chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm injection site/ Intense stabbing pain; Unable to lift left arm up past 90 degrees; This is a spontaneous report from a contactable healthcare professional, the patient.   A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 09:15 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included the patient to be generally healthy. The patient was allergic to latex. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) 40 mg QOD, cholecalciferol (VIT D) 5000IU QD, and multivitamins (MANUFACTURER UNKNOWN) QD on unknown dates for unspecified indications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 11:15 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. 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 COVID vaccine. On 31Mar2021 at 16:00 the patient experienced intense stabbing pain on left arm injection site approximately 10 hours after, no heat and redness at felt at injection site and unable to lift left arm up past 90 degrees. Intense pain lasted all night and most of next morning. The patient reported the pain to be at 10 with movement in the scale of 1 to 10. Therapeutic measures included treatment with TYLENOL and SALONPAS for intense stabbing pain on the left arm injection site and unable to lift left arm. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome for the events vaccination site pain and pain upon movement were recovering.   No follow-up attempts are needed. No further information is expected.
developed hearing loss in right ear; This case was reported by a nurse via sales rep and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 2nd dose of Shingrix. On 13th August 2020, 3 days after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was not recovered/not resolved.   The reporter considered the hearing loss to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed hearing loss in right ear that was still ongoing at the time of reporting.  The patient thought it was related to Shingrix
Case previously recorded as MA2009-6459. Initial case report received via Med Com from a health care professional on 30 NOV 2009: A 2-year-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 101263P) i.m. on 30 NOV 2009. No adverse event was reported. MedCom ref. no.: NA09-008898.
7x8cm area of erythema, had tenderness and induration, increased 24-48 hr after vaccine, 72 hours after vaccine, improved less tender and induration but still erythema and warmth. No TX observe.
Case number PHEH2013US019869 is an initial spontaneous report received from a physician on 19 SEP 2013. This report refers to a 39-year-old female patient (was a nurse). Her medical history and concomitant medications were not reported. The physician reported that on 05 SEP 2013, the nurse had MENVEO (batch number: M12098) leaked on to her hands from a Men CYW-135 vial that was cracked and leaking sometime around. No adverse events were reported following the maladministration.
2 month old male patient inadvertently administered expired dose of Pentacel with no reported adverse event; Initial information received on 20-Apr-2021 regarding an unsolicited valid non-serious case received from a physician via nurse.  This case involves a two month old male patient who was inadvertently administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 07-Apr-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ216AA and expiry date: 06-Apr-2021) (Frequency: once) via an intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Caller with question on whether dose need repeating at only one day past expiration. Reporter relationship: (HCP) health care professional Product used: not Applicable  At the time of report 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 the 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.
Severe breast first left breast the most the right right half as much and arm pit pain on both equally very painful Maybe a week before period but these are symptoms I?ve never had before during or after period ever  I used both heat and Ice on my breast and arm pits to ease the pain very temporarily but the symptoms lasted 1-2 weeks  After second shot and around the same time I have the same symptoms but so far much less still too early to see
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with first 2 doses of GARDASIL on the appropriate schedule in 2010 (reported as "2 years ago") and received a third dose on 18-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. Additional information has been requested.
I asked the patient to wait for 30 minutes in the waiting room after the vaccine due to his history of rash with the meningitis shot. 5 minutes after the vaccine the patient stood up and looked disoriented and confused. I asked him if he was ok and he said that we was dizzy and wanted water. I had him sit down. I had my coworker 911 and I got him a bottle of water. He was sweating but felt better after drinking water. He reported to the Firemen that he had not eaten or drank that day yet. I asked him if he was feeling anxious and he said yes. The paramedics arrived and they checked his blood pressure. They said he looked good and was ok to leave.
One week after injection a 3-4 inch area around the injection site began to itch, became red, raised and tender. Also, that arm aches somewhat.
january 2021: feeling generally unwell, increased headaches, increased chest pain, increased SOB, increased coronary artery vasospasms, increased dizziness. HAD 2nd moderna vaccine on 12/28/21:  in February started having facial pain, memory issues, increased migraines, balance problems, dizziness, hands and feet going to sleep..."pins and needles" feeling,
This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. In JAN-2015, the patient was vaccinated with the first dose of GARDASIL (frequency, route, lot # and expiration date were not reported). Then, in March 2016, the patient received the second dose series GARDASIL 9 (frequency, route, lot # and expiration date were not reported). No concomitant medications, no adverse effects and no product quality complaint were reported. Additional information has been requested.
migraines; fatigue; chills; This case was reported by a consumer via call center representative and described the occurrence of migraine in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2020, the patient received the 1st dose of Shingrix. On 1st May 2020, 1 days after receiving Shingrix, the patient experienced migraine, fatigue and chills. On an unknown date, the outcome of the migraine, fatigue and chills were not recovered/not resolved.   It was unknown if the reporter considered the migraine, fatigue and chills to be related to Shingrix.  Additional details were reported as follows:  Reporter was the daughter of the patient.  Her mother received the first dose of Shingrix the before reporting and has experienced migraines, fatigue and chills on the day of reporting. She did not want to share her email
Immediate pain after injection in arm at injection site with some pain moving up  in the neck muscle and lower arm. After 24 hours the pain increased and moved into shoulder and neck pain increased. No redness in injection site but muscle pain increased and continued into day three.
