chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her arm is a little bit painful.; This is a spontaneous report. A contactable female consumer(patient) reported that:   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 15Feb2021 at dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Feb2021, the patient experienced her arm is a little bit painful. At the time of reporting, the outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Muscle stiffness; Back pain; Pressure; Tense muscle; Sore arm; Muscle aches; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscle stiffness), BACK PAIN (Back pain), VACCINATION SITE DISCOMFORT (Pressure), MUSCLE TIGHTNESS (Tense muscle) and VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscle stiffness), BACK PAIN (Back pain), VACCINATION SITE DISCOMFORT (Pressure), MUSCLE TIGHTNESS (Tense muscle), VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle aches) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscle stiffness), BACK PAIN (Back pain), VACCINATION SITE DISCOMFORT (Pressure), MUSCLE TIGHTNESS (Tense muscle), VACCINATION SITE PAIN (Sore arm), MYALGIA (Muscle aches) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is 2nd of two reports. A 64-year-old female patient received PREVNAR 13 (Lot Number: S13847, Expire Date: 01Ju2020) via an unspecified route of administration at 0.5 ml, single in the right deltoid on 15Nov2018 for immunisation. Medical history none. There were no concomitant medications. On 15Nov2018, the patient experienced fever, swollen, red, and pain at injection site, chills. The  outcome of the events was recovered on an unspecified date in Nov2018.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018482600 same reporter same drug similar events different patients.
to get a Pfizer booster was a little sore; to get a Pfizer booster was a little sore; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (054550).  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), PAIN (non-serious), outcome "unknown" and all described as "to get a Pfizer booster was a little sore".  Additional information: Patient stated off xeljanz for a week to get Pfizer booster was a little sore on day 3 but not bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received from a nurse on 16 Dec 2009. This patient (a 3 year old child) was vaccinated with FLUVIRIN (batch no: 100814P) on 14 Dec 2009. No adverse event was reported.
Lips began to tingle and felt full but no swelling.  Bottom inside lip turned bright red.   some bright red spots upper on upper lips/gum.  Began about 5 min after first dose.  Redness began to go away after 45 min. Felt normal in about an hour.
12/23/22 presents to ED for "shortness of breath". PMHx of "COPD, GERD, A. fib, hypertension, CAD status post CABG x4"
1 week since second dose of vaccine-patient had spontaneous Small BowelObstruction (SBO)
Patient received both doses of Pfizer 22 March and 12 April and tested positive for COVID19 via nasal swab 03 May.
Debilitating migraines for 22 days so far, including vision loss for hours each day
After 3 weeks of second dose, I started having  muscle and joint pain  mostly left side of body. Still  having these issues. I've been tested twice for covid-19 since the vaccine, all negative. I've been out of work since 5/13/2021. I do not know if this has anything to do with the vaccine. I've had no issues  with my health until after the second shot, 3 weeks later.  Feel almost crippled.
My feet and my hand started burning; Back of my legs started cramping; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received first dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ER8729, Expiration date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single and also received second dose via an unspecified route of administration on 21Jul2021 as dose 2, single (COMIRNATY, Solution for injection, Batch/Lot Number: EW0172, Expiration date: unknown) for covid-19 immunisation (at the age of 51 years). The patient medical history and concomitant medications were not reported. On an unknown date in 2021, The patient experienced burning in feet and hand, and back of legs started cramping. Patient did not visit the doctor and received no treatment for the events. The outcome of the events was unknown.
Hardball pain; Bruising on her arm; Swelling; Feels bad; Really weak and tired; Continued severe allergic reaction; Severe pain; Red area of 5 by 4 inches; Fells exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hardball pain), VACCINATION SITE BRUISING (Bruising on her arm), SWELLING (Swelling), FEELING ABNORMAL (Feels bad) and ASTHENIA (Really weak and tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 016B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Hardball pain), VACCINATION SITE BRUISING (Bruising on her arm), SWELLING (Swelling), FEELING ABNORMAL (Feels bad), ASTHENIA (Really weak and tired), ALLERGY TO VACCINE (Continued severe allergic reaction), VACCINATION SITE PAIN (Severe pain), VACCINATION SITE ERYTHEMA (Red area of 5 by 4 inches) and FATIGUE (Fells exhausted). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Hardball pain), VACCINATION SITE BRUISING (Bruising on her arm), SWELLING (Swelling), FEELING ABNORMAL (Feels bad), ASTHENIA (Really weak and tired), ALLERGY TO VACCINE (Continued severe allergic reaction), VACCINATION SITE PAIN (Severe pain), VACCINATION SITE ERYTHEMA (Red area of 5 by 4 inches) and FATIGUE (Fells exhausted) outcome was unknown.            Treatment details include ice, pain medication and observing her. Concomitant medications include not reported.
