chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia; Lymphadenopathy; Arthralgia in the fingers; A spontaneous report  was received from a consumer concerning a 61-Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arthralgia in the fingers, lymphadenopathy and tachycardia.  The patient's medical history was not provided. Concomitant medications reported included Synthroid (levothyroxine sodium) and Lipitor (atorvastatin calcium).  On 08 Jan 2021, 6 days prior to the onset of the event Arthralgia in the fingers the patient received their first of two planned doses of mRNA-1273 (011J20A) in the left arm for prophylaxis of COVID-19 infection.    On 13 Jan 2021, the patient experienced arthralgia in the fingers. On 15 Jan 2021, the patient experienced lymphadenopathy in the left arm. On 25 Jan 2021, the patient experienced tachycardia.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  On 25 Jan 2021, the outcome of the event tachycardia was resolved. The outcome of the events arthralgia in the fingers and lymphadenopathy was not reported.; Reporter's Comments: This case concerns a 61-year-old female who experienced a nonserious unexpected event of tachycardia and nonserious expected events of lymphadenopathy and arthralgia.  Event onset was 6 days after the first dose of mRNA-1273. Treatment not reported.  Tachycardia resolved, but other 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.
She called because she is getting over stomach flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTROENTERITIS VIRAL (non-serious) with onset Apr2021, outcome "unknown", described as "She called because she is getting over stomach flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the GARDASIL (lot number K016966, expiration date 10-MAY-2017, lot number L035105, expiration date 14-MAY-2017, lot number M014929, expiration date 27-MAY-2017) (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients. From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder that 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA007375: US-009507513-1703USA007373: US-009507513-1703USA007374: US-009507513-1703USA007371: US-009507513-1703USA001520.
The patient presented to Hospital on 02/19/2022 with rectal bleeding.  She was recently admitted at another hospital for 10 days after a fall at home and complicated by PNA, severe encephalopathy, NSTEMI, atrial fib.  In the ED, the patient tested positive for COVID.  Other lab abnormalities in the ED included lactic acidosis.  The patient was placed on Bipap.   Chest x-ray showed low lung volumes.  The patient was hypotensive.  The patient was admitted to the ICU.   The patient's daughter elected to proceed with comfort care.  The patient expired on 02/23/2022.
pt recvd vax & devel hives; hoarseness; cyanosis; unresponsive; no wheezing; tx w/ epi x 2, solumedrol x 1, fluids, DPH;
Patient made an appointment for Adult Pfizer Booster vaccine at 4pm. Administering pharmacist mistakenly pulled Pediatric Pfizer vaccine from fridge, drew up the dose, and administered 0.3 ml of the Pediatric Pfizer vaccine to the patient. At closing, when submitting report, closing pharmacist noticed tally marks on Pediatric vial, not adult pfizer vial. Pharmacy manager had to review camera footage the following morning to confirm administering pharmacist pulled vaccine from pediatric section of fridge. The patient was notified the next morning. The wife explained she and her husband were extremely reluctant to get the booster as new data about long term side effects have been coming out regarding the vaccine. The patient was suggested the correct course of action (receiving correct dose of vaccine) but refused. She said she "feels more comfortable that her and her husband received the pediatric vaccine" and has decided against coming in again to receive adult pfizer dose.
The day I received the vaccine, my upper arm ached.  As days went by, it became worse, like I had been punched, very hard in the arm. Within two weeks, I felt a serious reduction in arm strength, perhaps  a25% loss of strength. In time, joint pain began, which has never decreased, while not severe, it is a constant 24/7 annoyance. The pain has since increased steadily.  I can no longer sleep with my arm under my head due to the pain, a severe ache.  Now, after 10-months, is is steadily getting worse.
Trigeminal neuralgia, hair loss,  brain fog. These have all Persisted 8 weeks since shot.
shivering; still very achy; muscle aches; This case was reported by a consumer and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   In May 2021, the patient received the 2nd dose of Shingles vaccine. In May 2021, less than a week after receiving Shingles vaccine, the patient experienced shivering, pain and muscle pain. On an unknown date, the outcome of the shivering, pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the shivering, pain and muscle pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The patient had experienced shivering and muscle aches. It had been 3 days still very achy.
Patient's friend called back said he was displaying rash starting with legs & over time spreading. He took BENADRYL, I advised to watch symptoms if worsen go straight to medical help.
ITCHY RASH ALL OVER THE BODY AND LOOK LIKE CHICKEN POX; RASH ALL OVER THE BODY; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced itchy rash all over the body and look like chicken pox. On 24-MAR-2021, the subject experienced rash all over the body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, cetirizine hydrochloride, methylprednisolone, and hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash all over the body, and itchy rash all over the body and look like chicken pox. This report was non-serious.
24 hours post injection a quarter size red spot appeared at site. It was warm to touch and lasted 3 days. No treatment was sought and irritation resolved itself.