About nine days after my vaccine my arm was swollen with a big circular rash around the site of the vaccination. It hurt and was hot and very itchy. The doctor did not give me anything but suggested that it was an autoimmune response. I started taking my Claritin again and it resolved in a week. I have not gotten the second vaccine on the doctors advice.
Itchy, red rash. Rash began to swell, welts appeared on abdomen. Was prescribed cortisone by allergist. Was advised to not get second dose by healthcare provider.
vaccine brand other=Moderna/ vaccine brand=Pfizer / BioNTech; 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 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 20Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "VSD" (unspecified if ongoing), notes: born with congenital heart defect; "several open heart surgeries" (unspecified if ongoing), notes: directly related or tangentially related to defect (repair of VSD, mitral valve repair, oblation); "mitral valve repair" (unspecified if ongoing), notes: directly related or tangentially related to defect (repair of VSD, mitral valve repair, oblation); "ablation" (unspecified if ongoing), notes: directly related or tangentially related to defect (repair of VSD, mitral valve repair, oblation); "currently in and out of A-Fib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=Moderna/ vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 treatment with Paxlovid, from 10Feb2023 till 15Feb2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a medical assistant refers to a 60 year old female patient. On 28-JUL-2014 the patient was subcutaneously vaccinated with an expired dose of ZOSTAVAX 1 single shot, lot # J000783 (expiration date 30-APR-2014) no adverse effects were reported. Additional information has been requested.
I had my vaccination on 11/11/2021. I tested COVID-19 positive on 01/01/2022. I started to experience leg and bone pain 3 weeks after. I had variety of tests to include MRI CT Scan and blood work. On 03/10/2022 the results came back normal. The bone pain comes and goes presently.
Approx 2 hrs p/receiving vax became unconsolable screaming persisted x 3 hrs, inject site red, swollen; mom called MD & gave pt APAP; recommended deletion of Pertussis from DTP;
Muscle pain, it's not that bad; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain, it's not that bad) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced MYALGIA (Muscle pain, it's not that bad) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain, it's not that bad) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that Concomitant products included  were asthma medicines (several medicals).  It was reported that patient had headache after 15 minutes after receiving the medicine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received included denial of consent for further followup
Approximately 4 days after the IM injection, patient reports waking up in the middle of the night "on fire." She believed that her skin was burning up, and was terrified. The patient had erupted into hives. After getting out of bed, she reported that her face, eyelids, throat, arms, hands, abdomen, feet, and legs were covered in erythematous, inflammatory lesions characteristic of hives. Patient reported coughing and shortness of breath, but did not need to use rescue inhaler at that time. Patient took Bendrayl 50mg within 15-30 minutes of awakening after seeing hives. Around 1 hour after awakening, patient reports severe diarrhea after dosing Benadryl (approximately 5 bowel movements over 1 hour).
Patient arrived back in the flu vaccine clinic at approx. 1315, flu vaccine received at approx. 1210.  She stated having tingling in lips and tongue. Asked her to stick out tongue, and there was some slight indentations on around her tongue. She stated she took two (likely 25mg, but could not confirm) Benadryl pills before walking back to our clinic location. She said it was about 45 mins post flu vaccine. She does state feeling sleepy and "fuzzy", but no short of breath. No feelings of swelling in throat. Offered her to go to ER at time of arrival back to clinic, but she declined. She asked someone to pick her up from work (arrived around 1402), supervisor is present while speaking with her. Before leaving employee stated that she was not feeling worse, but not better. She did have someone that would be able to watch her while she was at home. Contacted on 11/29/2022 and employee stated feeling better, no more swelling in mouth and no longer feeling tingly in the lips. Requested that she make an appointment with her PCP to review her risk of receiving vaccinations in the future, unsure if an appointment was ever made.
minor headache, all-over body aches, slight nausea, brief bout of diarrhea
Initial unsolicited report received from a health professional on 17-Jan-2018. This case involves a 59 years old male patient who was vaccinated with a 0.5 ml injection of ADACEL (batch number: U5798AB, expiration date and dose in series were not reported), via intramuscular route in left deltoid on 05-JAN-2018. The patient medical history and concomitant medications were not reported. On 16-Jan-2018, 11 days after the vaccination, the patient experienced pain and limited range of motion of the left shoulder area. Laboratory data and corrective treatment were not reported. The outcome of the event was unknown at the time of reporting. List of documents held by sender: none.
Information has been received from a consumer, concerning her daughter (age not specified) with no known allergies, who on an unknown date was vaccinated with the first dose of Gardasil (Lot # not provided). The mother reported that after her daughter went home, she complained of "not feeling right," and was weak and sleepy. Her daughter did not require treatment, and recovered after 3 days. The mother reported that 2 months later, the pediatrician decided not to administer the second dose of Gardasil. Additional information has been requested.
