chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He states that he had no reaction after his previous shots except for "a little bit of sore arm".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230519000021.  A 71-year-old male patient received BNT162b2, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: but controlled with meds. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "He states that he had no reaction after his previous shots except for a little bit of sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "He states that he had no reaction after his previous shots except for "a little bit of sore arm".".  Additional information: Patient did not receive any other vaccines 4 weeks prior to COVID-19 vaccine. Patient later received Moderna Covid-19 Vaccine, Bivalent (Original and omicron BA.4/BA.5), Davesomeran, Elasomeran on 09May2023 (Batch/lot number: 016H22A) via intramuscular route for COVID-19 prophylaxis and experienced achy and arm hurt/a little bit of sore arm (vaccination site pain), chills, fever/Low grade fever on 09May2023, which were not recovered at the time of this report. Patient stated that he had his 6th shot last 09May2023, lot number 016H22A. He had the 1st 4 (Pfizer) and the last 2 were Moderna. He stated that he had no reaction after his previous shots except for "a little bit of sore arm". But the last dose of Moderna which he had 8 days ago, in about 7 hours he had a reaction. He stated it was nothing significant - "little chills, fever, achy and my arm hurt, and he expected that and it was okay because he knew that his body was working". After a day or two almost all of them went away except for a low-grade fever. It had been 8 days and he still had fever which is a little less high than it used to be. He had already consulted with his doctor, but he could not give him an explanation. Had there been reports of fever lasting for about a week after getting the vaccine. The patient was in a rush, so he only provided the details of the last bivalent dose, but he agreed with Safety follow up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I am in active treatment for NSCLC adenocarcinoma with an oral targeted therapy drug Alecensa (alectinib). After 4 years of being stable I had progression within months of receiving the second dose of the COVID vaccine. I do not know if the two are in any way connected but felt it important enough to report
redness in her chest area; Dry heaves; Felt weak; Nausea; Fatigue; Burning sensation; Sweats; Chills; 100 degree fever; Body aches /  stabbing pain in right rib area; Headache; pain around her eye; stabbing pain in right rib area that shot across her chest; stabbing pain in right rib area that shot across her chest; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2021). Concurrent medical conditions included hashimoto's disease. Concomitant products included levothyroxine.   In December 2021, the patient received the 2nd dose of Shingrix. In December 2021, less than 2 weeks after receiving Shingrix, the patient experienced localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain. On an unknown date, the outcome of the localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain were recovered/resolved.   It was unknown if the reporter considered the localized erythema, dry heaves, feelings of weakness, nausea, fatigue, burning sensation, sweating, chills, fever, general body pain, headache, periorbital pain, chest pain and rib pain to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The reporter stated that, she received her second dose of the Shingrix vaccine one day last week from the day of reporting and experienced pain around her eye, a headache, body aches, a 100 degree fever, chills, sweats, burning sensation, fatigue, nausea, felt weak, stabbing pain in right rib area that shot across her chest, dry heaves, and redness in her chest area. The patient had a history of Hashimoto's disease and was taking Levothyroxine 125 mcg to treat it. The reporter's adverse reactions subsided after 2 to 3 days.  The reporter was inquiring if what she experienced was an adverse reaction and was also inquiring about the recommendation to receive the Shingrix series again in 4 to 5 years.  The reporter inquired if she should report her adverse reactions to the pharmacy who administered her vaccine and spoke from the Shingrix frequently asked questions. Provided the medical advice disclaimer. The reporter was referred to the Healthcare professional. The reporter did not consent to follow up and also declined the permission to contact her Healthcare professional.
Did fine day of shot but next morning  woke up felt like I got hit by a Mack Truck my left arm that I received  shot swelled alot. I not experience  that with previous flu shots or my pneumonia  shot. I felt weird and sort of sick for 2 weeks.
