chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 19 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 30-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) and second dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J014584, expiry date: 16-JAN-2016, reported as 04-NOV-2016) which were stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL and VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Anxiety, Depression, and Panic Attacks: Fatigue, Lethargy, Hopelessness, Chills, Sweaty Palms, Indifference, Thoughts of Suicide, Nausea, Headaches.  Occurring throughout the day everyday since the onset of symptoms. Receiving counseling and taking Lexapro: 5mg once a day.
short of breath; Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (short of breath) and DIZZINESS (Dizziness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperglycemia and Hypothyroidism. Concomitant products included CETIRIZINE HYDROCHLORIDE (BENADRYL ONE) for Hyperglycemia, LEVOTHYROXINE for Hypothyroidism, ROSUVASTATIN CALCIUM (CRESTOR).    On 18-Jan-2021 at 4:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DYSPNOEA (short of breath) and DIZZINESS (Dizziness). On 21-Jan-2021, DYSPNOEA (short of breath) and DIZZINESS (Dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
HERNIA; PAIN IN THE LEFT ARM; DEBILITATING PAIN IN JOINTS PRIMARILY, THE LOWER TORSO LIKE HIPS AND BUTTOCKS; BLURRED VISION; UNCOMFORTABLE DRIVING; HEAVY FEELING IN THE EYEBALL; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate sleep apnea, alcohol use, non smoker, mild hypertension, elevated cholesterol, hernia, and gastrooesophageal reflux disease, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin for elevated cholesterol, pantoprazole for gastrooesophageal reflux disease, hydrochlorothiazide/losartan potassium for mild hypertension, and metoprolol for mild hypertension. On MAR-2021, the patient experienced blurred vision. On MAR-2021, the patient experienced uncomfortable driving. On MAR-2021, the patient experienced heavy feeling in the eyeball. On MAR-2021, the patient experienced pain in the left arm. On MAR-2021, the patient experienced debilitating pain in joints primarily, the lower torso like hips and buttocks. On an unspecified date, the patient experienced hernia. Laboratory data (dates unspecified) included: Visual acuity tests (NR: not provided) 20/20 (normal). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from debilitating pain in joints primarily, the lower torso like hips and buttocks, blurred vision, heavy feeling in the eyeball, pain in the left arm, and uncomfortable driving, and the outcome of hernia was not reported. This report was non-serious.
Pt developed rash after 7-10 days after MMR vaccine. Rash macular, started on neck, head spread to trunk to extremities, including palm & sole. No pustular/vesicle.
The next morning I woke up to my arm hurting really bad.  My injection site was really red, the arm was swollen and it was a lot of tenderness associated.  I was very fatigued but by day 2 the fatigue intense and  I felt really run down and tired, no fever just felt real tired all of which lasted about 4 days.  I took Tylenol and Benadryl on day 2  and all symptoms subsided by day 4.
Pt presented to clinic on 07/18/2003 with edema and redness to left thigh. Dad reported he had been putting warm packs (the kind you microwave) to leg. instructed dad to put ice packs on left thigh and to give Tylenol and Motrin.
On Friday, November 19, 2021 client received her Pfizer Covid-19 vaccine booster (LOT #: FF8841) at 4:50 PM in her left deltoid. During assessment questions, client stated she has severe allergic reaction to penicillin and experiences anaphylaxis. Client to  be observed for 30 minutes after vaccination. Client's medical history included hypothyroidism and takes the medication Miccil for an unknown heart problem. At approximately 5:25 PM, while in Observation Area, client stated to EMT she was experiencing tingliness in her left hand in the palmar surface only with no pain or any other symptoms. Client denied SOB. Client was brought to sit in anti-gravity chair, offered water and vitals started. Lead RN offered 50 mg oral solution Benadryl to patient which she took with her water at 5:26 PM. At 5:26 PM: BP 126/68, HR 71, O2 sat 98%, RR 16, skin warm and dry. At 5:31 PM: BP: 124/70, HR 71, O2 sat 96%, RR 16, skin warm and dry. EMT educated client on drowsy side effect. At 5:35 PM, client stated she only felt slight tingliness in her left hand and felt stable to leave. No further interventions needed. EMT educated patient on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client left vaccination site with a steady gait at approximately 5:40 PM. Client's husband drove her home.
