chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Six and a half weeks previous to my vaccination (April 26) I had 2 basal cell carcinomas removed from my right lower leg; one by Mohs and one by simple excision. These were fully healed. On June 12, the day after my vaccination, both excision sites became red, hot, swollen and painful. I called Dr, the physician that performed the excisions and he prescribed Clindamycin.  The sites became increasingly red and painful with purulent drainage so I was seen at my PCP for a culture which came back positive for staph aureus. I was changed to Doxycycline for 10 days and completed the full course of antibiotics. I was also seen by the Dr. and he injected the sites with a steroid to reduce the inflammation. Approximately 48 hours after completing the Doxy, the excision sites began worsening again.  My PCP started me on Bactrim and I was seen again by Dr. on July 12 where he removed the surface tissue and re-injected the sites with steroid again. Both are still notable red but improving.
Pt experienced dizziness after dose.  She did not faint.  She stated that " this always happens".
Patient experienced itching and lip swelling one hour after vaccines.  Patient treated in ED and released.
headache; sleep apnea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (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: HEADACHE (non-serious) with onset 13Apr2021, outcome "unknown", described as "headache"; SLEEP APNOEA SYNDROME (non-serious) with onset Apr2021, outcome "unknown", described as "sleep apnea". Therapeutic measures were not taken as a result of sleep apnoea syndrome.  Additional information: The patient received the first dose of the Pfizer COVID vaccine on Friday and today she had a headache. She would like to know if she can take Ibuprofen or not. She doesn't think it was coming from the vaccine and that she has sleep apnoea and didn't use her c-pap machine and when she woke up she had a headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Wed Oct. 19, 2016 large red welts on both arms formed. Red, swollen and warm to the touch, hurt when touched. Slight fever. Not eating normal. Tired and inactive. Thus Oct 20, 2016 took to doctor's that morning. Given BENADRYL and Ibuprofen as prescription. Fri Oct 21, 2016 still large welts but starting to go down. Sat. Oct. 22, 2016. In the morning the welts are no longer red or large. Most of the swelling is down. One arm still hurts a little. She is less tired and more active than she has been in the last 3 days. She is starting to get her appetite back. Sun Oct. 23, 2016. The rest of the swelling is gone. Her arms no longer hurting.
pt recvd vax; 24 hrs later exp flu-like synd w/ severe arthralgia;
4 Month old received Kinrix; Received Kinrix instead of Pediarix; Kinrix given as dose two of the DTaP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Jan-2023 Reporter's comment: The nurse stated that  the medication error occurred at a different clinic and she did not had any additional details available so she did not consent to follow up from safety. Did not consent to follow-up.  Additional supportive information: The patient was inadvertently given Kinrix as dose two of the DTaP series instead of Pediarix at inappropriate age, which led to inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered.
Red swollen left upper arm CPNC injection site given 7/14/05. 7cm x 5cm size.
Red spot at injection site started about 8 days after administration. Spot was sore, warm to touch, lumpy at first, then swollen. Patient treated with benadryl and hydrocortisone cream, but the spot spread and the edges are very swollen and sore. Patient sought treatment on 6/21/21 - provider suspected cellulitis and will continue monitoring.
Suspected vaccination failure; got shingles / Believe me its hell.; got shingles after 3 years after my first round of shots / when the one came out for seniors I ran to get those; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine and Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving 1st round of Shingles vaccine, the patient got shingles. The patient stated that, when the one came out for seniors, he/she ran out to get those which led to extra dose administered. He/she reported that, they said they were much better and stated that, it was worth every penny not to go through that again. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles were not provided.
ROUGH TIME SINCE THEY GOT THEIR SHOT; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rough time since they got their shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rough time since they got their shot. This report was non-serious. This case, from the same reporter is linked to 20221248771.
Patient sent to ED from clinic due to worsening Covid-like symptoms.  Patient admitted as outpatient for observation.  Patient states he received the Pfizer two shot series , the second received in August, 2021, but is not able to supply exact dates.  Booster not completed.