Severe body aches; Severe headache; Fever  highest 103.2; Shaking chills; Shaking chills; Nausea; Stomach pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2022 10:30 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "I was diagnosed with Covid 19", start date: 28Dec2020 (unspecified if ongoing), notes: I was diagnosed with Covid 19 28Dec2020. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, dose administration time: 12:00 PM, dose vaccine location: Left arm, dose product: COVID 19, dose brand: Pfizer, dose lot unknown reason: Unable to locate or read the details), administration date: 01Apr2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "Dosage 1: 14Mar2020, Dosage 2: 01Apr2021", "Dosage 1: 14Mar2020, Dosage 2: 01Apr2021"; Bnt162b2 (Dose Number: 1, dose administration time: 02:00 PM, dose vaccine location: Left arm, dose product: COVID 19, dose brand: Pfizer, dose lot unknown reason: Unable to locate or read the details), administration date: 14Mar2020, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "14Mar2020, Dosage 2: 01Apr2021", "14Mar2020, Dosage 2: 01Apr2021". The following information was reported: PAIN (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Severe body aches"; HEADACHE (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Severe headache"; PYREXIA (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Fever highest 103.2"; TREMOR (non-serious), CHILLS (non-serious) all with onset 12Feb2022 17:00, outcome "not recovered" and all described as "Shaking chills"; NAUSEA (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Nausea"; ABDOMINAL PAIN UPPER (non-serious) with onset 12Feb2022 17:00, outcome "not recovered", described as "Stomach pain". The events "severe body aches", "severe headache", "fever highest 103.2", "shaking chills", "shaking chills", "nausea" and "stomach pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, headache, pyrexia, tremor, chills, nausea, abdominal pain upper.  Additional information included: Patient had a strong response to all 3 doses. She was diagnosed with Covid 19 on 28Dec2020. The third dose received on 12Feb2022 was the worst. 3 days now Saturday 12Feb Sunday 13Feb Monday 14Feb Tuesday 15Feb events still continued.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Felt a sudden rush of weird sensation that went from her feet to her head; Face went beat red; Face started to swell; Couldn't speak; Blood pressure went from 120/70 to 210/107; A spontaneous report was received from a nurse, who was also a 56-years-old, female patient, who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced a sudden rush of a weird sensation that went from her feet to her head, face went beat red, face started to swell, couldn't speak, and blood pressure went from 120/70 to 210/107.  The patient's medical history was not provided. Concomitant product use was not provided.  On 05 Jan 2021, fifteen minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) for prophylaxis of COVID-19 infection.  The patient reported she felt a sudden rush of a weird sensation that went from her feet to her head, and her face went beat red and started to swell. She could not speak. Her blood pressure went from 120/70 to 210/107. Treatment included diphenhydramine, intravenous fluids, and famotidine. Within 15 to 20 minutes after treatment was given, the patient reported that all the symptoms went down (blood pressure, swelling, and the rushed feeling she experienced).   Action taken with mRNA-1273 in response to the events was not provided.   The events, a sudden rush of a weird sensation that went from her feet to her head, face went beat red, face started to swell, couldn't speak, blood pressure went from 120/70 to 210/107, were considered resolved on 05 Jan 2021.; Reporter's Comments: This case concerns a nurse who is 56- year old, female patient, who experienced a serious, unexpected event of feeling abnormal, erythema, swelling of face, aphasia and increased blood pressure.The event occurred on 05 Jan 2021, fifteen minutes after receiving the first dose of mRNA-1273 (Lot number: 025J20A). Treatment for the event included diphenhydramine, intravenous fluids, and famotidine. The patient's medical history was not provided. Based on the current available information and temporal association between the use of mRNA-1273 (Lot number: 025J20A) and the start of the event, a causal relationship cannot be excluded.
Dull pain in left lung , left arm, and up neck within 5 minutes of receiving vaccine.  Pain increased over the course of the next 1.5 days until I found it was necessary to go to the hospital.  Trouble taking deep breaths and moving around was painful. Wheezing and crackling in lungs would occur if exposed to cold. Increased temp  occurred on day 4 (99.8). Currently am on day 8 and am mostly back to normal with occasionally chest pains/wheezing. I believe pleurisy was the final diagnosis.
