chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STOMACH ACHE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: HTN (hypertension), thyroid, cholesterol, asthma, COPD (chronic obstructive pulmonary disease), seasonal allergies, ex-smoker (The patient stated she smoked for 30 years but quit 18 years ago) and no alcohol use, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient had nausea when treated with codeine. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 06-APR-2021 for prophylactic vaccination.  On 06-APR-2021, the patient experienced fever, chills, headache, stomach hurt (Dose number in series 1). The patient stated that she had initially fever with body temperature 102.4 F and after 5 hours post vaccination fever came down to 99.9 F. The patient recovered from fever, chills, headache, stomach hurt on 06-APR-2021(Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 1 total administered on 15-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-NOV-2021, the patient experienced fever which reached to 99.9 F, headache, and stomach ache but with less severity than with the initial vaccination (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, headache, and stomach ache on 15-NOV-2021 after 10 hours of post vaccination. This report was non-serious. This case, involving the same patient is linked to 20220431821 (Dose number in series 1).
This spontaneous report as received from an unspecified reporter refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (-13 degrees Celsius for 8 hours) doses of VARIVAX (lot # K026385 with expiration date 15-DEC-2016, lot # M006156 with expiration date 05-FEB-2018, lot # M006726 with expiration date 08-FEB-2018 and lot # M010482 with expiration date 01-MAR-2018; dose and route of administration were not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Day after injection left arm ached, left shoulder ached, pain between shoulder blades.  A week later and the pain has not subsided.  The pain almost feels like a pinched nerve.  Deep aching that hasn't subsided.  Negatively impacts my sleep.  Have taken Tylenol, used heating pads and little if any relief.
Migraines; brain fog; Panic attacks; Psychosis; This is a spontaneous report from a contactable consumer, the patient. This 26-year-old male patient reported that he received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0182 59267-1000-01) via an unspecified route in the right arm on 05May2021 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to apples. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 06May2021, the patient experienced migraines, brain fog, panic attacks, and psychosis; all serious for hospitalization. Patient was hospitalized for 5 days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of the events migraines, brain fog, panic attacks, and psychosis was not recovered. Since the vaccination, patient has been tested for COVID-19, result was unknown.
Vaccine administered beyond use date after the thaw process; Vaccine number 2nd and dose volume 0.25; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 33 years and 01 months. No concomitant medications were reported. On 10-Jun-2022, the vaccine facility staff was notified of an audit that was done and they were made aware of vaccines that were administered beyond use date after the thaw process. Patient had not reported any adverse reactions after the administration of the vaccine. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:MCN number
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 28-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength, dose and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Neurological deficit - brief moments of complete disorientation- not knowing where I was, or what I was doing. These instances  were brief and temporary but did not occur EVER prior to the vaccine.  I have also experienced involuntary muscle spasms, and intermittent tremors. I am 45 with no underlying conditions other than hypothyroidism
approximately 60 hours after receiving the vaccine, i experienced extreme pain in the lower left of my abdomen.  i was able to manage the pain by exercising my legs over a 2 hour period.  when i felt the need to go to the toilet, a huge amount of watery substance came out.  the water in the toilet was brown.  there were small particles of feces floating in the brown water.  i had to flush twice to get rid of it. over the next 5 or 6 hours, there was less watery substance and somewhat larger pieces of feces.  by 12 hours from the onset of the pain, there were only small stools which were a bit larger as time passed.  i kept myself quiet for the rest of the day and had no more symptoms.    i kept myself hydrated throughout the day.   i ate a banana, later some rice,  later an apple  and later some tea and toast. the next day i was able to eat my normal diet.  stools were solid and small. i feel fine. my doctor insisted that i make this report.  i reported the incident on My Chart.
This spontaneous case reported by a consumer, describes the occurrence of cough (lingering cough) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunisation. No medical history reported. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced cough (lingering cough). At the time of the report, cough (lingering cough) outcome: unknown. Diagnostic results: On Mar 6, 2021, SARS-CoV-2 test: positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not provided. This case linked to MOD-2021-044179 (patient link). Most recent follow-up information incorporated above includes: On May 21, 2021: Reporter denied consent to follow-up.
Fevers to 104F, chills, body aches within 4 hours of vaccine lasting 4 days, also with right shoulder pain. Review of injection site appears to be too cephalad and may have been injected into the right subacromial bursa.
