chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within a few hrs of vaccine, leg became non-wt. bearing swollen from hip to toe. Not red ever acc. to mom until 2 d later. Went to hospital, dx with cellulitis, given IV ROCEPHIN, sent home on clinda.
Chills, fever of 102 degrees, aches, cough, H/A.
This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours), 26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours), 25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 29-DEC-2017. This is one of several cases reported by the same reporter. Sender's Comments: US-009507513-1801USA006569: Original Case: 1801USA006569.
Headache, chills, nausea, fever that went higher as day went on, went up to 101 with taking ibuprofen,  severe fatigue,  could not stay awake more than half hour,  fuzzy headed feeling, constant ringing in the ears , day 4 of effects  couldn't catch my breath when walking more than 10 feet. Day 6 still have ringing in ears, some fatigue,  breathing better but not 100%.
Immunizations given 4/30/04 at 6:00pm, returned to office at 7:15pm with erythema surrounding nose and upper neck, wheals and erythema spread to upper trunk and extremities at 7:20pm, vital signs stable. At 7:20 given Benadryl 12.5mg PO, spreading of erythema continued on upper extremities, at 7:30 given Benadryl 12.5mg IM. 7:40pm erythema and wheals noted to decrease. Parent requested to bring child to ER for further monitoring- sent to ER at 7:50p.m.
Patient started wheezing at bedtime. He went to a physician, who did an echocardiogram which showed an EF 15-35%. Diagnosed with viral cardiomegaly.
Information has been received from a physician concerning a 12 year old female who on 22-AUG-2007 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast)., 0.5 ml, intramuscularly. On 22-Aug-2007 the patient experienced headaches. Subsequently the headaches resolved after a short duration. On 22-OCT-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 ml, intramuscularly and experienced headaches and nausea within a few hours. As of 22-OCT-2007 the patient's headaches and nausea persisted. The patient sought medical attention via phone. Additional information has been requested.
Wrong route of administration; This case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a 23-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA087A, expiry date February 2020) for prophylaxis.   On 31st July 2019, the patient received the 1st dose of Menveo (subcutaneous) .5 ml. On 31st July 2019, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were received as follows: The age at vaccination was not reported.  The patient received menveo subcutaneously in right arm, which led to intramuscular formulation administered by other route. The medical science liaison is following up with provider.
Went to hospital 02/07/2022 for hernia surgery. (A large hernia pressing against case's stomach and esophagus was found). Pre-procedure case tested negative for COVID). Many complications arose following surgery and case was intubated.  Case was scheduled to be sent to another hospital for rehabilitation but tested positive for COVID 03/31/2022. Case remains hospitalized with a trach.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient reported trouble breathing for several minutes after being administered second dose of Pfizer. Water was given and patient recovered within 5 minutes
Tiredness; Injection site pain; Headache; Muscle pain; Chills; Joint pain; Fever; Light nausea; Feeling unwell; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the right arm on 12May2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included triamterene (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and nitrofurantoin (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 21Apr2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 13May2021 at 02:00, the patient experienced tiredness, injection site pain, headache, muscle pain, chills, joint pain, fever, light nausea, feeling unwell and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, injection site pain, headache, muscle pain, chills, joint pain, fever, light nausea, feeling unwell and arm pain were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Initial injection site swelling with redness and itching. Beginning to resolve after three or four days then coming back with a more pronounced reaction on day number eight. Current delayed reaction is more pronounced than the initial reaction.
yearly i feel itching under my skin in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of itchy skin in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient experience shingles problem year 2002 patient was 57 first attack , from back of head down to nick and to whole arm in right side its so much pain and burning).   On an unknown date, the patient received Shingrix. On an unknown date, 1 year after receiving Shingrix, the patient experienced itchy skin. On an unknown date, the outcome of the itchy skin was not recovered/not resolved.   It was unknown if the reporter considered the itchy skin to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot and yearly feel itching under his/her skin in arm just for 3 months. The patient experience shingles problem year 2002 patient was 57 his/her first attack, from back of his/her head down to neck and to whole arm right side its so much pain and burning. The patient asked the best medicine of arm the sales lady gave his/her the cream event patient feel pain so much itching but did not scratch it. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR177043 and US2021AMR177044 reported by the same reporter
Patient reported having chills, vomiting, fatigue, loss of appetite, and bruise at site of injection.
