chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; general aches and pains; headache; swelling in the arm.; This case was reported by a other health professional via sales rep and described the occurrence of fever in an unspecified number of patients 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.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever, general body pain, headache and swelling arm. On an unknown date, the outcome of the fever, general body pain, headache and swelling arm were unknown.   It was unknown if the reporter considered the fever, general body pain, headache and swelling arm 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 provided as follows: The age at vaccination was not applicable. Medical Assistant mentioned she has had a few patients that have experienced fever, general aches and pains, headache, and swelling in the arm.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019AMR119314:Same Reporter
came to ED with a cough that had been productive and some generalized body aches. He had been having some shortness of breath and fever
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: Caller reported that patient had a sore arm after receiving the Covid Shot. Patient could not lay on his side all night.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was signed up for a Flu vaccine but received the bivalent Moderna vaccine. This was an incorrect vaccination administered error. The parent said that patient experienced low grade fever and arm soreness and that lasted 2 days. No other adverse effects were noticed.
About 1 month after vaccination, began having extreme fatigue, shortness of breath, heat intolerance, heart palpitations, and high blood pressure. Went to PCP and was referred to cardiologist and they found nothing wrong. Was sent back to PCP who ran more tests and it was discovered that I no longer had hypothyroid but instead hyperthyroid. I was taken off of Levothyroxine and placed on Methimazole, and that seems to have remedied the issue.
PT STATED HE WENT TO THE CLINIC AND THEN THE ER WITH A BUMP ON THE BACK OF HIS LEG. PT WAS TOLD IT WAS A BLOOD CLOT.
The night of vaccination I had some mild soreness in my arm and then developed rigors at 2am on 12/31/20. Throughout the day on 12/31 I had a low grade temp (99.5) and felt poorly. My arm soreness progressed for 1-2  more days
Elevated blood sugar; Congestion; Cough; Fever of 100.4 degrees Fahrenheit; Chills; Headache; Achy all over; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Elevated blood sugar), NASAL CONGESTION (Congestion), COUGH (Cough), PYREXIA (Fever of 100.4 degrees Fahrenheit) and CHILLS (Chills) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronavirus infection in May 2020.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced BLOOD GLUCOSE INCREASED (Elevated blood sugar), NASAL CONGESTION (Congestion), COUGH (Cough), PYREXIA (Fever of 100.4 degrees Fahrenheit), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Achy all over) and FATIGUE (Fatigue). At the time of the report, BLOOD GLUCOSE INCREASED (Elevated blood sugar), NASAL CONGESTION (Congestion), COUGH (Cough), PYREXIA (Fever of 100.4 degrees Fahrenheit), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Achy all over) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medication reported includes Tylenol.
Felt slight warmth throughout body about 5 minutes after vaccine. Disappeared 2 minutes later. Arm started to feel sore as the day went on and was very sore by nighttime. Next day, arm started to feel better and over the next 3 days was no longer sore.  On the morning of the 30th, woke up feeling fine, took a 3.5 mile walk and felt fine. Around 12:30 pm, experienced sudden pain and a burning sensation in the chest and both upper arms. Thought it was possibly heartburn ; took a Prilosec. The discomfort (mild but steady) continued so checked blood pressure which was 141/91. Called cardiologist and went to emergency room per instruction, around 1:30. Admitted overnight with the diagnosis of a mild heart attack and performed a heart catheterization where they found no major blockage. One artery noted 30% blocked but that overall heart function looked good. Discharged on 12/31/2020. -reported by patient via email, on 1/3/2021 @ 4:49pm
One week from the time I had the vaccine(2/17/21)  my left arm (where the vaccine was done) started to itch and was red and was warm to the touch. That was Wednesday, 2/.24.  On Thursday the redness continued around my left arm.It was circling the area where the shot was given.  It was still hot and red.   On Friday the redness continued around my left arm but now it is in a much larger area..  The redness/warmth to the touch and itchiness  area of my arm was getting larger. I went to see the Doctor  He did not know if it was an allergic reaction or an infection from the shot.  He gave me an antibiotic today which I have not started yet.  My arm is very itchy and swollen near the shot area.   The skin around the area where the shot was done is hard.   I called the Health Dept and I was told to fill this form out.  Please advise what I should do next if the area continues to be warm to the touch and the redness/swollenness continues down my arm.
