chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to herself, a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified). Route was not reported. No other co-suspects were reported. No concomitant medications were reported. On 13-Dec-2012 the patient experienced sore arm. No treatment information was reported. The outcome of sore arm was unknown. Additional information is not expected.
24-48 hours after Double softball size, red, swollen, hand and hot to touch area. Treated with Benadryl prn.
This spontaneous report was received from an office manager and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates reported as "over the past 3 months", the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lots #: M037771 with expiration date: 21-FEB-2019, M023718 with expiration date: 09-SEP-2018 and M008551 with expiration date: 02-JUN-2018 (dose, route and site of administration were not reported). No adverse experience was reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 21 hours cumulatively over "3 months," on unspecified dates. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014473: US-009507513-1703USA014471: US-009507513-1703USA014470: US-009507513-1703USA014469: US-009507513-1703USA007914:
itching, swelling, redness, rash--Itching and initial swelling at the injection site (felt like a bump had formed) lasted for one day. The rash showed up on the second day and continued to get worse for 3 more days. It took 8-9 days from the start of the itching for the rash to go away.
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication, hypokinesia (could not move legs or hands and cannot stretch elbows), decreased mobility (cannot get out of bed) and feeding disorder (unable to eat) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included immunocompromised. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form; and the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication, hypokinesia (could not move legs or hands and cannot stretch elbows), decreased mobility (cannot get out of bed) and feeding disorder (unable to eat). At the time of the report, vaccination complication, hypokinesia (could not move legs or hands and cannot stretch elbows), decreased mobility (cannot get out of bed) and feeding disorder (unable to eat) outcome: unknown. Concomitant drug use and treatment information not reported. Reportedly, patient's physician recommended for her to take the 3rd dose. Patient had two surgeries this year.
Initial report was received on 15 March 2012 from another manufacturer national service center (service request number 1-4929446717), who received the report from a health care professional. A female patient with allergies to codeine and ammonia inhalant had received "years ago" a "flu vaccine" (manufacturer, lot number, route and site of administration were not reported) on an unspecified date and an unspecified amount of time later developed a severe anaphylactic reaction. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: none.
Started having slurred speech within 2 days. It continued to progress and by December was having a lot of difficulty talking and some difficulty walking. Went to see a neurologist in January and was diagnosed with ALS
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. On unknown dates the multiple unspecified patients were vaccinated with a dose of improperly stored GARDASIL 9 (lot # M041212, exp date: 21-JUN-2019) for prophylaxis. The temperature was in 32 F degree to 35 F degree for 200 hours. There was no previous temperature excursion and no data logger involved. No adverse event reported.
Severe dizziness started morning of March 29 Nausea & vomiting  Brain fog Headache  Fatigue Mild chest pain  All these lasted until April 6th
Chills, pain at injection site, headache, muscle pain, joint pain, fever and swelling.
Information has been downloaded from regulatory authority (US-1577272925-2011-10148). This spontaneous report was received from a consumer concerning a 2 year old male patient. It was reported that the patient had prior vaccines at an unknown office on 14-DEC-2006, no illness at the time of vaccination was reported. The patient had 2 sisters and a half brother. The patient's concurrent conditions and concomitant medications were not reported. On 06-MAR-2007, the patient was vaccinated with ACTHIB, lot # Z1038, PEDIARIX, lot # AC21B079BA and PREVNAR 7, lot # B08655C, all vaccines per intramuscular route (strength, dose, dosage schedule, anatomical location and expiry date were not provided). Subsequently, on 09-AUG-2007, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) per unknown route (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided) and varicella virus vaccine live (oka) (strength, dose, dosage schedule, route, anatomical location, lot # and expiry date were not provided). Later, on 09-NOV-2007, the patient was vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid; hepatitis a vaccine, inactivated and influenza virus vaccine (unspecified), all vaccines per unknown route (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided). Also, it was reported that on an unknown date, the patient was vaccinated with poliovirus vaccine inactivated (unspecified) per unknown route (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided). All vaccines were indicated for prophylactic vaccination. On an unspecified date in April 2009, the patient experienced autism. On unknown dates, it was reported that the patient never talk until age 2 and cried all day (also reported as was just crying all the time). No adverse events post-vaccination were reported to the treating physician during approximately the first two years of the child. At that time, the development of the child was normal. The outcome of the events was reported as not recovered. The causal relationship between the events and the suspect therapies was not reported. The agency considered autism spectrum disorder, speech disorder developmental and crying to be serious for the following reason: medically significant.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient will be monitored by her provider and pharmacist
psychosis episode after the 1st and 2nd dose of the Moderna COVID-; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (psychosis episode after the 1st and 2nd dose of the Moderna COVID-) in a 31-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSYCHOTIC DISORDER (psychosis episode after the 1st and 2nd dose of the Moderna COVID-). At the time of the report, PSYCHOTIC DISORDER (psychosis episode after the 1st and 2nd dose of the Moderna COVID-) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications  were not reported.   This case was linked to MOD-2021-416527 (Patient Link).
