chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her friend lost hearing on her right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Brain tumor" (unspecified if ongoing); "Muscle disease" (unspecified if ongoing), notes: Muscle disease; "Migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant) with onset 20Jul2022, outcome "unknown", described as "Her friend lost hearing on her right ear".  Clinical information: Caller is calling on behalf of her girlfriend. Her friend got the first dose of Pfizer COVID-19 Vaccine. Her friend lost hearing on her right ear. She wants information on this in relation to the vaccine. She mentioned that her friend has brain tumor and muscle disease and is on her way now to the ER. She also mentioned of migraine. Consumer calling regarding COVID-19 vaccination, the first one. They are aware of body aches and possible fever, but her girlfriend lost her hearing in her right ear. Her girlfriend is on her way to the emergency room, they just want to know how severe. Her girlfriend has a brain tumor and a muscle disease and stuff like that. She received the vaccine yesterday and lost her hearing today. Her primary care doctor, Dr. withheld, doesn't know about this. It was done at withheld, withheld. Her girlfriend is going to withheld in withheld on withheld to the emergency room. She thinks the address is withheld but is not sure. Just put withheld Hospital. A pharmacist gave the COVID-19 vaccine. Caller declines completing the report and requests transfer to Medical Information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax;rash on torso;red,blotchy;not itchy;"major ha for a wk p/ dose;sl redness w/ induration at site;had 3 doses series 10 yrs ago;will see dermatologist because uncertain w/ vax;has had pre dx skin condition in past;
fatigue, muscle aches day after vaccine; early morning of 2nd day after vaccine noted red, slightly raised rash to bilateral upper/lower extremities and anterior/posterior trunk and neck
headache; a 64 year old female inadvertently received a dose of Flublok QIV that had been expired on  30Jun2019; a 64 year old female inadvertently received a dose of Flublok QIV that had been involved in a temperature excursion as shipment took too long in transit; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse and additional information received on 30 -Oct-2019 from nurse.  This case involves a 64 years old female patient who experienced headache (headache) after receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] which was expired and exposed to temperature excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient was postmenopausal.   On 29-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1952 expiry date: 30-Jun-2019, via intramuscular route in the right deltoid.  On an unknown date, patient experienced a non-serious headache (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.as shipment took too long in transit  It was reported that Flublok QIV involved in a temperature excursion and expired on 30-Jun-2019.  It was an actual medication error due to expired vaccine used and incorrect product storage.  Final diagnosis was headache.  No corrective treatment was not reported.  The patient outcome is reported as Unknown for headache.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain necking that is getting worse; Cant move due to the strong pain neck; Excreting a lot of pee; Injection site is very sore; Nausea; Fever; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 10-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain necking that is getting worse), NUCHAL RIGIDITY (Cant move due to the strong pain neck), URINE OUTPUT INCREASED (Excreting a lot of pee), VACCINATION SITE PAIN (Injection site is very sore) and NAUSEA (Nausea) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced URINE OUTPUT INCREASED (Excreting a lot of pee), VACCINATION SITE PAIN (Injection site is very sore), NAUSEA (Nausea), PYREXIA (Fever) and HEADACHE (Headache). On 09-Apr-2021, the patient experienced NECK PAIN (Pain necking that is getting worse) and NUCHAL RIGIDITY (Cant move due to the strong pain neck). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, NECK PAIN (Pain necking that is getting worse), NUCHAL RIGIDITY (Cant move due to the strong pain neck), URINE OUTPUT INCREASED (Excreting a lot of pee), VACCINATION SITE PAIN (Injection site is very sore), NAUSEA (Nausea), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No  Concomitant medications were provided
Cold/flu symptoms for 2+ weeks. On and off chills and low fever. Had trouble sleeping for a little bit.
Administered two orange cap Pfizer "booster" vaccines on 10-12-22 afternoon.  Email from Health Authority had not been read at that time.  We are a very busy office and often read emails at the end of the day.    No adverse effects have been reported.   Thank you.
States she had nausea and chest pain within 30min. Then aching felt bad. Went to bed. Woke and went to toilet 4 hours after vaccine. "Passed out" knocked head. Went to ER. Assessed and sent home.
Pt developed swelling, pain, redness with varicella in Lt arm & with ADACEL given in Rt hip advised pt to take BENADRYL.
usual headache; This is a spontaneous report from a contactable female consumer (patient) reported for herself. An 82-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9810), via an unspecified route of administration on 16Feb2021 (age at vaccination: 82-year-old) as a single dose for covid-19 immunization. Medical history included High blood pressure, patient do take medicine and was under control. Concomitant medication included ramipril in the morning and 10 at night. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at the age of 82-year-old as a single dose for covid-19 immunization. On 16Feb2021 the patient experienced no immediate side effects other than a small headache the first couple of days. Starting on Friday (19Feb2021), she's been having headaches ever since. Patient wanted to know if it was normal for these headaches to last for this long. The headaches were not as bad now as they were and not a usual headache, as its more of a sharp pain. Therapeutic measures taken as a result of the events included Tylenol. The patient underwent lab test and procedure which included blood test past Monday and the result was unknown. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.  Follow up (25Feb2021): New information received from a contactable consumer included medical history added, concomitant medication added, treatment drug added, and lab data added.
I got a shingle (boost) shot from pharmacy one year ago (June 2014). I had a very bad injection site reaction for a month after I got the shot. Then, since December, I have been having Shingles all over my body. It is very painful.
With the second dose I ended up with severe pain on my upper back through my neck/shoulder area and also had pain in my rib cages (both). I experienced joint pain in my ankles and knees (no known case of arthritis) they were off and on and extreme fatigue. I still have pain in my upper back/neck shoulder area and the fatigue. The rib cage pain and the joint pain are gone
Approximately 11:55pm on the day of vaccination, patient felt very lightheaded, weak and nauseous, and actually fainted, falling to the floor.  After quickly regaining consciousness, and sitting on the floor for a few minutes, patient became very nauseous and vomited numerous times.  Vomiting subsided after 5-10 minutes and with my assistance patient was able to get to bed and sleep, without any further vomiting. Following morning patient reports extensive soreness at injection sites, continued weakness of legs, and substantial fatigue.
Vaccinee received second vaccination (IM-Deltoid) 2-Nov-89 experienced bilateral arthralgia of knees, muscular weakness, weakness of legs
stored within range standard freezer temperatures through 3/29/2021/ moved to a within range refrigerator on 3/29/2021; Given past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given past the expiration date) and PRODUCT STORAGE ERROR (stored within range standard freezer temperatures through 3/29/2021/ moved to a within range refrigerator on 3/29/2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored within range standard freezer temperatures through 3/29/2021/ moved to a within range refrigerator on 3/29/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given past the expiration date) and PRODUCT STORAGE ERROR (stored within range standard freezer temperatures through 3/29/2021/ moved to a within range refrigerator on 3/29/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vaccine was stored at within range standard freezer temperatures (Min/Max = -13.0 F to -9.0 F) between 19-Jan-2021 through 29-Mar-2021. The vaccine was moved to a within range refrigerator (35.6 F to 46.4 F) on 29-Mar-2021 at 1300 hours. booster dose (0.25 ml) was given to a patient past the expiration date of 28-Mar-2022 on 30-Mar-2022 at 1300 hours.  No treatment medications was reported.
No adverse event, client was given an inappropriate vaccine. A ten month old was given 0.5cc (IM) of meningococcal (group A,C,Y and W-135) Trade name: Menactra.
No additional adverse effect reported; 17-year-old patient is in office 6/16/2020 for GARDASIL 9 after was administered first dose of GARDASIL 9 when 14 years old; This spontaneous report as received from a registered nurse concerning a 17-year-old patient of unknown gender. The patient's pertinent medical history, drug allergies, reactions, or concomitant medications were not provided.  In approximately 2017 (reported as "when 14 years old"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, lot# and expiration date were unknown) intramuscularly for prophylaxis. On 16-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, lot# and expiration date were unknown), intramuscularly for prophylaxis (inappropriate schedule of vaccine administered). No additional adverse effect was reported.
Patient indicated to pharmacist, she has an episode of fainting when she get vaccination. she indicated it happened for both her 1st and second dose at Agency. She showed no symptoms of being sick before vaccination other than being nervous. About 2mins after shot, rph asked  lead tech to offer her some water. While the tech was out to offer her the water, she started to complain about being nauseous. Patient quickly deteriorated and fainted. she was placed on her side and ED was called. Patient had strong pulse  through out observation. Pharmacist waited with patient until paramedics arrived
6 days prior to hosp admission, pt diagnosed positive for COVID in the ED; left AMA to home; admitted to hosp with increase in weakness and SOB; O2 sats in the 70s; placed on NRB and NC; treated with remdesivir and dexamethasone; PMH renal transplant, HTN, monoclonal gammopathy; DNI/DNR; optiflow therapy for hypoxia; condition worsened; pt transferred to palliative care; pt's condition continued to decline and she expired in the hosp
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     The patient had no medical conditions.   On 19-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (covid 19). On 16-Dec-2022, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2022, SARS-CoV-2 test: Negative.  For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received 1st dose on 05-Feb-2021, lot no. 010M20A, 2nd dose on 04-Mar-2021, lot no. 014M20A and 1st booster on 01-Apr-2021, lot no. 048L21A.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient experienced chills, achiness, headache, congestion of nose, cough, nasal drip, and got diarrhea during approximately 2 weeks, it was not too bad but she got dehydrated.   No treatment was given.   This case was linked to MOD-2021-304545 (Patient Link).
