chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose of on 26-Apr-2021, not gotten third dose yet; first dose on 26-Apr-2021, second on 16-Jul-2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 29-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 26th April 2021).   On 16th July 2021, the patient received the 2nd dose of Twinrix (intramuscular) and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 16th July 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were 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 age at vaccination was not applicable for 3rd dose of Twinrix. The patient received 2nd dose of Twinrix late than athe recommended time interval, which led to lengthening of vaccination schedule. Till the time of reportingt, the patient did not receive 3rd dose of Twinrix , which led to incomplete course of vaccination. The reporter did not have the following information, lot or exp date of both doses, dosage, and whether the vaccine was administered on left or right arm. The reporter gave a consent to follow-up, However, he did not have a fax number or an email address to health care professional.
Myasthenia gravis. Hospital admission within 6 weeks of receiving the COVID vaccine.
My sense of taste and smell completely changed. I have phantom smells. Foods like onions and some meats taste very different. It has been over 8 months and it still has not come back.
rash devel all over body 4 days p/shot mainly on torso;rash off & on x 6 days;
Later tingly/numb feeling hand, arm, neck, face (left side); Within 15 minutes tingly hand, later tingly/numb feeling hand, arm, neck, face (left side); This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 02Apr2021 at 14:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), withania somnifera (ASHWAGANDHA), fish oil (MANUFACTURER UNKNOWN) and mentha x piperita oil (PEPPERMINT OIL), all from unknown date for unknown indication taken within 2 weeks of vaccination. The patient previously took naproxen (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 02Apr2021 within 15 minutes of vaccination, at 15:00 the patient experienced tingly hand. Later, on 02Apr2021 at 15:15 the patient experienced tingly/numb feeling hand, arm, neck and face (left side).No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event tingly hand(Paraesthesia) and tingly/numb feeling hand, arm, neck, face on left side (Hypoesthesia) were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
After I received the shot and left the doctors office I had a sore arm (Nurse said there may be sore arm and side effect) Throughout the day I had a headache and muscle pain. Felt like I had an empty stomach. I had redness on arm where I received the shot (left arm). On the evening of the shot I had a fever, shivers, and arm was very sore, and redness. Fever and shivering lasted for most of the night. The 2nd day I was tired most of the day and I slept most of the day, had soreness and redness sin arm. Did not feel like doing much of anything. Third day I felt much better but still had soreness and redness in arm. 4th day I still have redness and much less soreness in arm. I did call my doctor on day 2 to let them know of the adverse effect I had after the shot and throughout the day  and overnight.
First dose: mild arm pain, raised red lump (got about as big as a half dollar in size) near injection site (bruise formed after lump went away), "COVID arm" Second dose: moderate arm pain, raised red lump (so far  approx 1.5-2" in diameter and still growing) near injection site, severe pain near top of spine / base of neck causing discomfort and a migraine, nausea, fatigue, overall discomfort.
Upper left arm started hurting; hurt to move arm; upper arm swollen and felt hard to the touch; used ice on arm first night; morning of the 27th I felt very weak, dizzy, and nauseous, with chills. Morning of the 28th the swelling of the upper arm was now in the tricep and red.
Pain under my armpit, swollen lymp nodes.; Pain under my armpit, swollen lymph nodes.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 09:15 (Lot number: EW0191) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 12Jun2021 06:00, outcome "recovering" and all described as "Pain under my armpit, swollen lymph nodes.". Therapeutic measures were not taken as a result of axillary pain, lymphadenopathy.  Additional information:"No other vaccine in 2 qnd 4 weeks. No covid prior vaccination. Not tested for covid post vaccination. No known allergies."  No follow-up attempts are possible. No further information is expected.
1/2" bruise p/flu shot, unresolved 1wk later;somewhat painful (bled initially);
Patient contacted the pharmacy that administered the vaccine informing us of the timeline of side effects. Patient stated they had a sore arm the night following the administration of the vaccine but this subsided the next day. They then experienced nausea and stomach pain within a week of receiving the vaccine. The patient sought care and was found to have elevated liver enzymes. Patient said several tests were done did not give the dates etc. Contacted primary care doctor and they recommended contact local CDC office. The CDC office recommended starting a VAERS submission. Patient liver enzyme had started to normalize but are still elevated at this time.