Headache within 20 min. Generalized aches. Felt terrible through out night. Follow-up 9/29 pt felt better symptoms resolved with 24 hours.
vaso-vagal episode 10 mins p/inject; cont w/some dizziness for 2 days; now cont w/somnolence, also of hoarness as of 9AUG93;
Received dose @ 1445; 1458 had a cough and itchy throat and flushed; Bp 162/103 HR 86 Sat 99%; At 1459 gave IV push solumedrol 125 mg; 1510 bp 150/93 hr 80; sat 99%; feeling better
Patient came into the pharmacy with a round rash at the site of administration. Let her know to treat aches with Tylenol.
chronic auto immune response; angioedema/tongue is swollen; urticaria/hives; This is a spontaneous report from a contactable other healthcare professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), intramuscular in the right arm on 28Dec2020 10:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), omeprazole (PROTONIX), naproxen sodium (ALEVE), and birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 30Dec2020 16:00, the patient have a chronic auto immune response in the form of urticaria and angioedema. The symptoms of hives as well as swollen tongue was maintained with antihistamines. Outcome of the events was not recovered. The events were considered non-serious.  The following information on the batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the events chronic autoimmune response in the form of urticaria and angioedema with BNT162b2 can not be completely excluded.  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.
Information has been received from a physician concerning a 30 year old female patient who on an unspecified date, was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# not reported). A week after her first dose of VARIVAX (Merck), the patient developed chickenpox. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. The physician wanted to assess if the vaccine caused the varicella. Additional information has been requested.
p/ pt vax approx 8 days later pt devel inject site react. swelling in whole upper arm, fever, upper respiratory infect
did not feel good for a couple of hours; This is a spontaneous report from a Pfizer-sponsored program received from a non-contactable consumer. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein), via an unspecified route of administration on 13Dec2020 at single dose for immunization. The patient's medical history included COVID-19; relevant concomitant medications were not reported. The patient reported that he/she did not feel good for a couple of hours after vaccine, but it went away. He/she has had COVID but does not know if he/she still has antibodies or not. He/she doesn't want that again. He/she hopes pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) does not hurt him/her because he/she has had COVID. The reported event had resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 82-year-old female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020) for prophylaxis. On 27th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, several days after receiving SHINGRIX, the patient experienced rash and ptosis. The patient was treated with acyclovir. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the ptosis was not recovered/not resolved. It was unknown if the reporter considered the rash and ptosis to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on the left arm. The healthcare professional (HCP) reported that, the patient developed a rash on the left side of her head and a droopy left eye in the early April 2018. The reporter stated that this the patient went to her primary care physician and was started on acyclovir cream for the rash, but was diagnosed by her optometrist when she went to see him for her droopy eye. The HCP could not find the lot number or expiry date of the SHINGRIX.
slight fever (38.4 Celsius); felt very drowsy; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 24-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EJ1685) via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:45 as DOSE 1,SINGLE for covid-19 immunisation at Workplace clinic. The patient medical history was not reported. There were no concomitant medications. Other vaccine in four weeks was reported as no. The patient had no covid prior vaccination. The Patient had not covid tested post vaccination. On 02Mar2021 (around 18 hours after the first does), The patient experienced slight fever (38.4 celsius), felt very drowsy and tired. The symptom stayed for 1.5 to 2 days and went away.The patient underwent lab tests and procedures which included body temperature: 38.4 centigrade on. The outcome of the event was unknown.  Response: The date I became aware of the adverse events were 02Mar2021 and 03Mar2021 where I finished my first shot on 01Mar2021.  No follow-up attempts are possible. No further information is expected.
This case meets vaccine breakthrough criteria review.  SxS 12 days fevers and body aches with cough, weakness, fatigue and loss of taste and smell.
25 minutes after vaccine, became super flushed on face, arms and hands. Pulse 80-100; Felt dizzy and weird. Patient elevated feet and continued to be flushed and feel dizzy. Patient asked to be evaluated at hospital. Transported via EMS to hospital Emergency department around 1:40pm
Painful arm, swollen, red, rash developed the next day.  Pain and swelling/rash continued the following day as well.  I was vaccinated on a Friday, today is Monday and the area is still red and itchy.  It is not quite as painful but it is sore and there is a now hardness near the injection site when the area is touched.
