chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving my second dose of Pfizer Covid Vaccine on 5/14/21 the next day I felt like I had the flu and my arm was sore at the injection site (same symptoms I experienced for a few days after receiving my initial dose on 4/20/21).  After a few days I began to feel better (flu symptoms went away, but my left arm began to feel weak and painful).  My left arm (which I received all three of my vaccine injections in) continued to feel painful and my range of motion was limited and I had no strength in that arm.  It has continued to get worse and to date I have extreme pain in this shoulder and upper arm.  I have limited range of motion on that side and the pain is constant and the weakness is getting worse.  I am going to have an xray this week per my doctor.  I reported this to facility and explained to my doctor I cannot hardly lift the left arm at times.  It also throbs with pain  from the elbow up to the shoulder.  The inability and loss of strength has me extremely concerned.  Prior to receiving the Covid 19 Vaccine, I had no issues whatsoever with the arm and now worried because the pain is not getting better, and I feel like it is my shoulder and upper left arm.  The pain comes and goes, but mostly is there all the time.
4/4/2021 - feeling off, somewhat run down /// 4/5/2021 - feeling more run down /// 4/6/2021 - exhibiting sore throat and swollen glands throughout the day then at 5:45 was eating cocktail shrimp when I lost function and control of my right arm as well as a slight problem with my gait. As soon as the event took place my sore throat and swollen glands stopped immediately. My wife took me to the hospital where I was entered into stroke protocol. I was subjected to a series of tests including: EKG, ECHO, Platelet Cnt, Lipid Panel w direst LDL reflex, Hemoglobin, MRI Brain w/o contrast, CTA Stroke Alert (head/neck), CT Stroke Alert Brain, ECG, Basic Metabolic Panel, CBC, Protime - INR, APTT, Troponin I, Covid19, Influenz Influenza A/B, RSV PCR, and POCT GLUCOSE. I was kept for observation and determined I had suffered a small stroke. Released from the hospital 4/7/2021.
Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA254717 (same reporter). This case involves an 18 months old female patient who received a 0.25 mL first dose of FLUZONE QUADRIVALENT (lot number, expiry date, route and site of administration were not reported) on 30-Aug-2018 and second dose (lot UT6259JA, expiry date: 30-Jun-2019, via intramuscular route in the left thigh) on 06-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Severe migraine, fever, aches and vomiting on Day 2. Blistering at the injection site on Day 3. Blisters remain and are sensitive to heat and touch.  Previous vaccines were Moderna (experienced very high fever, aches, migraine and nausea but no vomiting or blisters).
I was diagnosed with sciatica in June 2021, I was on treatment- Gabapentin. It was not helping that much and the doctor felt I should take a higher dose. I can't remember when I started taking the higher dose, it was like a week or 2 prior to the vaccine. On 09/30/2021 - after the vaccine, I started to walk home. I thought I saw my postman and as I got closer there was no postman. I live like 10 minutes away I could not see straight. I was seeing things on my phone that were not there. I was acting like someone that had too much to drink. I don't drink. I was hallucinating, but did not know it at the time. I had a video chat with my doctor - he felt that it was a rare response to the gabapentin. He was pretty sure it was not the booster. He told me not to leave my house. And a few hours later I was back to normal. The doctor told me to stop taking the Gabapentin and they switch me to another drug, pregabalin 75mg once a day, and it has worked well.
Received shot at 1:10pm and was asked to wait 15 minutes before leaving.  At 1:20pm I became very lightheaded and anxious. I stood up to look for a drinking fountain then woke up on the floor surrounded by people. Blood pressure was 80/40. Spent next two hours in ER on an IV. I was released once BP came back up.  After getting home, I developed chest pain on the left side which I still have after three days so far.
