chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; pain in elbow/ pain in shoulders; lymph nodes at the armpits swollen; pain in arm; pain in neck; pain is spreading all over his upper body; ingling and numbness in his arm spread from the injection site down his arm reaching his hand and up his neck.; ingling and numbness in his arm spread from the injection site down his arm reaching his hand and up his neck.; Nerve pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (pain in elbow/ pain in shoulders), LYMPHADENOPATHY (lymph nodes at the armpits swollen), PAIN IN EXTREMITY (pain in arm) and NECK PAIN (pain in neck) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus, Cholesterol since 2001, Blood pressure (High Blood pressure) since 2000, Chronic pain since 1997 and GERD since 2018. Concomitant products included OMEPRAZOLE, FAMOTIDINE, CARVEDILOL, SIMVASTATIN and OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (pain in elbow/ pain in shoulders), LYMPHADENOPATHY (lymph nodes at the armpits swollen), PAIN IN EXTREMITY (pain in arm), NECK PAIN (pain in neck), PAIN (pain is spreading all over his upper body), PARAESTHESIA (ingling and numbness in his arm spread from the injection site down his arm reaching his hand and up his neck. ), HYPOAESTHESIA (ingling and numbness in his arm spread from the injection site down his arm reaching his hand and up his neck. ) and NEURALGIA (Nerve pain). The patient was treated with KETOROLAC at a dose of 60 mg and PREDNISONE at a dose of 10 mg. At the time of the report, VACCINATION SITE PAIN (Injection site pain), ARTHRALGIA (pain in elbow/ pain in shoulders), LYMPHADENOPATHY (lymph nodes at the armpits swollen), PAIN IN EXTREMITY (pain in arm), NECK PAIN (pain in neck), PAIN (pain is spreading all over his upper body), PARAESTHESIA (ingling and numbness in his arm spread from the injection site down his arm reaching his hand and up his neck. ), HYPOAESTHESIA (ingling and numbness in his arm spread from the injection site down his arm reaching his hand and up his neck. ) and NEURALGIA (Nerve pain) outcome was unknown.            Patient linked case is a duplicate case send for pending case deletion   This case was linked to MOD-2021-131953 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Medical history added, concomitant medication added, treatment medication added
my health is not that good; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "my health is not that good". Additional information: Patient thought he/she was getting a boost, but instead it looks like they used an experimental drug, which his/her health was not that good and he/she need them to tell him/her when they are going to do it. Patient told not to give him/her the information after they give him/her the shot. He/she wish he/she would have known it was a trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported that rashes developed on his left trunk 4 days after the administration of the first dose of Pfizer COVID vaccine. Rashes resolved one day without self-treatment. No difficulty breathing or other serious allergic reactions were reported.
Patient was sleeping when his brother noticed that he was snoring and acting "different" in his sleep as normal. Patient woke up and felt off. He had blood pressure checked and was high. Does not remember values.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-NOV-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 224, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
I immediately felt a strange sensation in my head, and the hearing in my left ear dulled as if I were listening under the ocean. My left ear has a constant feeling of fullness. I have experienced tinnitus and a persistent need to "pop" my ears in my left ear since, as well as bouts of vertigo. I am very sensitive to sound in my left ear, and background noise is amplified and sounds "spotlighted." I have intermittently been experiencing pain in both of my calves since the injection, as well as joint pain in my hands. I have been experiencing a flushed feeling in the evening, though it is not accompanied by a fever. My muscles in my hands, feet, and legs have been cramping often, which is not a usual occurrence. I have experienced intense chest pain in what feels to be my heart. I have also experienced very vivid dreams.
6 moths after 2 shot, skin is painful when exposed to bright sun; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (6 moths after 2 shot, skin is painful when exposed to bright sun) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN OF SKIN (6 moths after 2 shot, skin is painful when exposed to bright sun). At the time of the report, PAIN OF SKIN (6 moths after 2 shot, skin is painful when exposed to bright sun) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
67 YO patient presented for f/up post discharge for symptoms of dizziness and syncope. Patient was administered vaccine and came back next day complaining of n/v/d, malaise and chills.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored ROTATEQ, orally, lot # K005397, expiry date 29-FEB-2016 (dose was not reported) in immunization series. No adverse effects were reported. Additional information has been requested.
I have suffered from almost constant fatigue and brain fog since the day after receiving my second shot. Dr. has not given me any treatment, just two exams.
Itching with maybe minor rash, starting 2 weeks after shot.  Itching started at site of shot, and moved to different places, back, side, shoulders, arms, head, legs.  Regularly at first, then gradually subsided for 2 weeks and then no more.
Fever, chills, malaise, redness/swelling, pain at injection site starting within 24 hours.
