chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient received a pneumovax 23 vaccination in which he cant move his arm; This spontaneous report was received from a 65-year-old male physician (who is also the patient) via a company representative, refers to himself. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, lot# and expiry unknown), subcutaneous for prophylaxis. The patient reported that on an unknown date, he cannot move his arm (movement disorder). The outcome of movement disorder was reported as not recovered/not resolved. Causality assessment was not reported. Product quality complaints was not involved.
Chills, body aches, sweats and nausea  began about 8 hours after vaccination. Was received. Symptoms gradually got worse as the day went on.  The symptoms we the worst at around the 24hr post vaccine mark. It is now almost 40 hours post vaccine and symptoms have improved but still remain. Symptoms improved with ibuprofen and Tylenol and rest.
This spontaneous prospective pregnancy report as received from a physician refers to a 28 year old female patient. On 13-AUG-2013 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot # H019789, expiration 15-OCT-2013), injection, 0.5 ml, subcutaneously while pregnancy. The physician stated that her last menstrual period was 15-MAY-2013 but her estimated date of conception was 20-FEB-2013 which was determined by ultrasound and EDD of 19-FEB-2014. Initial exposure to VARIVAX (Merck) was at 13 week(s). The pregnancy outcome was outcome pending. The physician stated that the patient had no adverse effects at this time. Additional information has been requested.
ABDOMINAL PAIN; CHEST PAIN; LEG PAIN; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced abdominal pain. On 09-APR-2021, the subject experienced chest pain. On 09-APR-2021, the subject experienced leg pain. On 09-APR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, abdominal pain, headache, and chest pain. This report was non-serious.
Severe back spasms began on the evening of 10/20 that came back intermittently for several days and interfered with normal daily activities.  Severe leg cramps in left calf began on the morning of 10/21 and lasted for 36 hours before relaxing.  I was unable to walk without a limp for almost a month. I had never had leg cramps prior to this event.  General back and leg problems continued off and on until January.
fever 15JUN, fussiness, rash 17JUN, cold & cough 21JUN
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-JUN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 336 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
CHILLS,  LOWER BACK PAIN, TIREDNESS AT THE FIRST DAY  BUMPS ON MY HEAD AN MY MOUTH, MY GUMS ARE DAMAGED 2 DAYS AFTER.
Not feeling well; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ampicillin), Penicillin allergy and Hypertension. Concomitant products included DIPHENHYDRAMINE for Allergy, LOSARTAN for Hypertension, RIVAROXABAN (XARELTO) for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 MALAISE (Not feeling well) and PYREXIA (Fever). At the time of the report, MALAISE (Not feeling well) and PYREXIA (Fever) had resolved.            No Treatment information was reported.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-083625 (Patient Link).
SERIES COMPLETED OUTSIDE OF RECOMMENDED TIME FRAME.  FIRST DOSE WAS GIVEN ON 4-30-21.  NO ADVERSE EVENTS REPORTED AT TIME OF VACCINATION.
pt recv vax 8OCT96 & pt devel swelling, pain, pain, induration & papular rash @ inj site;w/in 2wk sx had resolved;
no energy; reaction to second covid shot; extremely fatigued; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy), HYPERSENSITIVITY (reaction to second covid shot), FATIGUE (extremely fatigued), CHILLS (chills) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A/80777-0273-99 and 025A21A/80777-0273-99) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus since 30-Mar-2019 and Hypercholesterolaemia (much lower LDL and higher HDL) since 11-Jan-2018. Concomitant products included METFORMIN from 30-Mar-2019 to an unknown date and INSULIN from 16-May-2021 to an unknown date for Diabetes, ATORVASTATIN from 11-Jan-2018 to an unknown date for High cholesterol, CALCIUM for an unknown indication.   On 05-Mar-2021 at 3:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ASTHENIA (no energy), HYPERSENSITIVITY (reaction to second covid shot), FATIGUE (extremely fatigued), CHILLS (chills) and PYREXIA (fever). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. On 04-Apr-2021, HYPERSENSITIVITY (reaction to second covid shot), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, ASTHENIA (no energy) and FATIGUE (extremely fatigued) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Added the reporter address, patient demographics (Concurrent medical conditions), concomitant medication (Insulin). Added the start date and stop date of the events and updated the outcome of the events (Fatigue, Asthenia) from unknown to recovering and (Pyrexia, Chills) from unknown to recovered. Added one more event  Hypersensitivity (Reaction to second covid shot).