This spontaneous report concerning a female patient of unknown age was received from a pharmacist. The reporter stated that the patient had no allergies or drug reactions. No concurrent conditions and medical history were reported. On 03-JUN-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot and expiration date were not reported) by subcutaneous route. There were no concomitant medications reported. On an unknown date in 2016, the patient experienced a rash under her throat and over her chest (rash) after receiving the ZOSTAVAX. In addition, the reporter stated that patient still had a purplish discoloration at the site of injection. No laboratory diagnostic studies were performed and no treatment for the adverse event was given. The patient sought medical attention by reporting her adverse event to her pharmacist. No product quality complain was involved. At the time of reporting, the action taken and the outcome of injection site discolouration and rash were unknown. The causality between the events of injection site discolouration and rash were not medically significant or life threatening. Additional information has been requested.
devel morbilliform rash over face & chest w/temp to 101 ax;clear coryza, sl dry & itchy;rx DPH, calamine, Ibuprofen;inc irritability, unable to sleep;seen in ER;inc pharyngitis & exudate w/conjunctivitis;labs negative;trouble bearing weight
I have been noticeably more tired since getting my first dose of this shot almost a month ago.  It is affecting my ability to concentrate.
Patient went to urgent Care with pain at injection site, pain radiating down through right leg and up through the right side of her neck
Vaccines administered at 9:30AM. Had episode of vomiting at 9:40AM while sitting in chair. 9:55AM mom screamed for "help" from the exam room. Pt pale - loss of consciousness. Pt. laid supine & woke immediately. Observed about 15 min. Back to baseline.
My son suddenly came down with an unexplained internal infection that required hospitalization. The symptoms were nausea, high fever and chills. He was taken to the ER given antibiotics and kept overnight for observation. The doctor(s) could not determine the source of the infection. He recovered within 24 hours.
I am experiencing a lot of pain in my hip like muscle. I am experiencing a lot of pain in my hip like muscle. This is a spontaneous report from a contactable consumer. This consumer (patient) of unknown gender reported for self that he/she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced a lot of pain in his/her hip like muscle. The patient was wondering if I could take Tylenol or Aspirin or something maybe that it help relieve it. The event outcome was unknown.  No follow-up attempts were possible; Information about lot/batch number could not be obtained.
patient received vaccine and waited the 15 minute observational period. patient stated she was okay and left pharmacy. around one hour later patient returned to pharmacy complaining of generalized redness, itching and burning not confined to the injection site. patient took 25mg of diphenhydramine. i monitored patient closely and after over 30 minutes the redness and itching subsided. after another 30 minutes patient stated feeling better and asked to leave. i made sure patient had another person take her home and counseled her to go to emergency department if symptoms return or worsen
last night she could not sleep; This is a spontaneous report from a contactable consumer (patient). A 88-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single (at the age of 88-years-old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included paracetamol (Tylenol); naproxen sodium (Aleve); alprazolam (Xanax) and cetirizine hydrochloride (Zyrtec) (all taken for an unspecified indication, start and stop date were not reported) and diphenhydramine hydrochloride (Benadryl) taken for sleep, start and stop date were not reported. On 09Feb2021, patient slept in afternoon for two hours after the shot and at night (last night), patient could not sleep. Patient stated that she takes Tylenol, Aleve, Xanax takes 1/2 of one in the morning, Benadryl to sleep and Zyrtec and stated that she did not take them last night or this morning and wanted to know if she can take them. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected. Information on the lot/batch number has been requested.
3/8/21: Immediate dizziness lasting all day.  Headache, fatigue/lethargy all day. Intermittent chest pain/tightness, throat tightness, gas, fever, chills. 3/9/21: Gas, loose bowls, tired, but otherwise pretty good. 3/10/21: Still tired and mildly dizzy all day.  In afternoon, chest pain/pressure with any exertion, even climbing the stairs in my home, Chest discomfort stopped when I stopped the activity.   3/11/21: Chest discomfort, mild dizziness and tiredness continued this day.   3/12/21: Chest pain gone.  Sore throat started in evening. 3/13/21: Sore throat all day.  Runny nose for about 10 minutes.  3/14/21: mild tiredness in afternoon.
