chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; a racing heartbeat; light headedness; sharp pain in her elbows; felt terrible; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Caller is asking if she can receive her 2nd dose a day earlier than the scheduled 21 days due to potential bad weather on the date of her appointment. She received the 1st dose on 21Mar2021 and scheduled for her 2nd dose this sunday, 11Apr2021. Caller mentioned that upon receiving her 1st dose of the Pfizer COVID Vaccine on 21Mar2021 she was out it and felt terrible. She experienced fatigue, a racing heartbeat, and light headedness. She also mentioned that she has noticed a sharp pain in her elbows. When she called her doctor's office, the nurse told that the doctor was also out for 3 days after getting vaccinated with a COVID vaccine and that they had several patients calling in for palpitations, fatigue, and fast heartbeats after getting vaccinated. She mentioned that even vitamins make her dizzy and that her body does not take well to anything foreign. She is asking if she maybe expecting the same thing with the 2nd dose. The patient underwent lab tests and procedures which included heart rate: a racing heartbeat on unknown date. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Lethargic,large red swollen rash at the site of the mmr vaccine,very irratiable,forgetful,non social.
inc fussiness over 48hr p/vax w/t103-104 on 2nd noc assoc w/hand tremors, eye rolling
3/12/22 Saturday morning - sore arm, swelling hands, feet, and arm redness where injection was given. Saturday evening - diarrhea, nausea, chills, and tired. 03/13/22 Sunday all day very tired, sore throat, loss appetite, and body aches. 03/14/22 Monday, whole body aches, had to call out of work. Sore throat, very tired.
pt seen in pvt office for localized rxn immun given in ER;advised ibuprofen & ice for 5cm induration;given for laceration prior to repair (suture);
Sat in recovery for 30 minutes before stating to the monitor that he felt lightheaded, hot.  His face was reddened and noted heavy hoody jacket around his neck.  He stated that he had not had much to drink today, so started to hydrate with water.  At 1:42 pm, VSS: 122/82-112 Hr-97% on room air.  His vitals were rechecked at 1:59 pm HR-107, O2 saturation: 97% on room air.  States that he works at specific location and needs the evening off to finish a paper that is due.  Attempted to call the place of employment as continues to feel lightheaded.  Card with contact information given to patient to show work and continued to hydrate until his release at 2:30 pm.  He was able to walk out on his own.
pain going into the back; chills; orange sized swelling at injection site; fever for one day (99.2F); bit of a cough; egg size lump on the neck above the clavicle; pain going into the neck; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (bit of a cough), NECK MASS (egg size lump on the neck above the clavicle), NECK PAIN (pain going into the neck), BACK PAIN (pain going into the back) and CHILLS (chills) 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.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Paracetamol.    The patient's past medical history included No adverse event (No reported medical history).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 01-Apr-2021, the patient experienced COUGH (bit of a cough), NECK MASS (egg size lump on the neck above the clavicle), NECK PAIN (pain going into the neck), CHILLS (chills), VACCINATION SITE SWELLING (orange sized swelling at injection site) and PYREXIA (fever for one day (99.2F)). On 05-Apr-2021, the patient experienced BACK PAIN (pain going into the back). On 02-Apr-2021, CHILLS (chills) and PYREXIA (fever for one day (99.2F)) had resolved. At the time of the report, COUGH (bit of a cough), NECK MASS (egg size lump on the neck above the clavicle), NECK PAIN (pain going into the neck), BACK PAIN (pain going into the back) and VACCINATION SITE SWELLING (orange sized swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-067350 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067350:
I only had 1 dose on 2/16/2021  and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway.   body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs.  I feel fine today
Information ahs been received from a health authority concerning a 4 month old infant who on 16-APR-2007 was vaccinated with a first 2 ml oral dose of Rotateq (Lot# 654663/0942F). The patient was not experiencing any known symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. This is one of two reports from the same source. Additional information has been requested.
Moderate to severe nausea with associated abdominal pain as well as treatment resistant hypo and hyperglycemia
Fever for 2 days, headache for 2 days, continuin muscle/joint pain, coldsore/cankersore like growth inside of mouth that continues to get larger in size, painful to lift arms up above waist.
Pt received PNEUMOVAX 23 on 8/15/17 at approx. 2:30 in the afternoon. At that time, she was advised her left shoulder may feel unusually sore. She was encouraged to continue using the arm and apply pain relief measures such as warm and/or cold compress and ibuprofen prn. That evening around 9 pm she began feeling some significant soreness, so she took ibuprofen 400 mg. The morning of the 16th she woke with increased soreness which significantly limited her shoulder mobility  had difficulty dressing or putting her hair in a ponytail. She took ibuprofen 400 mg at 9 am, then again at 12 noon due to increasing soreness. She repeated the dose again at 3:45 pm.