Significant tooth pain after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Significant tooth pain after the first vaccine) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (Significant tooth pain after the first vaccine). At the time of the report, TOOTHACHE (Significant tooth pain after the first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
This spontaneous report was received from a pharmacist via a company representative and refers to her mother, a female patient of unknown age. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX, 1 vial, (route of administration, anatomical location, lot number and expiration date were not provided). The vaccine was administered by an unspecified pharmacist. There were not concomitant medications reported. On an unknown date, the patient got a rash and swelling, and it was hot to the touch, she also felt a knot at the injection site. The patient did not seek medical attention and she treated the adverse events with ice only. There was no product quality issue involved. The outcome of injection site nodule, injection site warmth, injection site swelling and injection site rash was reported as recovered on an unspecified date, reported as "2 weeks after received the ZOSTAVAX vaccine". The reporter did not assess the relatedness of injection site nodule, injection site warmth, injection site swelling and injection site rash with ZOSTAVAX vaccine. This is one of two cases from the same reporter. Additional information is not expected since the reporter contact details were not provided.
Information has been received from a nurse concerning her 7 year old daughter who in May 2004, was vaccinated with the first dose of VARIVAX (Merck). Two-three years later, the patient was vaccinated with the second dose of VARIVAX (Merck). After receiving the second dose of VARIVAX (Merck), around 06-MAY-2010 the patient broke out in chickenpox and had a few lesions on her back that eventually turned in to MRSA. The patient went to doctor's office for medical attention. The patient was placed on antibiotics and had since fully recovered. Additional information is not expected.
a burn to skin in the location where the band aid was placed immediately following vaccination shot.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have allergies to medications, food, or other products. 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. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 13Mar2021 (at the age of 42-years-old), as a single dose for COVID-19 immunisation.  On 03Apr2021 at 12:00, the patient experienced burn to her skin in the location where the band aid was placed immediately following her vaccination shot. The burn was in the shape of the band aid. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the events. The clinical outcome of the event burn to her skin in the location where the band aid was placed immediately following her vaccination shot was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Patient called on  6/29 around 10:30 am stating that he has muscle aches, no energy, and trouble breathing since 5/21 (2 days after his vaccination).  Pharmacist advised patient to see a doctor immediately since he is very trouble breathing and to rule out any infection or other issues related or not related to vaccine.
Pfizer-BioNTech COVID-19 Vaccine EUA       Extreme sleepiness
Pt devel candidiasis following vax w/Hep B; No further details were provided;
This spontaneous report was received from a physician, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the first and second doses of GARDASIL (dose, route of administration, lot # and expiration date were not reported). Then, on an unknown date, the reporting physician stated that the patient received a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported) to finish the vaccination series. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Dizziness, Headache, Myalgia, decreased concentration; chills Narrative:
Patient reported fever, headache, diarrhea, nausea and vomiting on 1/4/23.  On 1/5/23 patient developed red raised vesicle on right upper arm.  Over the next several days more vesicles appeared on right and left upper arms
Pfizer Covid 19 vaccine- giving to kids today and diluted it with 1.2mL instead of 1.8mL of diluent/4 kids got a stronger dose than they should have; Pfizer Covid 19 vaccine- giving to kids today and diluted it with 1.2mL instead of 1.8mL of diluent/4 kids got a stronger dose than they should have; This is a spontaneous report from a contactable other hcp. A 13-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8734; Expiration Date: 31Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in left deltoid on 23Jun2021 13:00 (at the age of 13-years-old) as a single dose for COVID-19 immunisation (reported as she is over 12). Medical history reported as none. The patient's concomitant medications were not reported. No history of previous immunization with the Pfizer vaccine considered as suspect. Caller was not aware if the patient had any Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations. On 23Jun2021 13:00, Pfizer COVID-19 vaccine- giving to kids today and diluted it with 1.2ml instead of 1.8ml of diluent/4 kids got a stronger dose than they should have. Caller states that they were administering Pfizer COVID vaccines. They diluted it with 1.2mL instead of 1.8mL. It was reported that "caller states they were doing Moderna injections in one room and Pfizer in another room and it gets confusing. Caller will call the parents and let them know about this. Seriousness Criteria: Caller states this is serious. Verbatim event relatedness: Pfizer COVID Vaccine: Vaccine was diluted with 1.2mL instead of 1.8mL was administered - Related." Adverse events did not require Emergency Room and Physician Office visit.   Information about batch/Lot number has been requested.  Follow up (23Jun2021): This is a follow-up report combining information from duplicate reports [2021769141] and [2021781997]. The current and all subsequent information will be reported under manufacturer report number [2021769141]. New information included that: Patient's age and gender were added, Batch/lot number, expiration date, anatomical location were added, vaccine start and stop date, events onset were updated, events were upgraded with seriousness criteria of medically significant, medical history was updated to none, reporter causality updated in narrative,  Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspected vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-2021766740 same reporter/SD/AE, different patients