chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The diarrhea has continued on into a colitis flare. The diarrhea now has mucus and blood in it; Diarrhea was reported as worsened; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283), via an unspecified route of administration in right arm on 12Jan2021 (at the age of 72 years old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included she takes medication to control her Colitis and has taken it for many years. She has not had a flare in a solid 6 years. It is very under control. The vaccine is the only thing that could have brought this on. She takes nothing else, had no other vaccinations, has no new medications, no dose changes, no changes to her lifestyle, nothing. She has received both doses of the vaccine. Her first adverse event started after her first dose. She did not realize it at the time but looking back now she was feeling that all of it was from the vaccine. She started having diarrhea on Jan2021. She does have a colitis history but has not had an attack/flare in 6 years. The diarrhea started within 24 hours of the first dose. She cannot be exactly sure of the date. Other than that she felt fine. The diarrhea has continued on into a colitis flare. The diarrhea now has mucus and blood in it. That was how she knows it turned into a colitis flare. Diarrhea was reported as worsened. She has been reading online about colitis and she read that it can be brought on by an immune response which leads her to believe this was her response to the vaccine. She got the second dose on 02Feb2021. She realized that the diarrhea had turned into a colitis flare once she saw blood and mucus. It was around last Friday, 05Feb2021 that it started to occur. The outcome of diarrhea was not recovered, while with other events was unknown.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Patient received first dose Pfizer at age 15 prior to EUA for that age.  No AE.  Second dose deferred until age 16.
4FEB98 mom reported case of mumps in child;hx sore throat, cough, nasal discharge on 27JAN98 & small lump on lt side of neck below the ear;
This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date 15th November 2021) for prophylaxis. On 16th December 2021, the patient received Shingrix. On 16th December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The patient received expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up.
This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (his arms "go numb") and decreased libido ("his sex drive has depleted") in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypoesthesia (his arms "go numb") and decreased libido ("his sex drive has depleted"). At the time of the report, hypoesthesia (his arms "go numb") and decreased libido ("his sex drive has depleted") outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
This spontaneous report as received from a registered nurse refers to unspecified patients. The patient's medical history was not reported. On an unknown date the unspecified patients were vaccinated with doses of GARDASIL (Lot #, dose and route were not reported) that were exposed to a supported temperature excursion on unspecified dates. No adverse experience has been observed or reported. No product quality complaint (PQC) was reported for GARDASIL. Follow up information has been received from a registered nurse. The reporter stated that on 13-AUG-2014 one of the three patients were administered with GARDASIL (lot number and expiration date not reported). Follow up information has been received from a license practical nurse. The reporter specified the 9 year old patient was vaccinated on 13-AUG-2014 with GARDASIL (Lot # J006850, exp. date 31-MAR-2016). Also, it was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
She has not had a menstrual cycle since January 2023. On Sunday 5NOV2023 she started having a cycle and bleeding but is way more than normal.; This spontaneous case was reported by a patient and describes the occurrence of HEAVY MENSTRUAL BLEEDING (She has not had a menstrual cycle since January 2023. On Sunday 5NOV2023 she started having a cycle and bleeding but is way more than normal.) in a 50-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: moderna (dose 1, batch-07469) on 06-May-2021, moderna (dose 2 and batch-07469) on 03-Jun-2021; for Product used for unknown indication: pfizer (dose 3) in December 2021, pfizer (dose 4) on 28-Jun-2022 and pfizer (dose 5) on 03-Feb-2023. Past adverse reactions to the above products included No adverse event with moderna, moderna, pfizer, pfizer and pfizer. Concurrent medical conditions included Menopause since January 2023.    On 04-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HEAVY MENSTRUAL BLEEDING (She has not had a menstrual cycle since January 2023. On Sunday 5NOV2023 she started having a cycle and bleeding but is way more than normal.). At the time of the report, HEAVY MENSTRUAL BLEEDING (She has not had a menstrual cycle since January 2023. On Sunday 5NOV2023 she started having a cycle and bleeding but is way more than normal.) had not resolved.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. The dosage text was reported as unknown. No treatment medication was reported.
Following 3rd dose of Anthrax, pt went to ER with left arm joint pain, left fingers going numb and chest pain accompanied by shortness of breath.  At this time Pt has not experienced any other symptoms.
Patient was given an adult dose of Pfizer that was diluted using 1.3mL of sodium chloride and drawn up to administer a 0.2mL dose. Patient was observed for 15 minutes with no signs of allergic reactions. Patient's parents were contacted by Dr. but they stated they would call the clinic for follow up information.
Shoulder pain that restricted movement of arm for 2 weeks.  Could not move arm above head or rotate.  Even weeks later certain movements trigger pain and there is pain when sleeping
Patient received Pfizer Covid 19 "booster" although he did not qualify for this administration because his original series was Moderna.  Booster dose should not have been administered.