about a 1.5 weeks after first dose, I noticed my left hand felt swollen but didn't look swollen. I felt joint pain in my body but mostly my finger joints and wrist.  Left hand strength had become weak and couldn't put any weight in it or grip. After 12 hrs the swollen feeling went away.  The next day I noticed my index finger on left hand was very swollen but my hand didn't feel swollen like the day before.  2 days later I noticed my middle finger on the left hand was swollen. After 12 hours, the swelling is gone.  The next week I notice my middle finger on the right hand was swollen.  My hands are unable to make a fist when swollen feeling.  Now both of my hands are swollen.  A hot shower helps and sometime Motrin.
Patient called hospital call center at 2pm with c/o heaviness, which pt describes as on and off dizziness and sensation in left leg since 10am when pt woke up.  pt received pfizer vaccine yesterday (4/14/21) at Stadium. Reported to MD during telephone visit that she has HA and mild nonspecific decrease sensation in LLE but no other symptoms concerning for TIA/CVA or DVT. Pt advised to use Tylenol 500mg q6-8hours and adequeate hydrations.  If symptoms worsens, patient has ED precautions.
Approximately 2.5 weeks after the third Pfizer "booster" shot, I developed balance problems and dizziness. These problems progressed and worsened over the next 1-2 weeks requiring emergency evaluation to rule out the possibility of a stroke.  The diagnosis is vestibular neuritis.  Symptoms of tinnitus (constant loud ear ringing) and hyperacusis (sensitivity to normal sounds) also developed.  These symptoms have persisted for 3 months now. The treatment is currently a program of vestibular physical therapy exercises. The dizziness and balance issues are 70% improved from baseline. The tinnitus and hyperacusis are persistent.
tired; pain; broken femur and busted up shoulder; broken femur and busted up shoulder; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. Medical history included vertigo; allergies to penicillin, corticosteroids, nitrofurantion derivatives, statins, paraphenylenediamine, molds and smuts. The patient stated that she had gentamycin toxicity four years ago which cause her to have vertigo 24/7.  The patient's concomitant medications were not reported. The patient previously took gentamycin and experienced toxicity; patient also had allergy to penicillin G, sodium hyaluronate (AVIAN), dicloxacillin, formaldehyde, clarithromycin (MACROBID), pravastin, quaternium-15, restylane.  The patient experienced broken femur and busted up shoulder on 03Apr2021, tired on an unspecified date, pain on an unspecified date. The patient stated she received the first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 19Mar2021. She stated that her second dose would be on 09Apr2021. She is concerned about ingredients that might cause her problems. She stated that she had an injury after the first dose of the vaccine this past Saturday (03Apr2021) and has a broken femur and busted up shoulder. At the time of the report, she is in a wheelchair, is very tired and takes vicodin for the pain. Therapeutic measures were taken as a result of pain. Outcome of the events was unknown.  Information on the lot/ batch number has been requested.
loose stool; This case was reported by a consumer via GSK interactive digital media and described the occurrence of loose stools in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2021, the patient received the 2nd dose of Shingrix. On 14th December 2021, 8 days after receiving Shingrix, the patient experienced loose stools. On an unknown date, the outcome of the loose stools was unknown.   It was unknown if the reporter considered the loose stools to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingrix 10 days ago from reporting date and 2 days ago from reporting date, the patient developed very loose stool. The patient asked would he/she still get side effects. The follow-up would not possible as no contact details were available.
This spontaneous report as received from a nurse via company representative refers to a 16 year old female patient. No medical history and concomitant medications were reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose 1) (dosing regimen and frequency unknown) (lot number and expiry date unknown) for an unknown indication. No concomitant medications were reported. On an unknown date the patient experienced haematuria. It was reported that the patient sought medical attention and saw an unspecified urologist. The urologist determined that the hematuria was vaccine related. The action taken with the therapy with GARDASIL 9 was unknown. The outcome of haematuria was unknown. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported. Additional information has been requested.
