chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA and NAUSEA in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 013M20A, and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced DIARRHOEA and NAUSEA. The patient was treated with LOPERAMIDE HYDROCHLORIDE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, DIARRHOEA and NAUSEA had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. She has used Imodium for 2 days with some improvement.
flu-like illness with fever 101-102, myalgias, headache, malaise, nausea and vomitinh
First COVID-19 only sore arm. Second COVID-19 first day just sore arm. The following day felt achy feeling which progressed to a severe headache. The headache continued to worsen so much that is felt like the worst headache of my life and I went to the ER and they ruled out a head bleed with a CT Scan and diagnosed it as a atypical headache related to the vaccination. However it has persisted now for over two weeks and I have been on round the clock medications and not been able to work and can barely do my activities of daily living. I have never experienced anything like this! I am very concerned if this becomes a permanent. Working diagnosis currently is Aseptic meningitis.
Mild Itchy all over:15-ish min after injection, lasted for 1hr . Wasn?t so bad that i felt the need to talk pharmacist, took some benadrill Muscle pain at the site of injection: started about 6hr after injection amd lasted for a day. Lethargic  Irregular menstral cycle - extra light spotting for a day, but basically missed my period.
Information has been received from a mother concerning her 5 year old son with seasonal allergies and no other pertinent medical history who on 30-JUL-2007 was vaccinated with a first dose of MERUVAX II (lot # 655408/0036U). There was no concomitant medication. The mother reported that her son "slipped into a fog, started babbling and blinking real hard" three hours after vaccination. The mother stated that her son also seemed agitated and hyper and after that he started making strange facial movements and became light sensitive. Her son was diagnosed as having "transient disorder." He is still experiencing occasional sleep deprivation and movement disorder; however, it is occurring with less frequency. Unspecified medical attention was sought. Diagnostic studies included and EEG sleep deprivation test that came back normal. At the time of this report, the patient had not recovered. No further information was provided. No product quality complaint was involved. The mother also reported that her son received a dose of MERUVAX II and 5 days later he developed pneumonia. (WAES 0810USA00371). Additional information has been requested.
Subsequent to receiving varicella vaccine on 4/28/98 and exposure in May, 2000, pt had breakthrough infection on 5/4/00. Pt had 40 lesions on day 2 and a low grade fever.
Received dose 1 and 2 of Moderna vaccine.  Did not have card at the time of "booster" only a printout of dates of 1st 2 vaccines.  Received 3rd dose of COVID vaccine as Pfizer.  At the time, person knew she had received Moderna vaccines as 1st and 2nd doses, but wanted 3rd dose to be Pfizer.  Healthcare provider was not aware at the time, thought 1st and 2nd doses were Pfizer doses.   No signs/symptoms noted.  No reactions noted.
from the second day after vaccination -> itchy, swollen, aching feet and fingers, hard to walk (does not pass). On the third day -> chills, cold as with a fever (has passed).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In July 2016, the patient was treated at a physician's office for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome was unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
blood clot in jugular vein; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-037222).   A 66-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on 28Jan2021 as a SINGLE DOSE,UNKNOWN for covid-19 immunization. The patient's past medical history included cardiac disorder NOS, Allergy (Brilinta) and vascular stent insertion. The patient's concomitant medications were not reported. On an unknown date, the patient experienced blood clot in jugular vein. On 03-Feb-2021, the patient started ELIQUIS (batch no. ABQ5833S) (oral), 5 milligrams twice a day as treatment for the event. On an unknown date, the dose was changed to 2.5 milligram twice a day. The outcome of the event was unknown.  No follow-up attempts are possible, no further information expected.; Sender's Comments: Based on limited information in the case and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Jugular vein thrombosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Transverse Myelitis or MS; Transverse Myelitis or MS; diagonosed with Lhermitte's sign; The initial case was missing the following minimum criteria: [unspecified suspect product]. Upon receipt of follow-up information on [12Jan2022], this case now contains all required information to be considered valid.     This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 02Apr2021 10:00 (Lot number: EP7533) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EN6955), administration date: 12Mar2021, when the patient was 51 years old, for Covid-19 immunization, reaction(s): "mild back pain", "nerve pain". The following information was reported: MYELITIS TRANSVERSE (medically significant), MULTIPLE SCLEROSIS (medically significant), outcome "unknown" and all described as "Transverse Myelitis or MS"; LHERMITTE'S SIGN (non-serious) with onset 03Apr2021, outcome "unknown", described as "diagonosed with Lhermitte's sign". The events "transverse myelitis or ms", "transverse myelitis or ms" and "diagonosed with lhermitte's sign" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: MRI: (10Jan2022) showing either transverse myelitis or MS, notes: Further testing is needed. Therapeutic measures were taken as a result of back pain. Clinical course: After the 2nd shot on 02Apr2021 patient had severe back pain and was put on dexamethasone on 05Apr2021 and more on 19Apr2021. Since then he has been having issues with pain, tingling and numbness in his face, hands, fingers, legs and feet. He was diagnosed with Lhermitte's sign in Nov2021 and just had a MRI on 10Jan2022 showing either Transverse Myelitis or MS. Further testing is needed and his doctor wanted to know if he had any issue with his covid vaccines and he said yes.
Skin turned brown around the injection site and it burns/Has dark pigmentation around injection site; Skin turned brown around the injection site and it burns; Occasional pain in armpit, under rib, and that side of the arm where the shot was; Occasional pain in armpit, under rib, and that side of the arm where the shot was; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection)), dose 1 via an unspecified route of administration, administered in Arm Right on 13Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergic to every antibiotic from an unknown date and unknown if ongoing, Fell from an unknown date and unknown if ongoing and allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced skin turned brown around the injection site and it burns/has dark pigmentation around injection site, skin turned brown around the injection site and it burns and occasional pain in armpit, under rib, and that side of the arm where the shot was. The patient had dark pigmentation around injection site. Saturday or Sunday experienced pain under her rib and armpit. The patient would not be getting second dose. She Does not want more side effects. The patient was allergic to every antibiotic under the sun and doesn't know if that has anything to do with this. Her skin turned brown around the injection site and it burns. Having occasional pain in armpit and that side of the arm where the shot was. Confirmed is having pain in under the rib. Fell a few years ago and hit the left side of her rib cage, but this was on the right side. She was allergic to everything. She went to the doctor and was told she can't be treated. The patient doesn't want to give too personal information like her social security, and She doesn't want anyone coming to her house about this. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt recv vax on 11/18/98; on same day pt exp pain in LA w/ motion pain; tx=moist heat to arm & anti-inflammatory medicine
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (086396). The reporter is the patient. A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTICS taken for lymphoedema. The following information was reported: HOT FLUSH (non-serious), outcome "unknown", described as "lots and lots of hot flashes"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; LYMPHOEDEMA (non-serious), outcome "unknown", described as "lymphedema"; FATIGUE (non-serious), outcome "unknown", described as "tired days"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "she gets sad sometimes". Therapeutic measures were taken as a result of lymphoedema. Additional information: Patient stated she went off Ibrance for 3 weeks, so that she could get the COVID vaccine and also stated she has had both shots and was grateful. Further shared Adverse events she experienced and gets MDL treatment for lymphedema in which the affected area of her body was purified, and wonders how much time she has left. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: She reports having experienced palpitation and rash after the initial vaccination: *Palpitation: began the day after vaccination and occured intermittently for another 2 days - 4x episodes of <10 seconds each in total. A/w slight dizziness, but no pain, disorientation, syncope, weakness, nausea/vomiting. She notes having similar episodes in college and being diagnozed with "angina pectoris" at that time. She was not placed on any medications and did not go some sore of cardiac procedure (such as PCI) at that time. No known FHx of arrhythmias. Sister with reported congenital valvular issue. *Rash: began 13 days after vaccination, largest size described as circular/well circumscribed with ~2.3-3inches in diameter. Associated with induration, erythema, warmth to touch, mild pruritus. NO associated sloughing. The rash spontaneously resolved after a week. Only therapy applied was ice.
After second vaccine only side effect was sore breasts/lymph nodes on left side (opposite of the side I got the shot on) days 4-6 after shot.; After second vaccine only side effect was sore breasts/lymph nodes on left side (opposite of the side I got the shot on) days 4-6 after shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 09:30 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL; ZOLOFT. Past drug history included: Demerol, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (Product=COVID -19, brand=Pfizer, Lot unknown=False,, Administration time=10:00 AM,, Vaccine location=Right arm,, Dose number=1), administration date: 17Mar2021, when the patient was 60 years old, for Covid-19 immunisation, reaction(s): "sore arm". The following information was reported: LYMPH NODE PAIN (non-serious), BREAST PAIN (non-serious) all with onset 11Apr2021, outcome "recovered" (2021) and all described as "After second vaccine only side effect was sore breasts/lymph nodes on left side (opposite of the side I got the shot on) days 4-6 after shot.". Therapeutic measures were not taken as a result of lymph node pain, breast pain.  Additional information: No serious criteria reported. Patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination: multi-vitamin, tylenol, Zoloft. Only side effect of first vaccine was sore arm for a few days. After second vaccine only side effect was sore breasts/lymph nodes on left side (opposite of the side I got the shot on) days 4-6 after shot. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination,  patient was not tested for COVID-19. Allergies to medications, food, or other products Demerol.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately after shot c/o "feeling funny". Had her recline on table with cool air, cloth. After several minutes c/o dizzy, sweating, "arms feel heavy". v/s 120/70, resp 20, pulse 76. After 25 min Benadryl given. After 25 min pt still c/o of heavy feeling. Taken to ER by EMT. BP 110/60 pulse 116 resp 24. Pt observed in ER then released at 7pm.
Swelling, pain, reddness, area hot to touch; Referred to clinic, placed on Tetra Cycline x 5 days;
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
Developed pruritic lesions - (3) erythematous, macule/papule - ok - then scabs on (R) forearm, left upper arm & left thighs - 17 days after varicella vaccine.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 44-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 01-Jan-2012. On 04-Jan-2012, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 23-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
At time of initial injection, there was very intense burning at injection site which lasted several hours.  This made me think maybe a nerve was hit?  I had a headache the next day with soreness at injection site/arm for two days after.  The dull headache continued for a week.  On day 8 after injection the site became quite itchy.  On day 9 the injection site was very red, raised, and with intense itching, accompanied by a more intense headache and feeling of inflammation throughout body.  The size of the raised area was approximately 5 cm.  On day 10 the injection site was less red and it seemed to be spreading out/dispersing, sized around 6 cm, and the itching was not as intense.  On day 11 the itching and redness is reduced to a 1-2 cm area.
NONE Autopsy shows infant had upper respiratory infection week before death, found not breathing. Cause of death given as sudden infant death syndrome.
Pt received booster dose of original Moderna formulation rather than bivalent (NDC 80777-275-05).  No adverse events reported.
Metallic taste; This spontaneous case was received on 23-Sep-2020 from other health professional (nurse) via agency (reference number: SEQW20-02108) and concerned a 63-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 21-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 283848 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed metallic taste.   On the same day, the patient recovered from the event.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the event as non-serious.  This case is linked to cases 202004666, 202004667, 202004665, 202004664 and 202004610 due to the same reporter.  Company comment: Dysgeusia (reported as 'metallic taste') was associated with the use of the suspect product Flucelvax QIV. The event occurred on the same after receiving the product making chronology suggstive.  The patient had no relevant medical history and was not taking any concomitant medications. With information presented, causality is assessed as possibly related due to lack of other confounding factors.; Sender's Comments: Dysgeusia (reported as 'metallic taste') was associated with the use of the suspect product Flucelvax QIV. The event occurred on the same after receiving the product making chronology suggstive.  The patient had no relevant medical history and was not taking any concomitant medications. With information presented, causality is assessed as possibly related due to lack of other confounding factors.
No additional AE's; Caller reporting a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 12-MAR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form orally administered, as prophylaxis (lot number 1684149 which has been verified to be valid, expiration date reported and validated as 25-JUN-2021) (product storage error). The administered dose of the vaccine was stored at a temperature of 34.1 degrees Fahrenheit (F), during a time frame of 4 hours 15 minutes, as recorded by a digital data logger. There were previous temperature excursions of 34.8 F, during a time frame of 45 minutes; and 34.7 F, during a time frame of 2 hours and 45 minutes. There were no additional adverse events reported in the patient.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007436: US-009507513-2104USA007278: US-009507513-2104USA007276: US-009507513-2104USA007277:
Information has been received from a medical assistant which reported that there were at least two patients who had heavy and difficult periods and had more severe cramps after received GARDASIL vaccine (yeast). The medical assistant did not have any information regarding those patients. Follow up information was received which reported that the medical assistant did not know the names of the other 2 patients. She is wondering if the heavy and difficult periods are related to the girls starting to ovulate. Additional information is expected.
Got mine yesterday have a sore arm today; Initial information received on 01-Nov-2020 regarding an unsolicited valid non-serious social media case received from digital media via a consumer.  This case involves an unknown age who reported got mine yesterday have a sore arm today(Myalgia), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient who reported got mine yesterday have a sore arm today(Myalgia), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory test was reported.  Final diagnosis was Myalgia.  It was not reported if the patient received a corrective treatment.  The outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
A report was received from a distributor on 11/13/02, concerning a 45 year old female vaccinee who experienced a aching arm, felt unwell and broke out in red hives on her legs, chest, lower back and neck after receiving Fluvirin on 11/06/02. On 11/06/02, the vaccine received a pneumonia shot in her left arm and a flue vaccine in her right arm. Later that evening she experienced a pain in her right arm. On 11/07/02 the vaccinee did not feel well all day. On 11/08/02 she broke out in red hives on her legs, chest, lower back and neck. The vaccinee was treated by a doctor and was given an injection of Triamcinolone. She was also prescribed methylprednisolone and hydroxyzine. On 11/13/02, the vaccinee had fully recovered from the reaction. There was insufficient information to determine the reporter's causality assessment.