chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via other manufacturer and described the occurrence of passed out in a female patient who received MENVEO. Co-suspect products included TRUMENBA. In June 2016, the patient received the 1st dose of MENVEO (intramuscular) and the 1st dose of TRUMENBA (intramuscular). In June 2016, several hours after receiving MENVEO, the patient experienced passed out (serious criteria GSK medically significant) and dizziness. In June 2016, the outcome of the passed out and dizziness were recovered/resolved. It was unknown if the reporter considered the passed out and dizziness to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a Pfizer Territory Manager and was not provided product information by the reporter. The patient's medical history was unknown. Concomitant medication were unknown by the reporter. On 17th June 2016, the non-GlaxoSmithKline sales representative stated that he was on luncheon at a pediatric office and a nurse and a physician shared adverse events for 4 separate patients who received MENVEO and standard 1st dose of TRUMENBA (non-GSK vaccine). They stated that at least 3 patients also received MENVEO on the same day. The reporting sales representative had limited information regarding patient's details (initials, date of birth, age, height, weight and ethnicity was unknown) and adverse events. In June 2016, few hours after vaccination with MENVEO and TRUMENBA on the same day, the patient experienced dizziness, lightheadedness and passed out. The patient went to the emergency department. The date of visit to emergency department and the duration of the visit was unknown. In June 2016, the patient underwent blood test and the blood work was fine. Other investigation was unknown. The reporting sales representative did not have reporting nurse's last name. The reporter email and prescribing email was unknown. The National Drug Code (NDC), lot number and expiration date was unknown for both TRUMENBA and MENVEO. The nurse did not have time to provide that product information at the time of reporting. The patient had not received another vaccine due to the 2nd dose was not due at the time of reporting. This case was not associated with product complaint and there was no medical information request. This case has been linked to cases US2016GSK116036, US2016GSK116035 and US2016GSK116038, reported by the same reporter.
This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced burning sensation and tingling sensation. On an unknown date, the outcome of the burning sensation and tingling sensation were unknown.   It was unknown if the reporter considered the burning sensation and tingling sensation to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles on an unknown date and experienced burning and tingling sensation of neck and face. Consent to follow up was not possible as no contact details were available.
muscle and leg pains soon after the 2nd dose; muscle and leg pains soon after the 2nd dose; She has more difficulty on one side, has to drag her leg; All I want to know is if this is normal and will the weakness go back to normal?; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 03Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, (Lot number: Not provided)), for covid-19 immunization, reaction: "headache for one day". The following information was reported: MYALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "muscle and leg pains soon after the 2nd dose"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "She has more difficulty on one side, has to drag her leg"; ASTHENIA (non-serious), outcome "unknown", described as "All I want to know is if this is normal and will the weakness go back to normal?".  Additional information: Caller stated that she received her 2nd Pfizer vaccine dose on 03Feb2021 in her  right arm. She began having muscle and leg pains soon after the 2nd dose. She has more difficulty on one side, has to "drag her leg." Caller stated that after her first Pfizer vaccine dose she "had a headache for one day and that was it." She wanted to know is if this was normal and would the weakness go back to normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335652 Same patient and product; different dose and event
10 days post vaccination (Nov 1, 2020), patient developed numbness and weakness in the right leg. This progressed to inhibit walking and remained unchanged until day 15. At that point, numbness slowly went away and weakness slowly improved over the next three days with full resolution on day 18 (Nov 18, 2020). MRI scans of brain and lumbar spine were normal, so no explanation could be found for her symptoms. Due to the timeframe, I (parent) felt that perhaps it  could have been an adverse effect of the gardasil vaccine and wanted to report it in case there were others with similar events.
Adverse symptoms included, but not limited to, severe head aches, dizziness, neausea, vertigo & hot flashes. 23 year old patient had blood drawn approximately a week and half after first Gardasil injection and it was discovered that patient's FSH level was a 72, far above normal range indicating Premature Ovarian Failure or Premature Menopause. In addition patients menstrual cycle ceased after first Gardasil injection.
Patient presented for her first Covid vaccine dose.  Instead, she received a Bivalent Booster dose for age 5-11.
This spontaneous report was received from a Medical Assistant regarding an unspecified number of patients of uunknown age and gender. The patient's medical hisotry, drug reactions, allergie and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with a dose of an improperly stored oral, ROTATEQ, lot number K011663, expiration date 24-MAY-2016, lot number K016313, expiration date 31-MAY-2016 and lot number K023532, expiration date 21-JUN-2016, (dose, route and anatomical location were not reported). There was no concomitant medication reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Headache, Myalgia, Incorrect dose administered  This case was reported by a nurse and described the occurrence of headache in a 35-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  The subject had no pre-existing medical conditions.  There were no concurrent medications.  On 11 January 2006 the subject received 1st dose of Engerix-B in the left arm (lot AHBVB125AA). The subject received the .5 mL, pediatric dose of Engerix-B.  The .5 mL, pediatric dose is recommended for immunizing individuals 19 years of age and younger. On 12 January 2006, "24 hours" after vaccination with Engerix-B, the subject experienced headache and muscle pain. The muscle aches resolved on an unspecified date on or before 10 February 2006. At the time of initial reporting, 10 February 2006, the headache was ongoing. The nurse considered the headache and muscle aches to probably be related to vaccination with Engerix-B.
