chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started with generalized aching pain all over, then excruciating joint pain, muscle pain, pain in the skin that I couldn't even be touched. Enlarged lymph nodes under my left arm and left side of my neck. Unable to raise my left arm away from my body or turn my head due to stiff neck. Chills, shivering, nausea, diarrhea.  It felt like my entire nervous system was being attacked. I had one episode where I was laying still and my left leg jumped on its own and I screamed in pain. The worst was the first 24 hours, by 48 the pain was manageable with tylenol but I didn't feel back to normal for 4 to 5 days. I was easily winded when walking for the following 7-10 days and pain my chest with a deep breathe continued for several weeks.  Since receiving the vaccine my menstrual cycle (which has been regular for my entire life) has shortened and comes one week sooner.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 21-AUG-2015, the patient was vaccinated with improperly stored doses of VAQTA (dose and route were not reported, lot # L009445, expiry date 01-JUN-2017) and M-M-R II (dose and route were not reported, lot # K024035, expiry date 26-NOV-2016). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states symptoms lasted 9 days finally no vomiting and arm is clear. Nausea, vomiting and injection arm was red swollen, hot to touch and painful; sweating/chills; itching; weak.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection,  batch/lot# unknown), on Mar 26, 2021, at 09:20, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache, with outcome of unknown. Additional information: The patient wanted to know what to do about her headache. She received the first dose of the COVID-19 vaccine on Friday, Mar 26, 2021, at 09:20, since then she has had a headache. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Diffuse pain in my muscles tendons joints and all over my body to include nerve pain. I had symptoms after my first injection and also after the second injection that we did not realize it was from the injection. The overall inflammatory symptoms were severe and I could hardly walk. It was also difficult to use my arms and hands because my wrist fingers and elbows were very inflamed
Intractable migraine and nausea x 5 days  Unrelieved by any medical therapy  Finally aborted with steroid high dose pack for 14 days
3/20/2021 1215 - Intensified migraine within 10 minutes of injections - migraine lasted for 8 hours. 3/21/2021 0500 - woke with a migraine; chills; body aches in the shoulders, arms, chest and back; fever 100.7; fatigue
BREAKTHROUGH COVID: FULLY VACCINATED 59YO WITH Acute respiratory insufficiency -on 2L NC SARS CoV2/Pneumonia-vaccinated.  Dyspnea considered multifactorial due to asthma, allergic with acute exacerbation and CoV2 pneumonia. Pt presented to ED with complains of fever, cough, shortness of breath after she was expose from her grandson who tested positive for COVID with elevated D-dimer. PT MEDICATED WITH remdesivir 100 mg 540 mL/hr IVPB q24hr. MEDICATED ALSO SINGULAIR, LOVENOX,PERFORMIST, Pulmicort Respules, dexamethasone, rOPINIRole,sertraline.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-OCT-2014, the patient was inoculated (by an unspecified health care professional) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of Herpes zoster. On or about May 2016, the female patient was treated by a physician, and was diagnosed with Herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: swelling and tenderness in armpit/left side of breast/ left side of ribs-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: pt stated rxn started about 48 hours after receiving third booster of pfizer, previous 2 doses were pfizer, she states tenderness and swelling in left armpit area, on side of left breast and down left side of her ribs. She states no worsening of symptoms ( since 11/07/2021) and that ibuprofen helps with the pain. no limitation in mobility but tender/ and feels swollen. counselled pt to reach out to MD to look at, especially if symptoms worsen.
WEAK, TIRED, ACHY, HEAVY ARMS, FLU SYMPTOMS, BLACK AND BLUE ON SITE OF INJECTION.
Nurse contractor accidently administered 2 dose of RSV Abrysvo to patient. No immediate reaction occurred, made patient aware to watch out for fever/flu like symptoms or to report any major reaction.
had a seizure; This spontaneous report was received from a consumer (the patient's mother) referring to a female patient of unknown age. The patient's medical history and concomitant therapies were not reported. The patient was very sensitive and had a lot of food allergies.   On an unknown date in November 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (dose, strength, lot #, expiration date and route of administration were not provided).  On an unknown date in November 2019 (reported as when she got measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)), the patient had a seizure. The patient went to the emergency room and sought medical attention but it was unknown whether treatment was provided or lab diagnostics/ studies were performed. At the time of reporting, the outcome of the event seizure was unknown.   The causal relationship between seizure and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.   Upon internal review, the event seizure was determined to be medically significant.
This spontaneous report as received from a nurse, via company representative, refers to a 12 year old female patient. On 05-SEP-2013 the patient was vaccinated with GARDASIL (lot # J003727, expiration date 07-NOV-2015) (dose and route were not reported) injection. Other suspect therapies included M-M-R II (lot # J002504, expiration date 28-FEB-2015) (dose, route and indication were not reported), (Merck) VARIVAX (lot # J003224, expiration date 15-MAR-2015) (dose, route and indication were not reported), DTaP (unspecified) (lot #33AG5, expiration date 18-SEP-2015) (dose, route and indication were not reported) and MENACTRA (lot # U4556AA, expiration date 04-SEP-2014) (dose, route and indication were not reported). Concomitant therapies included VENTOLIN 9 mcg/once daily. On 05-SEP-2013, after patient received the vaccines she had a seizure and had to be taken to the hospital. It is unknown if the patient was admitted overnight. It was unknown which vaccine was the cause of the seizure. The outcome of seizure was not reported. No lab diagnostics studies were performed. Seizure was considered to be medically significant by the reporter. Additional information has been requested.
LETHARGY, ABDOMINAL PAINS, URTICARIA, SL. DIFFICULTY BREATHING, CLAMMY, DIAPHORETIC, DIFFICULTY SPEAKING, SPASTIC COUGHING, SWELLING FACE, ARMS, ITCHING ENTIRE TORSO, ESPECIALLY ARMS, STOMACH, INNER UPPER THIGHS.
had the shots / had them/suspected vaccination failure; had them lightly; had them lightly; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's spouse. The age at vaccination was not reported. The patient got the Shingle vaccine and Covid vaccine and still got them both (shingles and covid-19) lightly. It was unknown if the reporter considered the shingles and covid-19 to be related to Covid-19 vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Fever, chills, fatigue over 24 hours, gradual recovery for two days. On 4/17 began brain fog, slight disorientation, and general ill feeling without fever or chills.
Itchy red hives or welts on the face and head, torso arms and legs for greater than 3 weeks. Not improved by oral antihistamines and topical and IM steroids.
Patient was given second dose of Prizer only 2 weeks after the first dose instead of the recommended 21 days. First dose was given 12/07/2021, and the second dose was administered 12/21/2021.
Swelling of left side of left hand and 2 left fingers.  Swelling still exists as of today.
No ill effects for 14 hours following injection then sudden, unprovoked, free flowing nose bleed from left nostril. Bleeding continued unabated for 50 minutes. The flow rate gradually slowed and by 4:00 AM it had stopped flowing freely. Blood continued to slowly seep from the left nostril for another 4 hours stopping at about 8:00 AM. Bloody nose symptom did not recur as of 03:20 PM on 10/13/2018. While I have had a nose bleed in one nostril (left or right) before, I have never before experienced one as heavy or persistent as on this occasion.
Pruritic rash over lower back. Red, dry, slightly raised 18 x 12 cm Micro-papular rash over upper abdomen, diffuse and subtle.  The itching over lower back was intense for 3 nights but now seems to be subsiding on its own. No prescription medications were required. Patient was advised to use emollients and topical steroid or Benadryl prn if itching returned. Monitor clinically.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 13-OCT-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had multiple excursions varying from 46.2 degrees Fahrenheit (7.88 degrees Celsius) (lowest recorded temperature) for 24 hours to 64.8 degrees Fahrenheit (18.22 degrees Celsius)(highest recorded temperature) for 24 hours. The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Child had a seizure (not sure if generalized or partial complex, arms/legs shaking & fell down, partly awake) at home 2 - 2 1/2 hours after MENACTRA.
When I woke up I felt weak and sick and just didn't feel good. I told my girlfriend and she instructed me to take a COVID-19 test and the next day I did and I came back positive and the next day was my worst day.  I developed fever, headache, and dizzy.  I could barely move and just stayed in bed all day.  On the third day I called the after hours physician and was prescribed the Paxlovid for 5 days.  The very next day I felt better and by day 5 I felt normal just weak and by day 6 I felt like a million bucks.  By the time I finished my last pill I felt great and one or two days after that the symptoms came back and hit me again.   I have had headache, weak, sore throat and weak with congestion.  I been taking Tylenol to help with the headache.
Yesterday (March 30th 2021) I noticed that I have developed a rash on my left arm where I got my Covid Shot. It is bright red and itchy. Will be keeping an eye on it and if it gets worse I will go to my local urgent care. I will try to treat it with hydrocortisone cream and see if it gets better.
Fever to 102.3, severe swelling, and redness on 9/23/04.
pt recvd vax; exp induration & inflam at the inject site persisted for 10 days;
Information has been received from the nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 26-APR-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the report from the same source, linked reports. Additional information is not expected.
Headache FATIGUE, HOT FLUSHES, PAIN TO INJ SITE, CHILLS, STIFF NECK, RUNNY NOSE, SORE THROAT Narrative:
Dizziness, numbness in arms, legs, extreme fatigue, rash over body, stiff neck, rapid heartbeat, tenderness along back, choking when swallowing, headaches and pain in joints, constipation, now using laxatives to move bowels. Follow-up: Heart palpitations, numbness in lower extremities, emergency room.
however she was prescribed by her doctor with Enbrel for her Arthritis; This is an initial spontaneous report received from contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced arthritis on an unspecified date. It was reported that patient was about to schedule her second dose however she was prescribed by her doctor with Enbrel for her Arthritis. The outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
20 hours after dose extreme fatigue, chills, achiness, runny nose and earache.  48 hours after dose red rash at injection site, extreme fatigue and symptoms previously stated. 72 hours after dose extreme fatigue, swelling and discoloration at injection site with unusual feeling in right arm, mouth, tongue and lip burning. 96 hours after injection until present, extreme fatigue, burning mouth, tongue and lip sensation, unusual feeling in right arm.
SIRVA; symptom onset after vaccine, worsening with time. First sought treatment in our office today.
Doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 4:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 4:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Age of patient was reported as 81.98.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vials only punctured right before administration.  No treatment medication was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Patient reported continuous vomiting and black and blue marks on immunized arm that started the day after vaccine was administered.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: FK9262), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN controlled" (unspecified if ongoing); "GERD controlled" (unspecified if ongoing); "Hypercholesterolemia controlled" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; CHLORTHALIDONE; EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL; SALICYLAMIDE]; MAGNESIUM; OMEPRAZOLE; POTASSIUM; QUERCETIN; SWANSON 5-HTP; TURMERIC +; VIT D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Negative; (18Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Antiviral details: Product: COVID 19 Treatment, brand: Pfizer, Treatment start date: 05Jun2022 and stop date: 09Jun2022, Lot number=FP6522, indication is used for treatment of COVID-19, Administrator route: Oral. The patient did not receive other medication in 2 weeks. The patient had Known allergies to NKA. Adverse event tested negative for COVID-19 13June 2022 after completing course of antiviral meds. New onset of sneezing with rhinorrhea 17June 2022. Tested positive for COVID-19 18June2022. No fever. No cough. No shortness of breath. No body aches. No Fatigue. The patient experienced adverse event on 16Jun2022. The patient tested negative for COVID-19 13June 2022 after completing course of antiviral meds. New onset of sneezing with rhinorrhea 17June 2022. Tested positive for COVID-19 18June2022. No fever. No cough. No shortness of breath. No body aches. No Fatigue. The patient did not receive treatment. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Upon awakening Sunday Mar 28, I could not move right side of body without extreme pain. Could not lift head off pillow without extreme pain. Pain radiated from head,neck and down right side of body ( liver area very sore) down right hip and entire right side of right leg. I was able to walk etc but pain remained severe for 2 weeks. After that neck was more mobile and got better but pain in right side liver area remained as did leg pain. To date I still have discomfort in right knee area. Please note I am a very active person and have a high pain tolerance. This is not fibromyalgia pain. Also please not this is my first adult vaccine. I do not take pain meds and eat a very clean vegan diet. I do not drink or smoke
I received the vaccine ZOSTAVAX vial on August 3, 2015. On August 5, 2015, I suddenly developed acute urticaria: burning and itching hives on both legs. The injection site became swollen and hot, increasing to approximately the size of a large red tennis ball. My doctor advised me to go to ER after I had taken allergy medicine. After several hours of waiting in ER, the hives began to dissipate. I was given a prescription for steroids but I didn't feel the need to fill it. The injection site also became less aggravated and after several days of allergy medication, it has healed. I was advised to never take a shingles vaccine again.
Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart beat, dizziness and weakness. nausea.
No adverse events or side effects reported. Med error detected and client was notified on 7/20/21.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 04-AUG-2009, patient received improperly stored VARIVAX dose 2, from batch/lot # 664468/0684Y (expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.