Myopericarditis - chest pain with diffuse STE on ECG and a troponin of >20k
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:39 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:39 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 60.74 years  Concomitant products were not provided.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour.  On 27-Oct-2021, vial was stored in cooler 1, excursion time at 9 am: 41, at 10 am 29, at 11 am 32, at 12 pm 43, at 1 pm 43, at 2 pm 43, at 3 pm 46, at 4 pm 46, at 5pm 46.  On 27-Oct-2021, Excursion time was 09 AM , temperature were 29 and total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 , vial was moved to clinic on 27-Oct-2021. 2 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Treatment medications were not reported
At the time of the injection I had light localized pain at the injection site, light muscular pain, & fatigue that lasted a couple of days.  A week after the injection I noticed a red patch at the injection site; one side was slightly thicker than the rest.  No pain - just red... The patch has faded slightly, and increased in size to 1 1/2 inches, and now is slightly warm to the touch and slightly tender...  Although not bad pain, it feels as if I had just taken the shot.  In other words I am aware of the location of the shot.. and feel a slight sting if I move my arm just right....
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: FK5730), in right arm, on 18Jan2021 as dose 2, single (Lot number: FL1283), in right arm, on 30Sep2021 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Other medical history: Arthritis; "GERD" (unspecified if ongoing), notes: Other medical history: Arthritis; "seasonal allergies" (unspecified if ongoing), notes: Other medical history: seasonal allergies. Concomitant medication(s) included: MELOXICAM, start date: Jan2018; PRILOSEC [OMEPRAZOLE], start date: Jul2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
PATIENT BECAME NAUSEOUS AND VOMITED ABOUT 30 MINUTES FOLLOWING IMMUNIZATION.  FOR THE NEXT DAY SHE DESCRIBED FEELING DIZZY.
Pt was seen on 05/26/05 because of vomiting once the day before and the mother noticed some redness and scratching behind the ear. The physical exam was normal, I explained to the mother that she may develop diarrhea because of the intestinal viruses going around. The same day, after her office visit, she went to the ER because the pt fell, cried, and then went limp. Mother said she was walking a little bit unsteady before that happened. When MD saw pt in office next morning, T was 100.6 by ear thermometer. The mother took pt to ER where they made the Dx of possible febrile convulsion. She was given an injection of Ceftriaxone. A culture of CSF and blood were negative. The mother called me on 05/28/05 and the pt was perfectly alright and has not had any more episodes. She does not have vomiting or diarrhea at this time.
Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild
I had a runny nose, cough congestion, I felt achy late in the evening of 02/10/23. I awoke in the morning feeling a bit worse, I at first had thought it was allergies, but it persisted throughout the day, so I decided to use my home COVID-19 test that came back positive. I called my doctor letting him know I was positive, he prescribed PAXLOVID. It took a couple of days for me to start feeling better and I am feeling so much better now. It did take two weeks before I tested negative, but I feel that I had a very mild case.
Patient presents to the clinic at about 2:20pm for her 2nd dose of COVID vaccination. She was greeted and asked to fill out another consent form for the 2nd dose and was told it will be reviewed after she completes it. She states she has a history of seizure. State had one small seizure episode yesterday. States her doctor is aware and is running more tests and changing her medications around. States her doctor is aware about her COVID vaccination and made no mention that she should not get the vaccine. She states she is comfortable getting it. She states she received the first dose of the COVID vaccine and did ok. The only symptoms she had was fever for about a week. Again she states her doctor is aware and has not told her not to get the second dose of the COVID vaccine.  Consent and history were reviewed and COVID vaccination was given at about 14:27 with LVN. She was told because of her medical history, she will need to be monitored for 30minutes instead of the 15 minutes; she agreed.  After vaccination was given, patient sat with another co-worker talking and appeared in no distress. Co-worker left shortly after while she was still there for monitoring.  At about 2:30ish pm notice that patient was starting to slide down her chair appearing to have a seizure. Immediately rushed over to her, guided her down to the carpet, supported her head, she was lying to her side. She was not conscious, eyes closed, teeth clenched, no foaming of the mouth were noted. +strong radial pulse. Can hear her loudly breathing through her nose. Pulse oxygen on room air, 92% and heart rate was 67. She was not turning blue. Arms and legs were mild jerking. Called out to have staff called 911 simultaneously while supporting and monitoring patient. About 5 minutes into this, patient started to slowing open her eyes, still altered, teeth still clenching and extremities stopped jerking. Slowly, she started to relax, asked her name and where she is at and why she was there, which she was able to answer slowly. Asked her if she wanted us to call her daughter, she said he because she is a minor. Asked her who she is with and she said her husband is outside.  Paramedic arrived and took over care and she was told she will be transported to the ER.  Her husband, came into the room. After patient's husband spoke to paramedic, I also introduced myself to him. Per her husband, patient has a history of seizure that has not been controlled. Per husband, he states she had 5 episodes on Sunday, 3/21/2021. Her doctor is aware and is doing more testing and changing her medications around. Per patient's husband, he states she was doing an MRA yesterday to further evaluate the seizure and they were not able to complete it because she had 2 episodes. When asked if her doctor mention anything about getting the COVID vaccine, per patient's husband he states they did not say anything. Per husband, she did ok with the 1st dose of the COVID vaccine and only had fevers. Per patient's husband, there was no change in her underlying medical condition with the seizure with getting the vaccine.