Mom called 04/23/04 stating child has bump under skin on left leg where she had gotten Pediarix injection.  No pain, no infection noted at this time.
Itchy, red, large bump at the site of the injection 9 days after receiving vaccination
PATIENT HAD PANIC ATTACK FOLLOWING INJECTION, HYPERVENTILATING, FELT FAINT, BECAME SWEATY. SYMPTOMS RESOLVE WITHIN 30 MIN. PATIENT ALSO REPORTED NAUSEA AND STOMACH UPSET FOR 2 DAYS FOLLOWING INJECTION.
Large, inflamed area around the injection site that is warm to the touch, itchy, and hard.
This case was reported by a health care professional and described the occurrence of obsessive compulsive disorder in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), MMR II (non-gsk), (non-gsk) VARIVAX and (non-gsk) FLUMIST. The subject's medical history included delayed speaking and premature birth at 34 weeks. Concurrent medical conditions included streptococcal throat. On 27 January 2011 at 10:30 the subject received unspecified dose of KINRIX (details unknown). On 27 January 2011 the subject also received unspecified dose of MMR (non-gsk) (details unknown), unspecified dose of VARIVAX (details unknown) and unspecified dose of FLUMIST (details unknown). It was not specified whether all the vaccinations were administered at the same time. On 27 January 2011, 90 minutes after vaccination with KINRIX, less than one day after vaccination with MMR II vaccine (Non-GSK), VARIVAX and FLUMIST, the subject experienced obsessive compulsive disorder episodes. The health care professional reported that the subject planned to follow-up with his physician on an unknown date. The health care professional considered the event was disabling. At the time of reporting the event was unresolved.
Extreme Lethergy, nausea, vomiting, muscle weakness and pain, passing out.
Patient calls in and reports that after her vaccine on 1/4 she had some light swelling and redness at injection site. She states that now, on 1/12 the swelling is as big as a golf ball and the site is hot to the touch. She denies any pain.
Mild diarrhea, abdominal cramps, mild nausea, loss of appetite
Uncontrollable shaking for about 30-45 minutes; Dry Heaves (vomiting, but nothing coming out); Freezing; Hands and feet hurt; Massive Headache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 50-years-old), as dose 2, single for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omega-3-acid ethyl ester (LOVAZA), simvastatin (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8750) via an unspecified route of administration in the left arm on an unknown date as dose 1, single for COVID-19 immunisation. On 21Apr2021 at 02:00, the patient experienced uncontrollable shaking for about 30-45 minutes. The patient had dry heaves (vomiting, but nothing coming out), freezing and when finally warmed up, hands and feet hurt and massive headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events uncontrollable shaking for about 30-45 minutes was resolved on 21Apr2021 and dry heaves (vomiting, but nothing coming out), freezing, hands and feet hurt and massive headache was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccine facility information added
Patient received 2nd dose 47 days after 1st dose. She felt dizzy after this dose within a couple of minutes.
pt recv vax SEP95 & 18MAY96 pt exp a rash w/10 lesions;
Came home right after Flu Shot. Had a late lunch and watched TV as I ate.  When I finished, I got up to go into the kitchen and was so very dizzy I thought I would fall down.  Held onto my chair and tried to cont. to the kitchen.  It just got worse..I was so shocked to feel so badly so quickly.  Then I got very nauseated and began to throw up....afterwards, I laid down and slept solid for about 4 hours....When I got up, I felt much better, still a little weak and dizzy but not bad.  Went to bed for the night and woke up today feeling much better yet still just a little dizzy and a little nauseated....Very strange.  Have taken the flu shot numerous times and never had this happen.  I am not allergic to eggs but that is what I had for lunch--2 scrambled eggs, toast and milk....Don't know if that had anything to do with it or not. Just FYI.
Patient complained about lightheaded sensation right after receiving the vaccination and her body temperature increased with some stomach pain.    Watched the patient in increments of 5 minutes Treatment: Had her sit down in a dark room  Gave her water
Urticarial rash. Patient received the COVID-19 vaccine from another country for the first 2 doses and this was the 3rd dose.
1/4/2021   I received 2nd dose of Pfizer Covid vaccine.   The next day I had flu like symptoms, such as feeling tired and my muscles ached.  Also,  my femur bones ached horribly.   I stayed home from work 1/5 and 1/6 due to feeling badly.   Then on 1/7, I went back to work, but ended up going to employee health in the morning due to feeling like I was going pass out.  I made it to employee health and my blood pressure was high, 151/100, my pulse was fast, my oxygen level was low and I could not catch my breath.  My arms and legs felt like wet noodles and I could not move them enough to use them.  I was put on a gurney at employee health by nurses and taken to the Emergency Room.   On the way to the Emergency Room I wondered if I was going to die because I felt so bad.   I was given IV fluids, had an EKG done, and labs drawn.   The ER doctor came by and said my EKG and labs were normal.  And an hour and half after going to the ER I was able  to walk out of the ER and drove myself home.