chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she put it in top of shoulder left side, i do sleep on both sides tho, and neck was sore and stiff within 3 minuNumbness and burning sensation in arm and hand and swelling in forefinger Left side and pain and stiffness in joint within 5 min, then numbness in leg and pins and needles throughout leg within 30 min then dead feeling in the sole of my foot like complete numbness and heaviness, like club foot or something from the calf to the sole of the left foot. then within 1 day and on shooting pains in leg and arm  and also heavy hammer like a nail being put through the back of my knee and swollen maybe where the nerve or arteries lie and same pain like a hammer putting a nail thru the inside of the elbow too then slowly within 1 month weakness spread to right side but not the same pain / hammer/ shooting pain or numbness is weaker on right side not like the left , and low and mid back hurt and i lost my voice is very gravely can barely talk like if my vocal cords  are messed up and left face twiches tingles.  legs very weak can barely walk or sit or drive or dont want to get up from bed but sleep is uncomforable too
Symptoms of a severe flu (headaches, body aches, sweats, chills, muscle weakness) stated about 6 hours after the injection and last about 36 hours. Gradual recovery but not fully recovered until 4 days afterwards.
Patient stated that he was having pain at the injection site after injection. Stated that when he return home he started to have increased pain in his left shoulder area. Stated that he also had swelling in the should and back. Patient stated his arm also felt numb.  Patient did report any adverse events too the company until 07/21/2022. Denies having any current symptoms.
Sore arm on side of injection starting about 6-7 hours after injection. Next morning (28 hours after injection) arm soreness was more severe. I was very fatigued the whole day after the day of my first dose. That evening, around 36 hours post injection, I experienced some muscle twitching on the left side of my face and multiple cramps in my feet. None of these symptoms felt serious so I did not seek any treatment. Symptoms were gone by the fourth day after my vaccination.
No adverse event; not sure if it was the new Bivalent or the monovalent; This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (not sure if it was the new Bivalent or the monovalent) and NO ADVERSE EVENT (No adverse event) in a 70-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 prophylaxis.     The information was unknown whether the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No medical history was not reported.     On 25-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Sep-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (not sure if it was the new Bivalent or the monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (not sure if it was the new Bivalent or the monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (not sure if it was the new Bivalent or the monovalent).    The concomitant medication was not reported.  The patient had all four Moderna Covid shots.  The treatment medication was not reported. The reporter would like to know whether there was a 5th shot or need another dose.
Patient called pharmacy today stating they developed PMR ( polymyalgia rheumatic) after shingrix shot they got in 7/2019 and 9/2019.  Symptoms developed in October 2019.  Patients PMR is managed by Dr,  Patient stated hips and shoulders  are affected.  They also got a prevnar 13 in 8/2019.  Patient believe PMR was trigged by the shingles vaccine.
The patient called stating that he had some numbness in his arm that had traveled down to his hand starting a few days after vaccination and was not getting better. I suggested that he go to the ER to rule out at heart attack. He went to the ER and they ruled that out according to the patient. He said they admitted him on other reasons and upon discharge referred him to neurology.
Ringing in ears - still under doctor care. Rapid heart beat out of no where - still under doctor care. Violent projectile vomiting - two days. Extreme fatigue - 5 days. Was unable to move my left arm, shoulder, and neck. Was in extreme pain and no one could touch my left side. Could not sleep. Was on anti-inflammatories once a day, painkillers at night and muscle relaxers three times a day for 4 weeks and two days. First three weeks none of the medicine helped. It felt like glass was being jammed into my skin from my neck, shoulder, and all the way down left arm. Injection site still is sore. Have had flare ups with my left shoulder and neck still. I got 5 styes in my right eye and then another round of styes in Jan. Developed dry eyes now. Had two cold sores that developed that now come and go.
No other AE; PROQUAD was inadvertently given to a 32-year-old adult on 06April2022.; This spontaneous report was received from a nurse and concerns 32-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 06-APR-2022, the patient was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rHA)) (PROQUAD) 0.5 ml once, lot number: U029324, expiration date: 19-MAR-2023 (strength, route and site of administration were not reported) that was reconstituted in a sterile diluent (strength, dose, lot#, expiration date and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age).   No other adverse event was reported (no adverse event).
Chills, high fevers (Tmax 102) for 24 hours, headache, muscle aches, arm soreness at injection site, nausea requiring zofran
Pain at injection site (upper left arm) whenever arm is raised. Worse upon arising but never goes away. Topical remedies (Skinners Salve, Blue EMU) did not give relief. It has been over a month and the second shot will be due soon.
