chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; Welts; she had a very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid Vaccine, lot EH9099 or EH9899), via an unspecified route of administration in her left deltoid on 22Dec2020 09:32 at single dose for Covid-19 immunisation. Medical history included broken toe for 3 weeks. This was from her taekwondo and doesn't complain. No history of all previous immunization with the Pfizer vaccine considered as suspect drug. There were no additional vaccines administered on same date with Covid-19 vaccine. There were no concomitant medications. On 24Dec2020, she broke out in a rash on different parts of her body. She said the rash would come and go. She said she then had welts appear on different parts of her body and the welts would come and go. She said on the 3rd day, she had rash and welts together only on her trunk. She said on days 4, 5, and 6, she would have either a rash or welts come and go on different parts of her body. She clarified she had the rash and welts on her hands, wrists, ankles, and body. She reported that the rash and welts were serious-medically significant. On 22Dec2020, she had arm soreness and was just inconvenient and uncomfortable. She said she was not saying that what she was experiencing was related to receiving the COVID-19 Vaccine, but she doesn't know what else can be causing the rash and welts. She said she hasn't changed anything she has been eating or doing. She said she was worried about taking the 2nd COVID-19 Vaccine dose. She used Hydrocortisone 1% cream, Equate brand (reported to be expired) and took an oatmeal bath. She also took Benadryl and brand of Zyrtec called Wal-Zyr. Her height was 175cm, weight was 63kg. The rash and welts recovered on 30Dec2020; arm soreness recovered on 23Dec2020.  Information about lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events rash and urticaria cannot be excluded. This case will be reassessed once additional information becomes available. 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.
This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a nurse practitioner concerning a 24 year old female patient with asthma and no allergies who on 27-JUL-2007 was vaccinated IM into the left arm with a first dose of GARDASIL (Lot# 658100/0525U).  Concomitant medication included oral contraceptives.  Shortly after, the patient experienced a rash on her hip chest and thighthat was red and itchy (leg unspecified).  The patient mentioned the rash may have started prior to the vaccination but was unsure. The patient did go to urgent care and a dermatologist.  The patient was diagnosed with eczema.  The second dermatologist thougth the rash was poison oak. On an unspecified dates, the patient had recovered from the rash but was now experiencing an undiagnosed systomic itching. On 09-AUG-2007, the patient called the nurse practitioner and told her that the itching had occurred for 2 weeks. The patient was seeing an allergist because it was reported that in the last 6 weeks the symptoms have been worse. No quality complaint was involved. At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
Nausea, shortness of breath, headache, fatigue, sore arm, body aches
I had vaccination on 10/17/2022. I started to feel awful on 11/28/2022 to include sore throat and fever. On 11/29/2022 I started to take Tylenol every 4 hours. I had extreme fatigue on 11/29/2022 and 11/30/2022. I had a COVID-19 Negative test on 11/25/2022 and 11/28/2022. I tested COVID-19 Positive on 12/01/2022. Dr. said I was COVID-19 Positive for too many days to receive the Paxlovid.
100.8 fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th May 2020, the patient received the 2nd dose of Shingles vaccine. In May 2020, less than a day after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient received Shingles vacation shot yesterday morning from the day of reporting and last night developed a 100.8 fever. The reporter wanted to know was s this something he/she should be concerned about. The reporter reported that he/she would contact doctor.
Head cold.; he did on feel well; This case was reported by a consumer via call center representative and described the occurrence of head cold in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix (intramuscular). In August 2021, 2 days after receiving Shingrix, the patient experienced head cold and malaise. On an unknown date, the outcome of the head cold and malaise were recovered/resolved.   It was unknown if the reporter considered the head cold and malaise to be related to Shingrix.  Additional information was provided as follows: The patient had the vaccine about two weeks ago from the day of reporting. Two days post vaccination the patient did on feel well and developed a head cold. The reporter consented to follow up. This case was linked to case US2021193290 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193290:Same reporter
Chest pain, cramping, squeezing , sharp, unrelenting around the whole chest area, rib cage, almost felt short of breath, but still able to breath, tried to burp to relieve the pain but to no avail.Ibuprofen 800 mg helped resolve. After ibuprofen effect was gone, pain returned. Happened 2 times on 2/11  Today, 2/12 have rash in groin area, bilateral thigh area on both sides with redness and  mild itch
Knot at injection site; Red at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20a) for COVID-19 vaccination.     Concomitant products included FISH OIL, POTASSIUM, HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]), OMEPRAZOLE and CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 07-Feb-2021, the patient experienced VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site). On 29-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with topical cortisone and ibuprofen.
IT FELT KIND OF LIKE THE FLU; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced it felt kind of like the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from it felt kind of like the flu. This report was non-serious. This case, from the same reporter is linked to 20210730909.
