chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial misuse report received from a healthcare professional on 23 September 2013. The cases were received on 21 March 2014. Three children 10 and under, received FLUZONE ID at flu clinic. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
On 3/16/21 his wife found him poorly responsive so EMS was called. He had seizures on the way to the hospital and was found to be COVID positive. He required intubated. Discharged on 3/24/21.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 01-JUL-2013, the patient was vaccinated with VARIVX (Merck) (dos strength and route was not reported) (lot # H018796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
A pharmacist reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated and subsequently, developed a injection site reaction characterized by swelling and hardness and described as "looks like a boil". As of 6/11/00, the symptoms persisted. This is 1 of 3 pts from this facility who experienced this event following receipt of this vaccine, lot 471039. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is available.
Bilateral erythema swelling 2 cm (L) arm 3 cm (R) arm.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: EW0175) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Unknown Results, notes: COVID 19 Treatment; (May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID treatment).
one day of maculopapular rash started on the face and spread to the entire body, low fever, cough and runny nose. advised for supportive care and PRN use of bendaryl If with itching. Seek medical care again If with worsening rash, difficulty breathing or dehydration
Severe headache, ear pain both worse on the L side. Ringing in my ears, fatigue, low grade fever, sinusitis, tonsillitis on L side. My L ear pain has been awful, and ringing in ears. Both of these symptoms are worse when lying down. I've missed several days of work. I'm worried about my left ear pain, ringing in ears and left sided headache.
Patient received the 1st dose of SHINGRIX on 4/19/18 at around 3:45 PM. She stated later that afternoon she start feeling "crappy". She was feeling tired and feeling some body aches. The next day on 4/20/18 her symptoms worsened. She said she had "flu like symptoms", that she was extremely tired to the point that she didn't want to get out of bed. She had a fever (she did not know how high her temp was but she was feeling warm), her body aches increased, and she has shooting pain which traveled down her extremities. She described that the pain started from her upper arm and her thigh, and traveled down to her finger tips and her toes. She stated that the pain was pulsating in nature and it was a sharp shooting pain. She said even though she has chronic back pain, this pain was different than what she normally experiences and it was more severe. That same afternoon she went to her physician. She said he examined the injection site, which looked normal except for some minor swelling, and told her that he thinks this is the adverse effect she is experiencing from the SHINGRIX vaccine. As her systemic symptoms improved over time, patient said the injection site started to swell after about 3 days, and it was red and warm to touch. Patient said that all of her symptoms resolved after about 1 week.
Was ill with flu like symptoms after 2nd injection. A month or so later, my joints are all very stiff, a general ill feeling and fatigue.
This case was reported by a nurse via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 20th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache, fatigue, myalgia, pain and joint pain. On an unknown date, the outcome of the headache, fatigue, myalgia, pain and joint pain were unknown. It was unknown if the reporter considered the headache, fatigue, myalgia, pain and joint pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that a patient received a Shingrix dose. The patient developed myalgia, fatigue and headache (adverse event, unknown if recovered). The myalgia, fatigue and headache continued for weeks or months. The reporter reported that a patient, age unknown, received a dose of Shingrix. In 2020, after receiving Shingrix, she experienced pain all over and joint pain. It was unknown if the adverse events occurred after the first dose of Shingrix or the second dose of Shingrix. The pain all over and joint pain have lasted for months after the Shingrix was administered. The physician had ruled out rheumatoid arthritis and other auto-immune diseases. As of 8th December 2021, the patient continued to experience pain all over and joint pain. The reporter consented to follow up. Very limited information available. For tolerance to the 2nd dose refer case US2021AMR253393, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR253393:Same reporter.
Patient was to receive a Tdap.  He was given ADACEL which is indicated for age 11 yrs instead of BOOSTRIX which is indicated for age 10 yrs.  Pt was 10 yrs 6 1/2 mos of age.  Mother reports local redness after vaccine for 4 days.  8 days after the vacc he awoke w/ severe pain x2 hours.
Started getting very achy about 18 hours after my second shot. I had no side effects with the first one. Cold chills and bad headache. Nauseous waves coming on and off.