No adverse event; One of the patients got 0.5ml of a 2-day expired booster on 8Nov2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of the patients got 0.5ml of a 2-day expired booster on 8Nov2022) and NO ADVERSE EVENT (No adverse event) in an 82-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of the patients got 0.5ml of a 2-day expired booster on 8Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One of the patients got 0.5ml of a 2-day expired booster on 8Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (One of the patients got 0.5ml of a 2-day expired booster on 8Nov2022).    No concomitant drug was reported. The vial was initially stored in the refrigerator on 11-Oct-2022. Size of vial was reported as 2.5 ml. It was reported that vial did not undergo any temperature excursions. No treatment drug was reported.
itching when I wake up, when I move a certain way, itching a lot of the time but no rash.  Relative who is a nurse told me it should be reported and I should check with my doctor before getting second dose.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. Patient was inoculated with zoster vaccine live (ZOSTAVAX) on or about 15-OCT-2012, as prescribed and/or administered by healthcare provider at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by the healthcare provider at a hospital, for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Can?t remember names of objects or illness but can describe them.  I?m an RN and this makes it difficult!
Approxinately 14+ hours after 2nd dose on 03/30/2021 patient found unresponsive and brought to ER. DX with MI and Heart Block
Nausea, muscle aches, fever, mild fever, headache, fatigue, overall sick feeling, and pain at the site of injection for approximately 12 hours.
This spontaneous report as received from a Doctor of osteopathy refers to a patient of unknown age who on an unknown date was vaccinated a dose of VARIVAX (Merck) (dose, route and lot # not reported) instead of ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
Patient has a very large locallzed reaction at injection site.  Left arm over the tricep area is a >10cm area that is red raised and hot with a 3-4cm center that has an orange peal appearance. not fluctuant, no discharge or toxic striae.
PATIENT STARTED FEELING SLIGHTLY FOGGY WITH SLIGHT DIZZYNESS. STARTED SHAKING HEART RATE 125.  LIPS, ARMS AND HANDS TINGLING  PATIENT DRANK WATER AND OBSERVED.  PATIENT STATED FEELING BETTER. HEART RATE THEN 72.
I am retired handicap-MS.  I was doing light housework.  I started getting pain in right lung,  over course of 2  hours  pain became very severe.  Only in right lung.   Felt like blood clot or pulmonary embolism (which I had 15 yrs ago).  Went to hospital, check X-ray no clot/embolisms.   Blood work showed no clotting factor.    Was admitted 4 days.  We treated possibility of MS reaction (solu-methyl) as well as heparin in event of unknown clotting issue.    Here?s why this is strange:   If this was MS flare/relapse, I would have muscle lockup, drop foot, sight issues, sever balance issues  ...(i always have sight issues)..   with this even it was only severe lung pain.     Did not appear to be MS driven issue.  Being educated ?high analytic person,  in reflection,  My ms is very territorial,  it fights anesthesia,  colds/flus/covid when my husband had it.   My MS gets cranky when my immune system is attacked.    I suspect the second covid injection was doing its thing,  dna modification, and I had some lung inflammation and my MS compounded the reaction with crippling issue.  I was in hospital 4 days, IV fluids, heparin, and steriod IV.    Within first 36 hours the extreme lung pain disappeared and I got better.  I do have cats scan, mri, X-rays from stay.  Cat scan clear, X-ray, normal,  mri-classic ms history.  Was this Ms event?  I?m not sold as I didn?t have other normal MS flare symptoms.   Was this injection aggreviated?  Perhaps...  I?m sharing this because I think tracking auto immune disease people is important data gathering.  Feel free to call if more dialogue is necessary
can't hear out of the left side; coughing fit then pukes his guts up; coughing fit then pukes his guts up; chest feels like there are 10 people sitting on it; can't hear out of the left side and the left side is still ringing; head clogged up/ head is still plugged; almost like he had the flu; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 24Mar2021 08:51 at single dose for COVID-19 immunization. The patient medical history was not reported.   The patient's concomitant medications includes unspecified medications. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EIV6200) first dose via an unspecified route of administration, administered in Left arm on 03Mar2021 for COVID-19 immunization. On 24Mar2021, about an hour after he had the shot, the patient had some wicked side effects. It was like his head clogged up, his chest got heavy, almost like he had the flu, and now the left side of his head, he can't hear nothing out of it, it's just ringing. The patient has a hard time hearing anyway and now he has this other ear thing. He said that one side is plugged and the other side can't hear that great. Head clogged up: Caller states an hour after he had the shot, then he goes into a coughing fit, cough, cough, cough, then he pukes his guts up, then he's fine for half an hour and then he goes back into a coughing fit until he pukes his guts up again. Caller said that this is killing him.  He said that his head is still plugged, his chest feels like there are 10 people sitting on it, and he can't hear out of the left side and the  left side is still ringing and is like he had his bell rung playing football or something. The patient can't hear nothing out of it, it's just ringing. The patient rolled over on his right ear, power must have gone off because he couldn't hear the fan anymore, then rolled over on other ear and power must have come back on because he could hear it. The ringing didn't start until last night when he was sleeping. Stated he woke up and his ear was ringing. The patient knows it'll go away sooner or later, it's just the ringing The outcome of the event Head discomfort was not recovered. The outcome of the remaining events was unknown.  No follow-up attempts are needed. No further information is expected.