profound headache; resembling meningitis: could not turn neck from side to side; resembling meningitis: could not turn neck from side to side; pressure behind eyes when moving eyes quickly; profound body aches, primarily in the lower back; profound body aches, primarily in the lower back; 100.2-101.0 fever; chills; lethargy; This is a spontaneous report from a contactable Nurse reported for self. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:30 at single dose for covid-19 immunisation. Medical history was not reported. Concomitant medication included influenza vaccine inact split 4v (AFLURIA QUAD), desogestrel, ethinylestradiol (APRI). The patient experienced profound headache, resembling meningitis: could not turn neck from side to side, pressure behind eyes when moving eyes quickly. -profound body aches, primarily in the lower back. -100.2-101.0 fever -chills -lethargy on 10Jan2021 12:00. Patient had Rapid nasal swab with negative result on 26Oct2020. Outcome of events was recovering.
Morning after injection I experienced sever, muscle cramping in upper right thigh. Took me 10 minutes to get out of bed as each  time I moved my right leg the spasms would begin again.
35 yr old slender man in warm room felt faint 15 minutes after injection, placed supine, iced, hydrated, and self resolved, declined EMS call, departed without assistance with friend.
(11/28) On the second day after the shot it stung like a bee sting and caused a huge welt. Called doctor to set up appointment for 11/30. At the office I got a physical exam and it was determined structure infections at the injection site.  Was issued Cephalexin for the infection and currently taking it. Seven day course at 500mg.
localized erythema, swelling, tenderness and fever that developed over approx 36 hours. Seen in ER and treated with Benadryl
This spontaneous report as received from a consumer refers to a male patient of unknown age reporting on himself. Pertinent medical history, drug reaction or allergies were not reported. On 21-APR-2014, the patient was vaccinated with an improperly stored dose of GARDASIL dose 1 (lot# was not reported) by his physician. Concomitant therapy was not reported. The patient reported that he stored GARDASIL in his refrigerator at 28 F overnight. No adverse effects reported. Additional information is not expected.
Left arm large reddened, swollen area approx 3" x 5" warm to touch. No temp, no other problems. Tx with compresses and Tylenol.
Injection site pain; Fatigue; A spontaneous report was received from a Pharmacist, stating about multiple patients (no patient's valid identifiers) who received Moderna's COVID-19 vaccine and experienced injection site pain and fatigue.  Medical history was not provided. Concomitant medications were not reported.  On 28 Dec 2020, prior to the onset of the events, the patients received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.  On 29 Dec 2020, after receiving the vaccine, the patients experienced Pain at the injection site and fatigue. Treatment of the events were not reported. Pharmacist stated their employees were told to wait either until they were actually approved or 4-5 months to receive the 2nd dose of the vaccine.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events injection site pain and fatigue was not reported.; Reporter's Comments: This case concerns a patient with nonserious expected injection site pain and fatigue. Event onset Day 2 after first dose mRNA-1273. Treatment not reported.  Event outcomes unknown. 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.
her stool is black, a bit of "diarrhea but not diarrhea" as verbalized. Then the next stool is red liquid in color.; her stool is black, a bit of "diarrhea but not diarrhea" as verbalized. Then the next stool is red liquid in color.; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for covid-19 immunisation. On an unspecified date in May2021, the patient noticed that her stool is black, a bit of "diarrhea but not diarrhea" as verbalized. Then the next stool is red liquid in color. The patient asked if this was a side effect of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
a patient who presented to them for their 2nd dose of the Moderna Covid-19 Vaccine, and she's 16 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a patient who presented to them for their 2nd dose of the Moderna Covid-19 Vaccine, and she's 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a patient who presented to them for their 2nd dose of the Moderna Covid-19 Vaccine, and she's 16 years old). On 13-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a patient who presented to them for their 2nd dose of the Moderna Covid-19 Vaccine, and she's 16 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was provided. No treatment medications were reported.
Given an Expired Dose of Heplisav-B; Initial Report Received on 23-Nov-2021  A physician reported that a 22 year-old male (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient did not develop any adverse reactions.  Medical history was reported as Crohn's. The patient had no known drug allergies.  No relevant concomitant medications were reported.    On 23-Nov-2021, the patient received an expired dose of HEPLISAV-B (Lot # 934259, expiration date 25-Sep-2021 and NDC # 43528-003-05) intramuscularly.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Developed nausea, cervical and axillary LAD, fever, swelling in throat, difficulty breathing, anorexia x 3 ds. Sxs began soon after receiving vaccines. No prior rx from anthrax 1 except local rx and nodule that persisted 3 months.
during our covid site visit from DOH on 12.15.22. It was discovered that we had a pfizer in the frig past BUD date. during the DOH investigation they went back through all the covid injections that were given and saw this patients lot number was given past the BUD date. patient has been contacted and revaccination was offered. manufacture was notified and reports were filed pending outcome.