Patient states saw "fireworks" in left eye shortly after vaccination (maybe 30 mins). After 24 hours could not see out of left eye
positive COVID-19 test with symptoms; feel itchy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events in two patients (for her and her husband). This is the first of two reports. This is the report for the reporter (patient).  A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 69-years-old via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported; expiry date reported as 30Mar) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient reported that they, together with her husband received the vaccine on 09Mar2021 and then 5 days after they feel itchy, feel high fever, too much fever, it was going in and out; she does not want to eat and the report is positive. They went to the hospital and had a COVID-19 test and the reports were positive, her husband and herself was positive. The hospital gives services in hotel for 9 days after that, the 10 day is in the house, so the second vaccine is schedule on March but they did not go to there because they are under the isolation. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Had a COVID-19 test and the reports were positive) on 14Mar2021. The outcome of the event was unknown  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441601 same reporter/drug/event, different patient
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 06-NOV-2017, the patient received a dose of ROTATEQ (strength were unknown) (lot# M042169 and expiration date 22-JUN-2018). On 10-JAN-2018 and 16-MAR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# reported as M022173 and expiration date reported as 15-MAR-2019) orally for prophylaxis, respectively (Incorrect product storage). The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported.  The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958:
Red rash on chest and face, tingling feet, tongue swollen (patient said), child.  Drove home. Refused transportation to hospital.
severe myalgia all over my body; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:ER8727), via an unspecified route of administration as a single dose in the left arm on 19Mar2021 at 16:30 as a single dose for COVID-19 immunisation. Relevant medical history included menopause, high cholesterol, OA (osteoarthritis). Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN), both for unknown indication from on an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 26Feb2021 at 10:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 10:00, about 18 hours after vaccination, the patient experienced severe myalgia all over the body. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took ibuprofen 400 (mg) twice, separated by about 6 hours as a treatment for reported event. The clinical outcome of the event myalgia was resolved on an unknown date. No follow-up attempts are needed. No further information is expected.
ARM BECAME EXTREMELY SORE - UNABLE TO LIFT ARM - ARM RED, HOT AND PAIN EXTENDED FROM INJECTION SITE TO FINGER TIPS - ARM SWOLLEN AT INJECTION SITE AND EXTENDED DOWN TOWARD HAND - STILL ACHY AS OF 1/14/20 BUT ESSENTIALLY RESOLVED IN COMPARISON TO DAY AFTER INJECTION - USED LIDOCAINE PAIN PATCH TO HELP WITH PAIN
Admission Date: 8/30/2022 Discharge Date: 9/13/2022  Patient is a 91 y.o. male who presents today with medical history of emphysema, Parkinson disease, gout, hypertension, dementia brought to ER by her daughter due to chief complaints of weakness.  Patient lives with her wife, who has been hospitalized with COVID 19 infection.  The usually get help and support 2 caregivers who visit patient's home multiple times or daily basis.  Since his wife tested positive for COVID, caregivers have not been able to come to provide assistance.  Both patient and his wife have been dependent on caregiver and their daughters for iADLs.  Patient's daughter, at bedside provides history.  She states that for the last 2 days his father has been getting generalized weakness.  Last night he was getting confused.  She had great difficulty in helping him go to bed.  In this morning patient was too tired to get out of his bed.  At this point she decided to bring her further hospital. In ER, patient was tested positive for COVID-19 infection.  Chest x-ray without infiltrates.  Patient uses 2 L oxygen at home, his oxygenation requirement was unchanged from baseline.  Also found to have elevated creatinine 1.3 (4 months ago creatinine 1.1).  Due to lack of support at home, and acute kidney injury patient was admitted under hospitalist service.  He will likely require placement for short-term rehab upon discharge.   #Aspiration Pneumonia #Bacterial Pneumonia #COVID Pneumonia >finished abx course >clinically improved >excited to go home   #COVID 19 >dc home with hospice   #Goal of care <DNR/home with hospice
This spontaneous report as received from a physician refers to a 4 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 29-APR-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# M046140 with the expiration date of 27-SEP-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent a temperature excursion of 48 Fahrenheit degrees for 16 hours. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Headache, Myalgia, Arthralgia, 007M20A Narrative:
Spotting between period, cramping, now late period, Confirmed not pregnancy by 2 sources.
