chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Generalized skin rash; pruritus around both eyes and neck area/itchy scalp; Nausea; Vomiting; This is a spontaneous report from a contactable Nurse (patient) reported in response to Pfizer/BioNTech Covid-19 Vaccine Anaphylactic Reaction Data Capture Aid letter sent. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3249), dose 2 via an intramuscular route of administration, administered in Deltoid Left on 08Jan2021 at 11:30 (at the age of 62-year-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient history of any previous allergies to specific products or any conditions indicative of an allergy was none. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1685), via an intramuscular route of administration, administered in Deltoid Left on 20Dec2020 at 13:30, as single for covid-19 immunisation and experienced skin rashes and pruritus developed around eyes/neck/scalp. The patient was not taking any medications prior to the event being reported. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. On an unspecified date in 2021, after the 2nd dose of vaccination, the patient experienced generalized skin rash, pruritus around both eyes and neck area/itchy scalp, nausea and vomiting. The patient received treatment with Benadryl tablet and cetirizine tablet taken at home at onset of symptoms, Decadron 30 mg, 1 dose at urgent care. The patient underwent lab tests and procedures which included ANA (antinuclear antibody) was negative on 12Feb2021. The response to potential anaphylactic Reaction Data Capture Aid letter as follows: There was no multiorgan involvement of Dermatological/Mucosal, no respiratory involvement, no Bilateral wheeze/bronchospasm, no stridor, no upper airway swelling, no respiratory distress, no tachypnoea, no increased use of accessory respiratory muscles, no recession, no cyanosis, no grunting, no hoarse voice, no Difficulty breathing (without wheeze or stridor), no sensation of throat closure, no sneezing, no rhinorrhea and no other. Cardiovascular was Unknown, Measured hypotension was Unknown, Tachycardia was Unknown, Capillary refill time greater than 3 sec was Unknown, Reduced central pulse volume was unknown, no decreased level of consciousness, no loss of consciousness. Patient outcome following the potential anaphylactic reaction was recovering. The patient had no, no diarrhea, no and abdominal pain. The patient outcome of the events was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
SWELLING, REDNESS, PRURITIS TO LEFT UPPER ARM WHERE VACCINES WERE ADMINISTERED.
Vaccine given IM not SQ called CDC and is valid and does not need to be repeated.
Vaccine administered after temperature excursionVaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursionVaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursionVaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursionVaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion/frozen vaccine 47 minutes -13.79 C/refrigerator 59 minutes 12 C) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     Concomitant and treatment information not provided
This case was reported by a healthcare professional (distributor) and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject experienced allergic reaction, shortness of breath body pain and tongue numbness. The subject required medical attention in the emergency room. At the time of reporting the outcome of the events was unspecified. The reporter did not know if the patient had previously received any influenza vaccinations. It was also unknown if the subject had any adverse events following previous vaccinations.
Hello- I am a physician and had an unusual (but minor) health event that may or may not be related to the COVID vaccine.  I did discuss this with a Dr. who was previously employed by the CDC and is an expert in vaccines just to be sure I was not injecting irrelevant data to the CDC or Pfizer during what I?m sure has been very busy time.  Dr. advised me to report it just in case my experience is of interest.   I had symptoms that I had never had before ? an acute urticaria with the very typical wheals (hives) reaction 10 days post vaccination (again, have never had this before in any setting and I?m generally not a ?rashy? or ?allergic? person).  I have had no new exposures that I know of and no other symptoms to suggest URI or other infectious etiology.  I understand that this could potentially be be a delayed reaction that can manifest as a rash but I thought that these were more often various morphologic forms of maculopapular eruptions instead of urticarial type reactions.  The area of urticaria was localized and very well demarcated with moderate to intense itching but no other symptoms (no systemic symptoms ? no generalized urticaria; wheezing; swelling of the mouth, tongue, or throat; difficulty breathing; vomiting; diarrhea; hypotension; decreased level of consciousness; etc.).   I did take a photo of the area just in case they might be helpful and can provide it if requested.  The urticaria lasted for about 12 hours and resolved without intervention (I did not use oral or topical medication)  Anyway, I thought I would report this (after discussion with Dr.) just in case there was interest or if my experience might help identify aspects of the more severe atopy issue with the Pfizer vaccination.  However, I fully understand that acute urticaria has many different etiologies and I will still have the second dose of the vaccine done on schedule (of course will be sure to have appropriate supplies on hand just in case of a reaction).  Very respectfully submitted.