Deaf in one ear after 2nd Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Deaf in one ear after 2nd Moderna shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Deaf in one ear after 2nd Moderna shot) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Deaf in one ear after 2nd Moderna shot) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company comment:  This spontaneous case concerns a patient of unknown age and gender, with unknown medical history, who experienced the serious (medically significant) unexpected event of DEAFNESS UNILATERAL. The event occurred on an unknown date after receiving the second dose of mRNA-1273. The rechallenge is not applicable since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was upgraded to medically significant according to IME list and considering the nature of the event was kept as such, even if there is very limited information for medical assessment. A query was sent for further information.   This case was linked to MOD-2021-404251 (Patient Link).; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with unknown medical history, who experienced the serious (medically significant) unexpected event of DEAFNESS UNILATERAL. The event occurred on an unknown date after receiving the second dose of mRNA-1273. The rechallenge is not applicable since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was upgraded to medically significant according to IME list and considering the nature of the event was kept as such, even if there is very limited information for medical assessment. A query was sent for further information.
Information has been received from the registered nurse on 31-DEC-2013. It was reported that PNEUMOVAX23 was administered to an unspecified number of patients. This report refers to one of the event: unspecified number of patients (unspecified age and gender) were administered doses of PNEUMOVAX23 in March 2013 (lot number and Expiration Date were not reported). This is one of the report from the same source, linked reports. Additional information is not expected.
Bell's Palsy; This spontaneous case from the Country was received on 20-Sep-2020 from a pharmacist via Agency (reference number: SEQW20-01995) and concerned an elderly, female patient.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2017, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On an unspecified date, after receiving Fluad (TIV), the patient developed Bell's Palsy.  On an unspecified date, the patient recovered from the event of Bell's Palsy. The patient was referred by the physician to the pharmacist to see if the patient could take the Fluad this year.   The reporter did not provide a causality assessment.  The event of Bell's Palsy was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A elderly, female patient experienced facial paralysis, an unknown amount of time after administration of Fluad (TIV) vaccine. Temporal relationship needs more clarification. The patient's medical history and concomitant medications were not provided. Due to lack of information, causal role of the suspect product is unassessable.; Sender's Comments: A elderly, female patient experienced facial paralysis, an unknown amount of time after administration of Fluad (TIV) vaccine. Temporal relationship needs more clarification. The patient's medical history and concomitant medications were not provided. Due to lack of information, causal role of the suspect product is unassessable.
Ear ringing/felt like ringing was in the middle of her head; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ear ringing/felt like ringing was in the middle of her head) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced TINNITUS (Ear ringing/felt like ringing was in the middle of her head). On 02-Feb-2021, TINNITUS (Ear ringing/felt like ringing was in the middle of her head) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow- up received on 19 Apr 2021: included contact information( Email address)
11/18 admitted, septic upon arrival, treated 11/23 bivalent COVID vaccine given 11/27 septic shock, hypoxemic resp failure, intubated, Klebsiella pneumonia, Enterobacter and VRE UTI, AKI 11/28 1 PRBC 11/30 1 PRBC   She was weaned off pressors but had persistent encephalopathy, oliguric AKI, and finger necrosis. I had several discussions with her brother and also with her friend. Once it became clear she would not recover to a quality of life acceptable to her felt she would want to be transitioned to comfort care. This occurred and she died comfortably shortly thereafter
I received the flu shot at 13:26 in right upper arm and then woke up at 4am with severe right shoulder pain and limited ROM. I took MOTRIN 800mg, applied cold and heat however the pain persists and the limited ROM persists, I could not even open a door today, carry my purse, brush my teeth with my right arm. I am a APRN and I did alert my PCP, we will continue to monitor and if needed I will go see her. Thank you. Place which I work for provided education to staff today with the CDC hand out - know the site, get it right, reviewed what SIRVA is and how to prevent it, and also provided staff the links for the online program.
no adverse event; administered a dose of ROTATEQ that had been improperly stored; This spontaneous report has been received from a medicall assistant, regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.   On 21-AUG- 2019, the patient was vaccinated with an improperly stored dose (Product storage error) of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), orally,  (lot number S000961 and R033255 have been verified to be valid lot numbers; expiration dates: 19-OCT-2020 and 26-JUN-2020, respectively; however, it was not specified if a second dose was given) administered as prophylaxis. (strengths, dose and frequency were not reported).  On 21- AUG- 2019 Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at a temperature of 48.5 degrees Fahrenheit  for the time frame of 15 minutes with a previous temperature excursion  at 46.9 F for a time frame of 5 minutes. It was reported that the call was due to Data logger. No adverse effects were reported.
20 MINUTES POST DOSE 1, PATIENT WENT TO RESTROOM, BECAME DIZZY AND FELL ON FLOOR.
About one week after vaccination patient experienced headache, arthralgia, myalgia, fatigue, some erythema around innoculation site.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On multiple unspecified dates, the patients were administered improperly stored (Oka/Merck) VARIVAX (lot # L048468, expiration date 02-DEC-2017, dose, route not provided). No adverse effects were reported. Names of vaccines involved: (Oka/Merck) VARIVAX. Lot number (s) and expiration date (s): L048468, expiration date 02-DEC-2017. Temperature: 0.2C. Time frame: 1 hour and 30 minutes. Was it administered (AE): Yes. Previous temperature excursion: No. Was call because of a "data logger": Yes. Additional information has been requested.
