chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sinus drainage; watery eyes; little sore arm; inability to walk or balance; inability to walk or balance; total joint paint thought out the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (sinus drainage), LACRIMATION INCREASED (watery eyes), PAIN IN EXTREMITY (little sore arm), GAIT DISTURBANCE (inability to walk or balance) and BALANCE DISORDER (inability to walk or balance) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus drainage), LACRIMATION INCREASED (watery eyes), PAIN IN EXTREMITY (little sore arm), GAIT DISTURBANCE (inability to walk or balance), BALANCE DISORDER (inability to walk or balance) and ARTHRALGIA (total joint paint thought out the body). The patient was treated with HYDROXYCHLOROQUINE at a dose of UNK dosage form. At the time of the report, SINUSITIS (sinus drainage), LACRIMATION INCREASED (watery eyes) and PAIN IN EXTREMITY (little sore arm) outcome was unknown and GAIT DISTURBANCE (inability to walk or balance), BALANCE DISORDER (inability to walk or balance) and ARTHRALGIA (total joint paint thought out the body) had not resolved.            No concomitant medications was provided by the reporter. Treatment included steroid was noted.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information received captured patient demographics, product, events and treatment drugs updated.
AVA # 1 and Typhoid on 11 Jul 08, SPV on 15 Jul, and AVA # 2 on 25 Jul 08. He was seen by pcm on 31 Jul for a resolving puritic rash on his forehead, neck, and arms that was described as fine tan/brown macules, received AVA # 3 on 8 Aug and to date there is no documentation of recurrence of rash. Symptoms: Lesions, macule, Pruritus.
broke out in red rash-listless & limp; required visit to MD & tx w/med;
Fever of 102+,  weak and achy.   24 hours  in bed, 2nd day fever of 101, can be upright at least.
This spontaneous case reported by a consumer, describes the occurrence of headache in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced headache. At the time of the report, headache outcome: unknown. No concomitant medications or treatment information provided.
Nine hours following injection, I developed a fever of > 100F and severe all-over-body ache, which lasted 36 hours.
No menses since immunization.  Daily severe headaches accompanied by dizziness.  Headaches started the day of immunization.  Also local rxn-redness, swelling R arm.  Client just started menstruating 8-07.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. In October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: The healthcare professional reported the administration of Havirx to a patient that was expired.  The healthcare professional disconnected chat prior to obtaining permission for safety follow up.  No additional details available at this time of this report.  Additional supportive information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
HEADACHE; CHILLS; BODY ACHES; FATIGUE; STABBING PAIN IN JAW AND CHEEK BONE; MUSCLE SPASMS IN LEFT LEG; PAIN AT INJECTION SITE AT THE TIME OF WHEN INJECTION WAS ADMINISTERED/SORENESS AT INJECTION SITE THE DAY AFTER INJECTION; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 63.5 kilograms, and height was 170.18 centimeters. The patient's past medical history included covid infection, and viral infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ascorbic acid, biotin, sambucus nigra, and zinc acetate/zinc gluconate. On 04-MAR-2021, the subject experienced pain at injection site at the time of when injection was administered/soreness at injection site the day after injection. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced body aches. On 05-MAR-2021, the subject experienced fatigue. On 05-MAR-2021, the subject experienced stabbing pain in jaw and cheek bone. On 05-MAR-2021, the subject experienced muscle spasms in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, body aches, fatigue, pain at injection site at the time of when injection was administered/soreness at injection site the day after injection, stabbing pain in jaw and cheek bone, and muscle spasms in left leg. This report was non-serious.    Version created to amend previously reported information on 05-Mar-2021. Upon review the following information was amended: Labeling of event muscle spasms, body ache and chills updated.
The adverse symptoms I experienced were abnormally severe/heavy menstrual bleeding and abdominal pain. I was on Day 4 of my menstrual cycle on the day of my injection (April 3, 2021). My menstrual cycle usually starts to go away on Day 4 and concludes by Day 7. But the day after my injection, in addition to experiencing the common side effects of fever, chills, aches, and headaches, I also experienced an uptick in bleeding, which included severe/heavy menstrual bleeding with very frequent and large blood clots. That same day (April 4), I started my new birth control cycle as prescribed. By Day 8 (April 7, 2021), my menstrual bleeding continued to be so severe/heavy that I went to my OB-GYN for testing. The OB-GYN ruled out everything but the vaccine as an environmental factor. It was suggested that I take 600mg of Motrin every 6-hours for 48 hours. My menstrual bleeding continued for several more days until concluding on Day 12 (April 11, 2021) but I am still experiencing abdominal pain.