Tension headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Tension headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced TENSION HEADACHE (Tension headache). At the time of the report, TENSION HEADACHE (Tension headache) had not resolved.            No treatment information was not provided by the reporter.  No concomitant medications were available.  Patient reported of having migraines a couple times a year in a specific area, like the right eye. These are symmetrical headaches at both temples.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-068659 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: added details of the events in the supplement,; 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. US-MODERNATX, INC.-MOD-2021-068659:
No additional adverse events reported; administration of improperly stored PROQUAD; This spontaneous report was received from a physician, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 05-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (ml) (route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number U006314 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA), expiration date reported and upon internal validation established as 24-AUG-2022) as prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion of 45.3 degrees Fahrenheit (F) for 17 hours. There was no previous temperature excursion reported. It was unknown if a digital data logger was involved. No adverse events were reported.
Sx onset 7/22/21 with cough, runny nose, sore throat, nasal congestion, fever, chills, headache, loss of smell & loss of taste. Tested on 7/25/21 which resulted as positive. Traveled via airplane 7/20 to 7/22.
Headache and felt nauseous/achy next morning. Treated with Advil.
The patients wife called and said he'd had a possible reaction to the flu shot on 10/21/13. She said he had fever, finger tingling and SOB and went on to the ER but was discharged soon after.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a female patient of unspecified age. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVC [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. On the same day, after vaccination, the patient developed fever. The patient was reported to have been feeling better on the day, she was followed up by her healthcare professional (11-Oct-2018). On the following follow up (on 15-Oct-2018), the patient stated that she had no problems. At the time of this report, the patient was recovering from the event. This case was linked to original case 201804657 due to same reporter. Significant case amendment (19-Oct-2018): Description to be Coded was changed from 'extra dose administered' to 'overdose' for the event verbatim: "Received 1.5 ml dose instead of 0.5 ml". Narrative and case comment were amended accordingly.
Fevers to 104 h/a, stiff neck, extreme soreness @ inject site occuring w/in 10hrs p/inject; rash over body appeared p/36hrs; Skin peeling in bilat groin area; Appetite poor x 48 hrs; slept freq x 48 hrs;
SkinRash, Rash, NauseaVomiting, Chills, tightness in throat, SpO2 dropped to 88%, after Epipen administration went back to 100% Narrative:  Patient experienced severe adverse reaction approximately 30 minutes after the vaccine administration. She was treated by medical staff at the site and was sent to ED by ambulance around 17:30.
Red induration left thigh 34x20mm right thigh 34x30mm, redness on areas of face and body.
I feel tired and headache after around 10h after vaccination and I can see gross blood in my urine after 24h. This also happened after I received my second dose of the Pfizer vaccine.
Pfizer 9/9/21, 10/5/21. Positive on 8/3/22
Woke up at 6 am the day after vaccine disoriented. I had no short term memory. I repeated myself multiple times in a loop. I knew my name and my husbands name but no idea time of day, weather, if I worked, etc. husband was extremely concerned so took me to the hospital about 8:30 am.  Dr eventually had me admitted into hospital overnight for observation
The patient was complaining about her head hurting and feeling as if she needed to throw up, she also stated that she was feeling nausea and feeling as if she was going to faint. The patient was asked if 911 needed to be called and she responded, No.  The patient?s vitals were checked by the vaccinator who is licensed as an EMT, all vitals were normal and the patient was asked to stay in the observation area for another 15 min. After time was up the patient left with no further incidents.
PATIENT TOOK THE SAME VACCINE 4 TIMES.  WE DIDN;T KNOW AT THE TIME OF VACCINATION, BUT THE PATIENT HAS BEEN FINE WITH NO REACTIONS.  HE DID NOT REALIZE THAT HE DIDN'T NEED TO GET IT.   HE IS A HEALTHY 32 YEAR OLD MALE, WITH NO ISSUES.
This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), ASTHENIA (Weakness), ONYCHOMYCOSIS (Fungal infection of nail), NECK MASS (Neck mass) and SKIN ODOUR ABNORMAL (Skin odor abnormal) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis. The patient's past medical history included Cyst removal (cyst on back of neck removed). Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS). On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced LETHARGY (Lethargy), ASTHENIA (Weakness), ONYCHOMYCOSIS (Fungal infection of nail), NECK MASS (Neck mass), SKIN ODOUR ABNORMAL (Skin odor abnormal), VITAMIN B COMPLEX DEFICIENCY (Unspecified vitamin B deficiency) and CYST (Cyst). At the time of the report, LETHARGY (Lethargy) and ASTHENIA (Weakness) had resolved, ONYCHOMYCOSIS (Fungal infection of nail), NECK MASS (Neck mass), SKIN ODOUR ABNORMAL (Skin odor abnormal) and VITAMIN B COMPLEX DEFICIENCY (Unspecified vitamin B deficiency) had not resolved and CYST (Cyst) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. Concomitant product use was not provided by the reporter. It was reported that on unknown dates, the patient experienced lump on neck that had odor like was infected, weak and lethargic after Moderna COVID vaccine, vitamin B was low, had cyst on back of neck removed and left foot fourth toe toenail had fungus and infection. The patient had a lump on the back of neck that had an odor like it was infected. Patient took the Moderna Covid vaccine and it made patient weak and lethargic. Patient had been feeling lethargic. Physician said that Patient's vitamin B was low, and patient was needed to increase it. Patient had cyst on back of neck removed. Patient's left foot fourth toe toenail had fungus and infection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Follow-up received included new events, laboratory data was added and outcome of the events was updated.
