chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extensive rash/hives across hip and pubic areas; Spotty rash on thighs, chest, face; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 04May2021 at 20:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN), probiotics nos (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN) all taken for an unknown indication from an unspecified date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 20:00, the patient experienced extensive rash/hives across hip and pubic areas and spotty rash on thighs, chest and face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with prednisone(MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extensive rash/hives across hip and pubic areas and spotty rash on thighs, chest and face were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Received only the adjuvant; Received only the adjuvant; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 75XA2, expiry date 28th January 2023) for prophylaxis.   On 14th July 2021, the patient received Shingrix. On 14th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient received only adjuvant portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, reconstitution liquid administered not the actual vaccine it self. The Glaxosmithkline was contacted and were informed that we should wait 4 weeks before giving repeat dose. The patient was advised to came in 4 weeks from the date of injection to have shingrix vaccine readministered. The VAERS details were updated. This case was linked with case US2021167751, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167751:Patient 1
Patient started to not wash bath towel daily at night about day #8 post vaccination.  On day #9, he started to get small pustules on his face.  This then spread to his neck, suprapubic area, and back of thighs.  By day #11 he also had lower lip mucoaal and back involvement.
Patient started experiencing a feeling of warmth about 15 to 20 minutes post injection. Then partial vision loss, chest heaviness, left- side numbness, Jaw tightness. Around 12:40 we called 911 and she was taken by ambulance to Medical center for evaluation. 911 operator instructed us to give 4 Aspirin 81mg.
Intensely pruritic papular vesicular eruption affecting whole body (including palms, soles, scalp, oral mucosa), but sparing face. Swelling of dorsal fat pad.
Vaccines given at 0930; then at 1110 noted to have a rash that began on her cheeks and then spread to rest of body. On exam at 1145 pt with diffused patches of urticaria, body with raised irregular borders and wheals/ flares.
It started with headaches, they got worse and then I woke up one day with Bell's palsy, that was on July 7, 2021. I already had an appointment set up for the 8th of July so my doctor checked me out then. My doctor gave me prednisone for five days and told me if anything got worse, to go to the ER. I ended up in the ER on 7/13/2021 because of the migraines and they did a CT scan and everything came back normal so they told me to follow up with my PCP so I am seeing her on July 22, 2021. I also had a miscarriage, I was to deliver on September 24, 2021. I was 17 weeks pregnant when I received my second dose of the vaccine. I have miscarried before as well.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OSCILLOCOCCINUM, start date: 02Jun2022, stop date: 05Jun2022. Past drug history included: Tetrocycline, reaction(s): "known allergies;Tetracycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from healthcare worker refers to a male patient of unknown age. The patient had no known pertinent medical history or drug reactions/allergies. On 21-MAR-2014, the patient was vaccinated with his first dose of GARDASIL injection, 0.5 ml, intramuscular (lot#, expiration date not reported). There was no concomitant medication. The healthcare worker reported that the patient received his first dose of GARDASIL and had a syncopal episode. She stated that the patient received the dose of GARDASIL, waited in the physician office for 30 minutes, and once the patient was at the car, the patient fainted. The healthcare worker also stated that the patient's family got him in the car and elevated his legs and the syncopal episode resolved "after a few seconds". She stated that the patient did not sustain any injuries due to his fall. No treatment was given for the adverse event. No lab diagnostics studies was performed. No intervention to prevent serious criteria. The outcome of the event was recovered on 21-MAR-2014. Additional information has been requested.
heart palpitations/Her heart was palpitating; felt like she was panicking; She was under stress; chest pain; tightness in her chest; she had pain in her arm that went to her chest; She was scared she was having a heart attack or something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 37 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Aug2021 (Lot number: FC3180) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "She was scared she was having a heart attack or something"; PALPITATIONS (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "heart palpitations/Her heart was palpitating"; PANIC REACTION (non-serious) with onset 2021, outcome "unknown", described as "felt like she was panicking"; STRESS (non-serious) with onset 2021, outcome "unknown", described as "She was under stress"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pain"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "tightness in her chest"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "she had pain in her arm that went to her chest". The events "she was scared she was having a heart attack or something", "heart palpitations/her heart was palpitating" were evaluated at the physician office visit and emergency room visit. The events "chest pain" and "tightness in her chest" were evaluated at the emergency room visit. Clinical course reported as: After the first COVID vaccine, it was almost exactly a week later that she started having heart palpitations. It continued throughout the week for 2-3 weeks. She felt like she was panicking. She is a heavy person, but she still runs on the treadmill, and she still likes to workout. She was under stress. Her heart was palpitating. The palpitations have since went away, but they didn't go away until after the second dose. She also had chest pain and tightness in her chest. It was freaking her out. She was scared she was having a heart attack or something. She went to the Emergency room because she went to the pharmacist, and they said they wouldn't be comfortable giving her the next shot without seeing a doctor. She went to the clinic, and they said they couldn't help her so they told her to go to the Emergency room. The doctor there checked her heart, and told her to follow up with a regular care doctor. He said he still recommends the second COVID vaccine. So she went and got the second COVID vaccine a week later.  Follow-up attempts completed. No further information expected
Dizziness, headache, and nausea Went to ER on the 24th, the night the symptoms appeared. Received fluids and toradol Discharged that night and still felt dizzy. Symptoms went away the next day and returned on the 26th with feeling of dizziness, headache and nausea. Continued to the next day, called primary care provider the 27th and was perscribed Ondansetron for the nausea. Symtpoms of headache and dizziness continued the 28th
Red raised bumps from head to toe. Fussy, cranky, not himself. No treatment nec.
