chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; BONES HURT FROM INSIDE OUT; SIDE EFFECTS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 62 year old female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the patient ended up with Covid (suspected covid-19 infection). It was reported that, this was almost going on a year now where she was getting horrible month-long sick with covid and suffering all the effects (Dose number in series 1). She called in MAR-2021 (reported as March of this past year) when her symptoms were horrific and was not going away. The patient additionally received non-company suspect vaccine Moderna (elasomeran) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 19-NOV-2021 for covid-19 prophylaxis, which was Revaccination with different COVID-19 vaccine (Dose number in series 2). It was reported that, the patient had number of side effects with both the vaccines (Dose number in series 2). She had body aches and her bones hurt from inside out (coded to bone pain) (Dose number in series 2). The patient signed herself up for the Pfizer booster but thought she should look into it further before getting it. The patient was not sure if she wants to get another vaccination. She was fearful of putting something in her body that was already goofed up. Patient stated it might not have been from getting vaccinated but she has a multitude of a mess from getting covid. She stated there are theories of long covid that some part of the virus was not recognized by your body. She knows the vaccine was not active but does not know how her body will respond. She was also waiting to get into a covid clinic. Her appointment was not until MAR-2023. She has crazy symptoms. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of body aches, side effects, bones hurt from inside out and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
In the evening of 11/15, I became itchy. By the early morning of 11/16, I had broken out in hives across my abdomen, the side of my body, my arms, and legs. I had a health appointment with an NP at who diagnosed hives/dermatitis (cause unknown) and prescribed a course of prednisone and OTC antihistamines and anti-inflammatory medication. Serious adverse symptoms persisted for two or three days, including hives, itching, swelling and joint pain (maybe due to the steroids?), and fatigue. I was tired and not able to focus on work or do other activities, so I rested. Overall, it took about two weeks before I started feeling better.  During the second week of illness, I became congested and began taking Sudafed. I continue to experience very mild symptoms that seem related to the histamine reaction, e.g., I will develop red splotches on my hands, body, and face from time to time, including after washing my hands or taking a shower or exerting myself or experiencing some friction. But there is no longer any pain or itching associated with these reactions.
Woke up with severe headache, muscle aches, fever, chills.  Fever lasted for 24 hours.  101.3
The pt woke with a large, hot, red, swollen entire deltoid with distal area red. It was swollen 1 1/2 times the normal size. The pt experienced decreased range of motion.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. No information regarding the patients' pertinent medical history, concurrent conditions or concomitant therapies was provided. On 03-NOV-2016 and on unknown dates in 2016 (reported as "unspecified dates since 29-SEP-2016), the patients were vaccinated with doses of improperly stored GARDASIL 9 lot # L036301, expiration date 20-DEC-2017 (dose and site of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of min. 69.2 to 74.1 degrees Fahrenheit for 131 hours and the temperature excursion of 51.8 degrees Fahrenheit for 30 days. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had my vaccination on 10/19/2022. At the beginning of 02/2023 I started getting what I thought was allergic bites on my right leg and right arm. It was actually a rash. The skin because very swollen about 2 to 3 inches out. It kept getting worst spreading to my arms and face. I went to the doctors office and they gave me an antibiotic. That cleared up the cellulitis but the rash is still present as of 04/24/2023.
Patient developed a rash mostly on the lower portion of the leg from his knee to the ankle after intake of the third Vivotif capsule.  The nurse noted the rash to be multiform.  At the time of reporting the patient was on his way to Africa for several weeks.  He completed the immunization course with the fourth capsule.  Outcome is unknown.
Information has been receive from a pharmacist referring to a 65 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. On 10-JUL-2016 (reported as 5 days ago), the patient was vaccinated with ZOSTAVAX (lot # L036823, expiration date 24-DEC-2016, 0.65 ml, subcutaneously). Concomitant  therapy included LIPITOR. In July 2016, the patient experienced swelling pain and redness at the injection site and was seeking medical attention with the pharmacist for a hoarse voice and sore throat and feeling tired. The pharmacist reported that there was no vesicles to test. No treatment was given for the events. The outcome of the events was reported as not recovered. The causality was not provided. Additional information has been requested.
Unknown pregnancy at the time of shot. Found out a week later that I was 3 weeks pregnant. Left side of body went completely numb, couldn't feel toes or fingers. Went really cold on left side of body all within 20 mins of shot. Metal taste in mouth. Lasted 24 hours. Instantly after recieve shot. Slept for 5 hours once I was able to get home. Consistent headache for 2 weeks after shot and I don't ever get headaches. Lost baby at 3 1/2 weeks after trying for a whole year to get pregnant.  Since had a headache after loss of baby for a week.