Child wouldn't bear weight on legs that evening after vaccines were given, next morning child woke up with hives all over body and continued to complain of leg pain. Child just layed around for few days after vaccines.
77 y.o. male who was admitted with weakness. He has had poor appetite and upper respiratory symptoms for several days prior to admission. He slid off the bed onto the floor at home and he was too weak to stand and his wife was unable to get him up and had to call EMS. Tested positive for COVID in the ER however was initially on room air. He did briefly have low oxygen, was started on remdesivir and dexamethasone and seen by infectious disease. He improved faster than expected though is still at high risk for progression given his renal transplant status. As he is currently on room air and remdesivir was stopped.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itchiness (not sure if it was at injection site or in throat) and severe allergies on an unspecified date with outcome of unknown. The information on the batch number has been requested.
Severe neuralgia pain over 75% of her skin surface; Severe neuralgia pain over 75% of her skin surface; Severe joint pain; Muscle aches; Swollen lymph nodes; Headache; Fatigue; Upper body sporadic shivering; Interval between the first and second doses of BNT162B2 is 27 days; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in right arm, on 14Jan2021 at 17:15, at a single dose, for COVID-19 immunization. The patient's medical history included sporadic neuralgia, numbness to patches on legs, shift-work sleep disorder, and generalized anxiety. The patient's concomitant medications included armodafinil (NUVIGIL), paracetamol (TYLENOL), and alprazolam (XANAX). The patient previously took ferric subsulfate (MONSELS Solution) and experienced allergy; and the first dose of BNT162B2 (Lot Number: EH9899) on 18Dec2020 (6 PM) for COVID-19 immunization (in left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 14Jan2021 (05:15 PM), the interval between the first and second doses of BNT162B2 is 27 days. On 15Jan2021 at 9:15 AM, the patient experienced severe neuralgia pain over 75% of her skin surface beginning at 14 hours post-second dose (as reported) and still continuing now at 30 hours post-dose. Also, the patient experienced severe joint pain, muscle aches, swollen lymph nodes, headache, fatigue, and upper body sporadic shivering (not cold). It was unknown if the patient received treatment for the events. The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
SWELLING IN BOTH ARMS.  MODERATE CELLULITIS IN LEFT ARM.  PRESCRIBED STEROIDS FOR TREATMENT
tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Restless legs, Parathyroid disorder NOS and Osteoporosis. Concomitant products included CALCIUM for Parathyroid disorder NOS and Osteoporosis, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) for Restless legs.    On 25-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         On 25-Feb-2021, the patient received first dose (lot number 011A21A) of Moderna vaccine. On 29-Mar-2021, the patient received second dose (lot number 044A21A) of Moderna vaccine. On 31-Oct-2021, the patient received first booster dose (lot number 076C21A) of Moderna vaccine. On 04-Apr-2022, the patient received second booster dose (lot number 065K21A) of Moderna vaccine. He had flu vaccine on the same day he had the bivalent booster 25-Sep-2022.             No treatment information was provided by the reporter.
Redness, slight swelling, tender left upper arm. Pt described a "heaviness, like fluid accumulation" in arm day after vaccination - observation only.
This spontaneous report was received from a physician and refers to a 21-year-old male patient. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date in February 2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot number, expiration date, route of administration were not reported). On 03-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9, lot # M009378, expiration date 20-APR-2018, for prophylaxis (route of administration was not reported). No adverse effect was reported. Product quality complaint (PQC) was involved.