2/7/2021 Sore muscles at injection site 2/7/2021 Enlarged lymph nodes in left armpit (same side as injection).  2/26/2021 Headache/Fever/Chills for less than 24 hours
Administration of flu vaccine, GSK Fluarix, LOT# N549A, left deltoid, IM injection. This person was given their first flu shot in an observed mass clinic, drive-thru vaccine clinic setting. The patient experienced an instant swelling of the upper left arm at the injection site. It is believed to be an instant hematoma at the injection site. Underneath the skin was slightly swollen, and slightly purple. There was a little more blood than usual with this injection. The RN wiped away blood and held pressure. Then another nurse was called and held pressure for 5 minutes to make sure the bleeding stopped and slow the swelling. The patient complained of pain at the injection site. She said "I could feel it going in more than I thought I would." This was her first flu vaccine ever.  Patient did not appear to have any additional swelling after approximately 3 minutes post-injection.  It did not appear to be worsening. Overall, pressure was held over the site for about 7 minutes.  Patient was given an ice pack and advised to keep rotating ice off and on the site as tolerable to decrease the swelling.  The patient did not appear to have symptoms of respiratory distress or anaphylaxis. Patient appeared otherwise healthy after injection.
Severe pain in upper shoulder, went to doctor they x-rayed and no noticeable problems. Problem still persists. They gave patient the high dose vaccine and used a long needle. Patient is certain that the needle penetrated her bone. Patient only weighs 97 pounds.
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt reported with a large bruise and self reported "bubbling" - bruise center was approximately 2-3'' lower than an expected injection site.
The night after second vaccine (9/4/2021) patient developed hives with itching on chest, abdomen, back, neck, and bilateral arms.   Seen at clinic 10 days post vaccine, with the same symptoms.
This spontaneous report was received from a physician refers to a 76 year old female patient without medical history, drug reactions and allergies. In approximately January 2005 the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration and lot # were not reported). On 12-JAN-2015 the patient was vaccinated with her second dose of PNEUMOVAX 23 lot # J013555, expiration date 02-MAY-2015, 0.5 ml, subcutaneous in the left arm. Concomitant therapies included nortriptyline and LIPITOR. On 14-JAN-2015 the patient experienced pain and swelling below the elbow of the arm in which the dose of PNEUMOVAX 23 was administered. The patient also reported that the area which was swollen was also itching. The physician reported that the area of redness was warm to the touch. In response to the question about significant disability or incapacity, the physician stated that the patient could not use her left arm. Physician is being to recommend to the patient, BENADRYL and ADVIL along with ice to the area that was affected. None of those treatments had been administered to the patient at the time of this report. There were no laboratory diagnostics studies performed. The outcome of the above mentioned events was reported as not recovered/not resolved. Additional information has been requested.
PATIENT RECEIVED A DOSE OF PFIZER BIVALENT BOOSTER DOSE WAS PAST BUD, SPOKE TO PATIENT AND HE STATED HAS NOT EXPERIENCING ANY ADVERSE EVENTS. PATIENT WILL SCHEDULE TO BE RE-VACCINATED.
Headache, fever, sore throat, chills, diarrhea starting 48 hours after Gardasil vaccine was given.
More than 36 days since the first shot/ never got the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days since the first shot/ never got the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included COVID-19 in October 2020. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days since the first shot/ never got the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days since the first shot/ never got the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment was received by the patient.
Starting about a day and 1/2 later after the vaccine, I had body aches, fever, tinnitus and fatigue.  I took Tylenol.  These symptoms lasted for 2 days, but the tinnitus did not go away.  I decided to see the audiologist on 3/29/2021.  They did a hearing test and adjusted my hearing aids.  I was instructed to wait it out.  The tinnitus got better after 6 weeks and went back to baseline.
Pfizer vaccine vial punctured at 0825 gave Pfizer vaccine to Pt at 1555. Vaccine was expired by 90. No symptoms seen and no tx given at this time. Observation of 20 minutes
Cough  Fatigue  Muscle or body aches  Headache  Congestion or running nose
Pt received SHINGRIX vaccine September 1st, 2018. He went to the hospital on 11-10-18 and was diagnosed with shingles and genital herpes. Testing not done. Wife states ER doctor just looked at patient and told pt it was from the shingles vaccine.
This case was reported by a pharmacist, via a sales representative, and described the occurrence of nonspecific reaction in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown, unknown deltoid). At an unspecified time after vaccination with FLULAVAL, the subject experienced nonspecific reaction. At the time of reporting the outcome of the event was unspecified. On 28 October 2009, the pharmacist notified the sales representative via voicemail that a subject had a reaction to FLULAVAL. The pharmacist reported that the dose was given in the deltoid region and the reaction was probably self-limiting.
hives around neck; dizzy; pain all over her body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives around neck), DIZZINESS (dizzy) and PAIN (pain all over her body) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives around neck), DIZZINESS (dizzy) and PAIN (pain all over her body). At the time of the report, URTICARIA (hives around neck), DIZZINESS (dizzy) and PAIN (pain all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given
Soreness, swelling. Saw same MD ~48h later. Treated with ice, NSAIDs and monitoring.
extreme arm pain---goes down to fingers.  Also a general feeling of being "off" and dizzy spell/vertigo post vaccination day 5.
Patient reported no significant issues after 1st dose of pfizer vaccine or any immediate issues after 2nd dose.  Approximately 3 weeks after 2nd dose, patient presented to her PCP and she reports that her PCP said she had Bell's Palsy.  The PCP isn't apart of our health system so we don't have any more details than that.  She reached out to one of our case managers here to report the incident and that information was passed on to the pharmacy for reporting.
Cellulitis like reaction-swelling, redness, hot to touch. Swelling 3 1/2"x2 1/2" L arm.
This spontaneous report was received from an 80-year-old male patient regarding himself. Patient was taking medication for heart. Drug reactions/allergies were reported as none. Concomitant medications included lisinopril. On 01-NOV-2016 the patient was vaccinated with ZOSTAVAX, 1 DF for prophylaxis (dosing details were not provided). Other suspect therapies included sterile diluent (STERILE DILUENT). On 08-NOV-2016 (reported as about a week later after receiving ZOSTAVAX), the patients skin started to feel like cardboard. He further clarified that his skin turned stiff at the ankles and then spread up the legs to his back and shoulders. It was also stated that since receiving the vaccine, the patient had more black moles on his skin and he bruised easily. Lab diagnostics/studies performed: allergies test, patch test. The patient sought medical attention by visiting the physician's office and to a dermatologist. Unspecified treatment was given for the events. Action taken with the suspect drug was not applicable. The outcome of the events was reported as recovering/resolving. Causality of the events was not provided. No product quality complaint (PQC) was present. Upon internal review, the event his skin turned stiff at the ankles and then spread up to legs to his back and his shoulders and his skin started to feel like card board (scleroedema) was considered to be medically significant.
Fever 103 starting 24 hours after vaccine. Then seizure at 48 hours, no treatment required beyond Tylenol and Motrin. Seizure lasted 1 minute 30 seconds (approx.).
09/20/2022 I went to the doctor because I had shortness of breath before my vaccine. She told me that I had a sinus infection. I have asthma so she put on medication erythromycin and prednisone. 09/28/2022 I went to the ER. All of my right side was numb including my leg, arm, and face. I was there for 3 days from Wednesday-Friday. I had a mini stroke. They discharged me on Friday. They prescribed me with baby aspirin 81 milligrams, LIPITOR 30miligrams and I also have to continue my blood pressure medication.
12 hours after the injection, I had body aches, sweats, chills, headache, and nausea. These adverse effects lasted approximately 12 hours.
Patient was given flu shot in her left upper arm (but claims it was given in her the back part of her shoulder). She said she felt extreme pain and pressure when shot was given from her shoulder down her arm to her fingers. She states the pain started at that time until now. She said the pain got worse and then she could not raise her arm so she went to a doctor. He recommended an MRI.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 19:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "lowered immune system" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received other medication in 2 weeks. Patient received covid-19 treatment with Antiviral Product Paxlovid, from 07Jan2023 till 11Jan2023. Testing positive for Covid 4 days after finishing Paxlovid and having a negative Covid test   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two days, post vax, the pt developed a high fever of 104F and used acetaminophen. She had a rash and swelling along the jaw line with a gradual loss of previously acquired language. Diagnosed with seizures and pervasive developmental delay.
1/5/22 developed Bell's Palsy right side treated with steroids and antiviral (prednisone and valacyclovir) on 1/7/22 recheck 1/24/22 almost completely resolved symptoms
Booster dose given instead of first primary series vaccine. Pt did not report any immediate side effects, will follow up tomorrow.
Assuming from smallpox inoculation, patient developed vesicules and ulcerations of vulva. Viral cultures are pending, but I believe this is from autoinoculation from vaccinia wound. She had unprotected intercourse and reports that her partner is asymptomatic.
Pt. received PREVNAR and FLUZONE on 12/16/16, he came in on 12/22 and said the PREVNAR site has been itchy since Monday and noticed today that there was a rash spread over the area the size of a baseball. I recommended he take BENADRYL and apply hydrocortisone and call MD if not improved tomorrow.