This writer was given a list of clients to visit in the home today to administer the COVID vaccine. This particular client, answered no to having a COVID vaccine before, and to all questions on the questionnaire. This writer then administered the vaccine. While waiting in the home, this writer was walking around the kitchen and saw a note on the fridge that read: "You had your COVID vaccine on 3/9/21." I pointed this out to the client who stated she had no recollection of this note. Caregiver made to employee who confirmed pt had the vaccine previously on that date. Vitals- temp 97.8 pulse- 78 resp- 20 O2- 97% RA BP 130/76. Pt denied any symptoms. Caregiver made to pt's Dr. who advised to contact the family. MD also advised family is to monitor pt for 2 weeks for any side effects. Any concerns, they are to contact his office. MD stated ok to give tylenol PRN fever/pain. MD advised pt dx with dementia. Caregiver made to pt's emergency contact family member who is the DIL. Advised her of the situation. Daughter in law stated she will check in on pt and contact MD office with any concerns. Our on call team leader to follow up with client this evening.
Headache; Sore throat; Muscle aches; Congestion; This is a spontaneous report from a contactable other Health care professional. A 24-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in arm Left on 25Mar2021 at 14:30 (at the age of 24-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included Endometriosis, anxiety and IBS. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included fluoxetine (FLUOXETINE); ethinylestradiol, norethisterone acetate (MICROGESTIN) and acetaminophen (ACETAMINOPHEN). The patient was not diagnosed with COVID-19 prior to vaccination. On 26Mar2021, the patient experienced headache, sore throat, muscle aches and congestion. The patient did not receive treatment for the adverse event. Since the vaccination, patient has not been tested for COVID-19. At the time of this report outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Syncope episode at checkout window 4 min after Gardasil vaccine given. Upon forward fall, pt sustained blow to anterior aspect of neck on our counter top. Unconscious for approx 30-60 sec, then alert but confused as to what happened for about 1 min. Labored breathing and anxiety approx 4-5 min then relaxed. Red raised mark on soft tissue of anterior neck. Remained in supine position with neck neutral at still. EMS here within 10 min. To ER pre EMS with cervical collar and neck immobilizer on.
Sleeplessness- 24 hours Back and hip pain- 48 hours  Sharp armpit pain (injection arm)- 4 days Breast and armpit pain (non-injection arm)- 48 hours  Headache- 48 hours
Patient recieved vaccines on 3/17/09 around 1600 Mom reports that infant woke up in the middle of the night with 102.5 fever.  Patient did recieve amoxicillin as of 3/6/09 for OM but had to stop treatment after 5 days due to rash.  Dr. has advised mom to give tylenol to control fever and if fever continues follow up in office on 3/19/09 for further evaluation and treatment.
Rash on hands, welt on arm extending from shoulder to elbow. Aching joints and tiredness.
reported by mom-fever began several hrs later; vomited 27SEP & 28SEP; seen by MD in clinic 28SEP95 t105 R, P198;no redness of thiths @ inj sites, vomited APAP @ clinic; referred to ER
pt recv vax & devel anaphylaxis;addtl info recv 7NOV97 which the MD stated no adverse rxn occurred;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 22 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "She doesn't want to eat."; HEADACHE (non-serious), outcome "unknown", described as "Headache". Additional Information: The reporter was asking if those were common side effects. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
onset of sx 5 days post vax; h/a, overall myalgia, lethargic, stomachache & diarrhea;
swelling in mid thigh region / area being swollen/the reaction was reportedly still as large as mother's hand; Itchy / itching; localized redness / red; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 20th May 2020, the patient received Pediarix. On 22nd May 2020, 2 days after receiving Pediarix, the patient experienced extensive swelling of vaccinated limb, pruritus and erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pruritus and erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pruritus and erythema to be related to Pediarix.  Additional details were reported as follows: The patient received Pediarix in right thigh and that evening developed localized redness and swelling in mid-thigh region.  The patient returned to the vaccinating facility and on 22nd May 2020 and with complaints of affected area being swollen, red and itchy. No anaphylaxis reported.  The patient returned to same vaccination facility again on 27th May 2020 and the reaction was reportedly still as large as mother's hand with redness, swelling and itching. It was reported they would conduct an allergy test to see if patient reacted to any of the inactive ingredients.
(Possible) administration of extra dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: (Possible) administration of extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 01-JUN-2023 The reporter enquired that were there additional side effects, if the patient accidentally took three doses of Shingrix vaccine. Medical Information (MI) did not speak with the health care provider, so requested to follow up with the sales representative for more information.  The patient received 3rd dose of Shingrix (possible), which led to extra dose administered.
On 6/19/06 reported Hives on neck and chest c/o nausea. On 6/23/06 continues to have hives now all over described as weeping sores and itchy.