Narrative: Patient reports the evening following Shingrix vaccination, she developed, fever, chills, tiredness, swelling/redness to the injection site. Patient additionally reported myalgia, pain, and nausea. Patient presented to an urgent care clinic and was tested for COVID-19 and flu which were both negative. Unclear what discharge diagnosis was from urgent care clinic, but documented in system as cellulitis. No documentation available regarding vaccine administration given vaccine was administered outside of the clinic.
following inoculation, the patient experienced arm pain; This is a spontaneous report received via COVAES. A non-contactable consumer reported a non-pregnant 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on an unspecified date in Feb2021 (at the age of 66 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, however, it was unknown if the patient was tested for COVID-19 since vaccination. On an unspecified date in Feb2021, following inoculation, the patient experienced arm pain. The outcome of the reported event was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse practitioner, via a company representative, concerning a patient (age and gender not specified, who on an unknown date was vaccinated with the second dose of PNEUMOVAX (lot # not provided).  Subsequently the patient developed an injection site reaction.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
anaphylaxis within 10 minutes, epinephrine 0.3 administered, eval by ems, patient declinced transport to hospital, followed up doing well.
Headache, Myalgia, Fever, PRURITIS Narrative:  stated took otc tylenol and also vistaril
5:00 pm 2/23 headache/ fatigue 1:30 am 2/24 chills, headache, racing heart, shortness of breath, low grade fever , aches
had h/a-passed out-eyes were open, but would not respond; then fell asleep; vomited a little, but was sill sleepy; pt was unresponsive for @ least 35 mins; while pt was unresponsive, drooled;
This spontaneous report as received from a physician refers to a 11 years old boy with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated SQ with the first dose of 0.5 ml (Merck) VARIVAX (lot# not reported) years ago. The patient was vaccinated SQ with the second dose of 0.5 ml (Merck) VARIVAX (lot# not reported) on 13-SEP-2012. No concomitant medication was reported. On 13-SEP-2012 the patient returned to the practice, with a macular rash on the entire arm where the vaccine was administered. The physician reported that the patient's entire arm was also swollen, and that he was treating the patient for infection. The outcome of the adverse events was reported as not reported. Additional information has been requested.
I was sitting down, working on the computer and felt a little light headed/weak. I stood up and my heart started to beat rapidly/erratically. I stepped outside to try and get fresh air and take deep breathes in an attempt to slow my heart rate down. The erratic/rapid heat rate lasted for maybe a minute (could of been a little shorter or longer not entirely sure, I was scared because I?ve never experienced anything like this before so concept of time may be skewed ). The rapid heart rate resolved on its own, I just took it easy for the rest of the day.  I have not experienced another incident since then.
Client stated feeling lightheaded after vaccination. Client parent stated client had not eaten. Client lowered to the floor, legs placed on chair, and cool towel placed on client head by LVN. Client stated no longer feeling lightheaded. Client sat in chair. Client vital signs checked. Client blood pressure- 104/62, temperature- 97.3, pulse- 62, oxygen saturation- 98%, and respiration- 20. Client denies having any other symptoms prior to leaving post vaccination. Client parent stated that that they were going to eat. Client denies any distress prior to leaving post vaccination area.