Information has been received from a practice manager concerning a 69 year old female who on an unspecified date was inadvertently vaccinated with VARIVAX (Merck) (lot number not provided). Follow-up information received from the nurse who stated that the patient was given VARIVAX (Merck) (lot number not provided) instead of ZOSTAVAX (Merck). This was a case of the wrong product was grabbed by mistake. The nurse explained that they did not usually have VARIVAX (Merck), and the nurse grabbed it by mistake. It was not a case of product confusion. This is one of the several reports received from the same source. Additional information is not expected.
Information has been received from a nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On 21-OCT-2015, 22-OCT-2015, 09-NOV-2015, 23-NOV-2015 and 30-NOV-2015, multiple unspecified patients received improperly stored product PEDVAXHIB lot # I002866 with expiration date of 10-NOV-2017 (strength, dose, frequency and route were not reported). On 08-DEC-2015, 15-DEC-2015 and 17-DEC-2015, multiple unspecified patients received improperly stored product PEDVAXHIB lot # L012838 with expiration date of 10-MAR-2018 (strength, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Ten days after receiving the vaccine I woke up with extremely sore and stiff arms, hands and fingers.  I could not straighten my right arm for two days.  The elbow, wrist and finger joints were extremely sore.  Three months later and I continue to have joint pain in the same areas and now have pins/needles sensation.
This case was reported by a consumer (subject) and described the occurrence of ache(s) in a 45-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included SYNTHROID and Birth control pills. On 5 October 2009 the subject received 1st dose of TWINRIX (unknown, unknown). On an unspecified day in October 2009, at an unspecified time after vaccination with 1st dose of TWINRIX, the subject experienced ache(s)  and low grade fever for eight hours. On 6 November 2009 in the morning, the subject received 2nd dose of TWINRIX (1 ml, unknown, left arm). At the time of reporting the outcome of ache(s) and low grade fever were unspecified. On 6 November 2009 in the morning, the subject received 2nd dose of TWINRIX and experienced drug dose administration interval too long. On 07 November 2009, one day after vaccination with 2nd dose of TWINRIX, the subject experienced tingling (arms, legs and face), low grade fever, salivary gland pain and gastrointestinal upset. On an unspecified day in November 2009, at an unspecified time after vaccination with 2nd dose of TWINRIX, the subject experienced stool discolored. Relevant test results included a body temperature ranging from 99 to 99.5 on 07 November 2009. The subject felt sick on the day she was scheduled to have the second dose in the TWINRIX series 30 days later, so she postponed the vaccination for two days. On 06 November 2009, the subject was given the second dose in the series of TWINRIX. The following day (07 November 2009) she developed a low grade fever ranging from 99 to 99.5. The subject also suffered from gastrointestinal upset resulting in change in her stool color. The subject said as of 11 November 2009 all of these symptoms were improving. At the time of reporting the outcome of tingling (arms. legs and face), low grade fever, salivary gland pain, gastrointestinal upset, and stool discolored were improved.
Donor stated she woke up this AM (10/03/15) with some pain and puffiness in the armpit of arm that received vaccine. She denied other s/s and said "pain not that bad."
No adverse event; a patient was administered the MMR II vaccine intramuscularly; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.         On 28-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (recombinant Human albumin (rHA)) (lot # R008687, expiration date 22-MAR-2020, dosage detail and strength were not provided) intramuscularly for prophylaxis (Inappropriate route of vaccination). No adverse event was reported.
At 1am all muscles, inc. throat, started tightening up, chills, by morning I was completely paralyzed.  I could only lay and use the bathroom, I could barely move.  For the next 3 weeks, I suffered severe fatigue. I didn't move my bowels til day 9 and they were gray.  For the next 7 weeks, I only moved my bowels 6 times, w/ severe constipation, and Ive been regular my whole life. When I did attempt to do anything, I couldn't breathe. I put a call in to my Dr. cause it was so bad that while doing the dishes I sound like I ran up 10 flights of stairs.  She sent me to hospital, shocked by my breathing on the phone, and order a complete workup again.  Iwas also severely dizzy and nauseous all the time.  When I lay completely still, I was ok so I had to do that.  I couldn't work or take part in anything called life.  At hospital echo, EKG, lung xray, head, all done and found to be perfectly healthy.  They couldn't identify why I was so sick.  I knew exactly and tried to tell them.  One night in hospital I got up to take off the sheet and my blood pressure must have skyrocketed, cause anything I did w/ my upper body, I could not breathe and they rushed in.  My breathing is still not normal.  I was very aerobically fit.  Walked dogs everyday 3 - 4 mile.  Now even at a resting position, my breathing is not normal.  Went to pulmonary testing and she said I had trouble getting air out.  Neurologists speculate that I have a rare auto immune infection from the flu shot.  I have been so nauseous and dizzy that I have vomited in the last 10mos. more than my whole adult life, when I'm driving I have to pull over etc. neurologist sent me to vestibular testing saying that that part of my brain was damaged due to the initial attack.  I have an appt. w/ vng testing now coming up, and have had to file for disability etc.