After Moderna shot on 7/8/21 around 6:55p.m., patient complained throat swelled up, numbness of face and tongue, airway closing up, fast heart rate (heart rate went from 80 to 144bpm in a few minutes). Benadryl 50mg was given around 7:05pm but patient did not feel better. Epinephrine 0.3mg was injected around 7:15p.m. Patient felt better. Around 9 p.pm, patient felt hurt in stomach and dizzy that she could not walk and needed to be escort on wheelchair. With patient's agreement, I called 911 and ambulance came. BP measured 140/90mmHg. Patient was escorted her to the hospital.  On 7/9/21, pharmacy manager called to follow up and patient was doing fine with no symptom. On 7/12/21@12:31p.m, pharmacist called to follow up, patient complained patient has mild rash on skin and leg, light cough, chest pain, slight tingling on tongue and weird taste. Patient will visit her primary care doctor on 7/13/21.
Chest Pain, Headache, Dizziness, Blurry Vision; BP 124/65; HR 90, RR 32, O2 100%; Fingerstick 83. Pt observed for ~20 minutes, as per patient symptoms persisit.
Flu-like symptoms, chills, body aches and some redness in injection site; appearing 24 hours, post vax. Temperature 99.3F and 25mm induration at site with 75mm X 25mm erythema.
42 year old female with history of fibromyalgia, anxiety and depression that presents to the emergency department with epigastric pain.  She states she woke up with it this morning.  She has vomited multiple times today.  She denies diarrhea however states she had a normal bowel movement today.  He states the pain is mainly in her epigastrium and it is a nagging pain that intermittently is sharp.  Patient is also states she has been unable to hold down her medications today due to the vomiting.  She denies fever or chills.  No sick contacts. Associated Symptoms: anxiety, nausea, vomiting
5 hours after injection, felt chilled but warm forehead.  no temperature elevation.  headache.  fatigue and unable to focus that lasted 6 days. injection site is still sensitive to the touch 2 weeks later.  tylenol regular strength.  chills and feeling warm were gone after 2 days.  fatigue and mental "fogginess" lasted 6 days.
Within 15 minutes of receiving the shot, I developed a metallic taste in my mouth.  This lasted for the rest of the day, and the entire next day after the shot.  I also had very slight soreness around the site of the vaccination (upper left arm) a few times the day of and the day after the shot.
DAY AFTER VACCINATION, HAD LOW GRADE FEVER, FATIGUE, AND WEAKNESS
I had this shot on 3/13/2021 and I ended up with swollen red upper arm. Over time the swelling grew down to my elbow. I consulted my Doctor and she said this may be common and to get the next vaccine in my other arm. This covid arm lasted 3 weeks.
Hives over the injection site about 1 inch in diameter; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient). An elderly patient of an unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Mar2021 10:00 as a single dose for Covid-19 immunisation. Patient's medical history and concomitant medications were reported as none. No known allergies were reported. The patient has not had symptoms associated with Covid-19. The patient is not enrolled in clinical trial. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not receive any other medications within 2 weeks prior to the Covid vaccine. Patient was not diagnosed with Covid-19 prior to vaccination and also since the vaccination. The patient had not been tested for Covid-19 since the vaccination. On 16Mar2021, the patient experienced hives over the injection site about 1 inch in diameter that didn't appear until 8 days after the 'shop'. No therapeutic measures were taken for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter's last name was added. Protect Confidentiality checked since reporter is the patient self. Patient's full name and country added in patient tab. Removed the duplicate reported Indication of BNT162B2. BNT162B2 stop date/time was added. Lot# Unknown was removed from vaccine information tab and frequency "Single" was added in dosage regimens tab. Event treatment received was ticked as No as per source. Final sentence updated as "No follow-up attempts are possible; information about lot/batch number cannot be obtained". Relevant medical history added as none. Vaccination facility information "facility name/City/State/postal code" was added. Event term was updated as "Hives over the injection site about 1 inch in diameter" as per source; coding was updated from "Injection site hives" to "Vaccination site urticaria". Initial missed narrative was added "if other vaccine in four weeks: No", "If other medications in two weeks: No", "adverse event: Hives over the injection site about 1 inch in diameter that did not appear until 8 days after the 'shop'", "if treatment for adverse event AE: No, known allergies: No", "other medical history: None", "Prior to vaccination, was the patient diagnosed with Covid-19: No; Since the vaccination, has the patient been tested for Covid-19: No".
Pt was given Tdap, Menactra, and Gardasil. After the last injection was given the patient said she didn't feel well and thought she might pass out. She then passed out. I broke an ammonia capsule but that didn't help and she began having a seizure like episode. This lasted about 30 to 60 seconds. Then  patient came to but wasn't sure where she was at first. Then once we told her she started to remember. After checking vital signs and giving patient some juice we asked patient and mother to wait 15 minutes and we would recheck the patient. During this time she began to complain of nausea and seemed very sleepy. So we decided to call 911 so patient could be evaluated by a doctor in the ER. Mother agreed to this. I have tried to contact mother to check on patient but she has not answered or returned phone calls.