pt vax'd @ 1130AM, @ 830PM became nausea, rt arm painful, swollen, hot by 10PM t101, chills, body aches (joints); 11NOV t100 felt flu-like ate & drank alright; red (1" side) band around rt arm @ site of inject; 12NOV sore throat; sl cough;
Everything was fine when I got the shot, but when I left I was driving home and I started to lose vision. By this time I was about to pull in to my house so I put it in park and tan inside. By this point I couldn?t see barley and I started to lose my balance from being dizzy.
pt recv vax 10JAN96 & 26FEB96 & lab eval by IgG revealed a negative titer;
1 week after patient was given the Flu Shot his right eye showed signs of not moving properly. It looked as if he were going crossed-eye. 24 hours later he threw up for no apparent reason and his eye seemed to be even more crossed. After visiting the Pediatrician's office, Dr. concluded that his right eye was not moving outward to the left and we were sent to Hospital. Patient's eye could move inward and to the center but not outward. Over the next 48 hours movement in his right eye became more constrictive and he started turning his head to the right to see straight forward. Acetazolamide was given after a lumbar puncture showed high amounts of pressure in the fluid in his spine causing pressure on his 6th nerve. He took 125mg per day for a month. Improvements were seen within 24 hours and after 5 days patient appeared to have full moevement back in his eye. Treatment was extended to a month due to the 2nd dose of the flu shot.  His doctor kept him on it for 2 weeks following the 2nd dose. We were not aware at the time that this may have correlated with the flu shot.  3/30/09 Received hospital medical records of 1/2-1/5/2009. FINAL DX: right 6th nerve palsy; right conjunctivitis Records reveal patient experienced x 3 days: left crossed eye; right eye immobile.  Saw PCP who found isolated right abducence nerve palsy & referred to Ophthalmology who confirmed same. Exam revealed facial dysmorphism suggestive of Trisomy 21, right eye serous drainage, left middle ear effusion, lack of right eye abduction, heart murmur.  LP revealed increased ICP (opening pressure 26).  Tx w/Diamox.  Remained stable & d/c to home w/Ophtho, Neuro & Cardio outpatient f/u.    Seen in Neuro clinic 1/13/09 s/p viral gastroenteritic.  Additional testing planned r/t dysmorphism after karyotype WNL.  4/13/09 Received vaccine records & Neuro followup of 2/3/2009.   FINAL DX: post viral right 6th nerve palsy, resolving. Exam revealed lack of right eye abduction.  Diamox decreased.  To return for Neuro & Optho clinic visits in couple of mo.
Right thigh redness and swelling 2cm and 2 diameter.  Reaction to DTAP.
I developed shingles 2  1/2  weeks after my first shot.  I am not sure if the shingles are related?  Otherwise , I have been in good health.
Nearly 24 hours s/p vaccine, developed muscle aches, chills, headache and feeling feverish
Information has been received from a registered nurse concerning a 74 year old female who on Sept 14 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 645852/0685N). Between Sept 15 2004 and Sept 17 2004 the patient developed pain, redness, and swelling at the injection site. She sought medical attention from her family doctor and was given a shot of cortisone. Subsequently, the patient recovered. No product quality complaint was involved. It was noted that the patient had received a dose of pneumococcal 23v polysaccharide vaccine 5 or 6 years prior to this vaccination. No further information is available.
The following reactions happened after the second Shingrix shot (First shot had not side effects at all - was given in the same arm) Approximately 1 hour after shot - baseline pain of 3 (from shoulder fracture) in left upper arm mainly shoulder instensified to 9 (on a scale fo 1-10)  She took Tylenol , pain came down to 7  She also experienced pain in her left leg - she described it as sharp pain, like banging a big nail on her left heel  She had stiffness in the left arm all day friday, saturaday and stiffness started to go away by saturday evening  Felt weak too , and arm was swollen  Day 3 after shot - started to feel better by 50%, pain was still @6  Day 7 after shot - Swelling  gone down, soreness @injection site , shoulder pain down to 4 - very sensitive to touch, much better now