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID arm). At the time of the report, VACCINATION COMPLICATION (COVID arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included: daily vitamin, anti-histamine and low dose hormone . Patient has taken Benadryl capsules a few days before second dose. Treatment medications was not provided.   Reporter did not allow further contact
After taking 60mg of Prednisone a day for 7 days starting on June 25 2015 and going down to 40mg of Predisone a day for three days for auditory nerve damage caused by a viral infection, the patient developed a painful rash starting on the back and spreading to the chest and face, reaching its peak on July 7, 2015. The rash became pustules and traced along the right side of the face around the eye and caused puffiness along the cheek. Tests for allergic reactions proved negative, and it was determined and diagnosed as shingles from a weakened immune system. Patient was placed on Valtrex for 10 days and a recheck was scheduled for July 23, 2015. The only exposure to the herpes zoster virus was determined to be the chicken pox shot. Temperature and blood pressure was normal.
The vaccine did not prevent shingles as intended; contracted a persistent strain of herpes zoster also known as shingles and other complications/was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On or about 03-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported) as recommended for routine adult health maintenance for prevention of shingles, however on an unknown date the vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles, the patient suffered painful injuries, damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries, damages and required extensive medical care and treatment.  As further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering other damages.   The outcome of herpes zoster and vaccination failure was unknown. The reporter considered vaccination failure, and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested. This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA011066: US-009507513-1911USA011702: US-009507513-1911USA011705: US-009507513-1911USA011706: US-009507513-1911USA011703:
Passed out; felt dizzy; she experiencing shaking; Massive pain in my head; really achy; Didn't feel good; A spontaneous report was received from a consumer concerning an 70 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced achy, did not felt good, Massive pain in head, Dizzy, passed out, Shaking.  The patient's medical history and concomitant medications were not reported.  On 11 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 030A21A) via unknown route for prophylaxis of COVID-19 infection.  On 11 Mar 2021, during evening time patient did not feel good and achy, on12 Mar 2021 patient woke up and went to walk after some time she got a massive pain, felt dizzy, and passed out and shaking.   Treatment information provided was Tylenol.  Action taken with mRNA-1273 in response to the events was not applicable as.   The outcome for Ache was recovering and for other events recovered .; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected event of loss of consciousness and NS unexpected pain, feeling abnormal, dizziness, tremor and expected headache.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Low grade temperature, chills, headache, full body aches. Lasted 12 hours
Pt is a transfer from hospital due to perforated diverticulitis.  Pt has also been having fever, chills, and body aches and is COVID positive.
Around 4pm I felt a heavy fatigue come over me.  By 6pm I had the chills, fever and nausea.  This along with random pain throughout my body continued throughout the night an into the early morning.  My arms at the site of the injection and around it was also painfully sore to the touch.  The fatigue and overall flu like symptoms lasted throughout the following day and into the evening.  I started to feel better around 7pm.  The fatigue lasted into the next day.