fever; sore; This is a spontaneous report from a contactable consumer. A 42-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration on 28Mar2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021 at 13:00, the patient experienced fever and sore. It was unknown if the patient received any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the fever and sore was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/2/2023 PERNICIOUS ANEMIA I95.9 HYPOTENSION 3/29/2023 PERNICIOUS ANEMIA D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/2/2023 PERIPHERAL T-CELL LYMPHOMA, UNSPECIFIED TYPE, SPLEEN I95.9 HYPOTENSION 3/29/2023 PERIPHERAL T-CELL LYMPHOMA, UNSPECIFIED TYPE, SPLEEN D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/2/2023 LYMPHOPROLIFERATIVE DISORDER I95.9 HYPOTENSION 3/29/2023 LYMPHOPROLIFERATIVE DISORDER D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/2/2023 PERIPHERAL T-CELL LYMPHOMA, UNSPECIFIED TYPE, SPLEEN I95.9 HYPOTENSION 3/29/2023 PERIPHERAL T-CELL LYMPHOMA, UNSPECIFIED TYPE, SPLEEN D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/2/2023 ANEMIA I95.9 HYPOTENSION 3/29/2023 ANEMIA
Information has been received from a RN concerning a 12 yr old Caucasian female student with no known medical history who on 20Sep95 was vaccinated SC in the left arm with the first dose of varicella virus vaccine live (lot609302/0443B). There was no illness at the time of vaccination. There was no concomitant medication. On 08May05 at 19:20 the pt became febrile with temps up to 100.4F and developed a papular, vesicular, generalized rash. He also had headaches and the rash was described as itchy at times. The pt was seen in the physician's office on 10May05 with a fever and headaches for two days and red dots on body (trunk, neck, and face). On examination ENT was clear and the pt's lungs were clear. The pt was diagnosed with probable chickenpox. There was no information provided regarding the pt's recovery status. Additional information has been received from a RN indicating that as of 14Jun05 the pt has not been seen in the office since the last correspondence. Therefore, recovery status is unk. No further information is available.
1st time receiving a flu shot. Broke out in hives on right arm at point of shot insertion. Hives spread down right arm, along chest, back and all over neck. Difficulty breathing, tightness in throat, sneezing constantly, wheezing cough, itchy all over body, body hot. Went to ER and had Epipen and steroid shot. Symptoms came back Sunday 12/11/16: hives breaking out again and difficulty breathing. Went to urgent care for treatment. 12/27/16: hives breaking out again same exact places as when flu shot originally administered. Called doctors office to report. Took allergy medicine to try and relieve symptoms.
Went into the doctors office totally normal. About 8 hours after the vaccination ALL speech was GONE. He no longer was talking. Also 105 fever. Throwing up uncontrollable and diarrhea. Speech has slowly been coming back with speech therapy.
Narrative:  Patient is a 40 yoF who reported body aches, headache, chills, nausea vomiting. taking tylenol after receiving pfizer vaccine the day prior at 3pm. Pt was discharged on zofran for nausea/vomiting and encouraged to increase hydration.
got the shot,going thru shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, gone through 11th round with shingles. The reporter got the preventative shot and it did not stop from getting shingles again and again. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Treatment of COVID-19; Treatment of COVID-19; Vaccine Brand Other=Novavax, Vaccine Brand=Pfizer / Biontech, Vaccine Brand Other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 17Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 07Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 18Oct2023 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Dec2021, outcome "recovered", described as "Vaccine Brand Other=Novavax, Vaccine Brand=Pfizer / Biontech, Vaccine Brand Other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Oct2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid start date on 28Oct2023 and stop date as 01Nov2023. Clinical course: He tested positive for the first time on 28Oct2023 (8 days after his novavax vaccine), then started taking paxlovid that day.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366013 Same patient/reporter, different product/event;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient showed pharmacist a photograph of her rash that developed approximately a day or so after receiving SHINGRIX. The rash was described as being on the left arm about 1 inch from the injection site. The height of the rash was about 6 inches and the width was about 2 and a half inches below the injection site. The rash had resolved at time of report. The reporter consented to follow up.  No further details were known at time of report.
Reddened skin at injection site for several days, site then turned into an itchy rash a week after injection and persisted as a large area on upper arm of redness and itchiness until 9/12/2021  Pregnant with no health issues or concerns
Mother noticed that a week after vaccine was given patient started with runny nose and congestion. On 9/29, the skin of the vaccine site and surrounding skin started turning red and raised. Pt began having fevers on 9/30 of 102.7 then rash started breaking out with maculopapular lesions to whole body on 10/2, sparing palms and soles. No fluid filled lesions. Supportive care was advised. Patient followed a self-limiting course. Rash started disappearing on 10/3. No further fevers or signs of illness.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
1) vaccinated on 04/10/21 - 1st shot of Moderna Cov-19 Vaccine .  2) Next day had sensitive  and tender feeling at injection site  .  3) Tenderness continued for some days  , itchiness & redness developed after 6-7 days .  4 ) Started noticing  Circular pattern small Bumps  under the arm of the injuncted area . (Day 8 )  . some bumps were noticed scattered around the injected site  5) Day 10 -  Started seeing Blisters and are spreading  to other areas around the injected site (Like  upper shoulder and  upper left chest) .  6) Day  10   - contacted Physician (tele medicine ) - Advised  to use Benadryl  & Hydrocortisone .  7) 2 days since using those over the counter medication .  No Improvement Noticed .  8) Instead seen one another patch developing  , again circular patter and small bumps .
13Nov95 vax 1 dose of varicella virus vax live.SC. 13Jan98 Pt exp "rash on stomach,back & underarms w/itching.No fever."Papular lesions over trunk. A bit of vesiculation lining of nose.
