chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting 05/03/2022, I woke up at about 3 in the am and I use a c-pap machine. I noticed I wasn't breathing properly. I went to Urgent Care and they did imaging and didn't find anything. They didn't treat anything. It continued over time and I saw my pulmonologist and he gave me an inhaler but told me not to use it until I saw a cardiologist. By 06/06/2022, it was so bad that I did not know what to do, so I used the inhaler (Stiolto Respimat) which helped. I continued to use it. I saw the cardiologist on 07/12/2022, who ordered imaging that will be done next week. I stopped the inhaler after seeing him and the symptoms have resolved.
Given expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
On 03/19/2022, I was on a cruise ship and I had what I thought was a cold or allergies. It started with a post nasal drip and a sore throat. The following morning the sore throat was much worse. The health services on the cruise tested me for COVID-19 with a rapid test and it came back negative. They told me to quarantine in case. They then did a PCR that came back positive positive.  They did another PCR test prior to leaving the ship and it was still positive. I had exhaustion, body aches, brain fog and a very sore throat. The more extreme symptoms lasted about 3-4 days and very gradually decreased. The exhaustion has stayed with me the longest. At about 6 weeks after I am still recovering. My mental acuity is starting to recover as well.
I received my second Pfizer booster for COVID-19 on 4/7/2022. On 6/25/2022, I developed very slight body aches. I also had a slight cough with a little bit of phlegm. That day, I took a home test for COVID-19 and got a positive result. The mild symptoms lasted for 3 days. On 6/28/2022, I took two more home tests to confirm that I had COVID-19, and they both yielded a positive result.  On about 6/29/2022, my doctor gave me a 5-day course of Paxlovid. All of my symptoms went away and I felt fine. On 7/6/2022, I took two home tests and got a negative result with both of them.
myasthenia gravis; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (myasthenia gravis) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Double vision. Concomitant products included AMLODIPINE, ATORVASTATIN, BUSPIRONE, FLUOXETINE, MELOXICAM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (myasthenia gravis) (seriousness criterion medically significant). The patient was treated with EPINASTINE for Adverse event, at a dose of UNK UNK, bid (1 drop in each eye twice daily); PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE [PYRIDOSTIGMINE BROMIDE]) for Adverse event, at a dose of UNK UNK, tid (60 mg half table) and MYCOPHENOLATE MOFETIL HCL for Adverse event, at a dose of 500 mg twice a day. At the time of the report, MYASTHENIA GRAVIS (myasthenia gravis) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include issued patient a pair of glasses to correct the double vision  It was reported that on 01 Feb 2021 patient went to the eye doctor. Patient had double vision for several months, left eye was drooping, left arm could not be raised above horizontal position. Patient was diagnosed with Myasthenia gravis in between June to July 2021.  Company comment: This case concerns a 79-year-old male patient with medical history of double vision, who experienced the unexpected, serious event of Myasthenia gravis. The event occurred approximately 1 day after first dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Event myasthenia gravis was automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite it was reported as non-serious.   This case was linked to MOD-2021-326977 (Patient Link).; Sender's Comments: This case concerns a 79-year-old male patient with medical history of double vision, who experienced the unexpected, serious event of Myasthenia gravis. The event occurred approximately 1 day after first dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Event myasthenia gravis was automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite it was reported as non-serious.
First had Janssen on 3/10/2021 Then had Moderna on 11/2/2021. High Blood pressure began in March of 2021 Never ever had a history of high blood pressure in her life. High blood pressure began at the beginning of March 2022. Took three weeks to get in to see her doctor. He prescribed Lisinopril 40 mg which did bring down her blood pressure but also made her vomit and she could not keep anything down on the 4/1/2022.  She commented that the medicine was making her sick and she was not going to take it anymore. Less that 24 hours later we found her dead!
nerve damage; numbness; itching; tingling when trying to pick up something feels like an electric shock.; nerve type pain; pain located in the hands, feet, lower arms, and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVE INJURY (non-serious), outcome "unknown", described as "nerve damage"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; PRURITUS (non-serious), outcome "unknown", described as "itching"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling when trying to pick up something feels like an electric shock."; NEURALGIA (non-serious), outcome "unknown", described as "nerve type pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain located in the hands, feet, lower arms, and legs".  Additional information: Caller states his wife (age unknown, did not want to provide age but states she is a senior female) received prevnar20. After several days she started to have the following symptoms: numbness, itching or pain, in the hands, feet, skin on the lower arms and legs, tingling when trying to pick up something feels like an electric shock. The reporter want to know if Prevnar20 cause these symptoms and if it caused nerve damage. She received Prevnar 20, received date unknown, and several days after she started to develop symptoms of numbness, itching, and pain located in the hands, feet, lower arms, and legs. She has tingling. When she tried to pick up something it was like an electric shock, nerve type pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the morning following the shot, i woke up at 6am from severe pain in my left shoulder where the shot was given. i lost total use of my left arm because of the pain it was causing. the night before i also got a splint on my left ankle from soccer and i was using crutches. i couldnt use cruthches any more because of the pain in my shoulder, therfore i couldnt walk. i missed a lot of time from school and work due top that. i was told when i returned the next day that i had a reaction to the shot although iam not allergic to any medication, i was also told the pain will go away in the next 2 to 3 days. it has been two weeks now and the opain is still there. iam taking medication all day for the pain.
