chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe hives on ankles, itchy, red raised hives, swollen and still have mild moderate hives at various spots; Swollen lips; Itchy; Swollen; Warm injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the right arm on 18Mar2021 at 11:15 (at the age of 37-years-old), as single dose for COVID-19 immunisation. Medical history included chronic idiopathic urticaria. The patient was allergic to amoxicillin. Concomitant medications included cetirizine hydrochloride (Zyrtec), escitalopram oxalate (LEXAPRO), lorazepam (ATIVAN), hydroxyzine (MANUFACTURER UNKNOWN); all taken for unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 13:30, the patient experienced itchy, swollen and warm injection site (itchiness was continued). On 22Mar2021 (Day 4 after shot), the patient experienced severe hives on ankles, itchy, red raised hives, swollen and still have mild moderate hives at various spots and including swollen lips. 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 adverse events and included self-treatment with ZYRTEC and ZANTAC. The clinical outcomes of the events itchy, swelling, Injection site warmth, hives and swollen lips was not resolved at the time of report.  No follow up attempts are possible. No further information is expected.
09/11/22 That morning I wasn't feeling that well. I had very mild symptoms. I took a rapid antigen test, and it was positive. I spoke with my doctor, and she prescribed PAXLOVID. I began taking the PAXLOVID on 9/12/2022. My symptoms rapidly cleared and by the time I finished the PAXLOVID, my symptoms were gone and I felt fine.
12 hours: mild muscle pain, soreness at injection site, mild HA. 20 hours: increased fatigue, increased muscle pain, body aches, fever (100.0), swelling at injection site. 48 hours: increased fatigue, moderate-severe HA, brain fog, swelling at injection site and red. 72 hours: mild fatigue, mild HA, mild brain fog, itching at injection site, mild redness at injection site, decreased swelling at injection site. 96 hours: mild brain fog
weird feeling in my mouth; red, however like broken blood vessels near mouth and cheek; Lips still feel strange.; Itchy, left had; Itchy left had and swollen; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 06Apr2021 at 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic reaction to antibiotics and penicillin allergy. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), cannabis sativa (CANNABIS), lisinopril (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT) all from an unknown date for an unspecified indication. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 16:00 the patient experienced weird feeling in mouth, sat for 20 min, checked out. Took off mask and was red, however like broken blood vessels near mouth and cheek. Itchy left hand and swollen. Lips still feel strange. No shortness of breath or swelling. Patient took Benadryl. The events resulted in emergency room/department or urgent care. The clinical outcome of events oral discomfort, redness of face, lip discomfort, itching, swollen arm was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Shingles  - rash on face, scalp, neuropathic pain.  Current treatment with valacyclovir 1000mg 3x/day x 7 days.
Approximately 10 minutes after the patient got her second moderna vaccine she became faint and dizzy. The patient was sitting at the time. A law enforcement officer witnessed her becoming faint and ran over to attend her. I was called over to assess her as well. The law enforcement officer called EMS. The patient stated that she felt faint, dizzy, she said she had a headache, blurry vision, and was nauseous. The patient appeared sweaty and she appeared to loose consciousness briefly twice. She did not show any signs of redness, rash, or swelling. After sitting for a few minutes, and before EMS arrived, the patient said she was improving. She did not lose consciousness anymore but she still had a headache, nausea, and blurry vision. When EMS arrived they recommended that she get checked out at the emergency room, but the patient refused stating that she did not want to go to the hospital and that she was feeling better. The patient called her parents and they came and picked her up.
On 5/8/2022 had heart attack. Started having chest pains, was nausea, with arm pain. Went to ER, BP was elevated, EKG abnormal. Performed Emergency Cardiac Catherization and balloon Angioplasty, then put in 2 Stents in. Hospitalized for 2 days then out of work for 2 1/2 months. Currently in Cardiac Rehab.
Headache, Fever, CHILLS; FATIGUE Narrative: SX LASTED 3 DAYS EVEN WITH TYLENOL  Other Relevant History:
This spontaneous report was received from an office manager via a company representative and refers to a 18 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 15-MAY-2018, the patient was vaccinated with GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. On the same date, the patient also received hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot number and expiration date were not reported) for prophylaxis, and MENACTRA (dose, route, lot number, indication and expiration date were not reported). On an unspecified date in 2018, the patient's arm where the GARDASIL 9 was applicate was "swelled tremendously, the patient could not lift her arm, the arm had inflammation, she had fever on and off, myalgia and the patient missed school. It was unknown, if the patient received the hepatitis a vaccine, inactivated (manufacturer unknown) and MENACTRA in the same which received the GARDASIL 9. It was unknown if the patient received treatment for the events. The outcome of peripheral swelling, vaccination site movement impairment, myalgia and pyrexia was unknown. The causal relationship between the events and GARDASIL 9 was not reported.
No adverse event; May have received original vaccine instead of the Bivalent/may have received an incorrect vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (May have received original vaccine instead of the Bivalent/may have received an incorrect vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (May have received original vaccine instead of the Bivalent/may have received an incorrect vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (May have received original vaccine instead of the Bivalent/may have received an incorrect vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant product use was reported.  Husband wanted confirmation on the vaccine code, AS7764B if it was Bivalent or original vaccine.  No treatment information was provided.
pt recvd vax & complained of shortness of breath & slight petechia on anterior chest
Given client expired Rotavirus, had client to wait 15 min after meds; no problems noted. Inform Dr. & supervisor. Will call or send letter to revaccinate.
tested positive after the 1st dose last 13Jan2021; fatigued; This is a spontaneous report from Pfizer-sponsored program. A contactable Pharmacist reported that a 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176, expiry date: Mar2021), via an unspecified route of administration on left arm on 13Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The pharmacist reported, his team member has been tested positive after the 1st dose on 20Jan2021. The patient got the first dose on 13Jan in the afternoon between 05:00PM-06:00PM injected into her left arm. He says that the type of test given for COVID-19 positive test was unknown. He says that his team member has recovered, though she still feels fatigued. The patient received additional therapies for COVID-19 such as Remdesivir, Hydroxychloroquine/chloroquine, Azithromycin, Corticosteroids. The outcome of event COVID-19 virus test positive was recovered and for fatigue it was unknown.
sore arm; something with her throat; voice hoarse; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (something with her throat), APHONIA (voice hoarse) and MYALGIA (sore arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Seizure.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced THROAT IRRITATION (something with her throat) and APHONIA (voice hoarse). On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, THROAT IRRITATION (something with her throat) and APHONIA (voice hoarse) had not resolved and MYALGIA (sore arm) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On 21-NOV-2014, the patient was vaccinated with ZOSTAVAX dose 0.65 ml (strength, product lot# and expiry date not reported) intramuscularly. No adverse experience was reported. There was no product quality complaint involved. The outcome of the events was unknown. Follow up information has been received from the pharmacist regarding a 65 years old male patient. On 21-NOV-2014, the patient was vaccinated with the first dose of ZOSTAVAX lot # reported as K10620. There was no illnesses at the time of vaccination. On 23-NOV-2014, the patient experienced redness, itching and some swelling which lasted 3 days. On  26-NOV-2014, the patient recovered from the events. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Lot # K10620 is not valid for ZOSTAVAX. Additional information is not reported.
I gave undiluted pediatric pfizer vaccine to adult patient. After administering the vaccine, I immediately noticed it was the pediatric pfizer vaccine. I discarded the open pediatric vaccine. I contacted patient to inform him about the wrong vaccine administration. Patient said he is fine and will notify us if any serious adverse effect
After receiving my second Pfizer vaccine I have been having headaches. Several times a week I wake up with bad headaches. I also get them at night and during the days sometimes. Note, I do not have a history of headaches before the vaccine.
Patient relates that she had a reaction to the Hep B shot "right arm Bruised and swollen, with a rash from her right arm to her chest.
Severe pain and redness, redness spread from upper arm to chest, shortness of breath.
vomiting, diarrhea & malaise are reported in a pt who recvd 1 dose of flu vax; above sx occurred w/in 24-48 hrs p/vax; pt recovered;
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles (four times in the past). On 13th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th August 2018, 1 days after receiving Shingrix, the patient experienced injection site swelling, joint pain and fever. On an unknown date, the outcome of the injection site swelling, joint pain and fever were recovered/resolved. It was unknown if the reporter considered the injection site swelling, joint pain and fever to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left arm. The patient reported that she experienced shingles four times in the past, and planned to get her second injection.
Patient states 3 minutes after receiving the vaccine felt head to toe sensation of "blood rushed out of my body." Felt "nervy and tingling". States heart rate was 100 and was told she was pale. 2-3 days post vaccine developed severe left ear preauricular pain. Now continues to feel vertigo, lightheadedness, dizzy, on and off palpitations, fatigue, "nervy tingly"  and some changes in short term memory.
Received expired booster shot; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 020A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster shot). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Patient stated that a week after the booster shot, he received a letter informing him that the booster vaccine he received was in fact expired.
fever; runny nose; coughing; feeling really tired; nauseous; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 26 year-old male patient received bnt162b2 (COMIRNATY), administration date 09Nov2021 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "fever"; RHINORRHOEA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "runny nose"; COUGH (non-serious) with onset 23Nov2021, outcome "not recovered", described as "coughing"; FATIGUE (non-serious) with onset 23Nov2021, outcome "not recovered", described as "feeling really tired"; NAUSEA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "nauseous".  Additional Information: Agent stated that he knew someone who received the Pfizer Biontech Covid 19 vaccines, experiencing quite a few side effects. Agent stated that the reporter reported he was experiencing fever, did not provide an exact temperature, runny nose, coughing, feeling really tired and nauseous. States he received the first dose administered about 2 weeks ago, 09Nov2021. Stated he started experiencing the effects yesterday and they were worse today.  Declined to provide reporter information, consent to contact. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no prior Vaccinations (within 4 weeks. There was no family Medical History Relevant to AE(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical assistant referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose and route were unknown, lot # M001811, expiration date 04-NOV-2018). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Subsequent to receiving vax, the pt developed a splitting headache and an injection site reaction characterized by swelling, redness, hardness and warmth. Later he developed malaise which lasted about 1 week followed by mild flu symptoms.
local injection site pain, mild fever, chills, joint pain, fatigue,  with in 24hrs of receiving the shot.  there was also some spotting observed but full fresh menstral blood was observed starting 11/8/2021.  its 12/19/21 and Im still bleeding - I also had swollen lymph nodes under my right arm:( - Ive reported it to my ob-gyn (Name and location) and primary care physician (Name and location)
palms of hands itchy, red, feet felt hot, throat felt itchy;progressed go gen flushing, felt hot;noticed pulse more rapid;took DPH;hep lock inserted, DPH given IV solumedrol given;pred given;
Pernio lesions on toes, consistent with "COVID Toes" noted developing day after vaccine, persistent until at least 2 weeks out
DVT in right leg; pulmonary emboli and a stroke on 4/2/2021
Localized swelling and redness on left anterior thigh at the injection site; approximately 3-4 inches in diameter; warm to touch; patient monitered in office; no treatment administered; swelling resolved spontaneously approximately 20 minutes later.
None, Pt discovered she was pregnant after receiving the H1N1 nasal mist.
Symtoms:  headache, loss of vision in left eye, vertigo.  Stroke took time to diagnos, I thought it was a vision problem.  Long time delays occurred while scheduling further testing (CT and MRI). Summary from MRI:  "Study Result Impression:  There is diffusion restriction along the left thalamus consistent with subacute ischemia, greater than 6 hours in etiology but less than 2 weeks."  Outcome:  Vision is slowly improving, headache is mostly gone, vertigo &  mental status slowly improving.
Also on 11/24 on top of or along lips chills, diarrhea, headache, vomiting, fast heart beat. Time course  - from 9pm on 11/23/11 - 3 am 11/24/11.
Flu-Like Symptoms; Initial Report Received on 26-Mar-2021, 29-Mar-2021, 30-Mar-2021, and 11-May-2021.  A nurse practitioner reported that a 26 year-old patient (gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced flu-like symptoms.   No relevant medical history was reported.   No relevant concomitant medications were reported.  On an unspecified date in Jan-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, site not reported).  On an unspecified date, after the first dose of HEPLISAV-B, the patient experienced flu-like symptoms for 10 days and had a full recovery. Laboratory tests for COVID-19 and Streptococcus were negative.  Four weeks after the first dose of HEPLISAV-B vaccine, Hepatitis B surface antibody was greater than 600 mIU.  The patient was reported to have completed the series of HEPLISAV-B vaccine.   Additional information was requested.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
two month old patient received Menactra injection, No AE; Initial information received on 21-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a two months old patient (gender not reported) who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) [MENACTRA] (batch, expiry date, dosing details, route and site of administration were not reported) for prophylactic vaccination on an unknown date, which was indicated from nine months and older.  Medical history, past medical treatment, vaccination family history and concomitant medication were not provided.  It was a case of an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
That same day of the vaccine my arm burned when they put it on me and then became normal, at night I had a little fever and could not move my arm. On the 7th day, I got a burning feeling in the head, I called my daughter, and I took  liquid ADVIL of 200 mg, and the burning was removed and then days after since then I continue with that burning permanently in the head. I suffer from migraine and burning is different from pain.
No physical symptoms.  Pediatric HBV dose inadvertently given to adult patient wanting adult HBV.
having pain under my arm; lymph node on the left side is painful, and it started moving up to my shoulder on the left side of my lymph node; lymph node on the left side is painful, and it started moving up to my shoulder on the left side of my lymph node; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration in arm left on 26May2021 (at the age of 26-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 30Apr2021 as single dose for covid-19 immunisation. On 26May2021, after patient got the injection in left arm and almost immediately, no, not immediately; about 5 hours later she started having pain under her arm and lymph node on the left side was painful, and it started moving up to her shoulder on the left side of lymph node. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
CLIENT RECEIVED 5+ DOSES/MULTIPLE PRIMARY SERIES OF COVID IMMUNIZATIONS INCLUDING PFIZER AND JANSSEN.