Substernal chest pressure at rest for two episodes the day after the vaccine. No additional episodes since that time.
I got shingles from the vaccine/Suspected vaccination failure; I got shingles from the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got shingles from the vaccine/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles from the vaccine).The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient got shingles from the shingles vaccine. The patients doctor said it was not possible until he/she sent her a picture of it.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Dull jaw pain on the left side; left cheek was heavy without facial droop or swelling; A spontaneous report was received from a healthcare professional who was a female patient that experienced dull jaw pain on left side and her left cheek feeling heavy, without facial droop or swelling.    The patient's medical history included temporomandibular joint syndrome. Concomitant product use was not provided/unknown by the reporter.  On 04 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the left shoulder for prophylaxis of COVID-19 infection.   The reporter stated that soon after receiving the Moderna Covid-19 vaccine, she felt some dull jaw pain on the left side, which was resolved after a massage. Within an hour of receiving the vaccine, she felt heaviness in her left cheek, with no facial droop or swelling. Treatment for the event included 500mg acetaminophen and diphenhydramine hydrochloride. She volunteered that she always takes diphenhydramine hydrochloride following intramuscular injections.    Action taken with mRNA-1273 in response to the events is nor appplicabe.   The event, dull jaw pain on the left side was considered resolved on 04 Jan 2021. The outcome of the event left cheek was heavy, without facial droop or swelling is unknown.   The reporter did not provide causality for the events dull jaw pain on left side and her left cheek feeling heavy, without facial droop or swelling.; Reporter'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.
diarrhea; fever (101 to 103 F); soreness; vomiting; chills; swollen lymph nodes; headache; This spontaneous case was reported by a nurse and describes the occurrence of   in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to mod-2021-039953 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Follow up received on 23-Feb-2021, no new information was recorded On 11-Mar-2021: Patient details updated
Horse voice after 2nd shot; Lump under the left arm pit after 2nd shot; Left ear infection after 2nd shot; Can not hear on the left ear after 2nd shot; Inner left ear is getting large after 2nd shot; Inner left ear is getting more inflamed after 2nd shot; Inflammation under the left arm pit after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Horse voice after 2nd shot), INFLAMMATION (Inflammation under the left arm pit after 2nd shot), AXILLARY MASS (Lump under the left arm pit after 2nd shot), EAR INFECTION (Left ear infection after 2nd shot) and HYPOACUSIS (Can not hear on the left ear after 2nd shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced INFLAMMATION (Inflammation under the left arm pit after 2nd shot), AXILLARY MASS (Lump under the left arm pit after 2nd shot), EAR INFECTION (Left ear infection after 2nd shot), HYPOACUSIS (Can not hear on the left ear after 2nd shot), EAR DISCOMFORT (Inner left ear is getting large after 2nd shot) and EAR INFLAMMATION (Inner left ear is getting more inflamed after 2nd shot). On 02-Nov-2021, the patient experienced DYSPHONIA (Horse voice after 2nd shot). At the time of the report, DYSPHONIA (Horse voice after 2nd shot), INFLAMMATION (Inflammation under the left arm pit after 2nd shot), AXILLARY MASS (Lump under the left arm pit after 2nd shot), EAR INFECTION (Left ear infection after 2nd shot), HYPOACUSIS (Can not hear on the left ear after 2nd shot), EAR DISCOMFORT (Inner left ear is getting large after 2nd shot) and EAR INFLAMMATION (Inner left ear is getting more inflamed after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information was provided. No treatment medication were provided.
Since injection have had a sinus infection and swollen, hard, painful lymph nodes in armpit and groin areas.  Armpit nodes are almost gone but the groin lymph nodes are still there.
Second dose received on day 57; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 57) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 048C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included QUINAPRIL HYDROCHLORIDE (ACCUPRIL), METOPROLOL, METFORMIN, HYDROCHLOROTHIAZIDE (HCTZ), ROSUVASTATIN and OMEPRAZOLE 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 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 57). On 26-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 57) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received second dose on the 57th day from dose 1. Action taken with mRNA-1273 in response to the events was not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: follow up was received on 9-Jun-2021, contained no new information.