This spontaneous report as received from a consumer refers a 90 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first two doses of GARDASIL 9 (Strength, frequency, route, lot # and expiry date were not reported) to treat her basal cell carcinoma (Off label) (Product administered to patient of inappropriate age) as recommended in the official prescribing information. However, it was reported that the third and the final dose was given to a different basal cell carcinoma located on her legs which went away. There was no adverse reaction reported. There was no product quality complaint associated with this report. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1901USA009580.
Developed redness with welt to center within 2 min of injection on right leg BENADRYL 12.5 mg given, monitor x 20 min.
Severe headache, fever 100.3, chills, sweats, fatigue, arm soreness, body aches. All lasted about 24 hours.
Patient 8yrs old was administered the adult Pfizer Vaccine on Jan 02, 2022, at 9:31am. Nurse stated she was unaware of the appropriate Vaccine.
Pfizer-BioNTech COVID-19 Vaccine EUA. Rash developing around upper arms and shoulder blades lasting about a week. Treated with cortisone cream. was not too itchy.
One day post vax, the pt experienced a fever of 104.3. Mom was advised to take pt to her PMD or ER. Mother was told child had virus.
Note: I have no history of anxiety or panic attacks.  Roughly one week after the first dose, I had what was ultimately described as a panic attack - I went to the ER thinking it was a heart attack, where they did blood panels, x-ray, and a chest CT.  I was later discharged.  The problem recurred (but worse) the next day.  I have been chasing this ever since.  What happened - Six ish days after the first dose of Pfizer, I began having chest/abdomen pains, panic/anxiety problems.  Symptoms have lessened over time but returned later.  Symptoms - chest pain in middle-to-upper-left; panic/anxiety attacks began; unable to sleep many nights due to pain/constantly waking up with "impending doom" fears  What has been done - Four ER visits, several GP followups and lots of testing.  X-rays, chest/abdomen/pelvis CTs, blood panels, endoscopy and colonoscopy.  Diet changes.    All doctors (GP, ER) I've mentioned the timing to have mostly shrugged-off the timing with the vaccine, however, no other causes have been identified to-date, and the symptoms are still occurring - some days are better than others.  At this point, I'm wondering about the booster shot.
Grand Mal Seizure on March 19. 2021 at 7:00 am - Ambulance arrived to take patient to the hospital.  and Grand Mal Seizure on April 11, 2021 at 8:00 am - Guardian knew of event so kept patient home.
A report has been received from a Health Professional concerning a 51 year old male patient. The patient's concurrent disease (s) included TOBACCO ABUSE and VITAMIN D DEFICIENCY. Concomitant medications included ERGOCALCIFEROL. On 19-Feb-2014, the patient received nasal FLUMIST (INTRANASAL). On 19-Feb-2014, the patient received INADVERTENTLY FLUMIST QUADRIVALENT OVER 49 YEARS of age. The outcome of the event of INADVERTENTLY GAVE FLUMIST QUADRIVALENT TO PATIENT OVER 49 YEARS is unknown. The report was considered to be non-serious by the company physician.
My whole left side felt swollen. My left ear felt clogged and ringing in it. I have had tinnitus in the left ear ever since. A constant rising in my ear.
Initial right arm soreness for 5 days after the vaccination from 1/17-1/22; no symptoms until 1/30 when I had onset of severe right arm pain in the same area as the vaccine which radiates down my arm and up into the right side of my neck with pain that is constant and severe. I have taken Ibuprofen, Tylenol and Norco to try to continue working, sleeping and using my arm. The symptoms have increased and I have the next shot on 2/15/21.