Information has been received from a health professional concerning an 84 year old male patient with type 2 diabetes mellitus who on 28-NOV-2007 was vaccinated with zoster vaccine live (Oka/Merck), 0.65 ml subcutaneously in left deltoid.  On 03-DEC-2007 the patient notified the physician of a painful rash on the left side of the chest.  On 04-DEC-2007, the patient was admitted to the hospital via the emergency room for treatment of the shingles and pain control.  The patient is incapacitated by the shingles pain.  The patient continues to be hospitalized and received 1 gram of VALTREX three times daily (route unspecified).  The health care professional is interested in VZV analysis by PCR. No other symptoms were reported.  The event of the patient developed shingles after zoster vaccine persisted, was considered to be disabling.  Additional information was received via a telephone call on 06-DEC-2007 from the nurse.  The nurse indicated that the patient was still hospitalized for pain control.  The nurse explained that the physician was thinking that the patient might have been on the verge of getting shingles prior to vaccination since he developed shingles so quickly after vaccination.  She reported that the patient had a wound culture done at the hospital, however did not have any results.  She stated the plan was to possibly discharge him from the hospital on 06-DEC-2007.  The VZVIP program was discussed, and she indicated she would discuss sending a specimen with the physician.  No further information is available.
Information has been received from a certified medical assistant (also reported as nurse) reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 29-MAY-2018, the patient received inadvertently an expired dose of VAQTA, lot number reported as N022979, expiration date 26-MAY-2018, for prophylaxis (strength, dose and route of administration were not reported). Lot number N022979 is an invalid lot number for hepatitis a vaccine, inactivated.
Flu shot given, RN pulled back-no blood return in syringe.  After shot, immediate bruising and swelling.  No other side effects.
DATE GIVEN 7/19/2017. RASH ONSET 7/29/2017 3 POX... 1 LOWER EXTREMETY, 1 ON ABDOMEN AND 1 ABOVE EYE.
2/18--2/22 ACUTE SOB/shallow breathing, exhaustion (slept 26.5hr in 52hr period), swollen lymph nodes (under arms, across chest, clavicle), difficulty lifting arms, brain fog (memory/concentration) 2/23--3/2 CONTINUING SOB, anhedonia, no stamina, brain fog (concentration/critical thinking, memory), somnolence after 4pm daily, lethargy, malaise, neck/shoulder ightness/pain
red area at the injection site; arm is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Oct2021 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization; Bnt162b2 (2nd Dose), for COVID-19 immunization. The following information was reported: INJECTION SITE ERYTHEMA (non-serious) with onset 29Oct2021, outcome "unknown", described as "red area at the injection site"; PERIPHERAL SWELLING (non-serious) with onset 29Oct2021, outcome "unknown", described as "arm is swollen".  Additional information: stated she got the booster dose this past Wednesday. Caller reported she woke up this morning and her arm was swollen and there was a red area at the injection site. Caller stated this did not happen after the first doses. Caller asked stated this specific to getting the booster dose. Caller asked how long will it last. Caller reports that today, her arm is swollen and there is a red spot the size of a dime at the injection site. The patient had no issues with the first two vaccines.  No follow-up attempts are possible. No further information is expected.
small nausea, elevated blood glucose level 200- 300mg/dl  Narrative:
Patient was given the wrong vaccine - was supposed to receive the 6 month- 4 year vaccine, and received the 5-11 covid vaccine.
Information has been received from a physician concerning a 14 years old female who was vaccinated with the first dose of GARDASIL "2 and a half weeks ago", on approximately 21-JUN-2009. Concomitant therapy included MENACTRA and DTAP. The patient's skin became itchy all over her body "8 to 10 hours" after she received the 1st dose of GARDASIL and the patient's skin became blotchy from head to toe. The patient called the office and was prescribed BENADRYL and the symptoms improved within 48 hours. At the time of the report, the patient recovered. Follow-up information has been received from a physician concerning an 11 year old (previously reported 14 year old) female with no illness at time of vaccination who on 11-JUN-2009 was vaccinated with the first dose of GARDASIL (lot#661531/1311X) intramuscularly into the left deltoid at 1:20pm. Concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis vaccine (unspecified). In the evening of 11-JUN-2009, 4 hours after vaccine administration, the patient had full body hives with extreme pruritus. The patient was given a dose of BENADRYL and the symptoms improved within the first 24 hours. The urticaria completely resolved after 4 days. Additional information is not expected.
Febrile most of the day after vaccines. At 2 AM on 10/9 made choking noises in bed. Felt very hot. Parents gave Tylenol. Soon after face, neck and tongue became puffy and swollen and started to choke. Turned pale, then eyes rolled back and became limp. Temperature was 103 when EMT arrived. Became more alert with resolution of swelling within 1 hour.
Within 15 seconds of 2nd vaccine the pt developed bradycardia, cyanosis, and rigid apnea, head turned right. Pt given stimulation for apnea and O2 and pulse ox monitoring. Pt regained normal state approximately 5-10 minutes later. Entire episode lasted 2-3 minutes.
pt recv vax 9JAN97 & 15JAN97 pt devel a rash over entire body;the reporter questioned whether was an allergic rxn or measles rash;16JAN97 pt presented to an ER;
pt recvd vax; joint pain, v, sore throats, fatigue; HA
09:00 pm developed aching joints like with a fever. At 10:00 pm experienced uncontrollable shivering in bed until I finally fell asleep. At 01:00 am I woke up severely overheated but not sweating. It took hours to go back to sleep. After two full days, soreness at the injection site and a lingering headache remain. Treating with ibuprofen.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date since 08-NOV-2014, an unspecified number of patients were vaccinated with a dose of RECOMBIVAX HB (lot #, expiration date, dose and route of administration were not reported), that was exposed to supported temperature excursions. No adverse experience has been reported. This is one of several reports from the same reporter. Additional information has been requested.
1/6/2022 6pm - very sore arm, child did not want to move and cried with movement. Arm still bleeding an hour after shot. Nauseous. 1/7/2022 6:30am - still sore arm and lethargic, dizzy. Around 11am - Fever and severe headache. Around 11:30am, sent to nurse's office at school and confirmed very high fever and severe headache.  12pm - when picked up from school, dark circles under eye, lethargic, started crying with painful arm, headache, nausea, dizziness. 12:30pm - Temperature  103.7 forehead. Gave children's ibuprofen liquid dose for 5 year olds. Breathing quickly and more shallowly. Took pulse and 127 bpm. 1:30pm,  fever reduced to 101.5 forehead and 115 bpm pulse.  Still lethargic and didn't feel like could move. 2:30pm, feeling a bit more energy and better with medication. 6:30 pm, fever higher at 102 and headache returning along with dizziness, heart rate still at 115bpm. Gave another dose of children's liquid ibuprofen and he fell asleep. 1/8/2022 - 3:30 am, woke up in a panic with severe headache, chills, rapid breathing, and fever of 103.7F. Pulse 130bpm. Felt like was going to pass out, heart was on fire, and couldn't walk. Dizzy and nauseous. Fluttering heartbeat. Gave another dose of ibuprofen at 4am. Called nurse line and suggested be seen. Gave another dose of ibuprofen around 10:30 am when fever returning. 3:30pm, fever and heartrate starting to stabilize.
Started getting massive cold sores on lip, graduated, headache, severe pain, itching burning on chin & jaw, then app. one week later got several chicken pox lesions on chest.  Told this could not happen.  At the 2 wk. period Dr. prescribed 800mg meds of acyclovir twice a day for 7 days.  Still took another week to go away.  Am still having itching in chin.Developed many cold sores on lip, then chin started hurting bad and itching, A week later got chicken pox like lesions on chest. Told by Pharmacy this could not have happened. Got strong anti-viral meds from Dr., still took a month for it to get better. Am still having pain and itching in jaw and cold sores.