Severe chills and muscle spasms, sneezing runny nose, cellulitis around injection site.
I had a cold virus and it didn't seem to be getting better, so I went to the urgent care center thinking I might have a sinus infection or something.  Turns out that it was just a nasty cold virus.  I was also tested for COVID-19 at another facility and it was negative.
Vasovagal response. was conscious throughout the response, however temporarily low BP, extreme sweating, temporary numbness of arms and hands. Also had trouble with movement. After approximately 10-15 minutes was returned to normal bp and  was fine. Taken to local hospital. After 2hrs was followed up and patient reported being fine.
2nd day eye infection.  Matted, itching,red. Plus tearing & burning
no adverse events reported or described. received vaccine early, based on age 16yo, current EUA for moderna for 18yo or older
Right leg, radiating pain (Sciatica) Begining Prednisoslone oral series, 9/16/2022
mom states pt devel fines rash (feels like cornmeal) couple of days p/vax;rash began @ inj site & spread to back, chest, & neck;c/o itching;denies other sxs;
Patient reported having an extreme soreness at injection site. Then the entire arm swelled and went numb. Patient was fine day of vaccine. Symptoms started the next day and did not go away (spoke to patient 36 hours post vaccine). Patient used ice and Tylenol, but it did not help.
the first event was a few days after the shot when my cheeks turned bright red. This lasted about 2 and a half to three weeks. My cheeks are still a redder color than usual (my skin is light olive-toned( the second event(s) occurred April 23rd and again May 21st. My peripheral vision was obstructed by  shivering white rings with black lines. One of my eye doctors told me that they were ocular migraines. The first event lasted about one half to three quarters of an hour. The second event was 15 to 20 minutes.
No actual adverse reaction. Was suppose to get his second dose of Moderna and was accidently given Pfizer
This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 18-AUG-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose and route of administration were not reported) that had experienced temperature excursion. Reporter reported GARDASIL 9 with lot# K014191 (expiration date was not provided) which was not valid for GARDASIL 9. However, lot# K014191 was valid for GARDASIL. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I woke up the morning of April 11, 2021 with complete loss of use of the right side of my face.  I can not move my mouth, eye or nose.  I have numbness in my tongue as well.  I was given the diagnosis of Bells Palsy.
Body aches, chills, headache.  Treated with Tylenol for 24 hours and symptoms have started to subside
Stabbing abdominal pain with nausea. Patient removed from flying duty for 2 days and told to use OTC treatment.
received 1st dose covid19 vaccine on 12/18 and experience minimal soreness at injection site that resolved within 36 hours.   12/25 R arm became very sore and i developed a large, palpable "knot" at the injection site. The morning of the 26th it became very itchy and a visible raised welt/knot (approx 5cm) formed, skin around site was red and hot.  Resolved by 12/28
This spontaneous report as received from a Registered Nurse refers to patients of unknown age. The reporter reported that doses of M-M-R II (lot # was unknown) that had been exposed to temperatures exceeding 46 Fahrenheit for 9 hours, might have been administered to unspecified patients on 30-Jul-2012 and 31-Jul-2012. The nurse could not certain at the time of the call. No adverse effect reported. Additional information has been requested.
Fever and tired on 11/20/15. Arm was red and burning "like fire" on 11/21/15.
Injection site swelling; Injection site redness; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 28Apr2021 at 14:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afib). Concomitant medications included apixaban (ELIQUIS), diltiazem extended release (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN) and s (unspecified medication). The patient previously took meloxicam (MANUFACTURER UNKNOWN) and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 05Apr2021 at 14:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 16:00, the patient experienced injection site swelling and redness. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events injection site swelling and redness were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
PATIENT RECEIVED A PFIZER DOSE AS THE SECOND DOSE, BUT HAD MODERNA AS THE FIRST DOSE. NO ADVERSE REACTION IS KNOWN
2nd dose of SHINGRIX resulted in severe headache, nausea, muscle aches, and chills with low grade fever.
After receiving the Janssen vaccination my left arm became immediately sore. The soreness is still present. I also experienced joint pain and arm twitching. I didn't receive any treatment with regard to the symptoms as I was advised this is normal when receiving vaccines. I now have been diagnosed with Gout in my right toe. I have never experienced any of these symptoms before the vaccine. I am now on medication for joint pain and I do feel it contributed to the vaccination.
Swollen, red arm, aching ,chills, not feeling well, and lasted 48 hours.
Redness and warmth at vaccine site from 07/18/2007 DTaP series 3.
expired pentacel was administered to a patient with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient to whom expired pentacel was administered with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Sep-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection lot UJ752AAA, expiry date: 09-Sep-2023 via unknown route in unknown administration site for prophylactic vaccination (strength and dose: unknown), expired pentacel was administered to a patient with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered   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 the 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.