chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 11-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 02-JUN-2017, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered from a left sided facial droop and weakness in her left arm and left leg which was later diagnosed as an embolic ischemic stroke affecting the right middle cerebral artery causing upper extremity weakness. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events is not recovered. The causality of the events is related. Embolic ischemic stroke affecting the right middle cerebral artery was considered to be disabling. Upon internal review, embolic ischemic stroke affecting the right middle cerebral artery was considered to be medically significant. Additional information has been requested.
Information has been received from an office manager concerning a patient (age and gender unknown), who, on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently, the patient experienced syncope. The patient did not pass out but felt like she was going to. At the time of the report, the patient's outcome was unknown. N product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative and refers to a patient of an unknown gender and age. The patient's concurrent conditions included shingles. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient received ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported) as a treatment for shingles (indication also reported as immunization). It was reported that treatment with ZOSTAVAX "halted" the patient's shingles. Additional information is not expected as there was no consent for further contact.
Employee received Pfizer booster on September 29, 2021, Lot #EW0158. For about two and a half to three days she experienced "typical achy feeling" but no significant side effects. She reports on November 08, 2021 she noticed that she has continuous ringing in her ears. She is reporting this because this is a new symptom that has developed and is concerned that it could be related to the COVID vaccine as she has been informed that other people have a similar experience. She wanted this to be "reported" so that it can be made known. She received her flu vaccine on Oct 28, 2021.
DIFFICULTY BREATHING; FEELING DISORIENTED; DIZZY; VERY COLD; CHILLS; NAUSEOUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced difficulty breathing. On 13-MAR-2021, the subject experienced feeling disoriented. On 13-MAR-2021, the subject experienced dizzy. On 13-MAR-2021, the subject experienced very cold. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling disoriented, dizzy, nauseous, very cold, chills and difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
NauseaVomiting FATIGUE,PAIN AT INJECTION SITE Narrative:
I received the vaccine at 1250 hours on the 6th of January.  I woke up around 0130 am on the 7th with extreme body aches and freezing.  The body aches were for the most part were in my legs.  These extreme body aches and cold chills continued throughout the day of the 7th along with fatigue.   I currently at 0957am on the 8th am starting to feel slightly better.  I have been able to work with IB Profin and Tylenol on board.  I understand this is most likely a common issue but had heard it was more standard with the second vaccination.   Additional:  My blood type is O- if that is info kept track of and I had COVID in late March of 2020 and tested positive for the Antibodies in May of 2020
Wednesday 12/30/20; ~ 4:30pm  upon receiving vaccination, an immediate headache Thursday12/31/20 ~12 hrs later 4:30AM, woke to arm aching down to elbow, from elbow to fingertips, pretty good tingling. Hip to below knew, dull and numbish; from below knee thru toes, same tingling as fingers. Biggest concern was side of face and jaw; dull and numbish. All these reactions occurred on right side of body. Thursday late afternoon, the tingling and the dull and numbish diminishes but the arm aching along with inability to completely raise remains. Friday; arm remains the same Saturday; arm below injection site now feels only bruised NOTE: while I enjoy a strong immune system, by body is very sensitive to new medicines/tweaking medicines. Also applies to food.  APPROX 25 years ago, I believe I contracted Gullian Barre, where the immune system attacks nervous system. There was./is no test to confirm although I continue to endure some side effects. QUESTION- with all said is it advisable to receive the 2nd vaccine shot?   Please advise ASAP
Redness and warmth to injection site - no pain or itching. noticed on 9/17/22. could have formed earlier
Office visit 6/19/12 - given MENACTRA & GARDASIL. 10 days later - developed a left supraclavicular mass. Office visit 7/6/12 - 2 cm (L) supraclavicular mass. Placed on cephalexin 7/6/12, 250 mg QID x 10 days. Office visit 7/23/12 - mass smaller. Office visit 8/20/12 - mass resolved, no longer present.
Jan 3 vaccine administered, jan 4 started headaches, vomiting, pain in the back of the neck, Headaches, chills, loss of speech,
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe
VACCINE BUD WAS 04/29/2022 BUT WAS MARKED INCORRECTLY AND GIVEN TO THE PATIENT ON 05/16/2022.  THE VACCINE WAS KEPT AT THE CORRECT REFRIGERATED TEMPERATURE THROUGHOUT BUT WAS PAST BUD.