Pt had headache, muscle aches, fatigue, flushed face, large red circle at injection site.
Patient was given 1st Hepatitis B vaccination on 7/6/2022 Patient currently has Hepatitis B Infections without delta agent without hepatic coma
Right thigh - swollen, vomiting x 12 hours and fever. Warm compresses/massage leg and Pedialyte.
Information has been received from a physician concerning a 70 year old male with hypertension who on 05-JAN-2009 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included lisinopril (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown). On 07-JAN-2009 the patient developed a rash. On 08-JAN-2009 the patient visited the office and was diagnosed with herpes zoster. No laboratory or diagnostics tests were performed. At the time of this report, 15-JAN-2009, the patient's herpes zoster persisted. Herpes zoster was considered to be disabling. Additional information has been requested.
BRUISING AROUND THE INJECTION SITE AREA; KNOT (BUMP)  AROUND INJECTION SITE; INJECTION SITE SORENESS; REDNESS AROUND INJECTION SITE; FATIGUE; BODY ACHES; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic, high blood pressure, and high cholesterol, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure, rosuvastatin for high cholesterol, and zolpidem tartrate for sleep. On 21-MAY-2021, the subject experienced body aches. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced fever. On 21-MAY-2021, the subject experienced headache. On 21-MAY-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 22-MAY-2021, the subject experienced bruising around the injection site area. On 22-MAY-2021, the subject experienced knot (bump) around injection site. On 22-MAY-2021, the subject experienced injection site soreness. On 22-MAY-2021, the subject experienced redness around injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, body aches, headache, bruising around the injection site area, knot (bump) around injection site, redness around injection site, fatigue, chills, and injection site soreness. This report was non-serious.
This spontaneous report was received from a nurse and refers to a currently 14-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # R002344, expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA007946: US-009507513-1811USA007945: US-009507513-1811USA001303.
It is believed that after FLUZONE this person developed severe joint and muscle discomfort dizzy, symptoms of Lyme, Lyme has been ruled out, via testing, also had symptoms of facial pressure and numbness, feels like she is listing to the right. Unable to work due to symptoms.
This spontaneous report as received from a pharmacist via a company representative refers to a 69 year old female patient. On 24-APR-2014, the patient was vaccinated with ZOSTAVAX lot # J012660. Concomitant medication included unspecified blood pressure medication. On 24-APR-2014, the patient felt lightheaded and dizzy after receiving ZOSTAVAX. The patient was given water and told to sit down. The patient was then able to walk out of the pharmacy. The pharmacist noted that the patient's blood pressure was high before administration. The outcome of felt lightheaded and dizzy after receiving ZOSTAVAX was reported as recovered/resolved. The reporter did not assess the relationship between the event and ZOSTAVAX. Additional information has been requested.
Noticed extreme swelling, redness, heat, and complaint of pain of the entire half of his arm (shot had been administered on his upper arm).
About a week after getting this vaccine, patient started getting some neurologic symptoms that may or may not be related to the vaccine. To this day, they have not fully improved. When patient came in for second dose, we asked her to hold off on it in fear that it could make things worse. Patient started experiencing tingling at the tip of her tongue and fingertips of both hands, as well as hot spots on the inside of her elbow creases. Her doctor told her to skip the second dose of this vaccine and will monitor/treat her as necessary.
Severe headaches, loss of appetite, jaw claudication, tongue discomfort, difficulty swallowing, elevated CRP. Treated with prednisone 20mg, 1 tablet by mouth  three times daily. Continued headaches and jaw discomfort. Still treating with steroid.
Not looking straight in eye, no laughter, no babbling, congested, multiple allergies, peanut allergy, autism.
