chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain, weakness and loss of movement in the left shoulder.  Symptoms got worse as the days went by and I was having trouble sleeping. I made an appointment and went to an Orthopaedic doctor on October 31, 2016. I was diagnosed with impingement of the shoulder and treated with a cortisone injection.  As of today, November 7, 2016 the symptoms have not gotten any better and the pain is now extended down my left arm into my hand.
date/time of adverse event started:  8/24/21 8:00am upon waking, patient and numbness and weakness of the left arm 8/24/21 4:00pm felt first dizziness/fog spell lasting about a min  8/24/21 8:30pm: another dizziness/fog spell  8/26/21 8:00 am woke up to pain/numbness/tingling in the right arm (opposite arm of immunization) 8/28: numbness/tingling and aching joints bilaterally in lower extremity Ongoing numbness/tingling sensation in left arm, right arm, lower extremity, hip/knee pain, brain fog and dizzy sensation
Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with doses of improperly stored GARDASIL (dose, route, lot# were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reports waking up with a "bad headache that was not normal" the day after receiving this years flu shot.
Weakness. Seen by EMS on site. Discharged home with father at 12:50 p.m.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ with lot number M016238 and expiration date of 07-DEC-2017, orally (strength and dose were unknown), which was stored at 23.4 Fahrenheit degrees for 8 hours and 44 minutes (1 cycle). There was no previous temperature excursion. The temperature excursions were not detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
POTENTIAL ADMINISTRATION ERROR - EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned an 18 year old male. 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: 205A21A and expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced potential administration error - expired janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration error - expired janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210953327, 20210953012, 20210952662.
Patient reported pain that started at the site and worked up her arm to involve her shoulder. The pain has persisted for a week now. She reported visiting a chiropractor thinking it would help, which it did not. There is no visible swelling at the sight.
Child began fever 8/27 eve (vaccine given 8/26 aft DTAP, IPV, MMR V).  Has remained at 103 po for hours.  Mother alternating antifever meds Motrin/Tylenol with no relief.  Child is eating and drinking.  Is lethargic.  Instructed to continue with antifever med q 4 hours, give fluids - sx if no improvement tomorrow, to call doctor.
This patient experience left sided numbness (felt like left arm and left leg was heavy); This patient experience left sided numbness (felt like left arm and left leg was heavy); This is a spontaneous report from a contactable pharmacist. A 40-year-old male patient received first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 07Jan2021 11:00 at a single dose for covid-19 vaccination. The patient has no medical history. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications the patient received within 2 weeks of vaccination. The patient received the most recent COVID-19 vaccine in a nursing home/senior living facility. This patient experience left sided numbness (felt like left arm and left leg was heavy) on 07Jan2021 11:00 AM. The event was reported as non-serious. The adverse event result in emergency room/department or urgent care visit. No treatment was received for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
Patient had itching to her face, neck, legs. She had difficulty breathing 1130 am, EPIPEN 0.3 mg given at 1150 am (R) outer thigh.
Patient states three days after receiving vaccine his arm started itching and noticed rash. Rash intensified days four and five after shot and spread to cover entire body. Included welting with oozing. Patient tried Benadryl and oatmeal bath. Over time rash has been getting better and 80% better. Patient has no primary care provider that I could follow up with. I recommended that patient see ER or walk in clinic to be seen by a doctor before getting second dose due to risk of this being an allergic reaction.
My throat was scratchy and I was hoarse, As the day progressed I had increased hoarseness and scratchiness. I tested at around 03:00AM on July 6th and it was positive. Once I realized I was positive I moved out of my bedroom to isolate. I started taking Theraflu for the cough. I sent a message to my doctor later on that morning and since the symptoms were not so bad she advised me to isolate. Later that morning, I developed a fever of 99.4. Yesterday I started coughing and my head was stopped up. I went to pharmacy and got me some chest rub and cough drops. I am still recovering from my symptoms.
Sore arm and shoulder, Fever, achy and lethargic, tingling of hands.  Took Advil.
04/12/2021 - Pt received Janssen vaccine at County  07/06/2021 - Patient had COVID like symptoms including: shortness of breath, fever and chills, sore joints. 07/08/2021- Patient went to clinic for COVID19 testing. Patient tested with rapid testing and PCR testing. Patient's rapid test came back positive, patient is still waiting for PCR COVID19 test results.
large oval shaped red inflammation around the injection site, was hard to the touch and sent tingling pain down my arm. A few days later it morphed into inflammation that just encircled the original inflamed area and began moving down my arm a couple inches. It is also now itchy.
Information has been received from a nurse concerning her daughter who on an unreported date was vaccinated IM with the second dose of GARDASIL.  It was reported that the patient experienced fainting spells "in the months following her second dose of GARDASIL".  The patient sought unspecified medical attention.  Additional information has been requested.