Janssen COVID-19 Vaccine EUA  Extreme chills, fever,  Charlie horse in my thigh
hips at the right groin hurt so bad/Both sides of her hips are hurting/hips at the right groin hurt so bad; hips at the right groin hurt so bad/She had a pain that woke her up in her hips and groin/The pain is right at the top of her leg on the right side. She thinks that is her groin; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 66 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Feb2021 (Batch/Lot Number: EN6200) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included knee operation from an unknown date and unknown if ongoing, help with joints and muscles after knee surgery, anxiety from an unknown date and unknown if ongoing , blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication(s) included losartan (LOSARTAN) taken for blood pressure abnormal from an unspecified start date and ongoing; celecoxib (CELEXA [CELECOXIB]) taken for anxiety from an unspecified start date and ongoing; meloxicam (MOBIC) taken for knee operation from an unspecified start date and ongoing. The patient experienced hips at the right groin hurt so bad/both sides of her hips are hurting/hips at the right groin hurt so bad leading to arthralgia on 01Mar2021 05:00 with outcome of not recovered, hips at the right groin hurt so bad/she had a pain that woke her up in her hips and groin/the pain is right at the top of her leg on the right side. she thinks that is her groin pain on 01Mar2021 05:00 with outcome of not recovered. The patient underwent lab tests and procedures which included weight gained 20 lbs from quarantine and COVID. Therapeutic measures were taken as a result of these events with Tylenol. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored (9 °C to 25 °C for 1 hour) (incorrect product storage) ROTATEQ (strength, dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. No previous temperature excursion was reported.The outcome of incorrect product storage and no adverse effect was unknown. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1707USA009370: US-009507513-1707USA009369: US-009507513-1707USA006260:
got the two shots, a year later got shingles / Suspected Vaccination Failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shingles twice and got the shot. Then got the other shot a couple months later and now year later patient got the shingles again. The shot always did not work yeah, but it did not work they said it was only 90 percentage. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The follow up was not required.
dry cough; low grade fever 98.9 to 99.9; achy joints; achy muscles; headache; couple days of fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), COUGH (dry cough), PYREXIA (low grade fever 98.9 to 99.9), ARTHRALGIA (achy joints) and MYALGIA (achy muscles) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced COUGH (dry cough), PYREXIA (low grade fever 98.9 to 99.9), ARTHRALGIA (achy joints), MYALGIA (achy muscles), HEADACHE (headache) and FATIGUE (couple days of fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever 98.9 to 99.9), ARTHRALGIA (achy joints), MYALGIA (achy muscles), HEADACHE (headache) and FATIGUE (couple days of fatigue) outcome was unknown and COUGH (dry cough) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-054686 (Patient Link).
Pt began this am with flu like symptoms, chills, muscle ache and swollen gland, severe headache, syncope and neck stiffness. 11/22/06 conversation with ARNP, pt was diagnosed with Strep throat at the ER on 11/17/06.
Major Tinnitus in right ear. Minor Tinnitus in left ear  Doctor prescribed antibiotic and gave a asteroid shot. 24 hours later the symptoms still exist.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Date of refrigeration was  on 07-May-2021.
slightly more sore arm for a little bit longer as compared to flu shot; A spontaneous report was received from a Other health care professional (HCP) concerning a  female patient unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event slightly more sore arm for a little bit longer as compared to flu shot.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) Anatomical location unspecified for prophylaxis of COVID-19 infection.  On unknown date, The patient experienced the event slightly more sore arm for a little bit longer as compared to flu shot.   Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event include slightly more sore arm for a little bit longer as compared to flu shot was considered unknown.  The reporter assessed the event include slightly more sore arm for a little bit longer as compared to flu shot related to the study drug was unknown.
Reported by pt. 10/03/13 YF site 5 cm x 7 cm red, raised patch (R) arm resolved - 10 days. Bruise remains 4/10 pain if touched. 10/17/13 men site: 3 cm x 5 cm red, raised patch pruritic (L) arm verified.
Administration of 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On 29th September 2021, the patient received the 3rd dose of Shingrix. On 29th September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received 3rd dose of Shingrix vaccine, which led to extra dose administered. No patient details or date of administration was reported. The reporter consented to follow up.