to follow-up via postal. Additional Supportive Information: The patient received dose of Boostrix vaccine subcutaneously, which led to intramuscular formulation administered by other route.
The day after immunization given, started having (L) chest pain, chills, and pain going from chest to abdomen. Sharp stabbing pain on and off lasting up to 45 minutes per episode.
I caught COVID-19 in November 2020 for 17 days. I had shortness of breath, dry cough, and fever. So I went to the doctor on day 15 and was prescribed me prednisone. I missed three weeks of work and had horrible headaches and brain fog and fatigue. My short term memory was terrible and struggled with trying to identify words. It had settled until I received my first dose of my vaccination on 01/28/2021 and the fatigue, headache and brain fog returned. I didn't think anything of it, but then it occurred again after my second dose but even more intense fatigue, brain fog, and headache. I still have headaches and brain fog almost three times a week now currently and taking OTC Tylenol and/or ibuprofen to help it.
Patient states that he had blank spots in his vision and was having trouble dictating a letter at work.  This occurred about 2 hours after receiving the shot and went away shortly after.  He feels 100% 24 hours later.
Soreness at site of injection; This is a spontaneous report from a contactable nurse. A female patient of unknown age received BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on 03Mar2021 as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021,  the patient experienced soreness at site of injection. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested positive for COVID-19.The clinical outcome of the event soreness at site of injection was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Night of shot some discomfort ,next AM redness, swelling, welts to (R) arm. Lasted 2-3 days then resolved.
They had an accident where she ended up in an Emergency room; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable 76-year-old female consumer (patient) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported at the age of 76-year-old) via an unspecified route of administration on an unknown date Dec2020 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported they had an accident where she ended up in an emergency room and was later on in a rehabilitation centre resolving from that. Because of the event, the patient missed the scheduled second dose. The patient would like to know if she can just still get her second dose after 6 months or does she need to be revaccinated again. The patient was asking about information on possible booster dose. The response as follows the need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains had not determined. On 25Feb2021, Pfizer and BioNTech announced they initiated an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It was important for vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we had not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we were taking multiple steps to be ready in case a strain becomes resistant to the vaccine. The administration of more than a 2-dose series of Pfizer BioNTech COVID-19 Vaccine is not approved. Pfizer is unable to make any recommendations regarding administration of a booster dose of Pfizer-BioNTech COVID-19 Vaccine; Pfizer did not suggest or recommend the use of the vaccine in any manner other than as described in the authorized EUA prescribing information/authorized product monograph. The patient asked any data on patients who received second dose later than the recommended 21 days, specifically just like that of which she was like 6 months from her first dose. The outcome of the event was resolving.  Information about lot/batch number has been requested.
Upper left arm, where the vaccination was administered was very sore.; Mild headache; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 01Mar2021 at 14:30 (at the age of 40-years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, the day after vaccination, the patient experienced upper left arm sore, where the vaccination was administered and the patient also had a mild headache for most of the day. 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 upper left arm, where the vaccination was administered was very sore and mild headache were resolved on an unknown date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.