chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 67 year old female patient regarding herself. Current conditions included Chiari malformation type 1, fibromyalgia, myofascial pain disorder and migraines. Patient had drug reactions/allergies to LAMICTAL and DAYPRO. Concomitant medication included ZETIA. On 22-JAN-2018 (around at noon), the patient started therapy with PNEUMOVAX 23 lot# N030847 with expiry date of 09-JUN-2019 for prevention on Pneumococcal disease. On 22-JAN-2018 at 5:00 pm, the patient experienced top of left arm soreness and it progressively got worse and the patient could not lift the arm. Patient also had explosive pain in the shoulder joint. At 10:00 pm, the patient called insurance company nurse line and they told her to go to the emergency room as her temperature was 102 F. On 23-JAN-2018 (reported as after midnight), the patient was admitted to hospital. The hospital told the patient that her white blood cell count and lactic acid levels were too high. Her heart felt funny but the hospital said that was fine. The patient had horrendous pain and couldn't breathe without pain. Patient was started on IV. The patient was kept in the hospital. Next morning (23-JAN-2018), the repeat blood work to see if the white blood cell count and lactic acid levels had come down. The patient was discharged that afternoon around 5:00 pm on 23-JAN-2018. The patient still had pain and couldn't lay on that side. The patient reported that the PNEUMOVAX 23 injection was given in the muscle but very high up in her arm, like about an inch down from her shoulder. Consumer reported that this was her second PNEUMOVAX 23 and she had received the first injection when she was 65 year old (date not specified). The patient had received treatment for the events. Outcome of the events White blood cell count increased and Blood lactic acid increased was considered to be recovering. Outcome of the other events was reported as not recovered. Causality of the events was not reported.
Extreme vomiting and diarrhea in 5/21 causing pancreatic damage and esophagus.   Appearance of lipomas on triceps arms legs etc.   Now tiny lipomas everywhere.  Had nothing of the sort before.   Nurse practitioners and some docs think it could be worth looking into but not sure how busy you may be with your caseload to make any effective analysis or contact/research/recourse.
On 12/28/2000 the patient experienced chicken pox that included a mild papular rash, 7 lesions on her left side and arm and no fever. Subsequently, the patient recovered. Unspecified medical attention was sought. Additional information is not expected.
Vaccine was given 19 days prior to age 18 years.  Moderna vaccine currently is for 18 years and older.
pt recv 3 doses of vax & 4months p/dose 3 SEP94 pt was exhausted & exp fatigue;ER or MD visit was required;pt was found to have a thyroid deficiency which was treated w/thyroxine;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 1:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:23 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  On 28-Feb-2021, Excursion time was 09 AM and 1PM, temperature was 27 and 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.   On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
2/16/15 approximately 12 am: Headache/fever -> took ibuprofen. Approximately 8 am: dizziness, vertigo, jittery/nervousness, "heaviness in chest"/"labored breathing, achiness (esp. in neck/back).
Local induration 3 1/2 x 2 1/2 w/vessicles on left arm. Fever 103.8.
Pt/guardian wrote on screening form "16" as age and "20050928" for birthday.  After vaccination, it was discovered that the pt is 15 years old, not 16.
1st day = chills in early morning, leading to fever like body aches. 2nd day = body aches all day 3rd day = headache in the morning 4th day = left arm still sore since day one, hard to sleep on left side
10 10/12 who developed a macular rash on face, chest and abdominal area 10 minutes after influenza vaccine was administered. Pt. was treated with diphenhydramine 12.5/5ml 10ml and observed for 30 minutes. Condition improved and patient was released home with an Rx for diphenhydramine
LOST SENSE OF TASTE; DRAINING IN BACK OF THROAT; DIFFICULTY SWALLOWING; POSSIBLE WEIGHT LOSS; HAD NOT EATEN MUCH; SLIGHT RUNNY NOSE; SORE HIP MUSCLE; This spontaneous report received from a patient concerned an 87 year old female. The patient's weight was 130 pounds, and height was 61 inches. The patient's past medical history included lost sense of taste, and concurrent conditions included alcohol use, non-smoker, and detergent allergy, and other pre-existing medical conditions included the patient did not have any past medical history. the patient had no history of drug abuse or illicit drug use. the patient takes blood pressure pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced lost sense of taste. On MAY-2021, the subject experienced draining in back of throat. On MAY-2021, the subject experienced difficulty swallowing. On MAY-2021, the subject experienced possible weight loss. On MAY-2021, the subject experienced had not eaten much. On MAY-2021, the subject experienced slight runny nose. On MAY-2021, the subject experienced sore hip muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lost sense of taste, slight runny nose, sore hip muscle, draining in back of throat, difficulty swallowing, possible weight loss and had not eaten much was not reported. This report was non-serious.
next day pt woke up w/arm lt swollen, red, angry looking, & hot to touch;used APAP, ice packs x 2 days;swelling resolved;no further tx; (d/c next dose);
Client recv'd 2 vaccines, after admin, he immediately fainted, was non-responsive for few seconds, client was instructed to put his head down, was given juice and an ice pack. His BP and pulse were wnl. After a few minutes his color came back and was conversing well. Stated he felt well. Phoned his mother, she came to the health dept. Client and mother were educated on fainting. Mom reports that she faints at any sight of needle. After 45 mins, client was discharged ambulatory with mother.
She has chills; Body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she has allergies to some medications" (unspecified if ongoing), notes: she had allergies to some medications.; "some things and has strong allergies" (unspecified if ongoing), notes: Some things and had strong allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "She has chills", "Body pain"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "She has chills", "Body pain". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "She has chills"; PAIN (non-serious), outcome "unknown", described as "Body pain".  Additional information: Caller said she had a question and she got the three vaccines from Pfizer they recommended four doses but she had allergies to some medications and some things and had strong allergies and spoke with someone that Pfizer vaccines didn't ask anything that she couldn't have it.  She had chills and body pains and wanted to know if the 4 dose had the same things as the first 3 vaccines? The guy she talked to last time the vaccines did not have any components that mentioned all the medications  that she was allergic. Was the same components as 3 other vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282564 Same patient/product/events, different dose;US-PFIZER INC-202201282774 Same patient/product/events, different dose;
This spontaneous report as received from a pharmacist refers to a currently 74 years old female patient. The patient's pertinent medical history was not provided. On an unspecified date in approximately 2013 (reported as on an unspecified date approximately one year ago), the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, route of administration, lot # and expiration date were not reported). No concomitant medications were provided. Later, on an unknown date, the patient had radiation and then, on an unknown date, she developed shingles. As a treatment, the patient received unspecified antiviral therapy. The reporter stated that the patient's shingles lesion have resolved on an unknown date, however the patient continued to have pain and itching. The outcome of the shingles was reported as recovering/resolving. The outcome of radiation was unknown. The relatedness between the events and ZOSTAVAX was unknown. Additional information is not expected because there is no reporter's consent to follow up.