Three days following administration of vaccine, patient with complaints of pruritis, pain, and redness to site.  Denied breathing difficulties.  Six days following administration of vaccine, redness had spread, was warm, and slighly tender.  Patient was treated with Keflex at this time for cellulitis.
Information has been received from a doctor of pharmacy concerning a current 67 year old female patient with asthma, penicillin and sulfa allergy who, when she was approximately 35 year old "30 some years ago" was vaccinated with a dose of Rubella vaccine (manufacturer unknown) (Lot # and route not reported) and experienced severe arthritis type reaction that lasted for 6 months. On an unspecified date, the patient had recovered. Additional information has been requested.
Joint pain onset from roughly 48 hours after injection (including neck, lower back, and knees). Roughly 72 hours after shot severe headache that did not react to mediciation such as ibuprofen or acetaminophen. Severe menstrual cramping began 2 days after shot and are ongoing with discharge and bleeding. Pain in lower right abdominal area ongoing from within 48 hours of vaccinations.
Immunization (TDaP) given approximately 10:30am. Patient returned approximately 12:45pm with "stated" Right arm swollen to fingertips per stated by patient: Unable to lift arm and tingling. This nurse called by staff and advised to go to ER.
Swollen are, redness, pain. Patient states that it is getting worse and she feels like it's infected.
On 3/31/2021 went blind in left eye.  Diagnosed with major blood clot in left eye. Has had injections into eye on 3/31, 5/12, 6/23. Scheduled for another 8/4/21.
About the time I got the 1st vaccine, my chronic diarrhea (usually controlled by 0-1 loperamide 2mg qd) became severe.  Gaseous, explosive diarrhea, 10-15 times/day.  Even taking the loperamide with simethicone, up to 4 times/day, would not stop it.  This went on and on.  On 4-2-21 I took stool samples to lab, ordered by my healthcare provider. Those tests came back (or, I found out the results) on 4-14-21, 3 days after receiving the 2nd vaccine.  They showed that I have Pancreatic Insufficiency.   Fecal Pancreatic Elastase was 132 (norm >200, moderate pancreatic insufficiency 100-200 and severe is <100, per lab report).   Occult blood, lactoferrin, and culture were all negative (stool).  I have to wonder about this "coincidence".   36,000 units tid.  I started these mid-day on 4-18-21 (pharmacy didn't have enough immediately and RX picked up and started when filled on 4-18-21).
The pt experienced erythema and swelling approximately 5 cm at the site of injection. The pt also experienced a fever, headache, vomiting after 24 hour post vax.  Follow up on 01/16/2001: "Call to reporter about missing data, LM w/mgr.  Nurse will return call.  Call back indicates this was not Prevnar but Pnu-Immune 23.  The left leg site of the Pnu-Immune vaccination was involved.  Child had recently completed a course of Ceftin.  There is no history of vaccination adverse events, no other vaccination in the 4 months prior.  Follow up complete."
flu like symptoms; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16-year-olds (adolescent) and up patient who experienced flu like symptoms after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for prophylactic vaccination (Immunisation).  On an unknown date, the patient received unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (Solution for injection) (lot number and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested.  On an unknown date the patient developed flu like symptoms (influenza like illness) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event flu like symptoms.
Patient was sitting down and started to feel dizzy and her vision was starting to become blurry. She got up to let us know that she was having a reaction and fainted. She was awake immediately after she fell and said that she was experiencing the blurred vision still, extremely sweaty/hot flashes, and ringing in her ears. She drank some water and sat down for a little bit and started to feel better.
ill with Covid 19 virus; ill with Covid 19 virus; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "ill with Covid 19 virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Covid 19 virus, notes: has received 2 doses of Pfizer vaccine and booster. Became ill with Covid 19 virus. Clinical course: The patient became ill with COVID 19 virus. Symptoms included severe fatigue, cough, and loss of appetite. No underlying conditions. Patient was in good health.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events Drug Ineffective and Coivd19 cannot be totally excluded.