This spontaneous report was received from a nurse refers to unspecified patient of unknown age. The patient's medical history, concomitant medication and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of one of the following lots of PROQUAD, but she was not sure which of the lots the unspecified patient received from lot#s (M044021, expiry: 01-MAY-2018) (N008824, expiry: 28-AUG-2018) (N002917, expiry: 24-JUL-2018) (M034692, expiry: 24-JAN-2018) (M022400, expiry: 01-NOV-2017), (dosing details not provided), for prophylaxis. No adverse effects were reported. The vaccine lots were exposed to temperature in the range -9 degree Celsius to 8 degree Celsius for 1 hour and 45 minutes. Temperature excursion was detected by digital data logger. No previous temperature excursion occurred. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA005985.
Subsequent to receiving vax pt developed a fever of 102 - 103F and an injection site reaction characterized by a large knot, redness and warmth. The reporter indicated that 5 out of 80 pts experienced this event following the receipt of Tetramune lot #458-593.
pain wakes her up at night; Trouble writing or scratching; pinkie is numb; whole arm nerve pain that constantly wakes her up at night; Shooting pain; joint pain; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (whole arm nerve pain that constantly wakes her up at night), DYSGRAPHIA (Trouble writing or scratching), HYPOAESTHESIA (pinkie is numb), SLEEP DISORDER (pain wakes her up at night) and PAIN (Shooting pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced NEURALGIA (whole arm nerve pain that constantly wakes her up at night), HYPOAESTHESIA (pinkie is numb), PAIN (Shooting pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (injection site pain). On 24-Apr-2021, the patient experienced DYSGRAPHIA (Trouble writing or scratching) and SLEEP DISORDER (pain wakes her up at night). At the time of the report, NEURALGIA (whole arm nerve pain that constantly wakes her up at night), DYSGRAPHIA (Trouble writing or scratching), HYPOAESTHESIA (pinkie is numb), SLEEP DISORDER (pain wakes her up at night), PAIN (Shooting pain), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were taken. Treatment medication included Motrin 200 mg to relieve symptoms of pain.
Shingles - Right T1 dermatome Pain began 11/29/21. Rash erupted 12/3/21.  I also have a 39 yo healthy colleague who received both his Influenza Vaccine and Moderna Booster within days of me, and also developed shingles on almost the exact same day I did.
After a few minutes the patient complained of dizziness, then the patient progressed to complaining of shortness of breath. We could see patient had faster than normal respirations.  Called 911  Patient took some slower breaths and used a damp compress, after calmed down, EMT's evaluated her before she left and went back to her care facility.
Pt presented with erythema to left upper thigh area. Area warm to touch but non tender.
Received Moderna Vaccine, first injection in left arm, a couple of days ago, I developed a fluid pocket above the left elbow.  Pocket is about one inch in diameter.   No Discoloration, no soreness.
dizziness starting after administration  of vaccine .  within a day progressing to tinnitus, joint pain, cracking joints, lymph swelling, shooting pains all over my body, twitching-shakiness , unsteadiness, lightheaded when standing , numbness in my whole body and inability to feel my hands & feet well, nervous system feels over activated.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # L018499, expiration date: 25-FEB-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day 12 post-vaccine - both arms red and swollen, swelling in extremities, irritation in vagina.  Swelling worse in Right arm.  Both legs had rashes, particularly the knees, feet red to the end of the toes.  Top of legs were extremely dark. The symptoms are still present as of 2/9/2021
administration of a expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 53HA4, expiry date 26th March 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 28th April 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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 provided as follows: The patient received a dose Paediarix which had expired on 26th March 2021, which led to expired vaccine used. The reporter consented to follow up.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to an exact time not recorded, noted as equal to or >12C for an estimated total time out of range of 10.5 hours. On 11-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
I became confused and delusional, ran a fever, & had body aches for 37 hours.