In early AM 10/24/2001, pt's spouse states pt made gasping noise and then quit breathing. Spouse gave 2 rescue breaths and pt started gasping. Pt then stiffened up and tight hand curled inward. Pt had 2 episodes of this lasting about 25 minutes and then had period of confusion. Was transported to medical center and had CT scan that was negative. F/U with neurologist and he classified this as a non conclusive seizure.
when he went to bed and woke up with diarrhea; sore arm; aches and body pain, body ached all over; Initial information regarding an unsolicited valid non-serious case was received from consumer (patient) via Medical Information (Reference number- 00827229) and transmitted to Sanofi on 25-Oct-2021.  This case involves an 88-year-old male patient who experienced sore arm (pain in extremity), aches and body pain, body ached all over (pain) and when he went to bed and woke up with diarrhea (diarrhoea) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing lung cancer and neoplasm malignant (had 4 cancers and underwent chemotherapy treatment and is doing well).  On an unknown date, the patient received a 0.5 mL (total) dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sore arm (pain in extremity), aches and body pain, body ached all over (pain) and when he went to bed and woke up with diarrhea (diarrhoea) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported about patient's spouse that "Consumer has questions about the flu vaccine and states she received her FLUZONE HIGH DOSE vaccine, and her spouse received the FLUBLOK. Consumer would like to know the difference between the two because she thought that they were getting the same vaccine. Caller reports that following her spouse receiving Flublok."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  On an unknown date, the patient recovered from pain (it was short lived).  At time of reporting, the outcome was unknown for the events pain in extremity and diarrhoea.  There will be no information available on batch number for this case.
Newborn had been given Fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number FT779, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter called to report that, a newborn baby, had been given Fluarix on the day of her birth, which led to inappropriate age at vaccine administration.  The Lot number was taken from the box and not from PFS (pre-filled syringe). The reporter consented to follow up by email.
Bleeding every day started and havent stopped till doctors put me on progesterone and then iud, i still have breakthrough bleeding
seizure; complaining of headaches; This spontaneous report was received from a consumer referring to her son, a 16-year-old male patient with Penicillin allergy. The patient had no concomitant medication and no pertinent medical history.    On 18-JUL-2019 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) (frequency: 3 doses, lot# reported as R032766; route of administration and expiration date were not reported) in the left arm for prophylaxis. On an unknown date in 2019 (reported as "a couple of days after 18-JUL-2019") the patient started complaining of headaches. On 29-OCT-2019, the patient was taken to the physician to seek medication attention for the headaches. On the same day, the patient administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# reported as 1621929; dose, route of administration and expiration date were unknown). On 13-NOV-2019, the patient had a seizure. On the same day, the patient went to the emergency room at hospital. The patient was treated with anti-seizure medication levetiracetam(KEPPRA) and was admitted overnight. On 14-NOV-2019, the patient was discharged.   The reporter indicated the patient would not be receiving the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). There was no lab diagnostics/studies performed. The outcome of seizure and headaches was recovered. The causality assessment was not provided.   Upon interval review, seizure was determined to be medically significant.
15yo was given Pfizer bivalent vaccine for 5-11yo 10mcg/0.2ml as ordered. No adverse reaction was noted. Ordering doctor was informed; father of patient was informed.
One day after the injection, experiencing tinnitus in left ear only; Dose received 3/ dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 40-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 29Nov2021 at 12:00 (Lot number: 33030BD) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included: DAILY BIRTH CONTROL PILL, VITAMIN D3, VITAMIN C and M. Vaccination history included:  BNT162b2 (DOSE 1, SINGLE, Lot Number: EW0150, Route of administration: Unspecified, Anatomical location: Left arm, Vaccine Administration Time: 12:00), administration date: 02Apr2021, when the patient was 40 years old, for COVID-19 immunisation and BNT162b2 (DOSE 2, SINGLE, Lot Number: EW0171,Route of administration: Unspecified, Anatomical location: Left arm, Vaccine Administration Time: 12:00), administration date: 23Apr2021, when the patient was 40 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021 at 12:00, outcome "unknown", described as "Dose received 3/ dose number=3"; TINNITUS (non-serious) with onset 30Nov2021 at 00:00, outcome "not recovered", described as "One day after the injection the patient experienced tinnitus in her left ear only". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
pain at injection site, nausea, fever, muscle and joint pain, sleeplessness. and headache
Two days following the vaccine, Patient began to experience extremely painful chest pains and pressure in the chest area.  He was taken to the local emergency room.  The next day his pain increased and he began to have muscle spasms, he was taken to the hospital.  He has since been to the ER 2 more times and been seen by a cardiologist.
Reports that he awakened with shaking chills & took 2 ADVIL. Called out of work 10-1-10 body pain.
RASH AT INJECTION SITE. PATIENT SOUGHT MEDICAL CARE AND RECEIVER RX FOR CEPHALEXIN 500MG ON 10-15-18.
Abdominal pain with hx of NASH cirrhosis. CT shows no ascites, positive for colitis. Pt having diarrhea and nausea. Pt admitted for IV antibiotics for acute colitis. Monitor labs for NASH cirrhosis, CKD and DM.
SITE OF INJECTION-LEFT ARM IS SWOLLEN, WARM TO TOUCH,ITCHES AND HURTS