Syringe connection issue; Vaccine underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine underdose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine underdose). At the time of the report, DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
reporter believe that flu vaccine killed reporter's father; After internal review on 02-Nov-2020, the report upgraded from non-valid to valid: [suspect updated to INFLUENZA VACCINE].  Initial and live follow-up information regarding this unsolicited non-valid serious case from a consumer via social media on 07-Oct-2020.   This case involved a male patient of unknown age who died (death), after he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history of the patient were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant.  It was reported that the INFLUENZA VACCINE killed reporter's father.  Relevant tests were not reported.  It was not reported if the patient received a corrective treatment before he died.  It was unknown if an autopsy was done and cause of death was not reported.  Information on the batch number was requested.  Follow up information received on 02-Nov-2020 regarding an unsolicited valid serious social media case received from a consumer.  Case upgraded to valid case, suspect updated to INFLUENZA VACCINE, lot number requested and narrative updated accordingly.; Sender's Comments: Sanofi company comment dated 02-Nov-2020: Follow up information received changes the previous assessment of this case as follows. This poorly documented social media case concerns a male patient of unknown age who died after vaccination with INFLUENZA VACCINE (unknown manufacturer). Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: reporter believe that flu vaccine killed reporter's father
pt recv 3 doses of hep B vax on 5FEB93,16APR93 & 26NOV93,respectively;pt devel alopecia;
This spontaneous report was received on 21-JUL-2017. The article refers to 18 unspecified patients (ages and genders not specified) (Reference MARRS # 1708USA003597 for 16 of 18 patients) who received ZOSTAVAX (Dates of vaccinations, doses, routes of administration, sites of administration, Lot numbers and expiration dates were not reported.) Current conditions, medical history, allergies, and concomitant medications of the patients were not specified. The article stated the following:  Eighteen patients have filed a liability lawsuit against Merck, alleging the company produced and sold an "unreasonably dangerous vaccine" that caused serious injuries after vaccination. The plaintiffs were from 5 different places. Instead of preventing shingles, ZOSTAVAX caused the plaintiffs to "contract a persistent strain of herpes zoster," according to the suit, resulting in painful outbreaks, hospital visits and post-herpetic neuralgia in two cases (This MARRS # 1708USA003624  refers to 2 of the 18 patients.). The treatment and outcome of the Instead of preventing shingles, ZOSTAVAX caused the plaintiffs to "contract a persistent strain of herpes zoster", resulting in painful outbreaks and post-herpetic neuralgia was not reported. Additional information is not expected as there were no contact details.; Sender's Comments: GB-009507513-1703GBR007969: US-009507513-1708USA003597:
This spontaneous report was received from a registered pharmacist refers to an 84 years old female patients with active shingles and with none pertinent medical history and drug reactions/allergies. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX on 31-AUG-2011. No concomitant medications were reported. 2 months after the patient received ZOSTAVAX, In October 2011 the patient developed a rash. There were lidocaine, NEURONTIN and ZOVIRAX given for the AE. The outcome of rash was unknown at the time of reporting. The patient sought medical attention by contacting the pharmacist. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Medical history and concurrent conditions of the patient was not reported. On an unknown date approximately in 1988 (reported as "approximately 27 years ago"), the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) injection of strength 10/1.0 microgram/milliliter (MCRG/ML), (lot number, dose, route and site of administration was not reported/possibly manufactured by Merck) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as DTAP). No concomitant medications were reported. On an unknown date, the patient developed cerebral palsy (medically significant). The outcome of cerebral palsy was unknown. The causality assessment was not provided. No further information was provide. No product quality complaint (PQC) was filed. Upon internal review the event of cerebral palsy was determined to be medically significant. Additional information has been requested.
Have been having the heart inflammation that's been going on; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number and Expiry date was not reported), via unspecified route of administration on an unspecified date in 2021 (reported as: a couple of weeks ago), as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that a yeah, so patient got the Pfizer vaccine a couple of weeks ago (on an unspecified date in 2021) and patient have been having the heart inflammation that's been going on and patient just noticed that they recommend people that have that the heart inflammation to not get the second shot and stated, patient have had the heart too that have been going on. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Monday following shot, was getting heart palpitations that felt like my heart was beating out of my chest. Happened moat extremely at night while trying to sleep. Chest pain that I've never had is happening on the left side of my chest and started at this point and persists to this day. Palpitations persisted for the next 5 or so days and we're accompanied with hot flashes and heavy sweating. Had a very hard time sleeping longer than an hour or two at a time during this 5 day period due to waking up with heart racing through night.
Itching bilateral feet on the bottom started 25 min after receiving vaccine, she got vaccine at 12 PM. . Took Allegra at 12:45 PM and not sure if it helped. The feet were not painful or discolored. And the itching was mild. Itch is intermittent.  Also noticed tickle in back of throat 30 min after vaccine, and she felt nervous at that time. This tickle in the throat  lasted 15 min , and it was gone before she took Allegra .Has noticed intermittent back itching too.
sick; fever; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, fever and incomplete course of vaccination. On an unknown date, the outcome of the sickness, fever and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness and fever to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose on unknown deltoid. The patient experienced bad reaction to the first shot, she was sick and had a fever. The patient did not get her second dose of Shingrix within 6 months of the first dose, which led to incomplete course of vaccination. The reporter had consented to follow up
Fainting after administration, within minutes of receiving vaccine. Short episode, only fainted for a second.
