chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial consumer (healthcare professional) report received on 07 May 2010: The patient received MENVEO (batch no. unknown), 0.5 ml once, intramuscularly, on 07 May 2010. The patient experienced lightheadedness on 07 May 2010. The outcome of event was reported ongoing.
Fever; body aches; Back pain; nausea; fatigue; lack of focus; weakness; This is a spontaneous report from a contactable consumer. A 52-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Right on 26Jul2021 14:30 as DOSE 1, SINGLE (at the age of 52-year-old) for covid-19 immunisation. Medical history included hypertension, covid-19 from Dec2020 to an unknown date. Concomitant medication(s) included valsartan; hydrochlorothiazide; vitamin d nos. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jul2021, the patient experienced severe symptoms, such as the same as Covid-19 Virus that patient had in December which was fever, body aches, severe back ache, nausea, fatigue, lack of focus, weakness. The patient did not received any treatment for events. The outcome of the events was resolving.   Information on the lot/batch number has been requested.
Day 1 small reddened area. Pain at site. Throughout night c/o HA, back and neck pain. Day 2 increase swelling of upper arm, redness, pain and discomfort. Day 3 increase swelling, hot at site, decreased range of motion.
can't move her arm, she has a hard time putting on clothes; had a flublok wanting the child dose but about a week later her arm got sore and sore and sore and she had difficulty getting dressed that is why she is trying to figure out if she got the senior dose and not the adult dose of flublok; Initial information was received on 13-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an unknown age female patient who can't move her arm, she has a hard time putting on clothes and had a flublok wanting the child dose but about a week later her arm got sore and sore and sore and she had difficulty getting dressed that is why she is trying to figure out if she got the senior dose and not the adult dose of flublok after receiving influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (Injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization. The information on the batch number was requested.  On an unknown date the patient can't move her arm, she has a hard time putting on clothes (limb discomfort)and had a flublok wanting the child dose but about a week later her arm got sore and sore and sore and she had difficulty getting dressed that is why she is trying to figure out if she got the senior dose and not the adult dose of flublok (pain in extremity) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Reportedly, Caller also asked if FLUBLOK contains eggs and preservatives. She stated that she has the paper work at the time of call and wants to know which dose she got, if it is the adult dose or the senior dose.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
PATIENT WAS GIVEN MODERNA COVID VACCINE, THEN WE REALIZE SHE IS UNDER 18. NO ADVERSE REACTION FOUND AT THIS POINT
Patient developed hives to her left hand and bilat popliteal fossa following administration of 5 year vaccines.  In the left arm, MMR and DTAP were given. Patient was given 7.5 mls benadryl in office.  No difficulty breathing. Site of injection without hives.  Please report to adverse event website for vaccinations.
pt recv vax 10FEB97 & okay Tuesday-slept 16hr from Tuesday noc thru Wednesday;hard to wake;took bottle & went back to sleep until afternoon;woke up by bathing groggy-listless, afeb, back to sleep till 7PM;
Skull pounding head pain less than 24 hours after receiving Moderna Covid booster shot. I have never had head pain like this. This lasted 24 hours into the morning of 11/17. I did not go to the hospital but considered going multiple times as it was not relieved by taking hydrocordone. This reaction to having the vaccine was much worse than the second Moderna shot. I have Fibromyalgia and back issues.
I woke up at 5:10 am Saturday morning to go to the bathroom and stumbled getting out of bed with a tremendous feeling of dizziness.  I went back to bed and experienced bed spins - which I didn't have the night before, nor did I ever have as a result of a vaccination.  All day Saturday and Sunday I was still, and at home because of feeling dizzy when I walked or moved too quickly.  I stayed very hydrated and have no pain in my ears other than tinnitus which I have mildly as a result of having had covid but it's louder now, and no nausea.  I had flu-like symptoms too but the dizziness was the worst.  I am better today but I was not able to drive - though I did go to school to teach.
Itchy rash on leg and forehead; Pain in neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on leg and forehead) and NECK PAIN (Pain in neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced RASH PRURITIC (Itchy rash on leg and forehead) and NECK PAIN (Pain in neck). At the time of the report, RASH PRURITIC (Itchy rash on leg and forehead) and NECK PAIN (Pain in neck) outcome was unknown. Not Provided          Treatment medication was not provided.   This case was linked to MOD-2021-085748 (Patient Link).
Diabetes; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; His neck, his back on the left side, and his lung has been hurting; He said it feels like a bug is eating inside or by his head; This is a spontaneous report from a contactable consumer (Patient's daughter).      A 62-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8732; Expiration Date: 30Jul2021), via an unspecified route of administration on 29Mar2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient previously took first dose bnt162b2 (BNT162B2, solution for injection, lot # EN6199 expiration date: 30Jun2021), via an unspecified route of administration single for covid-19 immunisation. It was reported that, the caller is the caregiver of the patient, her father. The caller was called to report an adverse event from the Covid-19 Vaccine. The patient received his second dose of the Pfizer covid-19 vaccine at the end of March. The patient's neck has been hurting, his back has been hurting on the left side and his lung has been hurting. It felt like a bug is eating inside or by the patient's head. The patient was diagnosed with diabetes a couple of weeks ago. The caller clarified and confirms that the patient was diagnosed with diabetes 1-2 weeks ago. The patient has had the pains for a while now, he got the second dose around 29Mar2021. The patient's neck that has been hurting is the same but getting worse. The patient's lung pain comes from time to time. The caller later clarifies and confirms that the patient is 62 years old, not 61 years old as previously reported. The outcome of the events was Not recovered.  Follow-up attempts completed. No further information expected.
T103.2, sore throat, red glands swollen, fussy, drowsy, no appetite;
Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a non-other healthcare professional. This case involves 76-year-old female patient who was vaccinated with an expired dose of FLUZONE QUADRIVALENT expiry date: 30-Jun-2018 (batch number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. No reportable side effects. 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. List of documents held by sender: none.
Nausea, Rapid heart rate, Fever of 102 F with oral and 104 F no contact forehead.  Took Tylenol and drank plenty of water. Fever broke around 5 am and heart rate returned to normal.
vaccinated on 7/31/21 diagnosed with Covid on 8/10/21 COVID-19
Redness in the area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness in the area around the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the area around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness in the area around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received the first dose of Moderna between February 9th and 10th and reported that they experienced redness in the area around the injection site. No further details obtained.  No Concomitant product use was reported.  No treatment information was provided.
Pt received booster Covid vaccine and died the next morning in his sleep; Pt received booster Covid vaccine and died the next morning in his sleep; Pt received booster Covid vaccine and died the next morning in his sleep; This is a spontaneous report from a contactable physician via a sales representative.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received booster Covid vaccine and died the next morning in his sleep. The patient died on an unspecified date. An autopsy was being performed and results were not provided. It is believed the booster was Pfizer but that needs to be confirmed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events off label use, immunization and death and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Pt received booster Covid vaccine and died the next morning in his sleep
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium. Additional Details: Patient indicates that the swelling and pain, which began the day after receiving the vaccine, has slightly improved, but the itching has not gotten better, even after trying hydrocortisone cream. She was advised to see her PCP, to which she indicated that a visit would be expensive. She was advised to come in so we can examine the site and she was advised to try using an antihistamine (i.e. Benadryl) to see if that helps with the itching.
No additional AE reported; Vaccine expiration date recorded was 12-FEB-2015 when administred on 06-JUL-2016/did not know if product was expired then; She was not sure if someone at that time entered a invalid expiration date or if the product was expired then; This spontaneous report as received from a licensed practical nurse refers to a 15-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-JUN-2016, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot# L04862 (was verified to be invalid) (exact dose, route of administration, anatomical location were not reported) for prophylaxis. The nurse reportd that expiration date entered in the system on 07-JUN-2016 was 02-DEC-2015. She was not sure if someone entered an invalid date or if the product was expired then. No adverse event was reported.
Information has been received from a physician concerning a patient (age and gender not reported) who on unspecified dates was vaccinated with the first and second doses of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced flu-like symptoms after receiving the first and second doses of Gardasil. The patient sought unspecified medical attention. The outcome and causality of the events were not reported. Additional information has been requested.
Information has been received from a health professional concerning her 13 year old daughter with no medical history or allergies who on 08-AUG-2007 at 14:00, was vaccinated with a first dose of Gardasil.  On 09-AUG-2007 in the evening, the patient developed a rash.  It was described by a dermatologist as viral exanthem.  It was reported to have started near both armpits and spread all over her torso and upper legs.  The rash seemed to disappear after using 1% hydrocortisone cream which was prescribed by the physician.  On 24-AUG-2007, the patient recovered.  Additional information is not expected.
4 days p/inject devel fever, chills, muscle soreness; hive like rash-bilat arms, forehead, thigh; persistent, migratory myalgia; dx serum sickness;
Appendicitis, perforated appendix (maybe caused by swollen lymph nodes from vaccine?) Appendectomy 4 day hospital stay with IV antibiotics 7 week recovery at home
He would like to report that he has been sweating profusely; he had side effects like allergic reactions; 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 67-year-old male patient received BNT162b2 (BNT162B2), on 08May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (UNKNOWN MANUFACTURER, DOSE NUMBER 3), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (UNKNOWN MANUFACTURER, DOSE NUMBER 2), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine (UNKNOWN MANUFACTURER, DOSE NUMBER 1), for COVID-19 Immunization, reaction(s): "Covid-19". The following information was reported: HYPERHIDROSIS (non-serious) with onset May2022, outcome "unknown", described as "He would like to report that he has been sweating profusely"; HYPERSENSITIVITY (non-serious) with onset May2022, outcome "unknown", described as "he had side effects like allergic reactions".  Additional information: Patient would like to report that he had been sweating profusely since then like he had heat exhaustion. Caller references a gang several times and stated he might have caught something from them because they had broken in to his complex several times and are circling his street continuously. He was asking if the sweating/heat exhaustion was from the vaccine. He had side effects like allergic reactions.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On May 10, I had shortness of breath and lightheadedness. I nearly lost concussions. My arm and legs feel very heavy and I was unable to exercise. I currently undergo physical therapy.
12/30/2020 vaccination  1/6/2021 I got a migraine, HA lasted 7 days. Fuzzy head, fatigue, dizzy. I finally took a Medro dose pack and that helped it go away. They have been more frequent since vaccination and longer durations. It may or may not be related.  *Contacted Neurologist and she prescribed the Medro dose pack.
Flu like symptoms; fever night at 103 Deg; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever night at 103 Deg) and MYALGIA (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever night at 103 Deg) and MYALGIA (Body ache). The patient was treated with PARACETAMOL at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever night at 103 Deg) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.
COVID-19 treatment; COVID-19 treatment; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: 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, treatment: Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
1. Dizzy and faint immediately following immunization. Patient layed down on left side, drank juice and fully recovered within 20 minutes. 2. Pain in upper left arm started after immunization. 15 Days later pain started to get worse. No fever. No redness at site. Hurts to lift arm up. Does not feel pain to touch states "deep muscle pain", pain with arm movement. Pain level recently increased last 2 days. Home care - ice, Motrin as needed.
7 PM administered Flu HD shot 9 PM coughing 10 PM breathing problem - went to ER.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  The reporter stated the administration of expired vaccine were given as booster shot to patient.  The vaccines were stored in freezer, they take out one or two vials and placed it in fridge each day as needed.  No treatment given on the patient.
Extremely sore arm, radiating pain up neck and down to left forearm and wrist, weakness in arm
11:30 PM 12/6/14 - woke up with dry, shallow cough. Sat in living room as breathing became short and shallow. Breathing became increasingly difficult. 12:30 AM 12/7/14 began shaking with chills and body pains. 2:00 AM 12/7/14 breathing began to ease. 3:00 AM 12/7/14 Returned to bed but still shaking from chills - finally fell asleep about 4:00AM. Slept rest of 12/7/14.
Chills, body aches, fever 101.8, headache onset 2100-0300.
passed away; This is a spontaneous report received from a contactable consumer reporting for a male patient of unspecified age that received second dose of BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that the patient passed away late Saturday night after receiving his second COVID-19 Vaccine on Friday. An autopsy was not performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: passed away
Left arm tingling - 10/18/2011 continued left arm tingling down left leg tingling - cold sweat followed by fatigue. This has been ongoing since that date off & on different days.  Have seen doctor twice, had an EKG, blood work, will also have an MRI.  Everything is normal.
After I got the vaccine my heart rate went over 100 and I had to lay down at the hospital to recover because I was so dizzy. On Saturday night and Sunday I felt some normal side effects like a severe headache, chills, nausea, and fatigue. Monday I felt better than normal and I thought I was in the all clear. Today (Tuesday) I woke up feeling like I had a stroke. I can still lift both arms and both sides of my face, but I can not think and feel like I am dying. I am scared to go to the hospital. I am unable to work. I feel incredibly emotional and unable to think. I feel so tired and the pain at the injection site is now even worse. I am getting chest pains, dizzy spells, really bad headache, and it feel like I am in a dream state unable to do things I normally can do. I am not okay and really regret getting the vaccine. I had no prior health concerns and probably would have survived covid, but it feels like I may never get my mental functioning back again.
Patient experienced severe body aches, chills, numbness in both hands, stomach ache/nausea, Left side of face swollen.
12cm well demarcated, itchy red rash at injection site. Fever,  chills