Day 2 = HA, sore arm at injection site; Day 3 = sore arm at injection site. Narrative:
Redness at site began the day of injection (1 hour), warm to touch - size 3 inches in diameter. Began fever on day of injection - high 102.
itchy rash on face; itchy rash on face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy rash on face) and RASH (itchy rash on face) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 09-Jan-2021, the patient experienced PRURITUS (itchy rash on face) and RASH (itchy rash on face). At the time of the report, PRURITUS (itchy rash on face) and RASH (itchy rash on face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications taken by the patient were not provided.   Treatment information events was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very high fever; Body ache; Headaches; Sensitive to light and noises; Sensitive to light and noises; Lack of appetite; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic cough. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 17:00, the patient experienced very high fever, body ache, headaches, sensitive to light and noises and lack of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with Acetaminophen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very high fever, body ache, headaches, sensitive to light and noises and lack of appetite was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
On 09/21/2022 I received my Covid-19 vaccine. On 03/14/2023 I woke up with sinus congestion, cough and shortness of breath. I reached out to my doctor and did a home Covid-19 test. I was positive for Covid and was prescribed PAXLOVID. Symptoms are ongoing.
I do not have a peanut allergy but I did eat waffles topped with peanut butter for breakfast that morning. About 30 minuets after eating the waffles I started to feel sick to my stomach, both like nausea and also having to have a bowel movement. I went to lie down in bed and after about 15 minuets my heart began to race and I felt very hot. I got up to get my pulse oximeter and noticed my face was very red and I had red blotches down my neck, chest and shoulders. My pulse was at 120 so I laid back down for a few minuets. I felt like I needed to have a BM so got back up to go to the toilet when I saw the hives were now down my arms to my wrists so I took 1 Benadryl 25 mg. I still did not have a BM or vomit. My chest began to have tightness and pressure and I felt short of breath. I was home alone and was feeling very scared. I took 2 aspirin 325 mg each. I unlocked the front door and got my daughter's Epi-Pen Jr. 0.15 mg. I waited a few minuets yet and began to sweat heavily, I was feeling cold and like I was going to faint. I gave myself the Epi-Pen Jr and called 911 around 11:50 AM.   I never lost consciousness thankfully. EMS arrived and gave me another 25 mg of Benadryl IM in my left arm and they started me on fluids. I received a prednisone and pepcid shots at the hospital.
Developed lesions on trunk and back of body around end of February or March. Went to PCP and Derm. Lesions eventually turned into blisters, still have. Medications currently using: Prednisone and Clobex
Information has been received from a 51 year old female with "mast cell problems", allergy to "opiods", AVELOX, BACTRIM and LEVAQUIN, who on 21-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 vaccine. Concomitant therapy included influenza virus vaccine (unspecified), doxepin HCl and TYLENOL. The consumer reported that she experienced an allergic reaction after receiving a dose of PNEUMOVAX 23 vaccine and flu vaccine. The patient also developed red swelling from elbow to her neck. She also had fever and raced heart beats. The patient has sought unspecified medical attention. At the time of this report, the patient was recovering. Additional information has been requested.
Pt was checking out with mother. Fell backwards fainting. Place feet up. Came too approx 1-2 minutes.
unresponsive; he may be a carrier and can pass Whooping cough; It was not crying but making a weird sounds/ made sounds like a space baby; Initial information received on 01-Apr-2022 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional (hcp) via call center.  This case involves an unknown age male patient who reported it was not crying but making a weird sounds/ made sounds like a space baby, unresponsive and he may be a carrier and can pass whooping cough  while receiving vaccine Diphtheria, Tetanus and Acellular Pertussis Vaccine.  The patient's past medical history included Cardiac operation. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Heart disorder and Neonatal pneumonia.   On an unknown date, the patient received unknown dose of suspect Diphtheria, Tetanus and Acellular Pertussis Vaccine produced by unknown manufacturer (dose, formulation lot number  expiry date : unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious events it was not crying but making a weird sounds/ made sounds like a space baby (Unevaluable event ) (unknown latency) and serious events unresponsive (unresponsive to stimuli), he may be a carrier and can pass whooping cough (bacterial disease carrier) (unknown latency) following the administration of Diphtheria, Tetanus and Acellular Pertussis Vaccine. This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  Seriousness criteria: Medically significant for events unresponsive and he may be a carrier and can pass whooping cough.; Sender's Comments: Sanofi Company Comment dated 07-Apr-2022: This case involves an unknown age male patient who reported it was not crying but making a weird sounds/ made sounds like a space baby, unresponsive and he may be a carrier and can pass whooping cough  while receiving vaccine Diphtheria, Tetanus and Acellular Pertussis Vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information the role of the individual suspect vaccine cannot be assessed.