10 hours after receiving the 2 vaccine  shot in my right thigh, a severe attack of incredible bone pain lasting 16 hours and severe chills. And nausea. The bone pain was incredible. I felt every small and big bone in my body.  I took Tylenol after 5 hours, but the bone pain and chills continued. After next 2 hours I took Advil.  Then 2 more hours, I took one more Advil. The pain started to subside after 16 hours. (After my 1st shot, a months earlier, I had a 6 inchers wide Moderna  rash for 7 days).
COVID arm rash Red silver dollar size rash began approximately 7days after injection lasting approximately 7-8 days
extremely itchy lichenoid; got worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "extremely itchy lichenoid rash"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "extremely itchy lichenoid rash"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "extremely itchy lichenoid rash". The following information was reported: LICHENOID KERATOSIS (non-serious), outcome "not recovered", described as "extremely itchy lichenoid"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "got worse".  Additional information: On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date in Jun2022 with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 1, dose 2, dose 3 (booster dose) and dose 4 (bivalent booster) for Covid-19 immunization. Reportedly, the individual experienced an extremely itchy lichenoid rash after taking the original two-dose Pfizer COVID vaccine. The rash improved with time but got worse after the first Pfizer booster, improved again, and got worse after the bivalent Pfizer booster.  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.
Urticaria for 2 to 3 days following shots. Treated with Benadryl 2cc every 6 hours PO.
About four days after my first modern injection, I started having abdominal pain, more on the left side, I have a history of diverticulitis.  My last episode was about 5 months previously.   I have never had vomiting with diverticulitis and not such a severe  symptoms as with this case,  It was difficult to ambulate and  on day 4 of this, I started having projectile vomiting, which I have never had.  I was taking cipro once a day, because for some reason I could not hold down medications in the mornings so only took it at night.  I did not have to go to the hospital but stayed in contact with my colorectal physician.
Resurgence of rheumatoid arthritis symptoms, pain in hands, shoulders,feet, knees, after remission for over a year. I'm not saying it's directly related, because obviously it's not a surity, but I just want it reported to provide for researchers and scientists.
On SUN 9-7-08 pt passed away/diagnosed with S.I.D.S "most likely" no other info available at this time.  1/12/09 Autopsy report states COD as Sudden unexplained death in infancy.  Manner of death undetermined.  Report also states that patient found unresponsive on her side in crib by parent in AM.  Patient had been fed & placed on side in crib approx 1.5 hrs prior to being found unresponsive.  Parent reported cold s/s since vaccinations received on 9/4.
nurse reports an inc incidenceof nodules @ inj site in infants immunized from the same vial of Tetramune (lot# 260918); this was 1 of 3 pts to date who devel nodules @ inj site from 1 particular vial; no tx was initiated; recovered;
Fever (1.5 to 3.5 degrees fever) for at least 24 hours following the 2nd dose of vaccine, muscular body aches, joints aching, headache, inability to work or conduct normal activities
Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose; Trouble breathing; Headache; Tiredness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TUMOUR MARKER INCREASED (Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose), DYSPNOEA (Trouble breathing), HEADACHE (Headache), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B214 and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Adenocarcinoma (Right lung) since 28-Feb-2019, Drug allergy and Lung cancer (worsened) since 28-Feb-2019. Concomitant products included CALCIUM from 09-Jan-2018 to an unknown date for Bone density abnormal, ASPIRIN [ACETYLSALICYLIC ACID] from 07-Jan-2020 to an unknown date for Heart disease, unspecified, OSIMERTINIB MESILATE (TAGRISSO) from 06-Jan-2020 to an unknown date for Immunodeficiency secondary to oncology chemotherapy.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TUMOUR MARKER INCREASED (Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose), DYSPNOEA (Trouble breathing), HEADACHE (Headache), FATIGUE (Tiredness) and NAUSEA (Nausea). At the time of the report, TUMOUR MARKER INCREASED (Cancer antigen level was up at 13.7 compared to her normal baseline of 7 after receiving the second dose) had not resolved and DYSPNOEA (Trouble breathing), HEADACHE (Headache), FATIGUE (Tiredness) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Positron emission tomogram: extensive numerous pulmonary nodules (abnormal) Extensive numerous pulmonary nodules ranging in size from 6mm to 2.5cm with significant hypermetabolic activity and SUV of 8.2. On 26-Apr-2021, Blood test: 13.7 (abnormal) Cancer antigen at 13.7(double the previous number). On 28-Apr-2021, Chest X-ray: diffuse metastasis in both lungs (abnormal) Diffuse metastasis in both lungs.         Concomitant medication reported also included Poly-MVA indication of use cancer by oral route route of administration daily. It was reported that patient had to use inhaler daily about 30 days.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received included updated lab data details (PET scan shows more and larger nodules) and outcome of event tumour marker increased updated from unknown to not resolved.
No adverse advent, however reporting as a medication error due to other medications patient was on at the time of vaccination.  Client states she has had no adverse events or side effects due to vaccination at the time of this report.
Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Gave patient benadryl and had her stay for 30 minutes after vaccine.
Case number PHEH2016US029320 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to 71 year old female patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX Quadrivalent on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 Oct 2016. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour it was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Information has been received from a registered nurse concerning a patient at an elementary school who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed a case of breakthrough varicella with greater than 50 lesions. It was reported that the cases may be classified as serious because there were more than 50 lesions. There was no product quality complain involved.   Additional information was sought from the school nurse. However, a receptionist indicated that the reporting nurse did not work during the summer while school was out.   Breakthrough varicella was considered to be an other important medical event.   No further details were provided.
Chills, fever, muscle ache, nausea, headache for approximately 16 hours so far.
Felt she was going to pass out; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Began experiencing a hot, flushed and tingly sensation to her whole arm/whole body went completely hot and flush and tingly; Heart was beating fast and hard; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; The back of her nose, throat, and tongue was tingly and hot; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in left arm on 29Jul2021 12:45 (at the age of 48 years old) as dose 1, single for covid-19 immunization. Medical history included a fib (atrial fibrillation as one isolated event) from an unknown date to an unknown date; patient had a cardiac ablation in 2018; and allergy to penicillin from an unknown date and unknown if ongoing. The patient had no family history. Concomitant medication included aspirin [acetylsalicylic acid] at 81 mg taken for an unspecified indication, start and stop date were not reported. Patient had no prior vaccinations (within 4 weeks). The patient had no history of all previous immunization with the Pfizer vaccine suspect product. Most recent vaccine was administered at military facility. Patient received her first dose of the Pfizer Covid-19 Vaccine on 29Jul2021.  As soon as it was injected, she began experiencing a hot, flushed and tingly sensation to her whole arm.  She went and sat down and the feeling went to her entire body, then to her nose, throat, and tongue.  Her heart was beating fast and hard.  She felt she was going to pass out.  Everything subsided after 10 minutes and went away. Patient further reported that when the lady put the needle in the patient's arm and pushed the medicine the patient's arm went hot and tingly. The patient sat down for a minute and then her whole body went completely hot and flush and tingly. The back of the patient's nose, throat, and tongue was tingly. Then it felt like the patient's heart started beating fast and hard. Patient asked if this was normal. These events happened within 5 minutes of the patient getting the shot. Behind the patient's nose, throat and tongue was also hot. Patient asked if she could get the second dose. The events were non-serious as per reporter. The events did not require emergency room or physician office visits. The outcome of the events was reported as recovered on 29Jul2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
I had a seizure during the 15 minute waiting period after receiving the vaccine. Important to note that I have epilepsy, but I had not run into any typical triggers that could have caused the seizure. Seemed like a reaction to the shot, but maybe not. Hit my head directly on the concrete and had to get a stitch in my forehead
swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch; swollen and stiff neck; swollen and stiff neck; chills; hot flashes; radiating pain of arms; numb fingers; blue hands and feet; joint pain; muscle aches; weakness; tirednes; lethargic; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EL0140, via an unspecified route of administration in the left arm on 04Jan2021 16:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, ADHD, overweight, asthma and known allergies to milk, cat, roach mix, dust mites and bermuda grass. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), trazodone and montelukast. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced swollen lymph nodes at neck and sore to the touch, swollen and stiff neck, chills, hot flashes, radiating pain of arms, numb fingers, blue hands and feet, joint paint, muscle aches, weakness, tiredness, and was lethargic, all on 04Jan2021 at 17:30 PM with outcome of recovering. The events were reported as non-serious with no treatment received.  No follow-up attempts are possible. No further information is expected.
This medically confirmed health authority report (initial receipt 11-NOV-2014) concerns a female patient. On 24-OCT-2014, the patient received intramuscular AFLURIA (batch number 10149221A) at 0.5 ml one.  On 24-OCT-2014, within one hour after receiving the vaccine, the patient developed hives around the injection site. By 26-OCT-2014, the patient had hives all over the body. The nurse was notified of the adverse reactions on 27-OCT-2014. The outcome was reported not recovered.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: pt prone to fainting due to vagal-vasal  response. she expected it, her mom was with her. she did faint for about 30-40 seconds and then came to.
Chills, fever, dizziness, weakness, jittery, can?t sleep, fatigue, swollen, thirsty.  Received shot at 8:48am, symptoms began at 12:30pm while on a bike ride. I finished the ride but was too weak to do anything the rest of the day. That night I couldn?t stop shaking and lay in bed wide awake until about 2am. I felt dizzy like I was spinning when I closed my eyes.   I slept off and on until 6:30am. Today I?m feeling slightly better but still can?t sleep. I am drinking an excessive amount of water and herbal tea.
Full body rash/hives came around 2 weeks after first dose. body rash went away after three days using benedryl, but remained on neck and ears for two more weeks.