PT HAD A SEIZURE APPROX. 30 MINS AFTER RECEIVING THE COVID VACCINE, PT FAINTED, STIFFENED UP, AND BEGAIN TO CONVULSE.  PT WAS PLACED ON COTT IN THE RECOVERY POSITION, 911 WAS CALLED AND VS OBTAINED.   P74, R22, BP118/80, O2SAT 98% ON RA.  SEIZURE LASTED APPROX 10 SECONDS,  AMBULANCE ARRIVED WITHIN 10 MINS, AND TOOK OVER PT'S CARE.  PT'S COLOR REMAINED PINK THROUGHOUT, AND SHE WAS SLEEPY BUT ABLE TO ANSWER QUESTIONS APPROPRIATELY.  VS: P83, R24,BP116/80, POX99% ON RA.  PT TAKEN IN AMBULANCE TO HOSPITAL FOR FURTHER EVALUATION
Lymph node swelling in arm pit of the arm receiving the vaccine. Large tennis-ball sized lump appeared, which was moderately sore.
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Palpitations, chills; pain at injection Narrative:
5/25 - Pt developed a fever for 2 days and was irritable.  Temperature was up to 104 and his fever reduced after giving him Tylenol 5/29 -  Rash developed over pt body at 11:00am Our doctor has been notified and we are waiting for next steps.  He is in good spirits now and does not appear to have a fever so we are going to watch and see what happens.
Client received the COVID19 Janssen vaccine at 19:06.  It should be noted that our vaccination/observation room is located on the 2nd floor of the building and the air conditioning stopped working at approximately 14:00.  The client was accompanied by 2 friends and after receiving her injection, they proceeded to the observation area to wait for 15 minutes.  At approximately 19:08, the client?s friends waived for the EMT to come over to where they were sitting.  The client stated she felt dizzy, was starting to black out, and felt like she was going to pass out.  EMT called out to Lead and Co-Lead RNs who were nearby, and assisted the client into a zero-gravity chair.  They sat her in the chair at a 45-degree angle.  Lead RN observed that the client was diaphoretic.  The client was conscious and the Lead RN asked questions to determine if she was alert & oriented to person, place, time, and situation.  Lead RN determined she was.  Due to the client stating she was very hot, Co-Lead RN opened the nearest windows while Lead RN gave the client a bottle of water and began fanning her with some cardboard.  The client started gulping down the water.  Lead RN asked the client when it was that she had last eaten or drank anything.  The client stated it was earlier in the morning.  Co-Lead gave the client some crackers and a juice box and she immediately began eating and drinking the juice.  The client stated she was already starting to feel a lot better.  The client stated she does not have any underlying medical conditions, has no allergies, and takes no medications.  She also stated that she did not take anything before coming to get the vaccine, but had drank alcohol the night before and was a little dehydrated today.  At 19:17, EMT took the client?s vitals (BP: 120/70, HR: 77, SPO2: 97%).  The client stated she, ?felt a lot better.?  The Lead nurses requested the client sit for an additional 15 minutes to ensure she was feeling fine, and the client agreed.  At 19:32 both Lead RNs and EMT observed that the client was no longer diaphoretic and asked the client how she was feeling.  She was laughing and joking with her friends, stating ?she felt fine.?  Both Lead RNs requested the client stand up to confirm she felt fine.  Both Lead RNs observed client stand up with no problems and the client stated she was ?OK.?  Lead RN educated client on both the potential side effects and adverse effects of the vaccine, when to seek medical attention, and ER precautions.  Client stated she understood.  Lead RN observed client and her friends and exit the observation room walking with a steady gait.
pt recv vax; was very fussy and unconsolable, lt leg very red and swollen; T of 48;
Neck began itching and rash appeared.  The next morning my face was extremely swollen and also the second morning after the shot was given, the same reactions still occurring.
She began to experience ipsilateral facial/parotid swelling following her 2nd dose of Bexsero. Came to the office on 7/9/2016 with parotitis.
pt recv vax & exp lack of response;pt had negative rubella IgM antibody titer;
Raised band around arm, warm and itchy, presenting 2 days after injection. Instructed to contact PCP and report back to us.
Reddened area below injection site that was inflammed and tender to the touch. Instructed to apply cool compress and rubbing alcohol to area.
Extreme pain in hand, wrist and lower arm injected? felt like crushing blow with hard object.  Chills, Nausea, lightheaded, weakness, and fatigue?legs felt like a wet noodle when trying to stand.  This lasted approximately 16 hours. For the next 12 hours, experienced on and off moments of extreme weakness, lightheaded and dizzy.  No adverse symptoms since.
MMR and IPV and DTaP were administered on 05/02/06. Two days later pt developed papular rash, which was arranged in several groups. One spot on forehead, several on UE and LE, several in LUM, back area, lesions were impetigo like. Was treated with Bactrim for area also got amoxicillin for 2 hrs for positive strep throat from 5/8/06. On 6/8/06 reviewed rash, improved, but pt had new lesions which were considered as insect bites, seen by dermatologist.
Moderna 3/4/21, 4/1/21. Positive on 10/16/22
Redness, swelling of Rt thigh - large area - approximately 20 x 15 centimeters.