After receiving his 2nd dose outside of the 6 dose window, he came back for a 3rd dose of Moderna. His vaccination card did not include the date of his 1st vaccination and the patient did not reveal he had already received 2 doses until after he was vaccinated with his 3rd dose.
8 patients got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Fever of 102.8, chills, body aches, massive headache, very tired
Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medication information was provided.  It was reported that the patient was sick for 3 weeks after the Moderna vaccine second dose. Patient experienced achy, crabby and arm hurt after Pfizer booster dose.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: I-narrative supplement was updated. Action taken was updated.
She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 12-AUG-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number R028526, expiration date 04-OCT-2020, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260:
patient reported head pain for 2 days which occurred 2 days after vaccine. She could not lie down on that side of face for 2 days
I had the Pfizer vaccine in my left arm on Jan. 23rd. I had no side effects at the time, other than a sore arm, as with any shot. However, two days later I lost all hearing in my left ear. I had no history of ear infections or other ear or hearing problems, except for wax buildup two or three times. On Jan. 26th, I saw an ENT. To my dismay, there was no wax. He prescribed the standard treatment of Prednisone for Sudden Idiopathic Hearing Loss. No change after the first round, so I had a second round, and also had the series of three ear injections with Dexamethasone. Had an MRI, as well, which was normal. A couple of weeks into all this, I began to have a bit of sound-generated static in my ear, and this continues today. (Fortunately, I?ve only had the most minor of tinnitus in that ear, and even it is pretty much gone now.)
This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. The patients were vaccinated with the doses of VAQTA injection, lot # K026529 with expiration date 02-JUN-2017 and lot# L048460 with expiration date 14-JAN-2017 (dose and route of administration were not reported), which were exposed to temperatures outside of the recommended range for much longer than originally realized, and had been administered to the patients since these excursions began to occur on an unspecified date in July 2015. The refrigerator, in which the vaccine was stored, had been "losing power" each night for 8 hours since an unspecified date in July, 2015. The vaccine was exposed to temperatures as high as 66 Fahrenheit (F) for as long as long as 8 hours each night since an unspecified date in July 2015. The reporter's facility started to use a data logger, which was how the daily (also reported as each night) power interruption was discovered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Recieved the second dose of the vaccone on April 8 at 11 AM. Initial reaction was a sore arm and nothing else. By 2 PM I felt aching in all the major muscle groups in my arms and legs, some nausea, slight headache. By 9 PM, I had extreme pain in these muscles (on a pain scale of 1-10, it was an 8). I took Tylenol, which dulled the pain but didn't relieve it. I was nauseous and fatigued. All day Friday, the 9th, the pain was just as bad. I took Tylenol every 4 hours to manage it. The nausea and fatigue were just as bad, with some diarrhea. By Friday night, the pain was down to a 3 or 4, the headache was gone. By Saturday morning, the pain and digiestive issues were also gone. I still have some fatigue after one week.
Was given a flu shot have chills and fever ever since. Medical record states anxiety, depression. msv
Developed rash on left side of neck one day following vaccination.  Vaccine given in Rt deltoid
swelling at injection site; pain left chest; fever; first dose on 1/31/2020, Covid on 30-JUNE-2021; unable to make a fist; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix. In February 2020, 1 day after receiving Shingrix, the patient experienced stiff fingers. On 30th June 2020, the patient experienced covid-19. On an unknown date, the patient experienced injection site swelling, chest pain and fever. On an unknown date, the outcome of the injection site swelling, covid-19, chest pain, fever and stiff fingers were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, covid-19, chest pain, fever and stiff fingers to be related to Shingrix.     Additional details were provided as follows: The patient self-reported this case. The patient experienced pain in her left chest, fever and swelling at the injection site. She also stated that the morning after the dose, she was unable to make a fist with her left hard. The patient received dose of Shingrix vaccine and was diagnosed with Covid. The reporter did not consent to follow-up. For tolerance to the 2nd dose refer case US2022AMR004816.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR004816:Same patient
Myalgia, chills, fatigue Narrative: Employee reports experiencing chills, body aches, and fatigue. No medications were taken for symptoms.
Rash at injection site on left arm that spread to the chest area. Rash was itchy but he had no respiratory symptoms.
Patient's wife reports her husband became very weak and fell in his office and lost control of his bowels, he remained conscious thru the experience but was too weak to call out for help, the event resolved spontaneously and no follow up to primary has been planned
Itching rash on the injection site; rash on injection  site; Very large bleeding lesion on the roof of her mouth; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH HAEMORRHAGE (Very large bleeding lesion on the roof of her mouth), VACCINATION SITE PRURITUS (Itching rash on the injection site) and VACCINATION SITE RASH (rash on injection  site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced MOUTH HAEMORRHAGE (Very large bleeding lesion on the roof of her mouth). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itching rash on the injection site) and VACCINATION SITE RASH (rash on injection  site). At the time of the report, MOUTH HAEMORRHAGE (Very large bleeding lesion on the roof of her mouth) had not resolved and VACCINATION SITE PRURITUS (Itching rash on the injection site) and VACCINATION SITE RASH (rash on injection  site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported. Treatment details include steroids and antivirals.; Sender's Comments: This case concerns a 63-year-old female with a nonserious unexpected mouth hemorrhage and expected injection site pruritus and injection site rash. Event onset 4 days after first dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
slight numbness at her hairline between one ear and the other; moved down to her eyebrow and eyelids; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (slight numbness at her hairline between one ear and the other) and EYELID SENSORY DISORDER (moved down to her eyebrow and eyelids) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L020A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (it's under control).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (slight numbness at her hairline between one ear and the other) and EYELID SENSORY DISORDER (moved down to her eyebrow and eyelids). At the time of the report, HYPOAESTHESIA (slight numbness at her hairline between one ear and the other) and EYELID SENSORY DISORDER (moved down to her eyebrow and eyelids) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Person received Covid-19 vaccine booster 03/10/22 and started having side effects of headache along with body aches, dis take tylenol and ibuprofen regimens to help, side effects have subsided.
Patient states she felt ill the night of receiving Pneumovax 23 vaccine. She said she experienced sore throat, congestion, and fever. She went to her primary physician to get treated for a bacterial infection.
lt shoulder pain followed by motor weakness w/in 1wk, worse in deltoid, supraspinatas and infraspinatas;also sensory loss in lateral cutaneous;nerve of forearm;weakness persists;
Information has been received from a physician concerning a female with a sulfonamide allergy who in December 2007, was vaccinated intramuscularly with her first dose of GARDASIL (lot # not reported). There was no concomitant medication. The patient experienced nausea after receiving the first dose, but has recovered from the nausea. The patient discussed the nausea with her physician during a subsequent office visit. Additional information has been requested.
This case was reported by a physician and described the occurrence of influenza in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). In 2012, the subject received a dose of FLUARIX (unknown route, unknown arm, batch number not provided). 1 week after vaccination with FLUARIX, the subject experienced influenza. After 2 weeks, influenza was resolved. At an unspecified time after vaccination with FLUARIX, the subject experienced other events on injected limb: the arm slowly started freezing, joint was hurting, and the limb mobility decreased (the subject could not put her arm through the sleeves of a jacket and could not move her arm above her hair). In 2013, the subject's shoulder got severely frozen. As a result, the reporter said that she had been through emotional depression and also experienced extreme pain in her arm: she would scream if someone touched her arm. At the time of reporting, the influenza was resolved but the other events were unresolved.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 27-year-old female. Neither medical history nor concomitant medications were reported. On 05-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.