Patient states 3 days after vaccine was administered she started experiencing pain on the same arm( left arm) and the pain  extended to fingers , she states  the arm is a little swollen and she feels dizzy on and off. she states she has not been feeling well  since she got the vaccine as that entire arm is in pain constantly  .
testicular swelling (orchitis). Persisted for 3 weeks and exacerbated after second vaccine dose and then slowly subsided 3- 4 weeks after that.
Pt noted redness, swelling, tenderness in 2 inch diameter a few hours after injection. Pt improving with cool compresses and TYLENOL. No other associated symptoms.
since after injection pt has been having pain to left arm; up to now 4 weeks post vaccine; continues with pain to arm with limited ROM due to this.
The pt developed a temp of 103.2. The pt's mother gave him Tylenol prior to school in the AM.
Patient self reported allergies to unknown things. Patient was hesitant in receiving vaccine because of fear of having allergic reaction but patient self reported that her employer is making her get the vaccine. Patient consented to receiving first dose of Pfizer and let the clinical team know about her concerns. Clinical team extended observation time to 30 mins as per protocol. Patient received vaccine at approximately 1738. Patient went to observation area and within 5 minutes patient reported itchiness, redness and hives. Hives and redness observed by clinical team. Benadryl 25mg oral given to patient with good effect. Patient reports decrease in itchiness and no hives observed.
Patient had fever starting on 3-7-17 at 6:00 pm. His whole body started shaking lasting 10 minutes. Bottom of his mouth was quivering. Parents clothed him more and this stopped the shaking movement.
ErythemaMultiform fatigue, injection arm pain, horseness of voice, congestion, sneezing, Narrative:
itchy on injection site; burning/on fire; swollen; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchy on injection site), INJECTION SITE PAIN (burning/on fire), INJECTION SITE SWELLING (swollen) and INJECTION SITE ERYTHEMA (injection site red) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy on injection site), INJECTION SITE PAIN (burning/on fire), INJECTION SITE SWELLING (swollen) and INJECTION SITE ERYTHEMA (injection site red). At the time of the report, INJECTION SITE PRURITUS (itchy on injection site), INJECTION SITE PAIN (burning/on fire), INJECTION SITE SWELLING (swollen) and INJECTION SITE ERYTHEMA (injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information include ice.
At around 4:30 PM patient had a syncope episode immediately after receiving first Covid dose of Pfizer. Vaccinating nurse guided patient from chair to the floor with legs elevated, as patient verbalized feeling he was going to pass out. Patient verbalized he had both hands tingling and feeling numb. Patient also stated he was cold and appeared pale. Patient vitals b/p 140/92, pulse 89, O2 sat 100%. Patient was provided sweater and started to feel warm per patient. Symptoms began to resolve naturally and patient stated he was ready to sit up. Patient sat up against wall, and 5 minutes later sat up and transferred back into chair. Patient verbalized feeling well and no longer experiencing tingling/numbness in both hands. Pale skin was no longer observed.
Following day:  major headache; body ache; dizzy; coughing; short of breath; chills; nausea; extreme tiredness (stayed home from work) 2nd day:  big headache; very light headed; some coughing; short of breath; nausea (stayed home from work).  Not restful sleep. 3rd day:  pressure headache; very light headed (went to work).  Very tired at night.  Hard time sleeping. 4th day:  light headed; pressure in head; short of breath when going for a walk; hard time sleeping. Since 4th day, haven't slept well; light headed; on-and-off headache; at work but moving slow.  Feels like when I returned from being out with Covid + double pneumonia 6/30/2020-7/23/2020.