Information has been received from a physician concerning a female who was vaccinated with the first and second dose of GARDASIL on unspecified dates. The patient experienced tonic chronic type seizure activity after getting the second dose of GARDASIL. The patient didn't experience any adverse effect from first dose. Unspecified medical attention was sought. At the time of the report, the patient had recovered. Upon internal review, the tonic chronic type seizure activity was considered as other important medical event. Additional information has been requested.
Approx 15 min after vaccination, patient C/O tightness in chest and SOB.  Rash began to appear on face and back. POD vaccination site was held in local hospital. Patient was taken to ER. She was checked in by triage. Patient left ER without being seen by MD.  Was followed up by Nurse.  Is doing well as seems to have recovered.
Traveled to foreign country from 1/29/08 to 2/20/08. Had onset of severe HA, photophobia and nausea beginning on 2/19/08. Intermittent episodes of fever with profuse sweating beginning 2/21/08. Hospitalized in MA from 3/2/08 to 3/19/08. Principle discharge diagnosis: fever, CMV colitis, & candidas of esophagus. Also has Crohn's disease. While he was in foreign country, there was a large outbreak of Dengue fever in the area where he was. 4/8/08-records received for DOS 3/2-3/19/08- DC DX: Fever. CMV. Candidiasis of esophagus. Crohn's disease. Presented with 10 day history of intermittent fevers up to 105, profuse sweating, chills, myalgias and weakness. Returned from travel 11 days prior after spending 3 weeks there. Travels every year. Ate cooked mussels once. Episode of falling into water once. Bitten by mosquitoes. On 2/19/08 developed severe headache in occipital area associated with photophobia and nausea. Intermittent fever since 2/21/08 usually in afternoon and reoccur in evening. Loose stools. Decreased appetite. Chnage in mental status, moody and slightly aggressive in speech. Most likely diagnoses are Dengue or Yellow fever or reaction to Yellow fever vaccine.  During febrile episodes became hypertensive and tachycardia of 140. Abdominal distention on admission.
My arm was very sore Friday night. Saturday i seemed to be ok and had more energy. Today my back (lower and upper) is very tight and sore.
This is a solicited report from a Non-Interventional Study based on the information received by PFIZER (Mfr. Control No. 21K-163-4127915-00), received from a contactable consumer (patient).   A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscularly on 17Feb2021 (lot number and expiry date were not reported) as dose 2, single and intramuscularly on 25Jan2021 (lot number and expiry date were not reported) as dose 1, single for COVID-19 vaccination; and adalimumab (HUMIRA), subcutaneously from an unspecified date (lot number and expiry date were not reported) to an unspecified date, at an unspecified dose and frequency (reported as citrate free) for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 on an unspecified date in 2021. It was reported that the patient experienced an event of non-serious Covid-19 with Humira (adalimumab). On an unknown date, the patient experienced Covid-19. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The patient underwent lab tests and procedures which included Covid-19 virus test: positive on an unspecified date in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events was recovering.  The reporter's causality for the event(s) of Covid-19 with Humira (adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
pt recv vax 30MAR99 & 8APR99 T102, sz, rash noted 9APR99;fever gone 9APR99;discharged p/36hr in hosp;
Started sweating, forehead, hands and feet- that night progressed to muscles twitching and shaking, cold hands and feet, nausea, no appetite- shaking was all over at times, would come and go- had it first night, next day and night and less intense but still there 2 nd day and night
Left-sided weakness on 9/18/20; MRI confirmed an ischemic stroke.
On June 18, 2022 I noticed that I was having dizziness and drainage from my ears and sinuses. My symptoms started to get worse. I started coughing with chest congestion. June 14th my symptoms were getting better, but I contacted my doctor. I was referred to a clinic. I had a fever of 100.5 degrees, congestion, sore throat, coughing, and my blood pressure was slightly elevated. I had no shortness of breath, diarrhea, or vomiting. I was recommended to do an immunotherapy treatment. I received the bebtelovimab infusion in my home on June 16th at 6:30PM. Since then my symptoms have been getting better. I still have an occasional cough, and sometimes it contains mucus. I still have a little bit of fatigue. I was prescribed a cough pill called benzonatate.
Nausea , Chills, Fatigue, Loss of appetite, Dehydration Treatment was iv fluids 800 ml and zofran   She recovered in about 2 days after that
patient has a hx of anaphylaxis to pears. Within 5 minutes of  vaccine developed tingling and numbness to lips and tongue.  patient escorted to the emergency department for further evaluation and treatment.
A report has been received from a pharmacist concerning a Male patient, who had been receiving Nasal FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. Expired FLUMIST Quadrivalent was administered in a pharmacy setting, by a pharmacist on 08-Mar-2016. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
This spontaneous report as received from a medical assistant refers to a currently 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX (Merck) doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX (Merck) was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.