chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 16-SEP-2014, the patient was vaccinated with the first dose of ZOSTAVAX and then on 12-NOV-2015, received a second dose of ZOSTAVAX injection (doses, route, lot # and expiration dates were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Hives, itching, rash starting on right arm near injection site that spread to both arms, legs, and lower stomach
Within 10 minutes of receiving the Gardasil 9 vaccine, I had a strong metallic taste in my mouth and my tongue started swelling.
PATIENT DEVELOPED ACUTE RESP FAILURE WITH HYPOXIA 2ND TO COVID PNEUMONIA, AKI,
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 8 week old infant patient of unknown gender. On 09-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Bumps and itching on back, belly, and both arms from elbows to shoulders; Bumps and itching on back, belly, and both arms from elbows to shoulders; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID:.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "Bumps and itching on back, belly, and both arms from elbows to shoulders".  Additional information: Caller said he and his wife had reactions to the Pfizer COVID vaccine. Caller stated that it may be like getting a flu shot wherein sometimes it works right sometimes it doesn't to the point that you can still get a flu. Caller says that COVID mutates from one strain to a different one so he wanted to know how the vaccine is still the same, composition-wise, given that there have been a lot of new strains compared to the original strain and he doesn't know if the Pfizer COVID vaccine has the new strain of virus. Response: Spoke as per attached, provided disclaimer. Told caller that the Pfizer COVID vaccine does not actually contain a virus strain from COVID and that the main active ingredient of the vaccine is an mRNA. Explained to caller how this can still neutralize various strains of COVID, which is why it remains the same even though there have been a lot of different COVID strains. New AE added: Bumps and itching on back, belly, and both arms from elbows to shoulders Information has been updated for reporter and patient. Expiry Date of COVID-19 vaccine: Jul2021.Patient is caller's wife. Patient age: Just turned 68 years old, 2 years before that patient would have been 66 years old. Bumps and itching on back, belly, and both arms from elbows to shoulders. Start date of adverse event: Patient's 1st injection was 18Mar2021, so this started 20Mar2021. 1st dose: Date: 18Mar2021, received at withheld, Asthma and Allergies Building. Lot number: DN6207. Expiration date: Jul2021. Dose, route: Left deltoid, injection, doesn't know actual dose, looks like half cc, was a little TB syringe. 2nd dose: Date: 08Apr2021. Lot number: ER5727. Expiration date: Mar2021, really weird, just noticing that. Caller corrects himself and states that the 3, indicating March is a 7, indicating July. Corrects expiration date to Jul2021. 3rd dose, 1st booster dose: Date: 20Oct2021, Lot number: FF5790. Expiration date: Unknown  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 24 hours after the 2nd dose of the Moderna vaccine, I experienced a visual aura that lasted about 15-20 minutes. It was a bright "C" shape of lights that twinkled in the left part of my vision. It grew with intensity and then disappeared.
lost control of their urine function; unable to eat for several days; incoherent; nausea; vomiting; bedridden; could not sit up on her own; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (bedridden), SITTING DISABILITY (could not sit up on her own), URINARY INCONTINENCE (lost control of their urine function), FEEDING DISORDER (unable to eat for several days) and INCOHERENT (incoherent) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included cancer since an unknown date.     On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.  On 12-Feb-2021, the patient experienced BEDRIDDEN (bedridden) and SITTING DISABILITY (could not sit up on her own).  On 14-Feb-2021, the patient experienced URINARY INCONTINENCE (lost control of their urine function), FEEDING DISORDER (unable to eat for several days), INCOHERENT (incoherent), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, BEDRIDDEN (bedridden), SITTING DISABILITY (could not sit up on her own), URINARY INCONTINENCE (lost control of their urine function), FEEDING DISORDER (unable to eat for several days), INCOHERENT (incoherent), NAUSEA (nausea) and VOMITING (vomiting) had resolved. Not Provided
Rash on back, neck, arms and stomach despite medication rash is still present. Never had an issue until vaccine.
Information has been received from a physician concerning a 4 month old female, who had been breast fed since birth, who, at 8 weeks of age, was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  It was reported by the physician that the patient had a change in consistency of her stools, which were described by the mother as chronic diarrhea.  There were two stools per day for the previous two months.  At the time of the report the patient had not recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
red, swollen, itchy, painful upper right arm (in general area of injection site), hard lump
Upon arrival, patient noted laying down on floor with feet elevated. Patient noted pale, sweaty and clammy. Patient awake, alert and oriented x3. Patient states that he started feeling light headed immediately after receiving his vaccine. Bp 143/95 P 70 T 97.7 O2 99% on room air and Blood glucose 114. Patient states that he had breakfast around 8am and fruit as a snack at 1030am.  Vitals reassessed Bp 137/88 P 80. Patient states that he is feeling much better. Patient able to sit up without feeling dizzy or weak. Bp 126/91 Hr 83 Patient had granola bar and water. Patient had to rest an additional 30mins. will continue to monitor O2 remains @99% on room air. Patient states that he feels great. Vitals reassessed Bp 130/80 Hr 78 O2 99% on room air.  Patient left facility in stable condition.
pt recvd vax 4PM-@ 6PM became irritable & fussy; t102; APAP given 2PM-7PM & 11PM; legs were not red or swollen; MD notified said t103.2;
Tdap was given on 8/20/12 - states that since that time area was red & a large lump, since then currently noting a pea sized lump.
pt recv vax & shortly p/vax pt died;MD does not feel shot contributed to death;pt recv flu vax prev w/no adverse effects;COD Myocardial rupture (immed) complete heart block (4 days) MI (5 days);
pt recvd vax & 2 days later mom brought pt in for PPD to be read & noted rt arm had 9 cm wheal;
Numbness and tingling of left arm. Patient was kept for an additional 15 minutes for observation for a total of 30 minutes. During observation patient's BP and pulse were elevated and patient stated he had a slight pain in her chest.  Taken to Emergency Room immediately after 30 minute observation.
About 4 hrs after administration pt developed red eye, chest tightness, swollen lip.
Narrative:  Patient developed a rash after receiving the second dose of the MODERNA COVID-19 vaccine.
3/19/05 Cramps in calves of legs, feet, and arm. 3/20/05 Generally didn't feel good (nauseated) 3/21/05 Left arm swelled, big red mark, ached to bone then within an hour red half way around arm - fever in arm - swelling and painful.  Medication: Prednisone, ibuprofen, and ice pack.
Pt. reports that symptoms started 2 hours after vaccination (weakness, SOB, headache, leg pain).   She stated she had left-sided pain including the left side of her chest that developed last p.m. with shortness of breath. She had the leftsided chest pain that felt like a stabbing and a sharp knife running from the lateral left side through her chest. Shortness of breath. Hospitalized with PE.
Developed join pains and discomfort within a month of my initial vaccination ,  This has continued since then  First i felt my left hip pain... this seem to improved, then my fingers, these have remained and gotten worse,  Now its is a bit of all my joints, possible ligaments,  Discomfort that makes me feel the need to stretchy the joints to the point of hurting myself ...  most affecting my wrist and fingers .  My primary doctor checked labs, I had elevated ANA , ( never before ) told me it was normal after COVID and possible vaccination and that it would go away in 2- 3 months  I persist with symptoms and worsening 6 months latter, I had to stop playing golf , though it may made it better. It did not. My PCP repeated lab orders but I did not had time and did not collected. Thought with a bit more time it would go away   over months symptoms worsen . I found myself using anti inflammatory creams in hands and wrists at night as well as braces to see if immovilizating at night would help  I am a neurologists and I thought may be I could do an EMG NCS to see if it was CTS... ( even though my elbows , and other large joints where bothering me as well.   I had NCS by one of my colleges , not EMG.. in november.. NOT officially since I use my own office and techs.. another facility read it and told me it was normal I did not had CTS ,  Contacted back my PCP, ( always by phone since we are colleges and work together ) he ordered labs again which I got January 2022, called me to tell me my ANA is still high in the 300s, he ordered then an Xrs of my hands and is setting me up with rheumatology , I have my appointment on the 14th of February
Myalgia Narrative: 58 y/o Pt called stating that several days after getting his 2nd vaccinations on 3/11/21 he started feeling very tired with generalized body aches.
The next morning after my dose 3 when I woke up I was experiencing a significant amount of joint and muscle pain all over.  I stayed in bed  and took some Aleve. I contacted my doctor the following evening because the pain and discomfort continued the following day. By the the third day it was still present but was diminishing.  I think by the end of the third day it was completely gone.
administered 9 doses of expired Moderna to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 9 doses of expired Moderna to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 9 doses of expired Moderna to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 9 doses of expired Moderna to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided   Reporter did not allow further contact
Patient received an expired immunization, exp date 11/19/2013. Clinical Supervisor also reported the event to Sanofi, they instructed to re-immunize the patient. Patient didn't exhibit signs of not feeling well.
cough; nasal congestion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COUGH (cough) and NASAL CONGESTION (nasal congestion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough) and NASAL CONGESTION (nasal congestion). At the time of the report, COUGH (cough) and NASAL CONGESTION (nasal congestion) outcome was unknown. Not Provided      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.   No concomitant medications reported. No treatment information provided.
No other AE; a temperature excursion and the ROTATEQ had been administered.; This spontaneous report was received from a medical assistant referring to a 2 months old female patient. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported.  On 20-MAY-2021, the patient was vaccinated with a temperature excursion Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot# 1691303, expiration date 21-DEC-2021; dose, strength, frequency and route unknown) for prophylaxis (Incorrect product storage). The vaccine was stored at a temperature excursion of 34.9 Fahrenheit (F) for 2 hours. The date of excursion was 13-MAY-2021. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No adverse effect reported.
Felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non- HCP). Other Case identifier(s): 2021SA337125. A 58-old female patient received bnt162b2 (BNT162B2), administration date 01Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Felt sick".  Additional Information: This consumer reported for a (Age-58, Unit-unknown) female patient (Reporter sister). Brother (name-withheld) age 65 got the JNJ vaccination and then felt sick. 1.One on 01Sep2021 then felt sick. 2.One on 05Oct2021 then felt sick and developed 102 degrees fever. While driving in the car 10Oct2021 Son girlfriend (name-withheld) age 27 mentioned she received a vaccination and sight of injection very painful for 3days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue / experienced with previous vaccines; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue / experienced with previous vaccines) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Latex allergy.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 31-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue / experienced with previous vaccines). At the time of the report, FATIGUE (Fatigue / experienced with previous vaccines) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient had not been diagnosed with tested positive for COVID-19.  Patient had no acute illnesses at the time of vaccination and up to one month before.  Patient had no chronic or long-standing health conditions.  The event did not cause the patient to seek medical care.  The patient had experienced similar adverse event in the past and had other potential causes for the event.  Treatment information was not provided.   This case was linked to MOD-2022-654685.
This subject is a 73 year old female who died at home 240 days post immunization on 7/11/03 while enrolled in the RSV 11 study. The subject received the RSV vaccine or Placebo and influenza vaccine on 11/13/02. The subject was diagnosed with pneumonia a few days before her death. Subject was not admitted to hospital and was found in her home on 7/11/03. The death was reported by the investigator as not related to the study product. Death certificate states cause of death as "Probable complications of hypertensive heart disease." Other significant conditions, chronic obstructive pulmonary disease, obesity. No autopsy performed. Additional documents received and with source documents: Certificate of Death: 8/20/03.
Waited 15 minutes and seemed fine. Drove away and began to get a numb/tingling lips and face. Initially lasted 10 minutes, but came back periodically during the day.
Patient went home and soon after arrival had severe itching and parent noted rash over body which was red and blotchy-was about 1 hr to 1 1/2 hr after shot, then eyelid swelling. BENADRYL given x 2 and rash improved on way to E.R.
1/6/06: Mom calls into office states daughter developed a rash 3 days after MMR given 12/15/05.  Mom reports that they saw Dr. for rash 10 days ago.  She was put on a "steroid cream" Mom reports.  Stated that the rash was spreading & Mom wonders what to do - advised to see MD for further follow-up. (Did not see child or evaluate rash.  Only Mom's telephone call to report).
Got only partial dose due to administration technique; Got only partial dose due to administration technique; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number HFZYA, expiry date 15th July 2023) for prophylaxis.   On 17th November 2022, the patient received the 1st dose of Boostrix. On 17th November 2022, unknown after receiving Boostrix, the patient experienced incomplete dose administered and incorrect vaccine administration technique. On an unknown date, the outcome of the incomplete dose administered and incorrect vaccine administration technique were unknown.   Additional Information: GSK receipt date: 18-Nov-2022 Reporter's comment: The reporter did not exactly mentioned that the needle broke or there was not skin expose. The reporter mentioned that did not know if there was a skin exposure. No product quality complaint was confirmed. No patient details were available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient got only partial dose of vaccine due to administration technique, which led to incomplete dose administered and incorrect vaccine administration technique.
Rec'd immun 19APR91 11AM by 6PM developed fever of 101; 20APR91fever 103-105 giving APAP bathed down w/alcohol & water; temp dec child playing;
pain on the injection site; swelling; Inflammation; This is a spontaneous report from a Pfizer-sponsored program, reported by a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown) via an unspecified route of administration on 02Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the vaccine yesterday (02Jan2021) around 6 O'clock and then late in the afternoon she was experiencing pain on the injection site and she is asking if that is normal or if she can take Ibuprofen to relieve the pain. It was further reported that there was also a little bit swelling and inflammation. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Painful coughing; debilitating side effect; This case was reported by a consumer via interactive digital media and described the occurrence of painful cough in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included soy allergy.   In August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced painful cough and debility. On an unknown date, the outcome of the painful cough was not recovered/not resolved and the outcome of the debility was unknown.   It was unknown if the reporter considered the painful cough and debility to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comment: This case was received from patient via interactive digital media. The patient received the Shingrix 1st dose on 3 days ago from reporting and had debilitating side effect, the patient stated that all but one were included on GSK list and in addition the patient was struggling with painful coughing which usually happens when the patient exposed to soy products. Additional Supportive Information: Follow-up would not possible as no contact details were available.