chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On 30-SEP-2014 the patient received 2 doses of PNEUMOVAX 23 (lot # and dose not reported, intramuscular) for preparation for an elective splenectomy. Concomitant therapy was not reported. The patient received the 2 doses during unspecified timed during 8-hour shift. The patient has not experienced any adverse effects. At the time of the report the pharmacist does not have access to the patient's medical records, so he could not provide the patient's identifying information. He also could not provide the lot number and expiration date of the 2 separate doses of PNEUMOVAX 23 which were administered. Additional information has been requested.
Erythema and swelling at varicella injection site (non tender) on left arm, no fever. Advised warm compresses to area. No other treatment. Advised to call if area becomes painful or fever.
MYOCARDITIS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative through social media concerned an 18 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: extremely healthy before shot. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (unspecified manufacturer) (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s (Dose number in series 1). On an unspecified date, the patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (unspecified manufacturer) (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, following administration of covid-19 vaccine ad26.cov2.s, the patient was tested positive (suspected clinical vaccination failure) and got sick (suspected covid-19 infection). The patient also had myocarditis (Dose number in series 2). Laboratory data (dates unspecified) included: coronavirus disease (COVID-19) virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000218634. This case, from the same reporter is linked to 20220250720, 20220251028 and 20220251156.; Sender's Comments: V0: 20220250507-covid-19 vaccine ad26.cov2.s-Myocarditis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220250507-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient complained of having mild SOB, hoarseness, wheezing, that began 12/6/05.  Developed hives night of 12/7/05.  States took Benadryl capsules 2hrs or more ago.  Denies any reaction or problems at injection site.  Has had the vaccine yearly for many years.  Strongly advises to go to nearest emergency room for evaluation.  Client declined.  On a follow up report says client reports condition has improved.  Client states that they did go to ER as advised in report.  Client denies having SOB, wheezing, or hoarseness.  No longer has hives.  States she continues to take antihistamine.  Denies having any reaction at injection site.  Although advised to be evaluated by doctor promptly, client states she will see doctor as scheduled for checkup in January 2006.
This spontaneous report was received from emergency medical technician and refers to a unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date between 13-OCT-2016 and 31-OCT-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M022402, expiration date: 01-NOV-2017) (dose, route and anatomical location were not reported) and properly stored sterile water diluent (manufacturer unknown) (route, anatomical location, lot# and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 90 minutes. There was no previous excursion reported. The call was because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007917:
chills; fever; inappropriate schedule of vaccine; Sore for one day and a half; headache; A spontaneous report was received from a consumer and HCP concerning a 59 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events invalid dose (wasn't sure), headache, chills, fever, sore for one day and a half and inappropriate schedule of vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 26Jan2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 08Feb2021, prior to the onset of the events, the patient received their second dose (lot/batch:  031L20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient was told to come back in two weeks after the first vaccination to take the shot on 8Feb2021. On that day she had chills, low grade headache and fever for 20hs and sore for one day and a half (from 8 to 9Feb2021).  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events, headache, chills, inappropriate schedule of vaccine, sore for one day and a half and fever were recovered.; Reporter's Comments: This case concerns a 59 year old, female patient, who experienced a non-serious unexpected event of pain among other events, 1 days after receiving 2nd dose of mRNA- 1273 (Lot# 031L20A). This report also refers to a case of inappropriate schedule of vaccine for mRNA-1273, with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
LUA - redness, swelling warm to touch started 10/1 - provider seen patient - reports local allergic reaction. Ice/BENADRYL order.
Site: Pain at Injection Site-Medium, Additional Details: Patient called 14 days after vaccine to report that arm is still sore at site of injection and to see if that was normal.  he stated that it is 5/10 pain level when trying to do things with that arm.  no redness or swelling or warm to touch or rash.  patient stated he could lift it regularly just sore.  patient also stated that his wife got hers in her "shoulder" and his was given in his "arm".   Patient concerned it was given too low....
Pt received Anthrax vaccine #6 SC over the right deltoid area on 10/7/04. The evening after vaccine receipt she noted some local swelling, tenderness, pruritis and redness surrounding site. The reaction was worse this AM when she awoke and has become more tender following her PT test this afternoon. She denies significant systemic symptoms. She has never had a significant local reaction with previous anthrax vaccines. Treated wit Allegra, Diprolene cream and Motrin.
Large round, red, hot, circle around injection site.  Doctor advised to take Advil and benedril
Local site reaction - red wheal surrounding injection site with firm tender center. Resolved after 7 days without any treatment.
Pharmacist accidently gave me the Pfizer vaccine booster instead of the Moderna. My first two shots were Moderna. No adverse effects to date.
6/30/2022 mother of patient called health department concerned child having an adverse reaction. Stated starting today the  child developed a fever (38 degrees Celsius)   she has been vomiting and has burning with urination.  Referred to ER or Family Practice.