Expired ACTHIB was administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00647532) and transmitted to Sanofi on 18-Jun-2021.  This case involves a 15 months old male patient who received 0.5 mL expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot U6789AA and expiry date: 06-Jun-2021) via intramuscular route in right thigh (expired product administered) for prophylactic vaccination on 18-Jun-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for immunization.  The reporter asked does there need to be re-administered. The reporter also stated the Acthib, Diluent and Carton all had different expiration dates and asked why they are all different.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
An MD reported that an 18 mt old female received her 4th injection of Prevnar on 11/20/02. The reporter indicated that the child experienced "some leakage of the vax from the inject site in the arm". Concomitant vax therapy included DTaP, and MMRII. On 11/22/02, the child developed a local reaction 4 cm in diameter at the Prevnar inject site. The child recovered.
Redness, soreness, warmth at injection site which increased overnight.  Edema in arm.  Affected arm was 1 1/2" larger around than right arm.  Redness, pain, swelling extended from shoulder to elbow.   Unable to use arm.  Touch to it unbearable.  Called doctor's office day after vaccination and was told to come in.  Dx:  cellulitis  Prescribed doxycycline 7 days.  Today is day 5.  Arm size has returned to normal.  Some fluid and soreness remains on inner arm at elbow.  Still sore at injection site.
This non-serious medically confirmed health authority report (initial receipt 27-OCT-2014) concerns a 28-year-old male patient. The patient had medical history of allergies to penicillin, peanuts, tree-pollen and mold. The patient received influenza (seasonal) vaccine (no brand name) in the past and experienced dysphoria and paresthesias. On an unspecified date, the patient received influenza (seasonal) vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed dysphoria and paresthesias. Outcome was reported as unknown. Linked case: 2014046268 (same patient).
HYPOTENSION 4/5/2022 CANCER METASTATIC TO LIVER  HYPOTENSION 4/5/2022 HYPOTENSION
Patient states approximately 15 min. after receiving vaccine her arm and wrist started to hurt, described as a dull pain. Spoke with Pt on 10-21-09. Now has pain and tingling in both hands.
extreme joint aches; stiffness; weak and tired; weak and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Lot number: FF2590) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart attack" (unspecified if ongoing), notes: Verbatim: Heart attack, The heart attack was on his 60th birthday.; "Aflutter" (unspecified if ongoing), notes: Verbatim: Aflutter; "AFib" (unspecified if ongoing), notes: Verbatim: AFib; "ablation" (unspecified if ongoing), notes: Verbatim: ablation; "hemochromatosis" (ongoing), notes: He has hemochromatosis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd dose, lot number: EL9264), administration date: 07Jul2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "first dose: given on 12Jan2021/second dose: given on 07Jul2021"; Bnt162b2 (1st dose, lot number: EL0142), administration date: 12Jan2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "first dose: given on 12Jan2021/second dose: given on 07Jul2021". The following information was reported: ARTHRALGIA (non-serious) with onset 17Oct2021, outcome "unknown", described as "extreme joint aches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 17Oct2021, outcome "unknown", described as "stiffness"; ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "weak and tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that patient and his wife had the full series of the Pfizer Covid Vaccine and the booster dose, and he and his wife had no adverse events with the first two doses but had many side effects with the booster dose and a retired Pharmaceutical Operation Officer, who want information on the device that monitors the temperature of the shipper the Pfizer Covid Vaccine was shipped in.   Follow-up attempts are completed. No further information is expected.
Initial report received from a health care professional on 21 September 2011. A 40-year-old female patient received an intramuscular left deltoid injection of ADACEL, sanofi pasteur Ltd. lot number C3961 and sanofi pasteur Inc. lot number U4090BA, and an intramuscular right injection of FLUZONE, sanofi pasteur lot number UH454AA, on 18 September 2011. The patient had no illness at the time of vaccination and no other vaccines within 4 weeks of the ADACEL and FLUZONE. The patient's medical history and concomitant medications were not reported. Two days later on 20 September 2011, the patient developed tenderness under both arms. The reporter stated that no masses were felt under the arms. The outcome was reported as recovered. Follow-up information was received from a healthcare professional on 16 January 2012. The patient applied hot compress and the pain subsided. No further issues and no physician were consulted. The patient outcome was reported as recovered/resolved. Documents held by sender: None.
headache-lasted 72 hours, muscle aching, soreness, hardness, lasted 72 hours
administered 1 dose of the Moderna COVID-19 vaccine 24 hours after it was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 1 dose of the Moderna COVID-19 vaccine 24 hours after it was punctured) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 1 dose of the Moderna COVID-19 vaccine 24 hours after it was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 1 dose of the Moderna COVID-19 vaccine 24 hours after it was punctured) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 045821A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy. Concomitant products included METFORMIN, MULTIVITAMINS [VITAMINS NOS] and VITAMIN B COMPLEX (B COMPLEX (B50)) for an unknown indication.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Adverse event, at a dose of 2 tablets. At the time of the report, HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.            Concomitant medications also include Thyroid medications Patient had a suspect that the pharmacist injected a different vaccine. She was with her husband who was scheduled to get the vaccine for shingles on the same schedule of her second dose. As per patient, the pharmacist brought out three syringes at the same time, 1 for her husband which was a shingles vaccine and the other two which were Moderna vaccine, one for her and one for the other patient. She noticed that the pharmacist was kind of confused that time. She said she already informed the manager of the facility but they cannot prove yet if she got the Moderna vaccine or a different one.