No known side effects; Expired dose of M-M-R II was administered; This spontaneous report was received from an office manager and refers to a 55-week-old female patient. No information regarding the patient's medical history, concurrent conditions and previous drug reactions or allergies was reported. Concomitant medications included sterile diluent administered with the suspected vaccine.   On 15-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) subcutaneous injection, 0.5 milliliter, (lot #S036664 was verified to be valid, expiration date reported and established to be 14-NOV-2021), administered subcutaneously for prophylaxis. The administered dose of vaccine had no previous temperature excursions. The patient had no known side effects.
This spontaneous report as received from a physician refers to a 12 month old female child patient. On an unknown date in June 2013 the patient was vaccinated with PROQUAD (merck) (lot # not reported) injection, 0.5 ml, subcutaneous. On an unknown date in June 2013 (also reported as "within past month"), the child ran fever after receiving vaccination and demonstrated signs of a viral infection that resolved itself within a few days. The patient had been in the office for a wellness exam. No treatment was given to the patient. Additional information has been requested.
This spontaneous report was received from a registered concerning a 4 years old male consumer who on 17-MAY-2012 was vaccinated with the first dose of VARIVAX 0.5 mL (route and lot # not provided) and on 07-AUG-2012 received the second dose of VARIVAX (merck) 0.5 mL (route and lot # not provided). The nurse stated that on 23-AUG-2012, the patient received the third dose of VARIVAX (merck) 0.5 mL (route and lot # not provided). No adverse effects were reported. Additional information has been requested.
Tired/she felt tired; she felt bad for a day or 2. She didn´t feel good,; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired/she felt tired) and FEELING ABNORMAL (she felt bad for a day or 2. She didn´t feel good, ) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired/she felt tired) and FEELING ABNORMAL (she felt bad for a day or 2. She didn´t feel good, ). At the time of the report, FATIGUE (Tired/she felt tired) and FEELING ABNORMAL (she felt bad for a day or 2. She didn´t feel good, ) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received the Moderna bivalent vaccine she felt bad for a day or 2. Patient didn´t felt good, felt tired. Patient said it was the normal, no big deal. Patient didn´t had fever no rash, she was little tired. She mentioned that she was fine.  Treatment information was not reported.
24 hours within recieving HepA, HepB and Varivax developed R sided Numbness/tingling of tongue; within 48 hours could not close R eye lid-paresis/paralysis. Diagnosed Bells Palsy. Right side of neck and face paralyzed.
Pt states: Elbow sore up to deltoid muscle, hand weakness, but not constant. Claims to have pain in R elbow to deltoid. This has been occuring since injection. Pt received FLUZONE in L arm at same time - no problems noted.
Information has been received from a registered pharmacists concerning a patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot not reported) subcutaneously. After three days post vaccination the patient developed injection site welt that was warm to the touch. As of 7-JAN-2009 the present patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Fever and Severe Headache - treated with Tylenol- Felt Okay after taking Tylenol
Patient received the vaccine and 10-15 minutes later, while waiting in her car at the store, reported numbness/weird feeling occurring between her upper lip to her nose. Asked the patient to come back inside the store so we could monitor her more closely. She reported no other tingling or swelling. No medications were administered. After about 30 minutes, patient reported self-resolution of symptoms and was told to contact her doctor, the pharmacist, or to seek emergency care if symptoms were to return or worsen. She was advised to inform her primary doctor about the event.
Information has been received from a physician concerning a 40 year old male who on 6/30/99 was vaccinated with the second dose of Hep B vaccine in the right arm. Subsequently, "since that time" the pt has experienced severe pain at the injection site with pain radiating to the trunk and shoulder. The pt is experiencing overall weakness, fatigue, diffuse myalgia, a 25 pound weight loss and weakness in his right arm. The physician noted that the pt is a mortician and is having difficulty performing his job due to muscle weakness. Additional information has been requested.
Fatigue; This is a spontaneous report received from a non-contactable consumer. A 55 years old female patient received bnt162b2 (Pfizer COVID 19 vaccine) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue with unknown outcome.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
started running temp around 530PM 12APR93 ranging from 103 up to 105 during the noc; had temp around 101 most of 13APR93 & was aching & lethargic; seen by MD 13APR93 who said probable reaction to MMR; 14APR93 feeling a little bad;
2nd dose of COVID-19 vaccination the morning of 2/1/2021 . She had an adverse reaction including sensation of swollen tongue and tachycardia while being monitored during the 15-minute waiting period following the injection. She was given 25 mg Benadryl and advised to go home from work. She was advised to call 911 if symptoms worsened or she experienced any difficulty breathing.
Female patient that received the 2nd dose of the Pfizer COVID Vaccine and experienced an achy body; This is a spontaneous report from a contactable other healthcare professional and a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unknown date for covid-19 immunisation and experienced some pain at the injection site. The female patient that received the 2nd dose of the pfizer covid vaccine experienced an achy body on an unspecified date. It was reported that the event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 19-year-old female. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-Dec-2010. The patient received the expired FLUMIST on 20-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
pt recv vax 11SEP96 & on 28DEC96 pt devel chickenpox consisting of 8 lesions spread out all over body, including arms, neck & head;eventually the lesions scabbed;
Father brought patient in to Clinic to get dtap and mmr vaccine pt was given pediatric dosed Fluarix. Provider miss read consent form. Father stated pt had not received flu vaccines this season. Father stated they are against flu vaccines for personal reasons. Father denied allergic reactions to vaccines. Pt also received dtap and mmr all without complications. Patient was held in clinic for 45mins without complications.
Initial report received on 01 October 2009 from a consumer, who is a physician. A 48 year old female patient with no reported medical history developed a sore throat, low grade temperature of 99.3 orally, lethargy, and body aches one day after she received FLUZONE No preservative 2009-2010 (lot number U3173DA) intramuscularly in the left deltoid. The symptoms were severe enough to cause loss of work for a few days. The patient was improving, but not fully recovered. The patient reported that the same reaction occurred with a prior influenza vaccine (manufacturer was not provided) which was administered in the late 80's, early 90's. No further information was provided. List of Documents held by sender: none.
Developed 2 1/2" round, indurated, itchy area 3d after immunization. Symptoms have continued x 7d without resolution.
Significant swelling/pus in left thigh 2 days post MMR/V & KINRIX. Concern for possible cellulitis vs vaccine reaction. Started on KEFLEX.
Pt recv vax on 7/9/98; on same day pt exp rash w/ welts on face & body; tx=Benadryl.  Pt imp 2 day.
Day after Tdap patient started itching on right supraorbital region with progressed to swelling over the weekend. Started on Prednisone 60mg x 5 days.
Infanrix (DTaP) vaccine for children was administered to adults by occupational health for tetanus prophylaxis in patients of risk. Prefilled syringes were used that are not clearly labeled "for children use only" and so was administered instead of the adult booster Adacel (Tdap) which also has the same ingredients at a much smaller dose. Mix-ups between the children vaccines for tetanus/diphtheria/pertussis should be on high alert now that the CDC has recommended vaccines including pertussis protection should be administered to adults as well (although not the pediatric formulations since they are at much higher doses that adults don't tolerate as well). When mix-ups such as this occur, patients should be monitored for injection site reactions and should not be re-vaccinated. The shot should count as a TD booster and will not require another for 10 years.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated with Paxlovid from 23Jul2023 to 28Jul2023 for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300265196 Same patient, different drug/ AE;
CRYING, CHILLS, BODY ACHES, WHOLE BODY PAIN, SHORTNESS OF BREATH, PANIC ATTACKS, PAIN WHEN MOVING ARM.
Felt like her arm was hit by a truck; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Felt like her arm was hit by a truck) in a 62-year-old female 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, the patient experienced LIMB DISCOMFORT (Felt like her arm was hit by a truck). At the time of the report, LIMB DISCOMFORT (Felt like her arm was hit by a truck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on concomitant medication but did not specify.  After the first dose, the patient felt like their arm was hit by a truck. It was also reported that the patient was on concomitant medication but did not specify.  No treatment information was provided.   This case was linked to MOD-2021-407836, MOD-2021-407872 (Patient Link).
Pain in lower back; Pain in left leg; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in lower back) and PAIN IN EXTREMITY (Pain in left leg) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced BACK PAIN (Pain in lower back) and PAIN IN EXTREMITY (Pain in left leg). At the time of the report, BACK PAIN (Pain in lower back) and PAIN IN EXTREMITY (Pain in left leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Urinary tract infection; This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chronic uti (has had three that lasted about four months).   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced urinary tract infection. On an unknown date, the outcome of the urinary tract infection was not recovered/not resolved.   It was unknown if the reporter considered the urinary tract infection to be related to Shingrix.  Additional details were provided as follows: The consumer reported that his wife received the first Shingrix dose in mid October of last year. He stated that she had not been able to get the second dose because she has had a Urinary tract infection. He stated that they stem from Pseudomonas and Aerobacter and that Bactrim had not worked to resolve her UTIs. Consented to follow up
Approximately 24 hours after receiving the flu vaccine I started experiencing very sharp pain in my left shoulder.   The pain is consistent and increases any time I try to move my arm up past my waist or sideways.   I've iced it for some relief, but the pain comes back.   I do not have any redness at the injection site and touching the injection site does not hurt.  It seems to be deep tisse or muscular in nature.
Initial report received on 31 October 2009 from the investigator for the above-mentioned trial. This report was received from a phase II trial with investigational product H1N1 or H1N1 GSK AS03 ADJ. for which sanofi pasteur is not the sponsor. The following information was received via e-mail: SAE Term: Possible neuropathy. Onset date: Not reported. Causality: Unknown, not provided. Seriousness Criteria: Unknown, not provided. "A 21-year-old male subject was withdrawn from the study because of reactogenicity. Information has become available that he was prescribed meclizine and "prochlorperazine" for one week reportedly for reactogenicity. For reasons that are unclear at this time he had a medical work up including a lumbar puncture on 12 or 13 October 2009. He continues to report arm weakness in the arm where the vaccination was given." Additional information is expected from the sponsor of the trial.