Head is pulsing; Headache; A lot of chills; Fever; Couldn't sleep; Back pain; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), BACK PAIN (Back pain), CHEST PAIN (Chest pain), HEAD DISCOMFORT (Head is pulsing) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INSOMNIA (Couldn't sleep), BACK PAIN (Back pain), CHEST PAIN (Chest pain) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced HEAD DISCOMFORT (Head is pulsing), HEADACHE (Headache) and CHILLS (A lot of chills). At the time of the report, INSOMNIA (Couldn't sleep), BACK PAIN (Back pain), CHEST PAIN (Chest pain), HEAD DISCOMFORT (Head is pulsing), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (A lot of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported.  No treatment details were provided.
Sore arm; headache; muscle aches; weakness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 14:45 as dose 5 (booster), single (Lot number: GJ6742) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete but manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 4, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Nov2022, outcome "not recovered", described as "Sore arm"; HEADACHE (non-serious) with onset 02Nov2022, outcome "not recovered"; MYALGIA (non-serious) with onset 02Nov2022, outcome "not recovered", described as "muscle aches"; ASTHENIA (non-serious) with onset 02Nov2022, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of pain in extremity, headache, myalgia, asthenia. Additional information: The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
I am currently 20 weeks pregnant. y left arm was really sore after the injection. I had pain under my left armpit with fever and chills and felt fatigued. My symptoms lasted two days.  I slept a lot during the day and day after the injection . I did  not get care from a hospital or doctor.
I had the chills, fever, body aches, headache, and TINNITUS, which was what I saw my physician for.
Information has been received from a physician concerning a 60-year-old female who on 30-JAN-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included ROZEREM, CYMBALTA, BIAXIN, prednisone, clindamycin and other unspecified antibiotics. On 08-FEB-2007 the patient experienced a urinary tract infection and ringing in her ears. On 13-FEB-2007 the patient experienced clogged ears. On 19-FEB-2007 the patient experienced head congestion. On 20-FEB-2007 the patient experienced sinus pressure and jaw aching. On 20-MAR-2007 the patient experienced dizziness, nausea and fainted and was taken to the emergency room. On 21-MAR-2007 the patient went to an ear, nose and throat physician who did an MRI scan of her brain which did not show any problems. On 27-MAR-2007 the patient went to a dentist because of an abscess on her tooth. As of 11-APR-2007, the patient was still experiencing ear pain, but her status was reported as recovering. No product quality complaint was involved. Additional has been requested.
The client's mother completed the medical intake form with the client's date of birth as a few days early. Database had the date of birth recorded previously as a later date entered by another entity..
Numbness in legs especially bottom of right foot, tingling and random needle like poking on different parts of the body.  Muscle ache on the right calf.
On 1/16/2021 I stated having ringing in my ears. I had chills, pain on the vaccine site, dizziness, & weakness. I seen my doctor and they did a hearing test he diagnosed with tinnitus. Other symptoms were gone in 2-3 days except tinnitus that is getting worst.
Mother reports after shots-in waiting area started "shaking" and fell to floor. EMS called-patient very pale and responsive to name.
The morning after the second Pfizer shot, about 15 after I got up, I suddenly felt very weak and collapsed. I was out for less than a minute but felt very weak afterwards.
pt recv vax 3JAN96 pt was reported that metpath test (G098) done on 1MAY96 showed non-conversion;
Her lungs were hurting; Her chest was hurting; It hurt to breath; Could not lay down; Could not sleep; Could not walk too far; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Her lungs were hurting), CHEST PAIN (Her chest was hurting), DYSPNOEA (It hurt to breath), GAIT DISTURBANCE (Could not lay down) and INSOMNIA (Could not sleep) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PULMONARY PAIN (Her lungs were hurting), CHEST PAIN (Her chest was hurting), DYSPNOEA (It hurt to breath), GAIT DISTURBANCE (Could not lay down), INSOMNIA (Could not sleep) and MOBILITY DECREASED (Could not walk too far). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PULMONARY PAIN (Her lungs were hurting), CHEST PAIN (Her chest was hurting), DYSPNOEA (It hurt to breath), GAIT DISTURBANCE (Could not lay down), INSOMNIA (Could not sleep) and MOBILITY DECREASED (Could not walk too far) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided by reporter.
This spontaneous report as received from a registered nurse via a company representative refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. Approximately in 2015, reported as within last month, the patients were vaccinated subcutaneously with doses of (Oka/Merck) VARIVAX injection (lot # L010148, L023592, L015046; dose and expiry dates were not reported). It was reported that a total number of 3 doses was administered. There were no concomitant therapies reported. Approximately in 2015, the patients returned to the clinic with "similar unspecified complaints", which were then confirmed to be cellulitis.  All of the patients received treatment with unspecified oral antibiotics. IT was reported that all of the vaccines were stored properly and prepared properly before the injections were given to the patients. There was no product quality complaint involved. The outcome of the event was not reported. The relatedness between (Oka/Merck) VARIVAX and the event was not provided.  This is one of several reports received from the same reporter. Additional information has been requested.