Dizziness w/sx started after injection 8/9/12 and slight headache w/ice pack applied, legs, elevated, VS taken, and 20 oz of water.
experiencing body aches; soreness near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness near injection site) and MYALGIA (experiencing body aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included AMLODIPINE, LISINOPRIL, LEVOTHYROXINE and PRAVASTATIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness near injection site). On 17-Mar-2021, the patient experienced MYALGIA (experiencing body aches). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain and Myalgia, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness near injection site) and MYALGIA (experiencing body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On 3/9/2021, the 8th day following the vaccine, my son woke up from his afternoon nap hysterically crying. His temp was 101.8. He was very irritable. He presented as very shaky and wobbly. As time went on he could barely hold his head up, crawl, and sit up. He developed a bit of a head twitch. As time has gone on, these symptoms have subsided a bit but still he still continues to present as shaky, reduced coordination and balance, and slower in his gross motor functions.
Her arm felt warm to touch and tight; Her arm felt warm to touch and tight; her arm was swollen about 3 inches past her elbow; There was no pain at the injection site but more toward her elbow; her arm was red; unable to sleep because of the pain in her arm; unable to sleep because of the pain in her arm; This spontaneous report was received from a 66 years old female patient referring to herself. The patient's pertinent medical history and drug allergies were reported as none. The patient's concomitant medications included thyroid medications, blood pressure medication, cholesterol medication, vitamins, and zinc.   On 08-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route and lot #, expiration date were reported as unknown) for prophylaxis (reported as vaccine).  On the same date, the patient was unable to sleep because of the pain in her arm. On 09-JAN-2021, the patient took acetaminophen (TYLENOL) to help with the pain, and there was no pain at the injection site but more toward her elbow. On the same date, she also reported her arm was red. On 10-JAN-2021, the patient's arm was swollen about 3 inches past her elbow, and her arm felt warm to touch and tight. She called urgent care and they advised her to take diphenhydramine hydrochloride (BENADRYL). On 10-JAN-2021 and 11-JAN-2021, she took diphenhydramine hydrochloride (BENADRYL) as treatment. On 11-JAN-2021, she felt 70% better. She had slight pain along with swelling and the arm color improved to a light pink. She left a message with her physician's office in the morning of 11-JAN-2021 but had not heard back.  The causality assessment between all above events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
lip swelling, emesis, tongue and eyes swelling, hives. resolved by epipen
abnormal menstrual cycle post vaccine booster.  (normally very regular with 5-6 days and menstrual cycle lasting 8+ days
PATIENT SAID THAT SHE HAD NORMAL EXPECTED REACTION TO VACCINE ORIGINALLY, 4 DAYS FOLLOWING THE INJECTION SHE BEGAN TO EXPERIENCE RASH, MUSCLE PAIN, AND WHAT WAS DISCRIBED AS FEVER BLISTERS.
after approximately 16 hours I experienced, whether coincidental or not, gout like symptoms of extreme left ankle pain. Couldn't put any pressure on ankle at all without pain. Previously had last gout attack over 10 years ago but never in an ankle. reporting this occurrence for your information. Waited 24 hours before contacting doctor to see if it was temporary side effect of vaccination.(Thursday and Friday)  Treatment is Colchicine .6mg. taken once every 24 hours. After 2 doses pain is considerably less and walking is possible with walker. Ankle is stiff 4days later but not as painful.
+ covid rapid positive result on 1/19/2022 at 7am on the afternoon of 1/16 patient experienced congestion, sore/dry throat, and nausea and heavy night sweats through sheets, this is ongoing at this time
On 9/6/21 I developed a headache lasting 14 days and pulsatile (vascular) tinnitus in my right ear. I saw my primary care physician, Hx of migraines but this was unlike any previous episodes in duration and intensity. On 9/15/21 I went to the emergency department when the headache became unmanageable.  Head CT and carotid ultrasound did not reveal a cause. I continue to have daily headaches and the pulsatile tinnitus is still going on. Followed up with neurology and ENT as NF awaiting results of MRI of brain and ear canal.
Awoke with severe fevers, sweats, chills, body aches, and writhing movements. Felt as though cayenne pepper and been rubbed on my body. Improved with tylenol and ibuprofen. Next morning still had fevers, fluctuating hot-cold, fatigue, and "pepper on skin" sensation. Significant bloating, fullness in bowel and diarrhea episodes x2. Subsided over 36 hours.
Received vaccination dose 1 at 5pm.  Woke in middle of night with abdominal pain and thirst.  Day 1 woke at 6am extremely tired, woozy, nauseous (no fever).  I was able to work from home a little but napped several times.  Day 2 on a tired but functional, continued abdominal pain turning late in day to diarrhea (about 48 hours post vaccine).  Day 3 morning abdominal pain, diarrhea and tired. Day 4 mostly back to normal.  I had covid 90 days prior to the vaccination.  I'm scared to get the second dose.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates,the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M032649, expiration date 11-NOV-2018 (strength,dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 32 degree fahrenheit to 35 degree fahrenheit for 480 hours and 10 minutes (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA004176: US-009507513-1708USA004187: US-009507513-1708USA004189: