chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on 6/16/2021 at approx. 2:00 PM patient presented with hypertension (BP 184/115), Elevated Temp (104.1F), Increased confusion, lethargy, weakness. Was sent to  ER via ambulance where he was admitted. Per admitting H and P primary Dx. "Fever, Probably acute viral illness versus post vaccination syndrome".  Patient was treated inpatient at hospital with IV hydration, symptomatic care, lab monitoring. Patient is stable and planning to discharge from hospital back to this long term care facility over the weekend.
I?ve been experiencing fatigue, body chills, headache, fever, muscle and joint pain, nausea, vomiting, diarrhea, pain in the injection site, and the inability to sleep more than 10-45 minutes at a time. I have taken Unisom to help with the nausea and help me sleep better. I have been taking Tylenol to help with the fever, headaches, and pain.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patient were administered improperly stored ROTATEQ (dose and route unknown, lot # M004542, expiration date: 18-OCT-2017). The vaccines were exposed to temperature excursions in 3 different refrigerators, but not exposed to multiple excursions. The three refrigerators are described as " A: temperature: max 48 Fahrenheit degree for 15 hours, B: temperature: max 49.3 Fahrenheit degree for 15 hours, and C: temperature max 51.4 Fahrenheit degree for 15 hours". There were no previous excursions. There was no data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt came to desk stating felt like throat was "closing up and tongue swelling". Pt able to speak clearly, no audible wheezing or stridor noted, denies difficulty breathing. Taken immediately to ED, placed into room, nurse with pt and report given, Dr. with pt. No overt signs of anaphylaxis, but discharged with steroids, epi-pen, and benadryl and consulted on returning if new, worsening, or concerning symptoms arise
Patient fell off edge of bed face forward; ambulance was called.  They helped her up off the floor, then assisted her into a chair in the living room.  Later that same evening, patient got up and walked into the bathroom to use the toilet.  While sitting on the toilet, she fell forward and to the left hitting her head on the side of the bathtub that was positioned to the left of the toilet.  Her husband asked if she was okay.  She responded, "I hit my head", then she stopped talking and he went for help.  Emergency workers attempted CPR, but were unable to recussitate.
I developed shingles after my first shot approximately 2 weeks after. I took medication for it but it lasted for 3 weeks and I had to delay my second shot. Then after that I have recovered and did not have any re occurrence up to this day.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
01/27/22 inpatient admitted to Hospice for "Hypovolemic shock" "Renal cancer" PMHx of "colon CA s/p R hemicolectomy in 1988, PE, afib, CAD, Pacemaker, and normocytic normochromic anemia"
Big cluster swelling all over his body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Big cluster swelling all over his body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-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) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced SWELLING (Big cluster swelling all over his body). The patient was treated with PREDNISONE for Swelling, at an unspecified dose and frequency. At the time of the report, SWELLING (Big cluster swelling all over his body) had resolved.            patient said he took prednisone and his swelling went away after a couple of days, he is fine now and had no other AE   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional info was updated with outcome of the event.
die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: DEATH (death, medically significant), outcome "fatal", described as "die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Patient died in the first day of trials. One died instantly.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200047905 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: die
3/8/21 had first vax. 4/5/21 had second vax. Weeks later started to notice red spots on bottom of feet the itched. This continued until a full blown outbreak on 8/12/21. Hives on hands, feet, arms and legs. Very itchy. Also had itching in hairline at base of neck and ears.  Went to Dermatologist same day. Had punch biopsy. Results were hypersensitivity to drug. Hive lasted until 10/5/21. Only experienced few red spots primarily around elbows. Next outbreak was on 12/22/21 and lasted about one week. Less severe than initial outbreak. To date, still get a handful of red spots around elbows.