Lump under arm; Swelling under arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lump under arm) and PERIPHERAL SWELLING (Swelling under arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Lump under arm) and PERIPHERAL SWELLING (Swelling under arm). At the time of the report, AXILLARY MASS (Lump under arm) and PERIPHERAL SWELLING (Swelling under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported   Reporter did not allow further contact
Patient came by a few days after getting his flu shot and complained he was still having arm pain and it was recommended to him to take ibuprofen. Patient came back by the pharmacy on 9/21/21 and said he was still having pain in his arm that was not getting any better and said he has made an appointment to see his physician. Suspected that patient may have SIRVA.
My arm stayed sore; Muscle pain; I am unable to actually use it as a regular arm; Stiffness in my arm; Cramps; 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 received bnt162b2 (BNT162B2), administration date 29Mar2021 (Lot number: ER2613) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EN6208), administration date: 10Mar2021, when the patient was 77 years old, for COVID-19 immunization, reaction(s): "Muscle pain", "My arm stayed sore". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "My arm stayed sore"; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Muscle pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "not recovered", described as "I am unable to actually use it as a regular arm"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "not recovered", described as "Stiffness in my arm"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "not recovered", described as "Cramps". The events "my arm stayed sore", "muscle pain", "i am unable to actually use it as a regular arm", "stiffness in my arm" and "cramps" were evaluated at the emergency room visit. Additional information- It was reported that I just had the  first Pfizer shot in Mar. I think it was, 09Mar. I should look it into my calendar and my arm stayed sore for a really long time and I got the second one, it is 10Mar and my arm stayed sore almost up to I got the second one on the 29 and I have had muscle pain every since then. I went to see my primary, in like my muscle at the top of my arm and I cannot hold it right, my arm and it is excruciating pain, it is like my muscle be coming apart like a real sever muscle pain in my arm that I got both the shots in and then I told my primary about it in Apr and she says well do exercises of the arm. I have been doing exercises and I got into a exercise program and it hurts so bad that I had to go to the emergency room and tell them about never had this, muscle pain in my arm before and it came after I hade the Covid shot and I would just like to report that I do not know if anybody else has experienced this but I have been having a lot of pain in that arm and I am unable to actually use it as a regular arm because of the limitation of the pain when I practically experienced it." No follow-up attempts are possible. No further information is expected.
Pt was admitted with left-sided chest discomfort and weakness and increased falling at home.  a couple days into his hospital stay he developed a sore throat, fever, and chills and was COVID positive.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated 3 times with the Moderna product, having received vaccine on 02/15/2021, 03/15/2021, and 10/29/2021. They also received an influenza vaccination on 10/29/2021: A FLU-Quad (Lot #312874). They tested positive for COVID-19 on 07/17/2022 via antigen test at the assisted living facility at which they were a resident. The test came through after their death on 07/16/2022. Death certificate has "Head Trauma" and "Fall" in Part I (Cause of Death). COVID-19 is in the Part II (Other Significant Conditions). The individual had significant underlying conditions and had just been re-certified for hospice care about a week prior to their death.
Information has been received from a pharmacist concerning a female who was vaccinated with three doses of GARDASIL on unspecified dates and recently had an abnormal PAP test positive for HPV. The date of PAP test was unknown. At the time of report the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included sterile diluent. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (dose, frequency and route were unknown) lot # N028445 for prophylaxis. The temperature excursion was registered, without Digital Data Logger, between 6 Fahrenheit degrees and 14 Fahrenheit degrees along 1 hour and 13 minutes.
Unresponsiveness for approx 20 min, rescue breathing by the mother (she is a nurse), unconsolable/irritable for 2-3 hs
I received the second booster on September 16, 2022.  On the 27th my blood pressure was slightly elevated and on the 28th it was 181/99 I went to the ER and was given Labetalol.  I was almost 36 weeks pregnant.  I was sent home and told to contact OBGYN.  I was not prescribed anything else.  My blood pressure spiked again and it 175/90 (about) and I went to the emergency room again.  They monitored me and was not given any prescription and did not stay overnight.  I was diagnosed with gestational hypertension.  I was set up for labor induction on October 7th.  On October 7th during labor my pressure spiked again, and I was given magnesium and Labetalol again.  After delivery, I was monitored, and my pressure went down.  But on October 17th it spiked again to 190/70?s and I went back to the emergency room.  I was admitted to the hospital and upon discharge prescribed Labetalol.
Patient given wrong COVID Booster dose. Given 12 yrs and they are 11yrs old.