chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could not walk/could not move; was shaking; felt cold; felt terrible; had chills/ teeth were chattering; had a temperature; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (could not walk/could not move), TREMOR (was shaking), FEELING COLD (felt cold), FEELING ABNORMAL (felt terrible) and CHILLS (had chills/ teeth were chattering) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had COVID positive test or diagnosis and had no history relating to mentioned AE and both Acute and chronic illnesses at the time of vaccination.  Previously administered products included for Pneumonia: PNEUMOCOCCAL VACCINE in October 2021; for Flu: FLU [INFLUENZA VACCINE] in October 2021. Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE] and PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Penicillin allergy (Penicillin). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced GAIT INABILITY (could not walk/could not move), TREMOR (was shaking), FEELING COLD (felt cold), FEELING ABNORMAL (felt terrible), CHILLS (had chills/ teeth were chattering) and PYREXIA (had a temperature). In 2021, GAIT INABILITY (could not walk/could not move), TREMOR (was shaking), FEELING COLD (felt cold), FEELING ABNORMAL (felt terrible), CHILLS (had chills/ teeth were chattering) and PYREXIA (had a temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: had a temperature had a temperature.   mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Reporter stated that she had the adverse events after getting the 1st dose of the Moderna Covid-19 vaccine. These went on for 3 days and they resolved. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot number 010M2AA). On 21-Aug-2021, received 1st booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot number 053E21A). On 09-May-2022, received 2nd booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot number 056M21A). Treatment medications were not provided.   This case was linked to MOD-2022-573190 (Patient Link).
Information has been received from a consumer concerning her husband who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, and lot# not reported). Subsequently the patient experienced rash. The patient sought unspecified medical attention. No further information is available.
At 8:00 a.m. on 05/05/2019 I ran my weekly long run of 10 miles.  About 10:30 a.m. on 05/05/2019 I experienced joint pain, fever, headache, nausea, and malaise.  Around 11:30 a.m. I took 400 milligrams of Advil (ibuprofen) and 1,000 milligrams of Tylenol (acetominophen) and took a nap.  At 2:15 p.m. I am experiencing similar side affects (reduced intensity), still not fun but nothing so dramatic I can't handle .   BTW, your CDC website that explains how "normal" the side effects are is very helpful; knowing the benefits of Shingrix immunization gives the  side effects purpose.  As a general rule, I would consider recommending that providers give a heads-up to patients in advance so they don't plan anything important in their lives, they reduce activities, and they interpret any side effects rationally.
Narrative:  PT WAS IMMUNIZED IN A TIMELY MANNER 1-23-21 AND 2-13-21 RESPECTIVELY WITH PFIZER MRNA VACCINE. PT WAS PRESENTED TO ED APPROX 15 DAYS POST SYMPTOM ONSET WITH HYPOXIA (77% RA) AND WEAKNESS. PT WAS PROVIDED SUPPLEMENTAL O2 UP TO 5L NC FOR A FEW DAYS. HE WAS TREATED, RECOVERED, AND WAS DISCHARGED HOME
12 hours post vaccine developed extreme fatigue, difficulty completing routine tasks, intermittent syncope and pre-syncope. (Lasted x 2 months).
I have had pain in my left arm at the site where the vaccine was administered. I have had a lot of  pain and dullness in left arm. I saw my PCP and she prescribed cyclobenzaprine.
Within a few days, I noticed increased pain in my left hip joint. Initially it was only when I was lying down and when I was active. It gradually changed to where it hurts all of the time. It feels like it's getting worse. It's particularly difficult to go up my stairs or a steep incline has become quite painful. I started taking meloxicam, but it really hasn't helped much. I have also noticed that I have had strains and pains in my arms and hands. They don't impact me as much, but I noticed the pain.
truncal rash with pruritis started within 24 hours of both doses. Treated with zyrtec and pepcid. Patient on prednisone at time of 2nd shot.
Fever,headache,chills,body aches,nausea with vomiting.
Menstrual cycle changed: I got my period ahead of time, with very heavy bleeding. My period was always normal, in terms of amount, time, etc. At first, I didn't think of it was related to vaccine.  However, after the second dose (on 4/11/2021) , same thing happened again: I got my period in shorter cycle, and the bleed was very heavy, running pure blood (didn't see tissue in) and drag for ~10 days, I basically had to bed rest to let it stop.
pt recvd vax; devel mild fever & chicken pox rash w/ 4-5 pustules on throat & trunk area;
Seasonal flu shot FLUZONE 2009 on Oct 6th. 2 weeks later woke up with tingly feeling in both legs-like they were "asleep" but no weakness, pain or loss of feeling. Within a week the numbness spread from the chest down to the feet. after 3 weeks, saw doctor and a neurologist. MRI at 4 weeks showed inflammation in the spinal cord. Tingling now felt in fingers.  Hospitalized for Spinal tap and treated with heavy dose of steroids IV. All other test results were negative.  After 4 months all symptoms were gone.
Bloody urine; UA indicated red blood cells and bilirubin in urine; UA indicated red blood cells and bilirubin in urine; Basic Metabolic Panel indicated dehydration; Dose Number 1, Date of start of drug (21Dec2020) / Dose Number 2, Date of start of drug (13Jan2021); Dose Number 1, Date of start of drug (21Dec2020) / Dose Number 2, Date of start of drug (13Jan2021); This is a spontaneous report from a contactable pharmacist. This 32-year-old male pharmacist (Patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1284), via unspecified route at left arm on 13Jan2021 10:00am at single dose for COVID-19 immunization. Medical history was not reported. Concomitant drugs included Vitamin D3. Historical vaccine included the first dose of BNT162B2 (lot number= EH9899) on 21Dec2020 02:30 pm at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine in four weeks. On 15Jan2021 01:30 pm, patient had bloody urine, he was otherwise normal health, he visited healthcare provider within 3 hours of the incident. Point of care urine analysis (UA) and blood draw was done. UA indicated red blood cells and bilirubin in urine. Basic Metabolic Panel indicated dehydration, otherwise unremarkable. Events resulted in emergency room/department or urgent care. No treatment was received. Outcome of events was recovered in Jan2021. No COVID prior vaccination. No COVID tested post vaccination.
Both elbow and knee joints in severe pain. Lower back on the right side in severe pain.  Severe full body muscle pain, every muscle in extreme pain. Complete Lethargy, couldn't get out of bed.
Patient developed chest tightness while leaving the building following her vaccination, and had "a full blown asthma attack" by that evening. She was prescribed prednisone the next morning, and felt better after that. A couple of days later, she developed significant fatigue and achiness, substantially worse than her usual chronic pains.
Case number PHEH2015US026845, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 21 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered had a temperature excursion of 34 degrees Fahrenheit overnight. The reporter stated that she did not known why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
12 hours after vaccine administration: fatigue, chills/shivering, sweats followed by dizziness, falling x3, confusion in the middle of the night was oriented to person, place time per husband seen in the office at 3PM the following day, symptoms improved but not not completely resolved.
Headache, nausea, chills, muscle aches Slight muscle aches started around midnight and the rest came on full force at 5:00am - woke up very hot, did not have a fever, and then I got very cold and the chills started. Took tylenol and it helped.
Migraine; Fever; Swollen arm 3 out of 4 times; Off balance for 3 days; 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 73-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Congenital heart defect" (unspecified if ongoing), notes: Congenital heart defect. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Migraine", "Fever"; Bnt162b2 (Dose 1, Swollen arm 3 out of 4 times), for COVID-19 immunization, reaction(s): "Swollen arm 3 out of 4 times"; Bnt162b2 (Dose 1, Off balance for 3 days), for COVID-19 immunization, reaction(s): "Off balance for 3 days"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Migraine", "Fever"; Bnt162b2 (Dose 2, Swollen arm 3 out of 4 times), for COVID-19 immunization, reaction(s): "Swollen arm 3 out of 4 times"; Bnt162b2 (Dose 2, Off balance for 3 days), for COVID-19 immunization, reaction(s): "Off balance for 3 days"; Bnt162b2 (Dose 3), for COVID-19 immunization, reaction(s): "Migraine", "Fever"; Bnt162b2 (Dose 3, Swollen arm 3 out of 4 times), for COVID-19 immunization, reaction(s): "Swollen arm 3 out of 4 times"; Bnt162b2 (Dose 3, Off balance for 3 days), for COVID-19 immunization, reaction(s): "Off balance for 3 days". The following information was reported: MIGRAINE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen arm 3 out of 4 times"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Off balance for 3 days".  Additional information: States she has had many side effects from her previous four doses of the Pfizer BioNTech COVID-19 Vaccine: "migraine, fever, swollen arm 3 out of 4 times, and feeling off balance for 3 days." Patient got first and second doses and the booster shot and after getting these vaccines patient had some reactions to the vaccines. Patient called to ask if the Pfizer COVID-19 Vaccine Bivalent Booster Shot has any different than the original shot or the original boosters; if the ingredients are different; and if this is a 2 in 1 shot. The doctor wants her to take this Pfizer COVID-19 Vaccine Bivalent Booster Shot but neither he nor the pharmacist knew the answers to her questions, so she called Pfizer. Patient had the first and second doses of the original shot and then 2 of the original boosters and experienced reactions to everything, all of those doses. Patient had already reported this previously, did it in the past when she did the first and second one and all the reactions are the same for everyone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The pt's right arm was very swollen, painful, red and could not lift arm over her head, the next day, post vax. Has had to have follow-up with a Neurologist. He wanted to let you know it was due to flu vaccine. Not yet recovered.
Rash starting on her face down to her chest and its getting worse; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable female consumer reported for herself that a patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine; formulation: solution for injection), dose 2 via an unspecified route of administration on 24Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 1st dose for covid-19 immunization and no events were reported for 1st dose. The patient reported in Jun2021 that 2 weeks after her 2nd dose (24Jun) she experienced rash and it got worse. Rash starting on her face down to her chest. Patient was unable to remember her 1st dose schedule. She was asking what to do. The outcome of the event was unknown.  Information about batch/ lot number has been requested.
pain at site of injection; muscle ache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2019, the patient received the 1st dose of Shingrix. On 28th March 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and muscle pain. On 2nd April 2019, the outcome of the muscle pain was resolved with sequelae. On 3rd April 2019, the outcome of the injection site pain was resolved with sequelae.   It was unknown if the reporter considered the injection site pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. Patient's Shingrix shot resulted in pain and muscle aches which lasted for 5 days. The reporter did not consent to follow-up. There was a discrepancy with respect to the outcome date of the reported events. As per source document the outcome date was 3rd April 2019 (duration 6 days). However as per narrative description the duration was reported as 5 days. The outcome date was kept as per the structural field (3rd April 2019).
This case was reported by a nurse and described the occurrence of cellulitis of arm in a 12-year-old female patient who received MENVEO (batch number X15147, expiry date unknown). On 2nd August 2016, the patient received the 1st dose of MENVEO. In August 2016, less than a month after receiving MENVEO, the patient experienced cellulitis of arm (serious criteria GSK medically significant), injection site induration and injection site erythema. On an unknown date, the outcome of the cellulitis of arm was unknown and the outcome of the injection site induration and injection site erythema were recovered/resolved. It was unknown if the reporter considered the cellulitis of arm, injection site induration and injection site erythema to be related to MENVEO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to their office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. The physician had prescribed oral antibiotics for most of these patients. The patient concerned in this case had experienced 10 mm induration and redness at injection site (arm) after MENVEO vaccination, which had lasted for 6 days. An antibiotic was prescribed by the physician for cellulitis of arm. The reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc) but none had proved effective in reducing reaction rates. The reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their patients. This case has been linked to 4 other cases (MENVEO vaccine), reported by the same reporter.
Was given 2nd dose  12 days after 1st dose   Patient states he feels fine  no complaints @ all. They had recieved email to come in today for 2nd dose, and I gave 2nd dose, , then I realized  it was only 12 days apart, I immediately notified Provider here ., who came and spoke with patient.   I had given the 2nd dose too early.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Adverse event - Rebound on day 14. Mild symptoms and a positive test the night of day 14. Anti-viral details :Product = COVID 19 Treatment, Brand-Paxlovid, Treatment start date : 10Jul2022, Treatment stop date : 07Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201005434 Same patient, different product and event;
Patient presented with round, reddened, somewhat raised area of upper left arm the morning after injection.  Area is about 4 inches in diameter.  Reported  10/31/23 by nurse  I recommended treatment with cool compress and continue to monitor.  The nurse will escalate  care if condition worsens.
53 yo female received first dose of Pfizer COVID-19 vaccine on 12/24. Received second dose on 1/14. Pt had cataract surgery scheduled for 3/4. On 3/1, pt completes preoperative nasopharyngeal swab obtained at 1006. Coronavirus PCR test resulted positive later that evening. Repeat test on 3/16 resulted negative.
raised area over the injection site, warm and painful to the touch with a silver dollar size red rash just below the injection site. This reaction occurred about 7 hrs after the shot was given and lasted approximately 2 days after which all of the reactions disappeared. About 7 days later, a smaller rash reappeared with itching off and on during the day consistently up to this filing. The itch is not intolerable, it is just noticeable, no medication has been applied to relieve the itch. I have had no fever, chills, aches or any other more severe reaction, just this residual rash with occasional itch.
SUNDAY; BACK WAS SORE, MY ARM WAS SORE.  BREAST HURT, CHILLS, FEVER, HIPS HURT IN THE BONES, EARS RINGING, BOTTOM JAW LINE HURT, HEADACHE THAT WOULDN'T GO AWAY,CRAMPS FELT LIKE  WAS ON MY CYCLE. I AM  IN MENAPAUSE. MONDAY:  CRAMPING, SORE ARM, TINNITUS , TUESDAY: SORE ARM CRAMPING AND PELVIC PRESSURE, EARS RINGING WEDNESDAY ARM STILL SORE,
ARMS HAVE NOT BEEN THE SAME AND PAIN WHERE WE GOT IT AND ESPECIALLY IF RAISE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced arms have not been the same and pain where we got it and especially if raise arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arms have not been the same and pain where we got it and especially if raise arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211163843.
No ADR, timing ERROR 2ND dose given 42 Narrative: No ADR, timing ERROR 2nd dose given 51 days after 1st
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site tenderness and injection site warmth. On an unknown date, the outcome of the injection site rash, injection site tenderness and injection site warmth were unknown. It was unknown if the reporter considered the injection site rash, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX at the pharmacy. The patient had rash at injection site which did not itch but it hurts upon touch and it's warm. The patient was not sure if it's common side effect. The patient denied to share information regarding provider.
Swelling in left lower eye and cheek within minutes of the injection. Has not resolved itself as of this reporting.
Red raised rash at site of Proquad (MMR-VZV) vaccine.
PATIENT PRESENTED FOR 2ND COVID VACCINE AND REPORTED THAT SHE HAD A STROKE ON HER WAY HOME FROM THE 1ST VACCINE.  SHE STATES NOONE TOLD HER THE VACCINE CAUSED THE STROKE.  WE CONSULTED WITH NEUROLOGIST WHO STATED THERE IS NO INFORMATION REGARDING THE COVID VACCINE CAUSING A STROKE, THE RISK IS VERY LOW.  SINCE THIS HAPPENED ON THE WAY HOME REPORTING
Onset of right face lower eye pain 11/17/04. Diagnosed with Herpes zoster 11/22/04. Severe pain, rash progressing and now vesicular, opthalmic trigeminal distribution (right side of face, nose, periorbital, and conjunctival).  Evauated by family physician and opthalmologist. On Valtrex tid for 7 days and blephamide eye ointment, and Vicodin for pain.
acute pain armpit, fatigue, body ache, lethargy, headache, 102 temperature 17 hours after injection; temperature reduced after 3 hours. All other symptoms remain for 48 more hours.  Armpit pain wasn't reduced by 800 mg of tylenol. Fever reduced w/800 mg tylenol. Other symptoms improved over time & regular doses of 800 mg tylenol.
pt recvd Engerix-B & devel flu-like sx 2 wks;