High Fever >105 degrees F, Drowsiness, swelling of injection site for a week, sensitivity to light, imbalance in walking, reduced responsiveness and hearing
splitting headache for several hours; blood pressure shot sky high; left arm still bruised size of a marble; high sugar levels; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (splitting headache for several hours), BLOOD PRESSURE INCREASED (blood pressure shot sky high), CONTUSION (left arm still bruised size of a marble) and BLOOD GLUCOSE INCREASED (high sugar levels) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pre-diabetic.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HEADACHE (splitting headache for several hours), BLOOD PRESSURE INCREASED (blood pressure shot sky high), CONTUSION (left arm still bruised size of a marble) and BLOOD GLUCOSE INCREASED (high sugar levels). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 15-Jan-2021, HEADACHE (splitting headache for several hours), BLOOD PRESSURE INCREASED (blood pressure shot sky high) and BLOOD GLUCOSE INCREASED (high sugar levels) had resolved. At the time of the report, CONTUSION (left arm still bruised size of a marble) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The patient added that her blood pressure hit 204/96 for about 3-4 hours and then went back to 170/70 something. She always specified about her sugar levels that she had 117 or 98 or 124 but never had them go over 441 or 444 like at the time of the report. She stated she felt like her brain was hot.   No concomitant medications were reported.  Treatment of the event included Tylenol.
?COVID arm? - my arm around where I received the injection is slightly itchy, red, and hot to the touch
This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received Shingrix (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 14th June 2018, the patient received the 1st dose of Shingrix 50 µg. On 15th June 2018, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced extensive swelling of vaccinated limb and feeling bad. On an unknown date, the outcome of the fever, extensive swelling of vaccinated limb and feeling bad were recovered/resolved. It was unknown if the reporter considered the fever, extensive swelling of vaccinated limb and feeling bad to be related to Shingrix. Additional details were provided as follows: Less than a year after Shingrix, the patient stated that, she had arm swelling of 3 to 5 inches around at the site. The reporter also noted a fever that started the next day after the shot, it lasted for about 30 hours. The reporter noted she felt bad and stayed in bed for a day. The patient did treat the fever with over the counter medication.
Patient is a transgender male, he has been on testosterone replacement therapy for approximately 8 years. Since starting testosterone, his menstruation cycle has been surprised. Patient stated that approximately two days after receiving his first Moderna COVID-19 vaccine, he began to menstruating, which was consistent to a volume and flow similar prior to tesosterone treatment. He states he also had significant abdominal cramping that was debilitating.
Diagnosed as vaccine induced encephalitis requiring 5 day hospital stay, including ICU care. Per patient, symptoms included loss of awareness, lack of responsiveness, swelling of brain, extreme fatigue, and arm soreness
A couple of hours after injection i became dizzy off and on for around 12-24 hours. My balance felt off, low grade fever, weakness upon exertion, headache and fatigue ad injection site very red and tender x24 hours. nothing helped the dizziness. Tylenol was taken q4 hours for fever/bodyaches. The second day post vaccine i had trouble thinking of common words that ive used all of my life. I felt very confused and had a hard time getting my thoughts out. Continued with fatigue but after several hours of exertion. Day 4, some nausea and loose stool. Day 5 post vaccine, injection site has become very itchy, feeling like an insect bite.
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 21-JUL-2014 the patient was vaccinated with MMR II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a patient who was vaccinated on 27-MAR-2008 with her first dose of GARDASIL (lot# 659182/1757U). Concomitant therapy included MENACTRA (U2583AA) on the same day. Subsequently the patient fainted, but was fine when she left the office. No other information was available. A call was made to the office because the report says the above occurred with 4 or 5 patients. The office could only remember one patient's information. Additional information has been requested.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-SEP-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
50x35mm induration occurred after having shot on Thurs. 04/14/05. Pt states each day area got bigger and red. Soreness in area occurred also. Warm compress and massage did not help. Nothing eles follows. Lump is still.
Temperature of 100 for  4 days with administration of acetaminophen by mouth every 4-6 hours.  Red rash for 4 days located on injection site R Deltoid, chest, torso, abdomen, and back. Headache, fatigue, malaise.  Sore, swollen throat 6 days after second dose.  Diphenhydramine by mouth taken at 9P every day after second dose.
Pneumonia; Weak immune system; feels frustrated; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4361347-00.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01Jun2021 as dose 1, single (Batch/Lot number: unknown) and on 01Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Dec2021, outcome "recovered" (Jan2022), DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown" and all described as "COVID-19"; PNEUMONIA (medically significant), outcome "recovering"; IMMUNODEFICIENCY (medically significant), outcome "recovering", described as "Weak immune system"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "not recovered", described as "feels frustrated". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "pneumonia", "weak immune system", "covid-19" and "feels frustrated" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of fells frustrated with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for Covid-19, Pneumonia and Weak immune system was not provided.  Causality for Pfizer BioNTech Covid-19 vaccine: The reporter's causality for the event covid-19 with Pfizer BioNTech Covid-19 vaccine was possible. The reporter's causality for Covid-19, Pneumonia, fells frustrated and Weak immune system was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Employee called occupational health office today  at 0802  complaining of a large knot in her right axilla (she is a physician and believes it to be an enlarged lymph node), approximately the size of an orange. She reports a temperature of 101 last night but denies any today. Spoke with her again at approximately 1530 and she states the knot has decreased now to approximately the size of a clementine, continues to deny fever. She did not seek any treatment as of this time. She states if it doesn't resolve my Monday morning, she would see a physician.
"pt recv vax & pt exp fever, drowsiness, anorexia, inj site rxn & cough;"
significant swelling underneath both eyes; significant swelling of cheeks; face aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included facial filler which was done on Nov2020, COVID-19 and known allergic to sulfa drugs. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 19:00, the patient experienced face aches. On 19Mar2021, the patient woke up with significant swelling under both eyes and cheeks. The patient was nervous about second dose which was scheduled on 04Aug2021. The adverse events did not result in doctor or other healthcare professional office/ clinic visit/ emergency room/ department or urgent care. Therapeutic measures were taken as a result of adverse events included BENADRYL and CLARITIN for over a week and the reactions were slowly subsided. The clinical outcomes of the events face aches, swelling underneath both eyes and significant swelling of cheeks were resolved with sequelae on an unspecified date of Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient reported tightness/heaviness in her neck and shoulder on the (L) side as well as pain in that shoulder blade area. Also reported fatigue/"sluggishness". Symptoms lasted 2 mo.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect/still having the side effect as of today), INFLUENZA (flu) and VACCINATION COMPLICATION (tight symptoms/severe) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced VACCINATION COMPLICATION (side effect/still having the side effect as of today). On 07-Sep-2021, the patient experienced VACCINATION COMPLICATION (tight symptoms/severe). On an unknown date, the patient experienced INFLUENZA (flu). At the time of the report, VACCINATION COMPLICATION (side effect/still having the side effect as of today), INFLUENZA (flu) and VACCINATION COMPLICATION (tight symptoms/severe) had not resolved.     DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. No relevant concomitant medications were reported. No treatment information was provided.
Pt showed signs of anxiety including hyperventilation.  EMS evaluated and watched her 40 min.  Vital signs remained stable 122/88, 79, 98%.  However, her end total CO2 would drop to 19-22 until paramedics calmed her down and she was free to go home.  Patient gave us an extensive list of over 50 allergens and her reactions, including abx, pain meds, methadone, fire retardant, Tylenol and Advil.  However, she states that she refuses to carry an epipen even though she claims to have experienced anaphylaxis over 20 times.  Pt also refused transport for further observation.
9 hrs. post vaccine, pt developed fever 39.2 R, tachycardia, abdominal pain, huge emesis, P.E.-absent reflexes LLE. Treatment-fever mgt, elevated IV lipids. 1/18/15 AM balance off, absent (R) patellar reflex. 1/27/15 abnormal gait, (R) upper/lower weakness of extremity.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 12-MAY-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In 2015, the patient was treated by a physician for shingles. The patient was later treated by a physician for shingles in her eye and other zoster related injuries. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles and zoster-related injuries, 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. Causality assessment was related. Upon internal review, shingles in her eye was determined to be medical significant. Additional information has been requested.
No adverse effects; 6-month-old patient received VAQTA on 9/26/2019; This spontaneous report was received from a medical assistant referring to a 6 months old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.     On 26-SEP-2019, the 6 months old patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (strength, dose, dose of administration not reported; lot # S007769 and expiration date 24-JUL-2020) for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Pt called on 12/16/19 stating she had arm swelling at injection site where vaccine as administrated
pain in upper left arm at time of injection without swelling, redness or warmth. Continued pain in left upper arm now reaching almost to elbow
low back pain, followed by muscle stiffness in upper front legs, worsening to the point I couldn't do daily activities or sleep well