PT REPORTED TONGUE RIGHT SIDE OF FACE BECOMING NUMB AFTER ABOUT 30 MINUTES OF RECEIVING THE VCACCINE.  GAVE PT 2 DIPHENHYDRAMINES (25 MG TABLETS) AND CALLED EMS
Six days after receiving the Moderna COVID vaccine, my arm started to itch near the injection site. When I looked at it, it was red and swollen. Over the course of the next two days, the redness dulled to pink but the size spread and it is now slightly smaller than the palm of my hand.   I will mention that 4 years ago, I received rabies vaccines in that arm. I had mucositis from it, and still have it residually when I get a cold and my immune system kicks in.  I have had flu shots since then without problems, but I was stung by a bee two years ago and had a very similar reaction to this COVID vaccine at the site of the bee sting. I don't know if I have some sort of different immune response to things due to the rabies vaccines.
Persistent throbbing headache started around midnight on 12/21/20. The headache did not subside with Tylenol, rest, nutrients, or hydration.  The headache worsened with any head movements and made completing activities difficult. The headaches stopped by the morning of 12/23/20.
Pin and needle like feelings in both arms and hands; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pin and needle like feelings in both arms and hands) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced PARAESTHESIA (Pin and needle like feelings in both arms and hands). At the time of the report, PARAESTHESIA (Pin and needle like feelings in both arms and hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 09-MAR-2015, the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
After getting my 2nd dose of Moderna vaccine, I started experiencing ringing in my ears and it's getting louder. I went to see an ENT and he said it's tinnitus.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 33 year old  female. Initial information was processed with the additional information received on 07-JUN-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, depression, and sulfa drugs allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 in right arm for prophylactic vaccination. Age at time of vaccination 31 years old.  The patient additionally received non-company suspect vaccine included: Moderna (spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: 071F21A expiry: UNKNOWN) dose was not reported, administered on 04-NOV-2021 in right arm for prophylactic vaccination. Concomitant medications included fluticasone propionate/salmeterol xinafoate, levosalbutamol, spironolactone, valaciclovir and decongestant cough suppressant/expectorant with nasal.   On an unspecified date in MAY-2022, patient reported that symptoms never fully disappeared, still had a cough. On 18-MAY-2022, the patient was prescribed with Paxlovid (nirmatrelvir and ritonavir) for covid-19 treatment. Patient received last dose of Paxlovid on 22-MAY-2022. On 23-MAY-2022, patient had moderate shortness of breath in addition to cough but she tested negative. Laboratory data included: COVID-19 virus test Negative. Symptoms continued all week. On 27-MAY-2022, patient tested positive again, no change in symptoms (confirmed covid-19 infection (dose number in series 2), which led to confirmed clinical vaccination failure (dose number in series 1).  Laboratory data included: COVID-19 virus test Positive. Patient was still experiencing same symptoms on 28-MAY-2022. Treatment medications (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0-20220609449-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
SKIN BREAKOUTS; ACHES/PAIN; SERIOUS REACTION AFTER THE FIRST DOSE OF MODERNA COVID VACCINE; FEVER; This spontaneous case was reported by an other and describes the occurrence of RASH (SKIN BREAKOUTS), PAIN (ACHES/PAIN), ADVERSE REACTION (SERIOUS REACTION AFTER THE FIRST DOSE OF MODERNA COVID VACCINE) and PYREXIA (FEVER) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    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 and UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RASH (SKIN BREAKOUTS), PAIN (ACHES/PAIN), ADVERSE REACTION (SERIOUS REACTION AFTER THE FIRST DOSE OF MODERNA COVID VACCINE) and PYREXIA (FEVER). At the time of the report, RASH (SKIN BREAKOUTS), PAIN (ACHES/PAIN) and PYREXIA (FEVER) had resolved and ADVERSE REACTION (SERIOUS REACTION AFTER THE FIRST DOSE OF MODERNA COVID VACCINE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.