6/2/08-lg red swollen-warm area on R upper arm 5" at the widest by 4" at the longest.  Imm on 5-27 & on 6-2-08 (6 days later) noticed redness & itching.  6/2/08 went to doctor - he said to take BENADRYL.  Watch it - if it gets worse - come back to be put on steroids - no further treatment needed.  Called client 6-4 & was fine.
expired menactra vaccine to a consumer with no reported adverse event; Initial information was received on 08-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old female patient who received an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine to a consumer with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 08-Nov-2023, the patient received 0.5 ml of expired (30-Oct-23) of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7492AA) (strength: unknown) (expired product administered, latency same day) via intramuscular route in the deltoid nos for prophylactic vaccination (Immunization).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Wife states that about 8 days after the SHINGRIX shot, her husband started slurring his words. She called 911 and they did a CAT scan. He was physically and cognitively "out of it," and remains not back to normal per the wife. Doctors think it may be a TIA or something related.
Still getting sick with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Still getting sick with COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Still getting sick with COVID). At the time of the report, COVID-19 (Still getting sick with COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Pt reports she had constant left arm pain, located in the deltoid region from the date of the 1st injection. 2nd injection was given 3/11/21 and the pt has had pain radiating upward to posterior right shoulder, axillary area, and distal upper arm.  The pt did supportive care, took otc analgesics and pain continued to worsen.  Pt was evaluated in the ER 6/1/2021 and diagnosed with a DVT to left upper arm brachial vein.
Red, itchy, swollen area around inj. site - 4 inches in diameter - treated with antibiotics & antihistamine.
right arm swollen were the injection was given, redness, warm to the touch and itching.
REDNESS, SWELLING, PAIN R. DELTOID, HARDNESS, HOT TO TOUCH.
Pain: extreme amounts of pain and pustules on the inner thigh as they were leaking pus and still am in pain and it is still manifesting the pustules. I was trying to solve the issue myself with my clinic doctor who knows the entire history of my symptoms, etc. He put me on Zithromax twice daily. That was just one of the many medications he tried. Clinically, on April 22nd, I got a diagnosis, the Hospital ER doctor, Hidradenitis Supertiva; inflammation of the sweat glands, localized in inner thigh and groin region. Extremely uncomfortable, and I've never had anything like this before. Even last night, this happened. So much pressure of pus that when it burst last night it shot across the room and hit the wall. Right now, on Topical Hydrocortisone to relieve the incredible amount of itching and every once and a while it drains some cysts. I have complete rundown and records that I can upload for more details. I've had massive amounts of steroids and direct injection steroids and the antibiotics that I've taken for this.
Patient could hardly walk; Urinary tract infection; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Patient could hardly walk), URINARY TRACT INFECTION (Urinary tract infection) and COVID-19 (COVID-19) in a 68-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced GAIT DISTURBANCE (Patient could hardly walk) and URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, GAIT DISTURBANCE (Patient could hardly walk) had resolved, URINARY TRACT INFECTION (Urinary tract infection) had not resolved and COVID-19 (COVID-19) outcome was unknown.            No concomitant medications were reported.  It was reported that on unknown date patient took Moderna Booster dose through intramuscular route.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The reporters causality for HUMIRA(ADALIMUMAB) for the events were not provided.   No treatment medications were reported.  Company comment: This spontaneous case concerns 68 years old female patient, with no medical history, who experienced the unexpected non serious AESI event of Covid-19, which occurred unspecified days after second dose of mRNA-1273 vaccine. At the time of report event outcome is unknown. Current ongoing pandemia remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected.; Sender's Comments: This spontaneous case concerns 68 years old female patient, with no medical history, who experienced the unexpected non serious AESI event of Covid-19, which occurred unspecified days after second dose of mRNA-1273 vaccine. At the time of report event outcome is unknown. Current ongoing pandemia remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected.