chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Significant arm pain started five hours after injection and continued for approximately one day. One week later injection site developed redness, became swollen and became itchy.
"on 4/30 i left to go get my 2nd covid shot at a clinic. afterwards my arm was pretty sore. then over the next few days it continued to be really sore and developed a hard round lump, red and then the numbness started to kick in and became tingly. On wednesday my arm was still numb and tingly and the lump was even bigger. I left work and went to the hospital. thats when they monitored me and advised me to rest and gave me benedryl and a lidocaine patch,. advised to ice and heat. I am back at work today 5/8 and my arm is still numb and tingly and still hurts."
A few hours after getting the vaccine at 3:45PM (3/11/22), I experienced a headache.  Around midnight, I woke up with a headache and felt mild flu-like symptoms.  I took 2 Advil PM and went back to sleep.  I woke up at 6:30AM (3/13/22) experiencing significant flu-like symptoms including fever, chills, muscle aches and fatigue.  I took 600 mg of Advil and symptoms got somewhat better after a few hours.  The symptoms broke through again and I took antoher 600 mg of Advil at  12:45PM.  I spent the whole day laying on the couch unable to do my normal activities.  By early evening, around 7:00 PM, my symptoms were greatly decreased.  I took 400mg of Advil at bedtime and awoke the next day (3/13/22) feeling much, much better.
On 12/28/2022, I started having a tickling in the back of my throat. I suspected COVID-19 because my husband had the same symptom the day before. My symptoms were all in my head. My head was completely stuffed. It took me two weeks for me to test negative for COVID-19. I had a fever the fifth or sixth day of around 101. That lasted only around 24 hours. I treated myself with TYLENOL and lots of fluids. I did a telehealth visit on around the fourth day, after testing positive. He was unable to prescribed me PAXLOVID, but he said that it didn't seem like I needed it anyway since my symptoms were not in my chest. I just mostly rested, and the symptoms were gone within a week.
Fever, bodyaches, cellulitis on her arm, itching at the site of injection on her left arm
Seizure that lasted for 30 seconds. Taken to hospital CAT scan and blood work were all showing good signs.
Injection site pain within a couple hours of injection. Early the next day...headache, body aches, fever,chills, stomach ache, loss of appetite all of these things lasted about 24 hours...majority of these things went away except the injection site pain...arm is still sore
Patient became light-headed and faint immediately upon getting his flu shot.  Put his head down between his knees and stayed with him. He quickly regained consciousness.  We had him lay down for 20 minutes and he was fine.
she tested positive for Covid.; she tested positive for Covid.; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team and product quality group, Program ID:  A 53-year-old female patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 19Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 08Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jun2022, outcome "not recovered" and all described as "she tested positive for Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (12Jun2022) Positive, notes: diagnosed with COVID.  Clinical Course: It was reported that the patient was enquiring what will happen if she received the 4th booster shot while she tested positive for Covid. Caller states that she is seeking information on the fact the she had gotten the 4th dose of the Pfizer Covid 19 vaccine and tested positive for the Covid 19 virus days later. There is no information for that. Additional vaccines administered on same date of Pfizer suspect was reported as none. Prior vaccinations within 4 weeks was reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure and COVID-19 cannot be ruled out.
She signed up for a Moderna Bivalent but was given the Pfizer Bivalent in error
patient did at home pregnancy test, on 8/24/2019, that was positive; no adverse effects; This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 23-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent. The patient did an at home pregnancy test on 24-AUG-2019, that was positive. The patient became pregnant with last menstrual period LMP of 10-AUG-2019, approximate date of conception was 24-AUG-2019 and estimated date of delivery (EDD) was 16-MAY-2020 (all dates calculated based on LMP). Initial exposure to varicella virus vaccine live (oka/merck) (VARIVAX) was at 1 week. The pregnancy outcome was pending. No adverse effects were reported.
Woke in middle of night with pain down left arm clear down to my fingers. Could not lay on left side due pain. All day on the day after vaccination had nausea, fatigue, tiredness and aches. No fever. Symptoms went away on the following day-02/22/2021
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 05-AUG-2015 the patient was vaccinated with a dose of improperly stored GARDASIL (0.5 ml, lot # K008931, expiration date 04-MAR-2017, dose in series was not reported) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
bright flashing lights & vision as seen through a prism-lt eye &  papillary construction has had c/o paresthesias of lt hand,wrist & down lt side of face;saw ER MD & neurologist to f/u w/ allergist
Upper middle and lower right abdominal pains that were consistent and nothing helped - random spurts of increased pain. 6 days after no relief, I made an appointment with a gastrointestinal doctor. On day 8, I had vomiting and multiple episodes of diarrhea. I saw the doctor on day 9 but there was so much all-over abdominal pain, it was difficult to decipher the cause. A ct scan was ordered but needed authed by the insurance. On day 10 of symptoms with no reflief, I went to the ER. After a ct scan, it was determined that appendicitis was present for probably 10 days which lead to a perforated appendix with abscess and inflammation around the appendix. While admitted to the hospital for 3 days, I was treated with IV antibiotics but the appendix could not be removed due to so much inflammation and abscess. I have a follow up in a few weeks to remove the appendix once another ct scan determines the area is cleared up.
Covid diagnosis; Covid diagnosis; This is a spontaneous report from a non-contactable Nurse. The nurse reported the same event for three patients. This is the 3rd of three reports.    A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had a Covid diagnosis. The reporter mentioned that she knew 3 people who were vaccinated that went into the hospital that came out with a Covid diagnosis. She did not say which vaccine they had gotten. Outcome of the event Covid diagnosis was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events Drug ineffective and Covid-19 and suspected drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101468108 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101466426 Same Reporter/Drug/AE, Different Patient
After 2 weeks and three days of the first shot developed systems of Bells Palsy. Did not recognize symptoms until after second shot.
This spontaneous report was received from a Registered Nurse (R.N) regarding to unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 15-DEC-2015, the patient was vaccinated with a dose of VARIVAX (Merck), Lot # L016129, (dose and route of administration not provided), which was improperly stored. There were no concomitant medications provided. There were no adverse effects reported. This is one of several cases from the same source (MARRS # 1602USA002862, 1602USA002863, 1602USA002864 and 1602USA002865). Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headaches; This case was reported by a consumer via call center representative and described the occurrence of headache in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th September 2021, 6 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The case was reported for herself.   The patient stated that, she started with headaches.  The reporter spoke per Personal Information and referred her to health care professional for follow up. No health care professional information was provided. The reporter did not consent to follow up.
Quite suddenly, rash, large hard area around injection site, itch. No pain. Not excited over it. Just waiting to see what happens next.
Patient passed out and had brief seizure like activity. Patient has Spastic dysplasia Type 4 and was wheelchair bound. Mother on scene with patient as primary caregiver and refused transport to medical facility. Patient alert and oriented within a minute or so and able to protect her own airway. Patient able to drink water on her own. Mother said this was "normal" for patient when she gets injections. Patient smiling and laughing with crew and mother prior to departure. Advised mother to call 911 if patient relapsed.
Nauseous and vomiting; Nauseous and vomiting; Hip pain; Chills; Dizziness; Disorientation; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 06May2021 at 12:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included montelukast (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN) and etynodiol diacetate / ethinylestradiol (KELNOR) for unknown indication from an unknown date and unknown if ongoing. The patient previously received paracetamol (TYLENOL) for unknown indication on an unknown date and experienced drug allergy. 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 15Apr2021 at 14:15 (age at vaccination-unknown) as a single dose for COVID-19 immunisation. On 06May2021, at 22:00, the patient experienced nauseous, vomiting, hip pain, chills, dizziness and disorientation. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of nauseous, vomiting, hip pain, chills, dizziness and disorientation were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a young lady that got it [HPV vaccines] and it paralyzed her for 5 months; This case was reported in a literature article and described the occurrence of paralysis in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.  On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced paralysis (serious criteria GSK medically significant and other: serious as per reporter). On an unknown date, the outcome of the paralysis was recovered/resolved.   The reporter considered the paralysis to be related to HPV vaccine.   Additional Information: GSK Receipt Date: 19 Jul 2022 Author Comment: This case refers for a female patient from table no 4 theme 3 as described in the article. The author aimed to identify human papillomavirus (HPV) and HPV vaccine-related knowledge, attitudes, and beliefs among women aged 27-45 years, who became eligible for HPV vaccination in 2018. This study was in the region. The author conducted eight semi-structured text-based synchronous focus groups using an virtual chatroom. Focus group questions covered three areas: 1) knowledge and beliefs about HPV and HPV vaccination, 2) attitudes toward HPV vaccination for oneself, and 3) barriers and facilitators to HPV vaccine uptake. Concerns about HPV vaccine-related side effects were common and identified among participants across all racial/ethnic groups and education levels. The reporter stated that the patient got human papillomavirus vaccine. The reporter had a concern about HPV vaccine side effect and safety vaccination had a serious side effect. The reporter stated that the patient had paralysis for 5 months. "Unanswered questions, low awareness about eligibility, lack of knowledge about the benefits of vaccination after sexual debut, concerns and mistaken beliefs about side effects and safety, and perceived social stigma may serve as key barriers to shared clinical decision-making about HPV vaccination for women ages 27-45 years. Promising intervention strategies for addressing these KAB-related barriers include 1) disseminating basic information about HPV vaccine eligibility, safety, and efficacy that was specific to women aged 27-45 and 2) framing HPV vaccination as taking control of one's health and preventing illness, even after sexual debut."
her (left) arm got swollen, red and warm  if it got worse she was going to  go to MD otherwise just  leave it
Sat-16Feb91 @ 2000 low grade T, Sun-17Feb T 102, Mon-18Feb T 105.5, Tues-19Feb to MD T 101 & swollen glands, acts like she hurts all over, Wed-20Feb T 101, Thurs-21Feb afebrile, 0 rash yet.
Patient is reported "shooting pain that radiates towards neck and down arm" for right arm where prevnar 13 injection provided. She states that she is unable to lift right arm above her head.
No adverse event; Received Expired Monovalent booster after 30-day Use By Date; Received Monovalent instead of Bivalent Booster by mistake/Received Monovalent booster from a Pediatric Vial (6Y-11Y)  by mistake; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake/Received Monovalent booster from a Pediatric Vial (6Y-11Y)  by mistake) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date) and WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake/Received Monovalent booster from a Pediatric Vial (6Y-11Y)  by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date), WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake/Received Monovalent booster from a Pediatric Vial (6Y-11Y)  by mistake) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent booster after 30-day Use By Date) and WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster by mistake/Received Monovalent booster from a Pediatric Vial (6Y-11Y)  by mistake).    No concomitant medication information provided. It was reported that an adult patient received an expired booster dose from a Moderna COVID-19 vaccine from the vial intended for 6Y-11Y patient group.  The 30 Day beyond use date was 30-Sep-2022 and it was administered on 13-Oct-2022. They intended to give Bivalent but by mistake, they picked the Monovalent 6Y-11Y vial  that was also expired (Lot#  AR4504B & Exp. Date: 13Nov2022). The vial did not undergo any temperature excursions. No treatment information provided. This case considered of 1st adult patient of the three adult patients.   Reporter did not allow further contact.
Fever, cold sweats for about an hour in the middle of the night (2AM).  I took an Aleve and was better in the morning (7AM).
Given Flu vaccine on 10/6/16 - pain on scale of 8/10 started within a few hours. Seen in office on 10/7 for evaluation. No skin changes noted - pain noted with ROM -Limited ROM due to pain. Seen for eval today 10/10 -Refer to ortho for further eval for sore/tingling related to vaccine. Shot given in upper outer aspect of arm. Receiving narcotic pain med for pain relief.
9/8/12 late pm - arm swelling (L), legs & muscles in extreme pain, went to ER, was given BENADRYL & nausea medication, sent home. 9/9/12 late pm - severe vomiting & diarrhea, back to ER, what was thought to be diarrhea was blood. Colonoscopy in March showed no abnormalities, kept at hospital and released 9/12/12 am.
Information has been received from a registered nurse (R.N), concerning a patient of unknown age and gender. On 03-JAN-2013, the patient was vaccinated with a dose of GARDASIL (dose and route were not reported) (Lot #: 663559/1178Y; Expiration date: 11-NOV-2011), that had expired. There were no adverse effects. Additional information is not expected.
Headache, no other symptom: B/P 197/90 Refused transport   B/P  136/98
tachycardia, headache, muscle ache, hypertension. Given IV fluids. Patient responded to fluids, heart rate from 160-116.
Rash-itchy red spots on arms, fingers. She didn't report the rash appeared on her rear end after the first dose, until the rash appeared on her arms after second dose. Treating with Benadryl. Rash continuning to spread to legs, hips and stomach.
Pt developed breathing problems associated with asthma. He has asthma the significance of this is that he also has an egg allergy. He had the Flu vaccine last year but split into several doses.
giving patient the ID smallpox vaccine- wheal seen; after 1/2 of the dose was administered the needle came through the far end of the wheal.  Full dose was successfully administered in the opposite arm.
Fever (99-101 fluctuations), body aches, chills, nausea, headaches  Symptoms continued from 6:00pm March 13 into next morning
she developed Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration on 05mar2021 as single dose for covid-19 immunisation. Medical history included facial paralysis from Mar2021 to an unknown date.  The patient's concomitant medications were not reported. She was supposed to receive her second dose on 26Mar2021 but the week before on 19Mar2021 she developed Bell's Palsy (medically significant) and her doctor suggested waiting 14 days after finishing her steroids before receiving the second dose.  She is wondering does she have to wait the 14 days after finishing the steroids or can she get it 12 days after finishing the steroids. The patient went to the doctor on 22Mar2021.  She said she had difficulty drinking water from a cup and her mother had Bell's Palsy, so we were familiar with what it was. The event difficulty drinking water from a cup assessed as non-serious. She is going to see a neurologist. Therapeutic measures were taken as a result of she developed bell's palsy. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
soreness; dizziness; diarrhea; felt sick; Tired; nausea; had a robust reaction to first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick), NAUSEA (nausea) and FATIGUE (Tired). At the time of the report, PAIN (soreness), DIZZINESS (dizziness), DIARRHOEA (diarrhea), ILLNESS (felt sick), NAUSEA (nausea) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.