I got the shot (this my second in the series).  No adverse effects immediately.  I went to bed that night, and woke up just after midnight to tremendous ringing in the ears.  I thought I was hearing something outside, but it was in my ears.  I also had very sore body muscles.  I got up the next day the the symptoms persisted.l throughout the day.  The body aches slowly diminished and eventually went away, but the constant ear ringing has persisted.  Today is the 9th.
Pain is getting to her left leg to the back; Left leg is hurting more and more; Numbness in hands/feels as if everything is numb; Veins from knee down are sticking out; Veins are sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hands/feels as if everything is numb), SUPERFICIAL VEIN PROMINENCE (Veins from knee down are sticking out), VASCULAR PAIN (Veins are sore), BACK PAIN (Pain is getting to her left leg to the back) and PAIN IN EXTREMITY (Left leg is hurting more and more) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness in hands/feels as if everything is numb), SUPERFICIAL VEIN PROMINENCE (Veins from knee down are sticking out) and VASCULAR PAIN (Veins are sore). On an unknown date, the patient experienced BACK PAIN (Pain is getting to her left leg to the back) and PAIN IN EXTREMITY (Left leg is hurting more and more). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in hands/feels as if everything is numb), SUPERFICIAL VEIN PROMINENCE (Veins from knee down are sticking out), VASCULAR PAIN (Veins are sore), BACK PAIN (Pain is getting to her left leg to the back) and PAIN IN EXTREMITY (Left leg is hurting more and more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
It was noted later that no new vaccine vial was removed the day the vaccine was administered; presume that vial from previous day was used. The vial was kept at appropriate refrigerated temperature but punctured on 1/17/23 (more than 8 hours prior). Patient was notified, offered a repeat vaccine, though she declined a repeat vaccination.
This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the vaccine did not stop the shingles and made it much worse and more frequent. The reporter disconnected the call while on hold and about to transferred the call to Regulatory Authority. The reporter provided the external phone number to the inquired for future reference. This case was considered as suspected vaccination failure as details regarding vaccination schedule and time to onset were unknown. This case has been linked with case US2018GSK227344, reported by the same reporter.
sugar spike about a half hour after the vaccine. He mentioned it was much higher than usual.; A spontaneous report was received from a consumer concerning a 63-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sugar spike about a half hour after the vaccine. he mentioned it was much higher than usual.  The patient's medical history was not provided. Concomitant medications reported were lantus insulin, humalog insulin, atorvastatin 20 mg, levothyroxine 88 mg, fenofibrate 54 mg, amlodipine 10 mg, benazepril mg, aspirin, prilosec for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029K20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) sugar spike about a half hour after the vaccine. he mentioned it was much higher than usual.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sugar spike about a half hour after the vaccine, he mentioned it was much higher than usual was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tightness.  All mild symptoms.  tongue and Lip  Issues resolved in abt 1 hour and chest tightness in abt 2 hours.
Developed pulmonary embolism in right lung one week after vaccination. Sharp pain on right side when breathing. Treated with IV Apixaban while inpatient for 2 days, oral Apixaban 5 mg, 2 tabs twice daily 1/5/21-1/11/21, then one 5 mg tab twice a day. Pain has subsided as of 1/14/21.
Pt received 2nd dose vax and was in observation area w/ her sister. Pt denied any reaction after first dose, did report hx of asthma.Ten min post-vax, pt called observation nurse (RN) w/ complaint of "lung pain," some SOB and abd pain. Pt had also developed hives on her chest and neck, visible to observation nurse. Pt was transferred to EMT area for assessment and observation. Pt was alert and oriented to place & time and answering qx w/o WOB or apparent distress. However, during assessment of VS, pt developed add'l hives on face, w/ eye swelling. EMTs and charge nurse recommended transfer to ED d/t multiple early sx of possible severe reaction. Pt and parent agreed. Pt transferred to Hospital via ambulance d/t risk for emergent allergic reaction.