The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea. These went on for the next week. I didn't go into work February 26th. But did go in partial days all the next week. Very uncomfortable. The headache got worse each day until it was very bad. On March 10th I woke up with my left arm in excruciating pain and the headache. Went to urgent care and doctor gave me a shot of Tromodol. When I got to the parking lot, I became very dizzy and my legs gave out and fell in the parking lot down to t he ground.  Went to ER and waited for about 3.5 hours and left and went home. Went back to ER on March 12th due to arm in constant pain. Not able to sleep or relax. Wait this time was 3 hours and I was in too much paid so my daughter took me around the corner to urgent care. I was given steroid, muscle relaxer and a cream for my arm. My left arm from muscle up to shoulder and into wrist continues to hut. Today is 3/18/2021.
achy; painful muscle; painful joints; nausea; This is a spontaneous report from a non-contactable nurse, the patient. A female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727), via an unspecified route of administration in the left arm on 22Mar2021 at 15:00 hours as a single dose for COVID-19 vaccination. Medical history included autoimmune thyroiditis, environmental allergies and basal cell skin cancer. The patient was allergic to topical neosporin. The patient was on unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9809), via an unspecified route of administration in the left arm on 01Mar2021 at 15:30 hours as a single dose for COVID-19 vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at 03:00, the patient experienced achiness, painful joints, painful muscle and nausea. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as result of events and included the treatment with Tylenol. The clinical outcome of achy, painful muscle, painful joints and nausea were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Client is 12 years old and came and received 0.2ML of 5-11 year old Pfizer vaccine instead of appropriate dosage for a 12 year old (0.3ML 12+ year old Pfizer).  No symptoms or signs involved. Parent notified on 11/22/2021 2pm and informed of dosage mistake. Parent understood that client must receive 0.3ML of 12years+ Pfizer vaccine for 2nd dose. Will schedule accordingly.
had a seizure after getting the Bexsero vaccine / has other seizures since getting the Bexsero vaccine; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 15-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Menactra (received on an unknown date).   On 22nd July 2019, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 2 years after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was not recovered/not resolved.   It was unknown if the reporter considered the seizure to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was mother of the patient. The patient received 1st dose of Bexsero on 22nd July 2019 on an unknown arm. The patient had received the Menactra vaccine prior to getting the Bexsero vaccine, no information on the date or side effects were reported. The patient had a seizure after getting the Bexsero vaccine and has other seizures since getting the Bexsero vaccine.  The mother reports her son was on medication for seizures but did not disclose the name of the medication. The reporter would not provide any address, name of son, or any other details of her son's adverse events until someone from safety contacts her regarding the Bexsero vaccine her son received. The reporter did not consent to followup.
RN stated that while administering a first dose Janssen COVID vaccine she noticed the vaccine dripping from the cap and not entering the client's arm. RN stated less than half of the dose entered the client's left arm intramuscularly. Lead RN confirmed with lead operations team to confirm the CDC guideline to administer a full dose of Janssen COVID vaccine into the opposite arm since less than half of the original dose was injected into the client. Lead RN advised by lead operations team to have RN administer another dose of Janssen into the client's right arm and to have client stay for a 30 minute observation. At 1021 RN administered a full dose of Janssen COVID vaccine (LOT 205A21A, expiration date 08/07/2021) into client's right arm intramuscularly. Lead RN educated client on ER precautions and side effects warranting a follow up for medical care. Client stayed for a 30 minute observation without incidence and left the vaccine site on her own accord with a steady gait.
Extreme fatigue, hard to get out of bed, high fever, chills, headache, and extreme arm soreness that radiated all the way underneath my armpit and towards the back of my scapula
mom called the on call doctor at 8:14 pm as the baby had vomiting and diarrhea for the past couple hours - was to go to ER if symptoms not resolved within 4-6 hours - vomiting stopped within 4 hours, baby was pale - diarrhea stopped a few hours after the vomiting- the next morning the baby had 1 stool and then no further vomiting or diarrhea - gave Tylenol for discomfort and fussiness day of vaccines and the next day  baby was not seen as symptoms resolved
No additional AE/PQC; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute MMR-II and VARIVAX.; Caller reported inadvertent administration of expired STERILE DILUENT that was used to reconstitute MMR-II and VARIVAX.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 29-JUN-2023, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (strengths, vaccination schemes, anatomical sites of vaccination, routes of administration, lot numbers and expiration dates were not reported) as prophylaxis, that were reconstituted with an expired sterile diluent (strength, dose, frequency and route of administration were not reported; lot number T029529, expiration date reported and validated as 16-AP-2023) (expired product administered and product preparation issue). No additional adverse event.
I felt very tired, I had chills, sinus drainage, I knew I had something I just wasn't sure what it was, I took a home COVID-19 test that came back positive. I called my doctor to discuss my positive test and symptoms, we decided I would take the antiviral Paxlovid. I was able to start the medication the next day.  It took me took weeks to completely get over being lethargic. Even after having finished the five-day regimen, I felt tired, I did not want to do anything.
Shivery; Felt tired; Fever; Chills; Low grade headache; Arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Arm soreness), CHILLS (Chills), HEADACHE (Low grade headache), FATIGUE (Felt tired) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 06-Jan-2021, the patient experienced CHILLS (Chills) and HEADACHE (Low grade headache). On 11-Jan-2021, the patient experienced FATIGUE (Felt tired) and PYREXIA (Fever). On 12-Jan-2021, the patient experienced CHILLS (Shivery). On 08-Jan-2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, CHILLS (Chills) and HEADACHE (Low grade headache) had not resolved and FATIGUE (Felt tired), PYREXIA (Fever) and CHILLS (Shivery) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: 98.8. On 12-Jan-2021, Body temperature:. On 12-Jan-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pain in foot; Fever; shortness of breath; cough; Pain in head; Vomiting; Rash all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in foot), PYREXIA (Fever), DYSPNOEA (shortness of breath), COUGH (cough) and HEADACHE (Pain in head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in foot), PYREXIA (Fever), DYSPNOEA (shortness of breath), COUGH (cough), HEADACHE (Pain in head), VOMITING (Vomiting) and RASH (Rash all over). At the time of the report, PAIN IN EXTREMITY (pain in foot), PYREXIA (Fever), DYSPNOEA (shortness of breath), COUGH (cough), HEADACHE (Pain in head) and VOMITING (Vomiting) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-114889 (Patient Link).
really bad diarrhea; felt like having flu like symptoms; A spontaneous report was received from a consumer, concerning a  female patient of   85 years age male patient , who received Moderna's COVID-19 vaccine and experienced diarrohea and flu symptoms The patient's medical history was provided that diabetes and heart conditions. Concomitant product use was not provided by the reporter. Lab data was not provided. Treatment medication was provided that he took pepto bismol. On 12-FEB-2021 prior to the onset of events, the patient received their First dose  of mRNA-1273 (batch no. 031M20A )via unknown route to the left arm for COVID-19 infection prophylaxis.   Action taken with mRNA-1273 in response to the event was known. The outcome of the event, was considered to be unknown at the time of this report.; Sender's Comments:  MOD21-030784:Crosslinked
swollen lymph node near right armpit/breast. painful when palpated with more than a gentle touch.  ongoing for 2 days currently.
pt recv vax 20OCT94 & 4 days later pt exp a total loss of vision in one eye, which fully resolved in 6 wk;pt was examined by an ophthalmologist, but addtl details are not known as of the date of this report
Small localized rash to back area-no tenderness on inject site; no limited ROM noted;
Chest pain; Shortness of breath; Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12May2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medication. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021, the patient experienced chest pain, shortness of breath and heart palpitations. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the events. The clinical outcome of the events chest pain, shortness of breath and heart palpitations was not resolved.  The lot number for BNT162b2 was not provided and will be requested during follow up.
I developed a left kidney stone  unexpectedly on the morning of December 31st.  I did not have a history of kidney stones prior to this.  I was seen in the emergency room.  I had a CT scan that showed I passed a stone during my time in the ER. I was treated with pain and anti-nausea medications.   I was in the ER for 4 hours.
Herpes zoster - diagnosed 6/25/07. Varivax given - 5/3/07
notice lump 21APR95 @ 330PM size of a quarter 21APR95 @ 8PM lump was noticeably larger approx 5" in diameter w/redness; also exp nausea & diarrhea;
VACCINE WAS NOT DISPOSED OF DURING THE PREVIOUS NIGHT. MORNING SCHEDULE WAS HECTIC WITH MANY PATIENTS EARLY FOR VACCINE APPOINMENTS AND REQUIRING TRANSLATORS. PHARMACIST CAME INTO ADMINISTER VACCINES AND DID NOT DOUBLE CHECK IF THE VACCINES WERE JUST OPENED AND DREW VACCINE THAT WERE OPENED THE DAY PRIOR. VACCINE WAS 4 HOURS POST 12 HOURS PUNCTURE EXPIRATION. PATIENT WERE GIVEN MODERNA AS 2ND BOOSTER. PATIENT WAS CONTACTED AND REPORTED NO ADVERSE EVENT FROM THE VACCINE
Client had concerns of dizziness, throat tightness, lightheadedness, dry mouth. Onsite EMTs called to the patient. Vitals and blood sugar obtained. Client was given water and allowed to lie on back to rest. Client reported a decrease in throat tightness, still felt dizzy. Client denies any history of anxiety and panic attacks. EMTs performed orthostatics. Client's wife was called to pick the client up. Client states he did not drink water today. Denies SOB or chest tightness. Client states feeling better. Client's wife took the client home and a handwritten note was given to the client excusing him from work. Client left the space.
getting COVID; getting COVID; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "getting COVID".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Muscle and joint aches with a low temp of 100º.  Symptoms lasted 48 hours.
No adverse effect reported; 1 patient received expired but properly stored VARIVAX; This spontaneous report was received from a medical assistant regarding a patient of 34 years old of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 03-JUN-2019, the patient was vaccinated with expired but properly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (expired product administered) lot number N014371, expiration date 09-MAY-2019 for prophylaxis (dosage and route of administration was not provided). The varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect reported.