I had some scant bleeding; I did have a small bruise; Needle didn't make it to the muscle; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (I had some scant bleeding), CONTUSION (I did have a small bruise) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle didn't make it to the muscle) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle didn't make it to the muscle). On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (I had some scant bleeding) and CONTUSION (I did have a small bruise). On 20-Jan-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Needle didn't make it to the muscle) had resolved. At the time of the report, INJECTION SITE HAEMORRHAGE (I had some scant bleeding) and CONTUSION (I did have a small bruise) outcome was unknown.            Concomitant product details was not provided by the reporter.  Treatment information was not provided.  For mRNA-1273 (COVID-19 Vaccine Moderna), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-231790 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated Patient demographics , Ethnic group and Race .Added new events Injection site haemorrhage and Contusion
ON 1/9/21, DEVELOPED MILD HEADACHE. TREATED WITH ACETAMINOPHEN.
Headache, Arthralgia, chills, fever, neck hurts, nausea Narrative:  Other Relevant History:
Stiff neck, chills, fever, headache, body aches, painful injection site, nausea
Patient given both Pediarix and Hep B (instead of HIb). Follow up dated 9/8/05 states, infant had no adverse event. We were told that this should be reported because of the two injections given of the same medicine Hep B.
Severe muscle pain and aches in left arm where flu shot was given. Cannot lift arm over head; turn arm; or reach out without severe pain. This started Tuesday morning when I awakened. I iced arm a little on Tuesday. Called nurse on Wednesday morning and followed her instructions to ice more (ice pack for 20 minutes; rest for 1 hour and then ice again. I did this all day Wednesday. She also said to take Tylenol - very little improvement. I have never had a flu shot before and I have never had the flu.
fever 104.5; episodes of vomiting x 4; delirium; temp remained 104 even w/cool baths & APAP, 2nd day 101 then back to 104;
Ever since taking the vaccine. I've been having trouble sleeping. I'm constantly waking up. I'm using the restroom, urinating, 2 to 3 times a night also. I've also have had cronic diarrhea since being vaccinated. I also wake up every morning nauseated, every morning.
Severe headaches evening of vaccine, emesis (4) next day, fatigue + malaise, normal exam.
booster; Flu like symptoms; arm pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3, booster (single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; HEADACHE (non-serious), outcome "unknown", described as "headache".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Diaphoresis, Dry mouth, Metallic taste in mouth, increased blood pressure, throat felt odd - a bit hard to swallow, pale. Symptoms never progressed and lasted for approx. 45 minutes - 1 hour. Supportive measures. Check blood pressure and glucose. EMS called but patient refused transport.
Few weeks after vaccine administered patient began having hyper-sensitivity issues to things particularly from the waist down; ie tags on pants, stockings, seams in pants, seams of socks.
baseball size inflamation, bright res and sore/painful, headache, lack of energy, rash on upper chest below neck.  Today (April 13) arm is still swollen, red and sore and still have rash.
Pt developed severe hives, itching and redness all over body. She had hoarseness and fast heartbeat. Benadryl was administered after 8 hours.
After reaching out to confirm date to schedule second dose, patient explained that Shingrix had triggered / caused a severe episode of trigeminal neuralgia. Patient stated that he had been hospitalized for an extended period of time with multiple procedures with extreme pain and discomfort. Patient advised that he is now taking new medication to help treat his condition and only now is starting to feel some relief. Symptoms included severe headache, pain, discomfort, stress.
Patient was accidentally given 6 doses instead of 1 dose from the multidose vial.
This spontaneous report was received from a Registered Nurse regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored VAQTA (dose strength and route was unknown). No concomitant medication was reported. Patient experienced no adverse event. No product quality complaint was involved. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.