Severe shoulder pain, have been to the doctor 4 times. Been prescribed to Prednisone, Tramadol, MOBIC, given a steroid shot and now ordering MRI.
STROKE; HAD NOT BEEN SAME SINCE; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age race and ethnicity. 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 administration was not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had stroke, and had not been same since. It was reported that "a good friend who after shot stroked hasn't been same since, doctors even told him It was a adverse side affect from shot not to take anymore ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and had not been same since was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220256199-COVID-19 VACCINE AD26.COV2.S-Stroke. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pressure/pain; Chest pressure/pain; elevated BP; malaise; This is a spontaneous report from a contactable 39-year-old female Nurse reported for herself.  A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number E10140), intramuscular in arm left on 11Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included Low BP, depression, insomnia, latex allergy. The patient was allergy to morphine and diltiazem (CARDIZEM). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, E10140) on 24Dec2020 10:45 AM, intramuscular in left arm at age of 39 years old for Covid-19 immunization. Concomitant medication included cefixime (FLEXERIL), diphenhydramine hydrochloride (UNISOM), acetylsalicylic acid (ASPIRIN) and ibuprofen. The patient experienced l axillary lymphadenopathy, fever 102.8, muscle aches/heaviness, migraine, tachycardia, chest pressure/pain, elevated bp, malaise, all on 11Jan2021 23:00 with outcome of recovered with sequelae. The patient underwent lab tests and procedures which included blood pressure: elevated on 11Jan2021, body temperature: 102.8 on 11Jan2021 (H), nasal swab: negative on 12Jan2021 (Covid test post vaccination). The events were non-serious, result in emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received Bolus of IV (intravenous) fluids for treatment.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Gingival swelling and erythema, rash to trunk and axilla bilaterally, extreme fatigue, shortness of breath, decreased appetite and diarrhea.
That night, my body started turning red and my feet was on fire. These lasted for about a month. I went to the ER on Feb 01, 2021. They said that they could not determine if the vaccine caused it because it was to new to know. Then I went to my doctor and he said the same thing.
Post vax, 2-3 minutes later he became pale, diaphorectic, and vomited. Was laid down feet up, cool compresses. He became very tired and actually fell asleep.  He felt well enough to go home 45 minutes later. Follow up call later, mom reported he had slept a bit longer and was now playing, no rash itching, swelling or SOB.
Medical Assistant administered entire multi-dose vial of covid-19 Pfizer vaccine into patient's right arm.  Patient advised to monitor for signs and symptoms of anaphylaxis.  Patient was given ER precautions.  Patient denies any signs and symptoms at time of reporting.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.
My arm from the injection site to my elbow gradually got swollen throughout the day on 2/5/19. By 2:30 pm I had a lump the size of a tennis ball above the elbow. It was hot and itchy. I went back to the doctor's office. I was given injections of both of BENADRYL and a steroid. The swelling went down. Today is the 2/7/2019 and my arm is almost back to normal.
Cough, stomach ache, body ache, nausea, 2 days of flu symptoms.
I got the shot on the 4th and the next day was fine. Saturday, went for a drive and I was totally achy all over and could barely move. On the 7th, I got my first migraine. It did not get better with Zomig medicine. I went to the chiropractor on the 10th for my sciatic nerve and both of my feet were numb. The session helped for a little while. I had to go back to him on the 16th because I was getting migraines during this time - mainly when I woke up or else waking me up at 01:00 - 2:00 am in the morning. And I went to chiropractor on the 19th. I saw my pain doctor on the 18th for mechanical problems - I have back surgery history and so I am hardly any medicine of pain - but I take it once or twice a month when I have pain: Hydromorphone. I had about 20 migraines the month after the vaccine. I went back to chiropractor on the 28th - he was adjusting my back and my neck - it's not really an adjustment but a muscle deal that he rubs on my shoulder area for migraines - it didn't work. He did adjust my back a little bit. It was something that helped a little. I wasn't getting any help from the Zomig usually. Sometimes the Zomig would work but mostly it didn't. April 1st - Migraine pressure and so I went to ER - started getting a ridge on the top of my head going from the front to the back - chiropractor said it was a normal thing. He was trying to "adjust" the bones in my head/skull to help relieve the pain. I went to him on April 2. Also, I need to mention,  I did call into the doctor's office because I got dizzy - I was by myself and I was at home. I called the doctor and called the nurse. That happened about 2 weeks after the first time I passed out (which was about a week  before the second vaccine). They said to rest and drink water. I started getting pressure headaches after that first month after the vaccine, I saw the neurologist - the very end of March. I am still getting pressure headaches - I get them every day. Neurologist - for the pressure headaches - I now take Amitriptyline -  started at 10 mg and then it went to 20 mg and next it's at 25 mg in a new prescription. I can't wear a headband or a ponytail. Super sensitive to things like that. I have tinnitus now  - it started gradually getting louder- and I have hearing aids now. It sounded like a million crickets going on in my ear. It kept getting louder and louder. I couldn't hear over the noise. It was very disruptive. The hearing aids are helping. Within a week, the sound did go away with me wearing the hearing aids.