Itch/severe pruritus; Hardness in arm; Redness/arm redness; Rash; arm  swelling; Nausea; Sick and tired/Fatigue; Pain in left arm/arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm/arm soreness), ILLNESS (Sick and tired/Fatigue), INJECTION SITE PRURITUS (Itch/severe pruritus), INJECTION SITE INDURATION (Hardness in arm) and INJECTION SITE ERYTHEMA (Redness/arm redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Hypertension since 2007, Cholesterosis since 2007 and Acid reflux (oesophageal) since 2008. Concomitant products included LISINOPRIL from 2007 to an unknown date for Blood pressure high, ATORVASTATIN from 2011 to an unknown date for High cholesterol, AMLODIPINE from 2011 to an unknown date for Hypertension, OMEPRAZOLE from 2018 to an unknown date for Reflux esophagitis.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm/arm soreness). On 19-Jan-2021, the patient experienced ILLNESS (Sick and tired/Fatigue) and HEADACHE (Nausea). On 25-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itch/severe pruritus), INJECTION SITE INDURATION (Hardness in arm), INJECTION SITE ERYTHEMA (Redness/arm redness), INJECTION SITE RASH (Rash) and INJECTION SITE SWELLING (arm  swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 19-Jan-2021, PAIN IN EXTREMITY (Pain in left arm/arm soreness) had resolved. On 20-Jan-2021, ILLNESS (Sick and tired/Fatigue) had resolved. On 08-Feb-2021, INJECTION SITE PRURITUS (Itch/severe pruritus), INJECTION SITE INDURATION (Hardness in arm) and INJECTION SITE RASH (Rash) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Redness/arm redness) and INJECTION SITE SWELLING (arm  swelling) had not resolved and HEADACHE (Nausea) had resolved.            This case was linked to MOD-2021-052523 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Updated patient demographics, Medical history, added concomitant and treatment medicines, added new events Injection site swelling, Headache, updated outcome of the event injection site erythema, pain in extremity from Recovered to Not Recovered; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
chills, fever, injection site redness,feeling unwell,muscle pain back of neck and shoulders
sore arm; This is a spontaneous report from a contactable consumer (mother) reported for his son(patient).A 18-year-old male patient received first dose of BNT162B2(Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, batch/lot number not provided), via an unspecified route of administration on 18May2021 (at the age of 18 year) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced sore arm.They were uncomfortable that he wasn't vaccinated," she said. So, he got the COVID vaccine without telling me." Withheld other son, now 16, had an adverse reaction to his measles-mumps rubella (MMR) vaccine when he was younger, and has not been vaccinated since. After (Withheld) first Pfizer dose on 18May2021experienced a Sore arm but was otherwise. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
horrible pain in upper chest and back, skin sensitivity to touch. Today is the fifth day on a row that I have been enduring this.
Breakthrough case admission after 2 vaccines Moderna 4/24/21 Lot# 007C21A;  Moderna 5/22/21 Lot# 038C21A
No side effects; Hepatitis B (shot 2): Approximately May 2020, Hepatitis B (shot 3): Approximately August 2020, Hepatitis B (shot 4): Approximately September 2020; This spontaneous report has been received from a lawyer, regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (1808USA010560), referring to a 70 years old male patient.  Information about medical history, concurrent conditions and concomitant therapies was not provided.  The patient was vaccinated with hepatitis B surface antigen recombinant (yeast) (manufacturer unknown) (shot 1) (route, strength, dose, batch/lot # and expiration date were not reported) on an unknown date, hepatitis B surface antigen recombinant (yeast) (manufacturer unknown) (shot 2) (route, strength, dose, batch/lot # and expiration date were not reported) in approximately May 2020, hepatitis B surface antigen recombinant (yeast) (manufacturer unknown) (shot 3) (route, strength, dose, batch/lot # and expiration date were not reported) in approximately August 2020 and hepatitis B surface antigen recombinant (yeast) (manufacturer unknown) (shot 4) (route, strength, dose, batch/lot # and expiration date were not reported) in approximately September 2020 without any side effects (Inappropriate schedule of vaccine administered).  This case was split from a legal case regarding the same patient.; Sender's Comments:  US-009507513-1808USA010560:
Fever developed within two hours of receiving flu shot on December 17, 2004.  Symptoms of flu continued, and treated by physician, hospitalization and diagnosis of Guillain Barre Syndrome made on January 8, 2005.   Has remained in hospitals until November 23, 2005 when released home with no function of daily activities.  Discharge summary for 1/8-2/6/2005. FINAL DX: presumed Guillain-Barre syndrome, respiratory failure requiring mechanical ventilation & quadriparesis; Pulmonary emboli; basilar atelectasis vs pneumonia by x-ray; hyponatremia secondary to SIADH; prerenal azotemia, resolved;  transient hematuria likely related to cathether, resolved; HTN; N/V, possibly Flagyl related; depression; recent diarrheal syndrome resolved.   Also states developed low-grade fever, dizziness, weakness & diarrheal illness following flu shot.  Seen in ER & d/c to home.  Had syncope & worsening s/s, returned to ER & admitted.  Eventually developed gen weakness, syncope & quadriparesis, intermittent confusion, apnea, hypertension/hypotension, dyasthenia.   During hospital stay developed quadreplegia, pulmonary empolism, bradicardia, hematuria, hyponatremia(114).  Areflexic.  ICU.  Neuro & nephro consults done.  Developed resp distress & was intubated.  Had non-ST change MI s/p hypotension/hypoxia.  Tx w/IVIG w/minimal improvement.  Developed bacteremia from lines & tx w/IV antibiotics.  Transferred to inpt rehab.
warm at injection site; "sweat through bedsheets went through 6 pillowcases"; 99.3 temperature; itchy at injection site; bump like a bug bite; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm at injection site), HYPERHIDROSIS ("sweat through bedsheets went through 6 pillowcases"), BODY TEMPERATURE INCREASED (99.3 temperature), INJECTION SITE PRURITUS (itchy at injection site) and VACCINATION SITE SWELLING (bump like a bug bite) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C24C and 009D21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (bicep surgery) and Vasectomy. Concomitant products included LISINOPRIL, DULOXETINE and PRAVASTATIN for an unknown indication.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced INJECTION SITE WARMTH (warm at injection site), HYPERHIDROSIS ("sweat through bedsheets went through 6 pillowcases"), BODY TEMPERATURE INCREASED (99.3 temperature) and INJECTION SITE PRURITUS (itchy at injection site). 07-Jun-2021, the patient experienced VACCINATION SITE SWELLING (bump like a bug bite). The patient was treated with TRAMADOL for Pain, at a dose of UNK dosage form. At the time of the report, INJECTION SITE WARMTH (warm at injection site), HYPERHIDROSIS ("sweat through bedsheets went through 6 pillowcases"), BODY TEMPERATURE INCREASED (99.3 temperature), INJECTION SITE PRURITUS (itchy at injection site) and VACCINATION SITE SWELLING (bump like a bug bite) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Body temperature: borderline (Borderline) 99.3.         Patient reports taking Multivitamins (NOS).    This case was linked to MOD-2021-214591 (Patient Link).
Approximately 1 hour after receiving vaccine, became very irritable; unconsolable.  Given Tylenol.  Wouldn't take bottle.  Symptoms persisted about 3 hours.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. In July 2014, between 08-JUL-2014 and 11-JUL-2014, an unspecified number of patients were vaccinated with an improperly stored PROQUAD (merck) (strength, route, lot number and expiration date not reported). No adverse symptoms reported. Additional information has been requested.
A report has been received from a Health Professional concerning a patient born on 26-Nov-1962, Female subject, who had been receiving FLUMIST started on an unknown date. The reporter stated that the we inadvertently administered FLUMIST to a 51 y/o patient. The outcome of the event of inadvertently administered FLUMIST to a 51 y/o patient is unknown. The report was considered to be non-serious.
joint pain; tiredness; muscle pain; chills; feeling unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 20Apr2022 at 09:00, outcome "recovered"; MALAISE (non-serious) with onset 20Apr2022 at 09:00, outcome "recovered", described as "feeling unwell"; ARTHRALGIA (non-serious) with onset 20Apr2022 at 09:00, outcome "recovered", described as "joint pain"; MYALGIA (non-serious) with onset 20Apr2022 at 09:00, outcome "recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 20Apr2022 at 09:00, outcome "recovered", described as "tiredness". Therapeutic measures were not taken as a result of arthralgia, fatigue, myalgia, chills, malaise.  Additional information: No other vaccine received in four weeks. No Covid prior vaccination and not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.