chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From Emergency room medical record "Multiple red, scabbed oozing lesions scattered over most of body, reports rash started...on legs and spread from there. Noted a couple of days after receiving influenza vaccine. Rash burns and itches, worse pain on back. Large swollen area L lat chest. L ear swollen, painful and solid red. Treatment- In ER- Ketorolac inj 30mg IV, Diphenhydramine 50mg IV, Methylpred Succ 125mg IV all x1,  Given rx for Bactrim DS, sig:1 bid x 10d, and Prednisone, descending dose pack.
A 43 year old patient with a history of pneumonia may receive PNEUMOVAX 23 which would be off label use but was prescribed by an unknown physician; This spontaneous report was received from Pharmacist and refers to a 43-year-old patien of unknown gender. The patient's medical history included  pneumonia. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was prescribed pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), which would be off label use but was prescribed by an unknown physician.  It was confirmed that the patient did not received the vaccine.
Began with fever of 100 degrees and lethargy and soreness and redness at injection site. As time went on, the redness, swelling, and pain expanded to cover area about the size of a paperback book. Fever remained at 100, sweating, feeling ill.
Staggering/ Unsteady; light chest pains; oxygen level went down to 86%; Couldn't stand up; lost taste buds; runny nose; headache; shooting pains in every joint in her body; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (light chest pains), ASTHENIA (Couldn't stand up), GAIT DISTURBANCE (Staggering/ Unsteady), AGEUSIA (lost taste buds) and RHINORRHOEA (runny nose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 at the end of October 2020 which lasted about a month.) in October 2020. Concurrent medical conditions included Diabetes, Hypertension, Hiatal hernia, Heart disease, unspecified and Gout. Concomitant products included LOSARTAN for Blood pressure management, SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes, FUROSEMIDE for Diuretic therapy, ALLOPURINOL for Gout, AMLODIPINE and CLOPIDOGREL for Heart disease, unspecified, OMEPRAZOLE for Hiatal hernia, MONTELUKAST, LEVOTHYROXINE, ACETYLSALICYLIC ACID (aspirin), ROSUVASTATIN CALCIUM and METOPROLOL TARTRATE for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced AGEUSIA (lost taste buds), RHINORRHOEA (runny nose), HEADACHE (headache) and ARTHRALGIA (shooting pains in every joint in her body). On 23-Apr-2021, the patient experienced ASTHENIA (Couldn't stand up). On 24-Apr-2021, the patient experienced CHEST PAIN (light chest pains) and OXYGEN SATURATION DECREASED (oxygen level went down to 86%). On 25-Apr-2021, the patient experienced GAIT DISTURBANCE (Staggering/ Unsteady). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 22-Apr-2021 for Adverse event NOS, at an unspecified dose and frequency. On 24-Apr-2021, CHEST PAIN (light chest pains) and OXYGEN SATURATION DECREASED (oxygen level went down to 86%) had resolved. On 25-Apr-2021, ASTHENIA (Couldn't stand up) and GAIT DISTURBANCE (Staggering/ Unsteady) had resolved. On 26-Apr-2021, AGEUSIA (lost taste buds), RHINORRHOEA (runny nose), HEADACHE (headache) and ARTHRALGIA (shooting pains in every joint in her body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Oxygen saturation: low (Low) oxygen level went down to 86%. On an unknown date, Oxygen saturation: normal (normal) has been 95-99% which is normal for her.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Shot placed way too high on shoulder, not in the muscle. Immediate pain that got worse over the next 24 hours and beyond.  Bursitis and adhesive capsulitis. Cortisone shots provide some relief. Still experiencing symptoms
Patient lost consciousness and passed out. She fell down in the process. Patient also developed a small seizure and had muscle rigidity and cramping. Patient eventually regained consciousness and report pain due the fall. I gave her some water and pain medication. Patient was observed for 30 minutes before releasing her to her guardian.