This is a spontaneous report based on the information received by Pfizer from Galderma (reference number: GL-041621-9614). A non-contactable 45-year-old female consumer (patient) reported that: A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as Dose 2, Single (age at vaccination:45-years-old) for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccination includes administration of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as Dose 1, Single for Covid-19 immunisation, and on 21Jan2021 injected Restylane Kysse into lips. On 09Apr2021 the patient experienced severe swelling, pain and discomfort to upper and lower lips. Therapeutic measures were taken as a result of severe swelling, pain and discomfort to upper and lower lips includes administration of steroids and antihistamines. The outcome of the events was recovering(swelling improving but not resolved).    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
loss of smell after weeks of sinusitis that begin the next day after vaccination; loss of smell after weeks of sinusitis that begin the next day after vaccination; severe back pain; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), dose 2, via an unspecified route of administration, administered in the left arm on 24Aug2021 at 10:00 (Batch/Lot number was not reported) at the age of 31-years-old, single, for COVID-19 immunization. The patient had no relevant medical history. The patient had no known allergies, did not have COVID prior to vaccination, and did not receive any other vaccine in four weeks. There were no concomitant medications (no other medications in two weeks). The patient received the first dose of BNT162B2 on 04Aug2021 at 10 AM (Lot number: FA9585) in the left arm. The patient experienced loss of smell after weeks of sinusitis that began the next day after vaccination and severe back pain on 25Aug2021 at 18:00. The patient did not receive any treatment for the events. The patient was not tested for COVID after the vaccination. Outcome of the events was not recovered. The case was reported as serious (disability or permanent damage).  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Initial unsolicited report received from a healthcare professional on 07 June 2016. This case involves a male patient of an unknown age (current age 62 year) who was vaccinated with a dose of DIPHTHERIA AND TETANUS TOXOIDS (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient allergic reaction to vaccine. It was reported that, "horse antigen it in which caused it". The patient did not experience any adverse event this time with the Sanofi product. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Left arm at site of injection when move arm above head or behind back shooting pain normal position - no pain.
Neuropathy started in both feet and have radiated up towards knee. Started end of May, still ongoing. Also headaches, fatigue, dizziness.
Father called to report that his daughter had a grand mal seizure on 9/6/01 and he brought her to ER. She was discharged late PM. Follow-up being done with another doctor; a neurologist.
Patient received above 3 slots for 1 year in Rural Japan, 10 min after JE given was found on floor, face down, bleeding.  Mother in room. Nasal x-rays indicate fracture of nasal bones.
2 month old was given PPSV23 instead of PCV13. Doctor ordered PPSV23 in epic, in error, and MA gave it. Date of injection 3/14/16. Error made known on monthly error report 4/14/16. Dr talked to mom, no tx necessary. PCV 13 to be given.
This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown. It was unknown if the reporter considered the bullous pemphigoid to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported.
Onset of neck pain July 2009. Persistent. Managed by ortho, PT, pain management. Thought to be related to tics most recently. Referred to neurology. Parent concerned related to HPV.
Tdap= given wrong vaccine on 6/13/23 from MA, was supposed to be Dtap.Pt mom informed and office informed.
I haven?t had a period in almost two years since I?ve been pregnant and breastfeeding and am now having the heaviest period I?ve ever had and saturating through my tampons past my undergarments.  My SIL was hospitalized for the same reason and received two transfusions.
Headache; nausea; body ache; muscle ache; pain on left left side in my rib cage; freezing; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), NAUSEA (nausea), PAIN (body ache), MYALGIA (muscle ache) and MUSCULOSKELETAL CHEST PAIN (pain on left left side in my rib cage) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.    On 25-Jan-2021 at 3:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced HEADACHE (Headache), NAUSEA (nausea), PAIN (body ache), MYALGIA (muscle ache), MUSCULOSKELETAL CHEST PAIN (pain on left left side in my rib cage) and FEELING COLD (freezing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), NAUSEA (nausea), PAIN (body ache), MYALGIA (muscle ache), MUSCULOSKELETAL CHEST PAIN (pain on left left side in my rib cage) and FEELING COLD (freezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 98 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received captured no new information.