Low back/sacroiliac joint inflammation. Tingling in feet and pins and needles in feet after walking 1/2 mile.; Low back/sacroiliac joint inflammation. Tingling in feet and pins and needles in feet after walking 1/2 mile.; Low back/sacroiliac joint inflammation. Tingling in feet and pins and needles in feet after walking 1/2 mile.; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on an unspecified date (vaccinated at the age of 29-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient experienced low back/sacroiliac joint inflammation, tingling in feet and pins and needles in feet after walking 1/2 mile. These adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No hospitalization required or prolonged. On an unknown date, the patient underwent nasal swab test for covid-19, which resulted negative. The treatment received for the adverse events was physiotherapy (PT), chiropractic care and unspecified medications. The outcome of the events was not resolved.  Device Date : 01Jul2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Information has been received from a physician concerning an approximately 4 month old male who in January 2008, was vaccinated PO with his second dose of Rotateq. There was no concomitant medication. In January 2008, a few days after the second dose, the patient experienced intussusception and was subsequently hospitalized. In January 2008, the patient underwent surgery. The outcome was unknown at the time of this report. There was no product quality complaint. Intussusception was considered to be an other important medical event (surgery) by the physician. Additional information has been requested.
pt was given last feeding @ 4AM, smiling & doing well;found in crib @ 7AM unresponsive;CPR started & taken to hosp, unsuccessful in resuscitation;mom states pt cranky 31MAR when someone touched where immun given;
flu like symptoms; felt very achy; muscle aches and pains; fatigue; Joint pain; Fever; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 13Mar2021 (at the age of 80 years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient experienced flu like symptoms and felt very achy. It had been a month now, he had no temperature, no other symptoms. He wanted to know if we have more information specifically about flu like symptoms 1-2 months after the vaccine. He later added that it was like he had muscle aches and pains one month after the second injection. Patient also mentioned of fatigue, joint pain and fever. Outcome of all the events was unknown.  No follow-up attempts are needed. Information related to batch/lot number can not be requested
Little itchy; Pretty large, red oval in the injection site; Sore; This spontaneous case was reported by a physical therapist and describes the occurrence of VACCINATION SITE PRURITUS (Little itchy), VACCINATION SITE ERYTHEMA (Pretty large, red oval in the injection site) and VACCINATION SITE PAIN (Sore) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Allergic to sulfas). Concomitant products included VITAMINS NOS and FISH OIL for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Little itchy), VACCINATION SITE ERYTHEMA (Pretty large, red oval in the injection site) and VACCINATION SITE PAIN (Sore). On 08-Feb-2021, VACCINATION SITE PRURITUS (Little itchy) and VACCINATION SITE PAIN (Sore) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Pretty large, red oval in the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not use any medications for treatment.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. On unknown date, the patients were vaccinated with a combination of GARDASIL (dose, route of administration, lot# and expiration date were not reported) and Gardasil 9 (dose, route of administration, lot# and expiration date were not reported) to complete a three dose series. No concomitant therapy was reported. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested.
Information has been received from a Registered Nurse concerning her daughter, a 12 year old female patient with no pertinent medical history and no known drug allergy who sometime this summer, approximately in June 2010 was vaccinated with the third dose of GARDASIL. There was no concomitant medication. The nurse reported that there were no issues with the first 2 doses, however on the 3rd dose the patient's mother noticed a significant weight gain. The patient was originally 118 lbs prior to the 3rd dose, and after the 3rd dose increased weight to 140 lbs in an unspecified time interval. Apparently, the patient was a very active girl and everyone seemed to have no answers as to why this had occurred. As was told that unspecified lab work was done which the did not have available to her and at this point, everything was still unresolved. The patient sought unspecified medical attention. Follow up information has been received from other health professional concerning a 12 year old female patient with no illness at the time of vaccination who on 18-MAR-2010 was vaccinated with the third dose of GARDASIL (lot  # not reported). Patient's mother stated that her daughter had abnormal weight after since receiving last injection on 18-MAR-2010. The patient was 129 lbs on 10-MAR-2010 and weight gain to 144 lbs when she was seen 13-OCT-2010. The patient did not seek medical attention. Outcome of event was unknown at the time of reporting. No further information is available.
Headache; sinus congestion; face and jaw pain; face and jaw pain; nausea; vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 02Apr2021 at 13:00 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to allium and lactose intolerance. Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 12Mar2021 at 13:30 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 03Apr2021 at 06:00, the patient experienced headache, sinus congestion, face pain, jaw pain, nausea and vomiting. The patient did not receive any treatment for these events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events headache, sinus congestion, face pain, jaw pain, nausea and vomiting was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Approximately 25 minutes after administration the patient noted swelling around the mouth and tongue. She also noted feeling like her throat was closing up.  She explained she had previously allergic reaction to shellfish and this was a similar feeling.
Messed up my period bad. I now have extremely heavy flow that is extremely painful. 10 super tampons in one day. I ne vet had any kind of issue like this before.  Also memory loss. I used to have a semi eidetic memory. Now I can?t even complete while sentences without forgetting what I was talking about. Never had any kind of memory issues at all until after the vaccine.
Feels a little bit sore today; A spontaneous report was received from a consumer concerning himself a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feels a little bit sore today/pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient felt a little bit sore. Treatment details included none.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event feels a little bit sore today was considered not resolved at the time of this report.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Medium, Additional Details: patient collapsed after feeling very nauseated about 24 hours after having vaccine. wife reported tensing of all muscles and patient laid back on stairs, lasted about a minute then subsided
This spontaneous report was received from a pharmacist via Pfizer and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were unknown. On 02-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, lot reported as: H33604, expiry date: March 2015, route of administration were not reported) or PREVNAR 13. It was documented by the administering nurse just as a pneumonia vaccine. It was intended for the patient to receive PREVENAR 13, but the clinic also had PNEUMOVAX 23 in stock. Concomitant therapy was unknown. Relevant tests were unknown. Additional information has been requested.
A consumer report has been received. The report concerns a 10 year old, female consumer, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that patient experienced vomiting, stomach pain and sore throat. The outcome of the event vomiting, stomach pain and sore throat is unknown. The report was considered to be non-serious.
Only one recorded dose of vaccine administered, second dose was not registered, but partially immunized patient cotracted covid infection
Extreme chills and fever.  Cold sweats.  Shaking.    I took 1 Aleve and went to bed at 8pm.  Had chills throughout the night.  Woke up the next morning feeling much better.
1. Chills and body aches after 7 hours 2. Sweating and fever after 8 hours 3. Numbness in left toes  after 8 hours 4. Low grade fever (99.1) after 18 hours 5. Vomiting and nausea after 18.5 hours
Pt had rash develop approx. 10 days after MMR immunization. She had maculopapular red rash on trunk and face and arms. Symptomatic treatment was done.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2016) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 1608 hours, the highest recorded temperature was 59.9 F (15.5 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Complained arm where she received vaccine was getting sore and very heavy.; Complained arm where she received vaccine was getting sore and very heavy.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sales representative. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm on 04Jan2021 morning at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine this morning (04Jan2021) and complained arm where she received vaccine was getting sore and very heavy. The events took place after use of product. She took Tylenol and stated that she feels better. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
She wakes up in the middle of the night and feels like there is a worm crawling underneath her skin.  She cannot go back to sleep. Pharmacist advised her to take Tylenol and ice on the arm.  Follow up with doctor.
pt recvd vax & devel induration @ the inject site, & it became black & blue;
Case-patient had first Pfizer COVID-19 vaccine on 12/7/21, developed MIS-C symptoms on 1/5/2022, and received second Pfizer vaccine on 1/7/22.  Case reported having an undiagnosed upper respiratory infection in late December/early January (specific date unknown).  Case-patient met case definition for MIS-C, with evidence of clinically severe illness requiring hospitalization, fever, multisystem organ involvement (cardiac, hematologic, and GI).  The case-patient experienced tachycardia, headaches, abdominal pain, vomiting, and various elevated inflammatory markers (see box 19 below).  Case-patient was treated with IVIG, ASA, and steroids and survived after a 2 day hospitalization.
arm pain; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm pain) 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 22-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-425166.
Pt received the pfizer vaccine and pt had an anaphylactic reaction. Pt was given epinephrine x2 and Benadryl to take at home. Pt was seen in urgent care with me and given solumderol inj, medrol dose pack and hydroxyzine.
Patient called 8/16/2023, stated R upper arm/deltoid area, sore, hard to raise all the way up. Started 1st couple of days following the injection and has continued and soreness has not improved. Stated feels bruised. Work at dental office and feels interferring with work. Advised to see PCP and report back. States she is planning on trying to see PCP tomorrowinterfering
Information has been received from a physician concerning a 16 year old female who on 13-FEB-2007 was vaccinated with the first dose of Menactra. The physician reported that the patient experienced aching in her body and neck after receiving the first dose. The patient subsequently recovered. The patient had since received the second dose of Gardasil and did not experience the symptoms again. Additional information has been requested.