At or before 10 minutes after administration of COVID vaccine, patient felt light headed, dizzy, shaky. She felt cold and shivery with an increased heart rate. Patient was drinking water and ate one cracker out of a box of saltines that was provided to her. After 15 min we called 911. The emergency services cleared her to leave with her sister driving her home. She was told that if she did not feel better in a few hours, she was to go to the ER.
excruciating headaches; He had no sleep; This is a spontaneous report from a contactable consumer reporting for himself. A 75-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in left arm, on 20Jan2021 at 08:45, at single dose, for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications were none. The patient experienced excruciating headaches on 20Jan2021 at 23:00 with outcome of not recovered, he had no sleep in Jan2021 with outcome of unknown.   The information on the lot/batch number has been requested.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with GARDASIL (dose, route of administration and lot number were not reported). There were no concomitant therapies reported. On an unknown dates the patients experienced localized redness, swelling and pain after receiving GARDASIL. The physician reported that the patients also felt lightheaded and had fainted in the office. According to the physician, these adverse events seemed to happen to the most of the patients who had been vaccinated with GARDASIL. Outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single, as dose 2, single, as dose 3 (booster), single and as dose 4 (booster), single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gallstones" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Oct2022, latency 1 year 5 months 16 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Oct2022) Positive, notes: I had mild COVID symptoms for two days before finally testing positive on 07Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has received vaccine and two of boosters. She had mild COVID symptoms for two days before finally tested positive on 07Oct2022. She started taking Paxlovid 07Oct2022 to 12Oct2022. She felt better but not 100 percent and tested negative as of 13Oct2022. The evening of 16Oct2022, she started having symptoms again and the evening of 17Oct2022 she tested positive again. Other medication she took was reported as Iburprofen from 07Oct2022 to 09Oct2022.  No follow-up attempts are possible. No further information is expected.
Injection site pain, arm soreness,  burning at injection site, burning in the middle of my back, loss of appetite, extreme tiredness,  nausea, horrible headache, body aches
Patient developed cellulitis after ZOSTAVAX vaccination. Needed antibiotic therapy approximately 4 days after vaccination.
Woke up with a red spot where vaccine was given, felt warm and itchy. Thursday spot got bigger and by Friday it spread out a little.
This was a booster dose. I had no adverse reaction to either of the previous, full vaccination doses (both of which were also Moderna, in April 2021 and May 2021). Date that the main, serious adverse symptom (lasting full-body rash) began was 12/22, but other symptoms have other dates: Initial symptoms began 12 hrs after booster dose, included ache, headache, serious chills, suspected fever, sweating, nausea, and intolerance of contact lenses. These symptoms got progressively better over a period of about two days and cleared up after approximately 48 hours. Then, a blood clot/blister appeared on back of mouth/jaw on around 12/12- unclear if related to booster. On night of 12/22, sever full-body rash broke out. Dermatographia/skin writing as well as large, bright red, inflamed hives several inches across-- rotating severity (a patch/body part at a time, for an hour or two), but covering whole body over the course of a day.  Hives continued unabated for first three weeks, then with lessening severity but occasional flare-ups. Now (on 1/27) some hives are still present on a daily basis but much less severe.  On night of 12/24, hives were joined by a searing internal pain up and down esophagus/chest and stomach, in waves or pulses every minute or so. Have been experiencing general intestinal/digestive inflammation on and off since then, with diarrhea periodically (approximately 1x per week) for the first few weeks. On approximately 1/08, also experienced eye inflammation (red, watery, could not tolerate contacts) for two-three days again.
pt recvd vax 25OCT94 & devel fever of 103, rash on arms & legs, ached all over rash, ache started 48 hrs p/inject; fever 72 hrs p/inject; given Pred 10NOV94 for tx; cont w/fever & noc sweats;
I have the vaccine and I'm now enduring shingles on my scalp and head/suspected vaccination failure; shingles on scalp and head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have the vaccine and I'm now enduring shingles on my scalp and head/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on scalp and head). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-JUN-2023 This case was reported by a consumer via interactive digital media.  The patient had the vaccine and was now enduring shingles on his/her scalp and head. It was awful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
it was rpt from person in MD ofc concerning pt who was vax & subsequently pt exp measles w/small bumps all over lasting 2-3 days