Chills and Fever the first day a few hours after injection along with Fatigue, Multi-day Headache, Slight Body Ache, and Injection Site Pain all for about 2 or 3 days.  Some leg pain was noticed the 2nd or 3rd day. And I have experienced ear ringing randomly about a week and a half after vaccination. Those may or may not be related.  Also I feel it important to note in March of 2020 (before testing was available) I experienced a very similar set of symptoms: fever, chills, fatigue, multi-day headache, body ache, 6 weeks of slight cough, leg pain, and a day a few weeks after the coughing started where I had shortness of breath. I wasn't tested back then as it was not available. But based on the symptoms I experienced, I truly believe I had COVID-19 last year prior to vaccination.
LOCAL REACTION TO LEFT DELTOID. REDNESS, SWELLING, WARMTH OF LEFT UE. TREATED WITH BENADRYL, ICE AS NEEDED. RECEIVED TDAP AND MENACTRA IN THAT ARM 2 DAYS AGO.
Positive for COVID asymptomatic; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (Positive for COVID asymptomatic) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neutropenia and Microcephaly (Microcephaly neutropenia). Concurrent medical conditions included Drug allergy (Extremely sensitive to medications), Soy allergy (soy sauce), Behcet's syndrome (Bechet syndrome (autoimmune)), Legal blindness (Legally blind), Learning disorder (Non-verbal), Kidney failure and Rheumatoid arthritis (Rheumatory arthritis). Concomitant products included ADALIMUMAB (HUMIRA) for Autoimmune disorder NOS, METRONIDAZOLE (METRO [METRONIDAZOLE]) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2020, the patient experienced ASYMPTOMATIC COVID-19 (Positive for COVID asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (Positive for COVID asymptomatic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) Positive. In April 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant also included booster shot.  In April 2021, the patient was possibly positive for COVID asymptomatic and outcome was unknown.  No treatment medications were reported.  Company Comment: This is a regulatory case concerning a 46-year-old male patient with medical history of Behcet's syndrome and Kidney failure, who experienced the unexpected non-serious adverse event of special interest, Asymptomatic COVID-19 which occurred on an unknown date and interval (vaccination date not provided) after receiving a dose of mRNA-1273 Vaccine. SARS-CoV-2 test yielded positive result, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The medical history of Behcet's syndrome and Kidney failure remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-523037 (Patient Link).; Sender's Comments: This is a regulatory case concerning a 46-year-old male patient with medical history of Behcet's syndrome and Kidney failure, who experienced the unexpected non-serious adverse event of special interest, Asymptomatic COVID-19 which occurred on an unknown date and interval (vaccination date not provided) after receiving a dose of mRNA-1273 Vaccine. SARS-CoV-2 test yielded positive result, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The medical history of Behcet's syndrome and Kidney failure remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
ACHES AND PAINS; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced aches and pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of aches and pains was not reported. This report was non-serious.
After sitting for a bit after receiving the vaccination, the patient and I proceeded to the appointment desk to schedule the second shot.  While  talking with the clerk, he fainted and hit his head on the floor.  He was taken to an examination room where possible concussion was ruled out, he rested for approximately 45 minutes, and I took him home.  He slept at home for approximately two hours and had a headache all that evening for which he refused treatment.
Area of swelling and redness noted in distal left axillary skin on day 9 following vaccination.  Appears to be an autoinoculation; patient's vaccination site is on deltoid area of upper L arm.  Patient reported shaving axilla after vaccination.  Patient reported to employee health at workplace; instructed to keep site covered with a tegaderm while working and to avoid shaving axilla for time being.
Started getting a slight headache/ he has the same symptoms as me; pressure headache/he has the same symptoms as me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Started getting a slight headache/ he has the same symptoms as me"; HEAD DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "pressure headache/he has the same symptoms as me".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, fever (103 F), muscle aches, dizziness, neck pain and headache.
dose received 3; Severe headache and flue like symptoms starting 18hrs past the vaccination and continuing 26 hrs past the shot; Severe headache and flue like symptoms starting 18hrs past the vaccination and continuing 26 hrs past the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left (Lot number: ew0164) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history was not reported. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0183, Location of injection: Arm Left), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: fj8757, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "dose received 3"; HEADACHE (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset 17Dec2021 04:00, outcome "not recovered" and all described as "Severe headache and flue like symptoms starting 18hrs past the vaccination and continuing 26 hrs past the shot". Therapeutic measures were not taken as a result of headache, influenza like illness.  Additional information: the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not received other medications in two weeks. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.
Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
Same day-severe swelling at site of shot (right leg). Dad thinks he may have gotten 0-5mg instead of 0.25mg. Next day temperature 103.