Patient fully vaccinated (J&J), but not boosted, admitted to the hospital on 7/13/22 (after Dose 1) with COVID-19 and associated hypoxia. Patient was discharged on 7/16/22.
expired vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; Expired vaccine was administered after the manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry) and PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022).    No concomitant medication were reported.  It was reported that patient received 0.5 dose of vaccine during PM time.  It was unknown that patient had ever been diagnosed with nor tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination up to one month before. It was unknown if patient had any chronic or long standing health conditions.  It was reported that HCP gave Moderna Covid 19 vaccines and it was discovered after they had given 21 doses that it was expired recently from  monovalent Individual vials of Vial size 5.5 ml. The vial had not undergone any temperature excursions.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-648572 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648572:Master case
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2013 the patient was vaccinated with MMR II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr. and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406, and 1310USA008407 (same reporter linked). Additional information has been requested.
brief sz; pt recvd vax & mom states that when got about 10 mins from office pt began shaking, eye were jerking even while closed; pt limp & unresponsive;
Swollen, red rash five inches in diameter over injection site. Itchy. Slightly painful.
This spontaneous report as received from a currently 69 years old female consumer with seizures. The patient's medical history included shingles and 6 thoracic operations. On 14-DEC-2005, the patient was vaccinated with ZOSTAVAX (Lot # not reported), 0.65 ml, single injection, subcutaneous. Concomitant therapies included oxycodone and morphine. The patient reported that after receiving ZOSTAVAX, initially did not have any adverse events, but on an unspecified date, after getting back surgery at an unspecified time and location, the patient experienced numbness throughout her entire body for an unspecified time, "unexplained" extreme pain along the left side of her body, encephalitis, terrible memory loss, confusion and the patient stated she was paraplegic with a slipped disc in her back. The patient did not recall when the adverse events first started. There was no treatment given for the events. The patient sought medical attention by a physician visit. No further adverse events reported. At the time of the report, the patient's outcome for back surgery, numbness throughout her entire body, "unexplained" extreme pain along the left side of her body, encephalitis, terrible memory loss, confusion and paraplegic with a slipped disc in her back was not recovered. Upon internal review encephalitis and back surgery were considered to be medically significant. Additional information has been requested.
Fullness in ears and head; Ear fullness; Anxiety; inflammation casuing the Tinnitus; Dizziness; brain fog; Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears), DIZZINESS (Dizziness), CONFUSIONAL STATE (brain fog), HEAD DISCOMFORT (Fullness in ears and head) and EAR DISCOMFORT (Ear fullness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 020821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Septra). Concomitant products included RIZATRIPTAN BENZOATE (MAXALT) from 01-Jan-2010 to an unknown date for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced TINNITUS (Ringing in ears). On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness) and CONFUSIONAL STATE (brain fog). On an unknown date, the patient experienced HEAD DISCOMFORT (Fullness in ears and head), EAR DISCOMFORT (Ear fullness), ANXIETY (Anxiety) and INFLAMMATION (inflammation casuing the Tinnitus). The patient was treated with PREDNISONE (Predensoine) for Inflammation, at an unspecified dose and frequency. At the time of the report, TINNITUS (Ringing in ears), DIZZINESS (Dizziness), CONFUSIONAL STATE (brain fog), HEAD DISCOMFORT (Fullness in ears and head) and EAR DISCOMFORT (Ear fullness) had not resolved and ANXIETY (Anxiety) and INFLAMMATION (inflammation casuing the Tinnitus) outcome was unknown.            The patient had an MRI  for hearing test ,seen by ENT and audiologist ,his hearing was fine .   This case was linked to MOD-2021-265350 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added treatment medication, Added events and updated outcome of events; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Immediately felt burning down arm and into shoulder after vaccine was administered; went to sit down in observation area felt like she was light-headed and going to pass out, hot, sweaty, pale, flushed, vomited x1 while observed. EMS on site responded with cool packs, elevated feet, gave water to drink.
shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. The patient's medical history, concomitant therapy and concurrent condition were not provided.  In 2013 the patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated for shingles. The outcome of event was unknown.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Tiredness; Swelling in left armpit.; Booster; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Oct2021 at 11:45 (at the age of-56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included first dose of influenza vaccine (FLU) on 11Oct2021 in the left arm and vitamins (unspecified) for unknown indications from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENS318) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of-56-years-old) and second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of-56-years-old); as a single dose for COVID-19 immunisation. On 16Oct2021 at 12:15, the patient experienced tiredness and swelling in left armpit. 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 and swelling in left armpit were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.