chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my first Pfizer shot on March 3rd. No reactions at all. About 13 days later on Tuesday, March 15th, I noticed a small rash on my right side upper eye lid and the side of my eye but thought it may just be an allergic reaction to something. No pain or itching. I had a couple of similar spots on my scalp but didn?t think much of it. On Thursday, I had a headache but I do get headaches now and then. When I woke up on Friday morning, March 19th, I found my eye lid completely swollen and saw the rash had turned to blisters, and there was a new one by the inner corner of my eye and a very faint rash on my forehead. Still no fever, pain or fatigue but had a lingering headache and a burning sensation on the rash. Saw my opthalmologist right away who diagnosed it as shingles and did a complete eye exam. Luckily no shingles in the eye as that can lead to glaucoma or even blindness in severe cases. I was prescribed Valtrex (1000 mg x 7 days) and prednisone (60 mg x 5 days) by my PCP. Hoping that I was still in the 72 hour window when the antiviral med is effective, I started on the meds immediately. Today is the third day of treatment and the blisters seem to be crusting away and healing faster. Luckily, no new blisters as of now. The prednisone caused my eye area to swell up further so I am gradually tapering off the dosage from 60 mg prescribed to 40-30-20 mg.  Keeping a watch for any complications such as ear pain or numbness in the face. Have a follow up appointment with ophthalmologist who will be dilating my eyes for further checks. I was glad to have found the Reddit board and see that there are over 50 cases of people reporting shingles after the first or second covid vaccine. I plan to delay or skip my second Pfizer vaccine for now.
Unsteady gait (poor balance) for the past four months. Ongoing, though improving.
Information has been received from a physician concerning a 14 year old female who on 30-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) injection.  Concomitant therapy also given on 30-JUL-2007 included Varivax (MSD) and MENACTRA.  On 30-JUL-2007 the patient became dizzy, had a headache and felt weak after receiving the first dose of Gardasil.  The patient also had low blood pressure.  Medical attention was sought.  The physician gave BENADRYL 15mg.  The patient was taken to the emergency room.  On an unspecified date the patient recovered from the events.  No additional information was provided.  Additional information has been requested.
PATIENT WAS A MINOR WHEN HE RECIEVED HIS 1ST DOSE OF VACCINE ON 4/23/2021: HE RECIEVED MODERNA INSTEAD OF PFIZER. TODAY HERE FOR 2NDDOSE. I AM THE PHYSICIAN DOING CLINICAL REVIEW, REPORTING THE INCIDENT. PATIENT HAD NO ADVERSE REACTIONS TO HIS FIRST DOSE.
Ive got a big redspit inder arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Ive got a big redspit inder arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Ive got a big redspit inder arm). At the time of the report, RASH ERYTHEMATOUS (Ive got a big redspit inder arm) outcome was unknown.            Concomitant and treatment medication were not reported Action taken in with mRNA-1273 in response to the event was not applicable
Fever of 100.8 - rash covering entire body that spread within 20 minutes and was hot to the touch -swollen throat and redness in the back of the throat - upset stomach.
This case was reported by a healthcare professional and described the occurrence of rash in a female subject aged between 20 and 29 years old who was vaccinated with ENGERIX B. In March 2008 the subject received 2nd dose of ENGERIX B (20 mcg, unknown, left arm). At an unspecified time after vaccination with ENGERIX B, the subject experienced rash below the injection site on the same arm where she received the vaccination. She was seen by her physician and some blood was draw. The reason for the blood draw was unknown. The reporter also noted that the subject did not have this issue with the first dose. At the time of reporting the event was unresolved.
Widespread, red, heated, itchy rash from injection site down to elbow area. It covered a large area and patient reported it had continued to spread from Saturday (10/15) until 10/18 when she came back in the pharmacy to ask me about it.
heavy red circle around inj site lt arm swollen by noc;cellulitis devel; rx w/IV ATB;
Local vaccine reaction (R) thigh redness & swelling about 6 x 8 after.
an incomplete dose was administered to the patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number TY2Y) for prophylaxis.   On 31-MAR-2023, the patient received Shingrix. On 31-MAR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: an incomplete dose was administered to the patient). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt date: 09-NOV-2023 A pharmacist reported that while administering shingrix one or two drops leaked out and an incomplete dose was administered to the patient which led to incomplete dose administered.  The reporter consented to follow up by email.
I tested positive for COVID-19 on 12/07/22. I had a cough, fever, fatigue, and congestion. I was prescribed a 7-day course of doxycycline, and a 5-day course of molnupiravir. I am feeling better now, but still have some congestion and a cough.
The patient was given the Bivalent Booster dose instead of the first dose in the original series.
Mother called stating that left arm is red, swollen, warm to touch, has a red splotchy rash and is the size of a "grapefruit".  Patient denies any pain, but complains of itching.
Soreness & swelling. Fever of 101 & chills, unable to lift arm. Rx was TYLENOL ES two po prn.
Information has been received from a consumer concerning a 7year old male who in 1995 was vaccinated with varicella vaccine. On 04/17/2001 the tp experienced 400-500 lesions all over his body, except face and arms. The pt has no fever and no itching. The pt sought medical attention. Additional info has been requested.
-Patient develop hives all over body the next day after receiving vaccines. Patient was seen by Urgent Care on 2/8/2020. Patient was prescribed Prednisolone 15 mg oral solution, Zyrtec 5mg, take 2.5 ml daily up to 1 week, Children Tylenol 32 mg, 5ml every 6 hours for fever. -patient was seen again on 2/23/2020 at urgent care for hives all over body. He was prescribed Decadron 0.6 mg one dose. Zyrtec 5mg/5ml oral solution, sig: 2.5 ml daily until hives gone(up to 1 week). -2/27/2020 Patient came in for f/u from urgent care. Mom reports, that if she gives him the Zyrtec, the rash will disappear almost immediately. Referral placed to Pediatric/Allergy/Immunology
Fever and chills, body aches,  mild headache, pain at injection site  for 20 hours, treated with rest and Tylenol every 4-6 hours
Hand - size rash on med torso area which spread over time to shoulders and mid - thigh area (on both sides).  Patient recovered on 10/10/09.  Rash completely gone.  Only hydrocortisone cream was used.
low fever; headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (low fever) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (low fever) and HEADACHE (headache). At the time of the report, PYREXIA (low fever) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not provided.
This case was reported by a nurse via call center representative and described the occurrence of overdose in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 9377F, expiry date 25th March 2023) for prophylaxis. Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX). On 24th November 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 24th November 2021, unknown after receiving Shingrix and, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown. Additional details were reported as follows: The nurse stated that patient received two doses of Shingrix. Both doses were from the same lot number. One dose was given in the right deltoid and the other dose was given in the left deltoid which led to overdose. The reporter consented to follow up.
Headaches; swelling of the face, hands , ankles. Swelling of the veins , veins sprouted
Husband & wife had same immun & illness hx; aching muscles, joints, anorexia; little if any elevated temp; onset 12DEC91 progressed to respiratory sx & bronchitis dx 15DEC w/productive cough;
left arm pain /  The pain goes down her arm/ includes injection site pain; left arm and left hand go numb; she cannot drip items well and thus she drops items from the left arm / cannot rotate her arm in a circle; the pain goes up her arm to her left shoulders; as a result, she could not drip items well and thus she drops items from the left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date.).   On 10th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, couple of days after receiving Shingrix, the patient experienced pain in arm, numbness of extremities, injected limb mobility decreased, shoulder pain and weakness of arms. The patient was treated with acetylsalicylic acid (Aspirin Oral) and diclofenac (Voltaren). On an unknown date, the outcome of the pain in arm, numbness of extremities, injected limb mobility decreased, shoulder pain and weakness of arms were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, numbness of extremities, injected limb mobility decreased, shoulder pain and weakness of arms to be related to Shingrix.  Additional details were reported as follows: The patient did not know the date of the first dose of Shingrix vaccine and also she did not know the lot number of the vaccine. The patient received second dose of Shingrix vaccine in her left arm. Few days after, the patient she started to have left arm pain which also included injection site pain. The pain went down her arm and also made her left arm and left hand go numb and as a result, she could not drip items well and thus she drops items from the left arm. She could not lift her left arm and also the pain went up her arm to her left shoulders. She could not rotate her arm in a circle. She had tried topical Voltaren and topical Icy Hot which had not helped her with her pain. She did take oral aspirin. The pain was constant. She reported lack of drug effect for Voltaren gel and the call center representative had emailed the Voltaren gel event to the Agency. The patient consented to follow up.
Havrix was administered to a 9 months of age patient instead of Hiberix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 9-month-old male patient who received HAV (Havrix) (batch number Y4FL4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 13th April 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The registered nurse reported that a dose of Havrix was administered to a patient instead of Hiberix, which led to wrong vaccine administered. The reporter consent to follow up.
Patient reported itchy rash around the injection site and spreading a little way down the arm appearing approximately 12 days after immunization. Description by patient  sounded consistent with presentation of "covid arm," and immunizer suggested patient contact regular provider to confirm. Patient spoke to providers nurse who confirmed that it was a localized immune reaction.
Extreame left arm pain. Tender to touch and movement. Unable to sleep at night due to discomfort and pain. Unable to lift arm above head due to pain level. Pain has not decreased at all.
Patient noted chest tightness, has had this before related to MS medication, no other symptoms. Declined any intervention but monitoring.
Anaphylaxis; drooling; This is a spontaneous report from a non-contactable health care professional. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7533, Expiration date: Not reported), via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that  patient had facial/throat swelling after the 15 min waiting period while driving home. No medical treatment, self-resolved with Benadryl at home, Differential Diagnosis: Anaphylaxis (dyspnea, stridor, drooling, tongue swelling). The patient underwent lab tests and procedures which includes patient Vital parameters results included: BP (138/89), HR (81), O2 (96%) at 11:45 am and BP (141/89), HR (68), O2 (97%) at 12:04.. Treatment included: Antihistamines, Epinephrine and IM steroids. Pre-treatment with Benadryl, Pepcid, and Zyrtec. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: The event anaphylaxis and drooling was considered related to suspect drug based on strong temporal association and known safety profile of the drug.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Pt. reported of headache and chest pain. He felt like there was excess fluid in chest area.
This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Diagnosed and admitted with Bilateral pneumonia due to SARS-CoV-2 infection--breakthrough infection
p/vax pt noticed swelling & redness which has advanced down arm;on exam arm is red, swollen from injs ite down to beyond elbow;no pain or itching noted;no other sx;
Left sided arm and facial redness and numbness for 2 hours that then went away with no other issues
He then developed Covid and tested on 01Jul2021; He then developed Covid and tested on 01Jul2021; This is a spontaneous report from a contactable other health care professional.  A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN 6204) via intramuscular route on 03Mar2021 (at the age of 57-years-old) as dose 2, single and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL 9267) via intramuscular route on 12Feb2021 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was none and concomitant medications were not reported. The patient had no known allergies were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient received any vaccines within four weeks prior to the vaccination was unknown and no other medications in two weeks. On 01Jul2021, Nasal Swab (rapid PCR) test was positive. The patient received 2 doses of Pfizer vaccine, he then developed covid. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included positive rapid PCR, nasal swab on 01Jul2021. The events were reported as non-serious. The outcome of the events were unknown.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, there is a reasonable possibility that events vaccination failure and covid-19 were related to suspect drug based on the temporal relation between the vaccination and onset of events. 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.
A month and a half after COVID-19 vaccine I got a Flu shot; The following week I woke up and could only hear a fuzzy white noise out of my right ear; Believe it could be Tinnitus; Went to an urgent care to find out if there was any wax build up or fluid in my ear, there wasn't; Went to an ENT the next day and was given a visual and hearing test; There was no hearing loss out of my left ear; Was told to come back for a follow up appointment for further testing.
1st Covid vaccine given  had expired , Patient was ask to wait 15 min after injection w/o reaction
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On 22-OCT-2015 the patient was vaccinated with ZOSTAVAX, (strength, dose, frequency were not reported) subcutaneously for prevention of herpes zoster. No concomitant medications were reported. On 21-NOV-2015 (about 30 days later), after vaccination the patient developed a red rash on her neck with a small blister inside the rash. The patient sought medical attention via visiting the physician. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Pt started developing raised lesions with in one week of vaccine. When I saw her on 01/25/2022 she was noted to have Bullous. She was then referred to a dermatologist.
a golf-ball sized ball in arm; Initial information received on 05-Apr-2021 regarding an unsolicited valid  non-serious case from a non health care professional in courtesy from Pfizer.  This case involves female patient of unknown age who had a golf-ball sized ball in arm (limb mas) , after receiving YELLOW FEVER VACCINE, HEPATITIS B VACCINE ,HEPATITIS A VACCINE and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR VACCIN].  The patient has Familial Mediterranean Fever (FMF) but do not present active symptoms (Genetic asymptomatic carrier for Familial Mediterranean Fever) and also frequently suffered from migraines. Also reported that patient's immune system generally reacts strongly to all vaccines. Patient also has ongoing Allergy to Iodine. Patient reported that she shared all of this in case so as to help in documentation.  Past medical treatment(s), medical treatment(s), vaccination(s) and concomitant medication(s) was not provided.   In 2019, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer; a dose of suspect HEPATITIS A VACCINE not produced by Sanofi Pasteur ; a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur and a dose of suspect MMR VACCIN not produced by Sanofi Pasteur (lot numbers and expiration dates were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  In 2019, the patient developed a non-serious strong reactions including a golf-ball sized ball in arm (limb mass), in the same year following the vaccinations and on the 3rd HepA/B dose.   It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  Steroids as a corrective treatment was received by the patient to bring down the limb mass.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.  It was also reported that at the age of 42 Years (Pregnancy: no); start Date/Time: [Pfizer] 10- Mar-2021 07:15 AM, patient received the most recent COVID-19 (coronavirus disease, Two doses) vaccine in Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and also no any other medications was received within 2 weeks of vaccination. Reported Event: For both doses: Chills for about an hour (began exactly 3 hours after the shot was administered in both doses). First dose had a hangover-type headache the day after the shot. Second dose the hangover-type headache started the same day as the shot and with much greater intensity. It was day 2 and the headache was still present but with less intensity. Some chills in the morning sporadically. Patient thanked and said let's get rid of this COVID pandemic. She did not received treatment for the adverse event;  Prior to vaccination, the patient  was not diagnosed with COVID- 19 and since the vaccination, she had not been tested for COVID-19; Vaccine Facility information available. Ethnicity information was available. Race information was available.
Possible inadvertent inoculation of Smallpox vaccination site. Pt has 2 small (2mm) pustules on right deltoid area that are c/w folliculitis, but pt states that direct contact to wife's vaccination site may have occurred. Pt requiring submission of Vaers form. Wife vaccinated on 2/27/03.