Information has been received from a licensed practical nurse concerning a 12 month old white male with no medical history and no allergies who on the morning of 29MAY2003 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live. The patient had a mild upper respiratory infection and a rectal temperature of 99.1 degrees at the time of vaccination. On 07JUN2003 the patient developed a fever of 100 degrees F (rectal) that lasted through 09JUN2003. On 08JUN2003 the child broke out/erupted with small yellow, clear fluid filled blisters on small red patches initially on his trunk and then they quickly spread to his extremities. There were over 50 pox on his trunk alone. His behavior was reported as "fine". On 09JUN2003 the mother of the patient had also reported that he had developed a chicken pox rash with lesions with yellow fluid filled pustules on top of a red area. Most of the lesions were raised but there were some that appeared flat. Some lesions had already popped and were crusting over. The mother reported that they started in the lower abdominal area, went to the torso and neck and then scattered down the arms and legs. She counted the lesions and stopped at 50 and just said "there are more than 50". No diagnostic lab tests were performed. Unspecified medical attention was sought and no treatment was required. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
pt recv vax 13AUG97 & 15AUG97 pt devel a fever of 100.4 & a sore throat;f/u info from MD reported that pt sx were caused by strep throat & were not r/t vax;
Info has been received from a physician concerning a 31 year old female who several years ago, in approximately 2003, was vaccinated with a dose of MMRII. Subsequently, a "recent" titer did not show seroconversion to rubella. It was noted that the pt had no symptoms. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
I developed a very sore arm.  It swelled around the injection site, turned red, formed a hard lump and was hot to the touch..  This has lasted all week but it has become progressively less.  I am very active (for my age).  I swim 1/2 mile laps twice a week; do regular exercises for balance and to relieve back pain and regularly do tai chi.   I think this exercise, especially with my arms has helped reduce the symptoms.  The symptom wasn't serious and did not impede my activities.  I am sending this because I thought it might be helpful.
Redness and swelling at injection site 5 cm x 3 cm area.  Benadryl 50mg IM x 1 dose given.
First vaccine dose 3/26/21 First health event 4/7/21:  pre-syncope and palpitations Second vaccine dose 4/16/21 4/18/21: strange heart feelings on any exertion, pre-syncope, weakness, malaise, winded by even walking the dog, hands turn purple, weird thump/click in chest, visual changes (seeing colors or spots, greying of vision, migraine-like hallucinations), shortness of breath  Episodes like the one described on 4/18 daily, especially in the morning and on exertion until now, 5/1/21  Seen in the ER on 4/19/21 and 5/1/21. EKGs normal, CBC and metabolic panel largely normal. Holter monitor 4/21/21-4/26/21 placed by healthcare Center; hasn't been read yet.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # L035105 exp date 14-MAY-2017 and lot # L043213 exp date 28-AUG-2017) (route and doses not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Large, raised, red swollen spot on arm, hot to touch. Noticed 20 hours after vaccination was administered. Medicated with diphenhydramine. Visited PCP; however no treatment course was provided.
Narrative: Per ambulatory care note on 11/6/20, pt reports receiving the second shingrix vaccine on 09/16/20 and developing pain around the vaccination site on the left arm afterward. The pain did not improve with arm exercises. No fever was reported. Symptoms: Myalgia Treatment:
This spontaneous report as received from an office manager (healthcare worker) refers to a 66 year old female patient with diabetes and hypertension and with none drug reactions/allergies. On 05-NOV-2013 the patient was vaccinated intramuscularly with a dose of PNEUMOVAX23, in the right deltoid, dose not reported, lot # reported as J005071 and expiry date 19-JAN-2015. Concomitant therapies included Amlodipine, Aspirin (manufacturer unknown), Hydrochlorothiazide, DIOVAN HCT, fish oil, FLONASE, Metformin, Omeprazole (manufacturer unknown), Simvastatin (manufacturer unknown), VAGIFEM, vitamin B complex, ascorbic acid, vitamin D (unspecified), vitamin E and calcium. In November 2013 the patient experienced redness, pain and swelling at the injections site after vaccination with PNEUMOVAX23. The patient's outcome was unknown. The patient was treated with BENADRYL ZYRTEC, and Cephalexin. There were none lab diagnostic studies performed. The patient sought medical attention in office. The relatedness between adverse events and PNEUMOVAX23 was unknown Additional information has been requested.
TDAP mixed in with MMR vaccination and given SQ. A second dose of TDAP was given IM then.
Localized hives in lower extremities. Hives treated with non-petroleum jelly. Hives have increased in size and are still present on 7/31/2010.