24 hours after 2nd SHINGRIX, pt had flu like symptoms....N&V, diarrhea, ache all over. 1st SHINGRIX, her arm was very achy.
diarrhea; severe headache; pain in arm; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HEADACHE (severe headache), PAIN IN EXTREMITY (pain in arm), PYREXIA (fever) and NAUSEA (nausea) in a 25-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Flu.    The patient's past medical history included COVID-19 in June 2022.   On 02-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 02-Nov-2023, the patient experienced DIARRHOEA (diarrhea), HEADACHE (severe headache), PAIN IN EXTREMITY (pain in arm), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), HEADACHE (severe headache), PAIN IN EXTREMITY (pain in arm), PYREXIA (fever) and NAUSEA (nausea) was resolving.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   Concomitant product use was not provided by the reporter.  The patient received flu and covid shot in same arm.   The patient experienced severe headache, pain in arm, fever-like symptoms, nausea and diarrhea.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Around 4am the morning after I received the vaccine I began experiencing severe muscle and joint pain. I had a fever of about 100F. While standing up to take my temperature and take some Tylenol I began to feel dizzy and fainted. At around 5am I became extremely nauseous and vomited several times. After this I attempted to use the toilet and fainted, falling off the toilet. After I regained consciousness I called for help but was unable to stand up without becoming dizzy or fainting. I attempted to drink some water but was unable to keep anything down. I became dehydrated and both my blood sugar and blood pressure dropped. Around 8am I had thrown up so much that I was dry heaving. Even though there was nothing left for me to throw up I continued to dry heave and was unable to keep any water or medication down. At around 9am my roommate drove me to the student health clinic where I was treated by the doctor with an injection of Zofran and an IV of saline, glucose, and water. I was also given a prescription of Zofran tablets to take home with me. After a few hours I was sent home to rest. I slowly began drinking water but was unable to eat anything except a few saltine crackers later that night. I spent much of the recovery time sleeping and attempting to treat my fever with Tylenol, water, and cold compress. My fever lasted another 24-36hrs and I was unable to complete any daily tasks such as bathing or dressing etc.
The patient got Moderna with no problem other than sore arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The patient got Moderna with no problem other than sore arms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (The patient got Moderna with no problem other than sore arms). At the time of the report, PAIN IN EXTREMITY (The patient got Moderna with no problem other than sore arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient got Moderna with no problem other than sore arms. No Concomitant medications were reported. No treatment medications were reported.  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.
I developed an uncontrollable itch, pain and swelling on both ankles, feet and lower legs after receiving the second dose of the Pfizer COVID-19 vaccine.  The swelling was so severe that I had to wrap them with ice.  I had hoped that this would alleviate some of the swelling but it did not.  I also used an over the counter anti-itch medication.  On September 27, I met with my doctor and got a prescription for steroids.  The swelling has gone down but I still have an unusual itch that was not there before the shot.
Patient presented to the emergency room with complaints of severe left arm/shoulder pain.  Patient reported receiving vaccine around 230pm in clinic, and noted a sting when received.  Patient reported that her arm began to hurt around 7pm in evening and described as a constant ache that radiated done the arm to hand.   Patient also reported increased discomfort when trying to move arm.  Patient had attempted Tylenol and ice at home with no relief.  In the ED patient was treated with IV Toradol, Deep Blue topical to shoulder/arm and ice.  Referral made for Outpatient Physical Therapy/Ultrasound.
It was reported 2 hrs post vaccine pt developed an injection site reaction characterized by redness, swelling and heat at an unspecified site.
Received vaccine 6/28/04. On 7/7/04 developed fever with temp 100.4 Ax, Fuzziness, scattered areas of breaking out resembling chickenpox except areas are smaller and fewer than a normal case. Areas on face, trunk, legs, on 7/8/04 report has a few more areas than on 7/7/04. Mother at this time only giving infant Tylenol for comfort.
Adverse event(s): rash at the injection site, bone and body ache  Signs: redness at injection site, pain  Time course: on-going
Mom states pt cried for most of 24 hrs p/vax was administered; Pt continued whining the 2nd & 3rd days;
Fever (~100 degree F) and fatigue on one evening only (26 Dec); since then -- running nose, chest congestion, coughing up dark phlegm.
Abdominal pain, low fever, headache, muscle and joint soreness, fatigue/ weakness, nausea, diarrhea, congestion.
Following administration of Influenza vax, pt 80+ yrs old devel nausea & general feeling of illness;
Information has been received from a nurse via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date the patient was vaccinated with GARDASIL 9, pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, frequency, lot #, expiration date and route were not reported for all the suspect vaccines) and meningococcal vaccine at the same time. The patient had a "mini seizure" in the exam room after receiving the vaccines and fainted outside of the office. It was reported that the patient was recovered from the adverse events at the time of reporting. The relatedness between adverse events and GARDASIL 9 and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Upon internal review, the event of seizure was considered to be medically significant. Additional information is not expected as no contact details available.
Patient called office had Gardasil Vaccine this AM, Now c/o pain between shoulder Blades, hurts to Breathe. Patient Advised to go to sisters Hospital Emergency Room per Dr. instructions.
pt recv vax & 2-3wk later pt devel a few pustules scattered throughout body however, there were non @ the inj site;8wk p/vax pt devel t102 & papular rash that looked like hives;to MD lab eval revealed nl CBC;dx serum sickness;
Nausea (in an individual who hasn't been nauseous in over 30 years), mild headache, malaise. No fever.  Drank gingerale, which settled stomach. Went to sleep 9:00 p.m., woke up 4:00 a.m., 10/30/09, with mild headache, malaise.
Pt recvd vax 24AUG93 seen in clinic for fever, diarrhea & dehydration same day; LP pos for H. influenzae type B; tx'd w/ATB; neuro consulted pt w/profound hearing loss & has lost ability to walk;  chickenpox & rotoviru
A 2ND JANSSEN COVID VACCINE WAS GIVEN 5/5/21, #1805031; pt had a positive COVID test at the Medical Center on 9/20/22; was given Paxlovid and dc'd to home; 9/30/22 pt to Hospice with hospice dx of COPD, GIP for dyspnea; bedbound, unresponsive; O2 supplementation; pt passed away in hospice facility
Patient had received covid 19 vaccine approximately 5 minutes before onset of symptoms. Patient experienced tachycardia and "felt like she was going to pass out". Patient given 25 mg oral benadryl and code called. Patient remained alert during episode, no LOC.  Patient transported to ED for further assessment and monitoring. Discharged.
injection site got red and felt super itchy; injection site got red and felt super itchy; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. Caller said after her 2nd dose, the injection site got red and felt super itchy. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
GARDASIL 9 at the age of 50; No adverse effects reported; This spontaneous report was received from the patient's wife concerning his husband, a 50 year old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with the first shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects reported.
Severe nausea, dizziness, fatigue, headache, muscle aches, red skin rash on both arms, joint aches, irritability
Periphral Neuropathy.  3-6mo after vaccine. Tests, pain medication.
14 day IMOVAX RABIES dose was delayed/ NO AE; Initial information received on 06-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional via call center via Global Medical Information (GMI) (Reference number- 00670358).  This case involves a patient of (unknown demographics) whose 14th day dose was missed for RABIES (HDC) VACCINE [IMOVAX RABIES] (missed dose).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an unknown route in unknown administration site for product used for unknown indication.  It was an actual medication error case due to missed dose (latency: same day).  Caller wanting to know how to proceed for a delay in dose and The pharmacy reported that the delay in dose is due to a unusable dose of Imovax that exploded and that the consumer is due for day 14 today. Stated that he has questions on the Imovax and dosing. Pharmacy does not have the Imovax vaccine on hand.   At the time of reporting, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
When patient came in for second dose she said the first dose of the vaccine was given too high stating it was right up by her bone.  She said she did not have any side effects from the vaccine and stated that her arm was not sore.
Vaccine received on Thursday at 3:08 pm.   Headache, nausea, temperature (Tmax 101.7), extreme muscle pain and joint discomfort all day Friday.   2 Tylenol Extra strength taken at 10 pm on Friday evening and repeated at 10 am on Saturday morning (I don't like to take medicine and held off as long as I could). Temperature on Saturday in the 100.3 to 100.7 range down to the 99.1 - 99.5 range on Sunday.  Intermittent muscle and joint pain that subsided by Sunday morning.  Remain with occasional slight headaches and not feeling "normal"
aches; loss of appetite; nausea; diarrhea; extreme tiredness; chills; oral temp max of 101.7; slept almost that entire time; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 17:45 (Lot number: FF8839) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "mild hypertension" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin, sulfa drugs; "known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; OMEGA 3; LYSINE; VIT D; MG; FLU, administration date 21Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK9231, Location of injection: Arm Left, Vaccine Administration Time: 05:15 PM), administration date: 11Jan2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 05:15 PM), administration date: 21Dec2020, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "aches"; DECREASED APPETITE (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "loss of appetite"; NAUSEA (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "nausea"; DIARRHOEA (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "diarrhea"; FATIGUE (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "extreme tiredness"; CHILLS (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "chills"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "oral temp max of 101.7"; SOMNOLENCE (non-serious) with onset 11Oct2021 23:00, outcome "recovered" (Oct2021), described as "slept almost that entire time". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, decreased appetite, nausea, diarrhoea, fatigue, chills, body temperature abnormal, somnolence.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination: B Complex,   Follow-up attempts are completed. No further information is expected.
59-year-old female with possible history of SJS, diabetes, hypertension presents ED 20 minutes after receiving Covid vaccine for concern for anaphylaxis.  Initially in the ED, patient is afebrile, with normal heart rate, respiratory rate, blood pressure; nonhypoxic on room air at 100%.  No stridor or adventitious lung sounds appreciated.  Normal rate.  Clear to auscultation bilaterally.  Patient is nontoxic in appearing.  Exam unremarkable.  Patient was given Benadryl and Decadron.  She was watched for approximately 30 to 45 minutes in the ED.  She had no further concerns after this observation.  Patient was discharged home with a prescription for epinephrine pen.  Recommendation to follow-up with her primary doctor and also with an allergist.  Patient was comfortable this plan.  At time of discharge, patient is hemodynamic stable.
received Havrix expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received HAV (Havrix) (batch number BE554, expiry date 1st August 2021) for prophylaxis.   On 4th August 2021, the patient received the 1st dose of Havrix. On 4th August 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: On 4th August 2021, the patient was administered Havrix, which was expired on 1st August 2021. The reporter consented to follow up via mail.
Pt called the store and reported that she was having allergic reaction including hives, diarrhea, possible swelling in the throat and some difficulty breathing. Pharmacist on duty advised her to go to the ER. Pt did go to walk in clinic but by the and she was seen, symptoms were gone and no treatment was needed or given.
On 5DEC91 pt was given DTP/HIB/OPV 2 days later devel fever to 101; Pt seemed limp & pale, minimally responsive, cool moist to touch; p/1 1/2 min came out & seemed well; no further episodes;
Information has been received from a physician via a company referring to a male patient. The age of the patient was reported as "in their mid 60's" or "around 89 years of age". The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N019838, expiration date 16-FEB-2019; dose, strength unknown) intramuscular in unspecified side of deltoid for prophylaxis. On 28-DEC-2017, the patient had severe pain in the injection area for a couple of days. There was no redness or swelling on the area. At the reported time, the patient was better. The causality between pain and PNEUMOVAX 23 was unknown. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA002540.
I.T.P. developed on 9/2/03. Received steroids and (?).
Severe chills and uncontrollable shivering alternating with low-grade fever and cold sweats, onset 24 hours after injection. Duration of 2 days.  Diarrhea, onset after 48 hours. Duration 6-7 days. Treated with OTC antidiarrheals (loperamide HCl) Headache, onset 5-6 hours after injection. Duration 11 days. Treated with ibuprofen.