chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient first felt dizzy and nausea.  she also has blur vision and tingling on extremities.  up on checking blood pressure first it was error, than switch arm it was 70/52 HR 66; 2 minutes later blood pressure went back up to 103/77 HR 90; continue monitor patient for the next 20-30 minutes, sent patient home with her mother who is the ER nurse when the patient was stable at blood pressure 128/88, HR 99.  vision came back, no more tingling sensation when she was leaving the facility.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 21-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N017698, expiration date: 09-JUN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Friday 3/19/21: Sore shoulder later that evening. Took two Extra Strength Tylenol before bed at 9:00 pm.  Saturday 3/20/21: Woke at 2:00 am having the chills. Saturday 3/20/21: Got up out of bed at 5:30 am with Body Aches, Headache, Extremely Sore Left Shoulder/Injection Site, Elevated Fasting Glucose level of 174 with a temperature of 101.6. Started taking two Extra Strength Tylenol every four hours while continuing to drink lots of water. Went to bed that night at 8:00 pm with all symptoms remaining the same but with an elevated temperature reaching 103.    Sunday 3/21/21: Got up out of bed at 5:00 am with Slight Body Aches, a Moderate Headache, Moderately sore Left Shoulder, a Temperature down to 100.2, but now with the addition of Moderately Sore Left Underarm Lymph Nodes. Continued taking Extra Strength Tylenol every four hours while continuing to drink lot of water. Temperature back to normal by 5:00 pm and all additional symptoms now slight.  Monday 3/22/21: No Temp and only slight lymph node soreness and Shoulder.
itchy bumps starting near my lower back, then popping out on my legs five days after vaccine.  These itchy bumps have now shown up on my torso, arms, legs and behind.  They haven't stopped since they showed up and new areas have shown up 9 -10 days after vaccine.
stridor & SOB 27OCT94; has severe asthma on steroids; also has URI type sx;
Patient received a Moderna for her 1st dose and a Pfizer vaccine for her second dose in the series. Spaced 28 days apart.
Parents begin to slowly notice that child began to not make milestones appropriate for his age. He slowly stopped doing appropriate behaviors for his age and began to regress. Child continued to lose language he had previously had and could not work simple puzzles that had been easily mastered.  1/23/09 Received Neuro medical records of  12/20/2005-2/23/2006. FINAL DX: Autism, static encephalopathy, speech deficits Records reveal patient was in early intervention program when evaluated.  Socialization skills were delayed, speech mostly jargon, poor eye contact, unable to follow simple commands, stereotypical repetitive behavior.  10/28/08 Reviewed PCP office records of 10/31/05. FINAL DX: delayed expressive speech, allergy.   On day of Hep A vax (no record of flu vax), pt w/recent ear infection & cough.  PCP noted delayed speech & referred to early childhood intervention.
There has been a series of things. Starting 2/4/21,severe, sporadic  chest pains, lasting approximately 3 weeks.  At that time, mild ankle swelling is beginning. Saw cardiologist March 1, 2021. Wore a 48 hr heart monitor then a 14 day monitor. See results below.  Late March:  Extreme (i.e. debilitating) weakness and fatigue set in, lasting almost a month. Feet and ankle swelling increasing. Feet and toes turning pink. After 4/14/21 telehealth meeting with neurologist, increased Amantadine .  Livedo Reticularis appears late April. Weakness ebbs and by May, feet and ankles very swollen. Shoes unwearable. Feet turning red, toes occasionally purple to black.
Received 5th DTA and a VZV vax on 3/25/03. Redness / swelling noted left shoulder to elbow. Denies pain or fever.
Patient sitting in chair passed out  sternal run performed   lowered to floor  sternal rub performed again   responsive  breathing shallow  lost bowels  pulse weak  ammonia salts used and EMS called
Symptoms: Fatigue, foggy-headed, tunnel vision, cold symptoms stuffiness, coughing - Day 1 Began taking Pfizer Paxlovid on Day 2 - 6 All symptoms subsided with taking Paxlovid Drug interactions: on and off metal taste; loss of taste and smell on day 3 for only one day. Tested positive on day 3; tested negative on day 4
Flu-like symptoms: chest congestion, cough, sneezing, sore throat.
Upon leaving from well exam pt. had vasovagal syncope, hit forehead on wall, pale, spit-up, HR 46 - pulse Ox 98%, B/P - 82/58, brought into exam room to lie down, water and lollipop given, color returned, HR - 72-80, BP - 92/64, after 20 minutes resolved and discharged home. Called later that night and doing well, called 11/13/18 - and completely fine.
J&J covid 19 Vaccine. Administered. J&J vaccine 6 months prior to 18th birthday. Father contacted by per phone  - None
Eye became red on lateral corner and painful to move. Next day vision blurry and reduced vision on same side. Diag. as optic neuritis and have ruled out MS with MRI. Currently less painful (comes and goes), but still no peripheral vision from that eye.
Received second dose of COVID vaccine on 1/6/21. On 1/9/21, expericenced left axillary swollen lymph nodes/ tenderness to left axillary region. Received  vaccine in left arm. Spoke with employee via Employee Phone hotline and was instructed to fill out safe watch report.   Employee took Ibuprofen for discomfort and performed massage to lymph area.   Left arm and axillary area swollen on 1/12/21 during EH visit.
numbness in right side of face after shot   next morning same side of face drooping and trouble opening right eye
Pt recvd 1st dose of vax on 7JUL92 & on 24JUL92 pt exp pain & stiffness in rt shoulder & neck; also devel numbness of arm & rt hand & difficulty grasping items w/rt hand; rt shoulder pain & weakness in rt arm;
After both injections, I had swelling, warmth, redness, and itching in a circular rash with a 3 inch diameter around the site. Two days later the symptoms had not subsided and a layer of skin peeled off. Four days later another layer of skin peeled off and several circular 0.5 inch diameter spots began to develop on my left upper arm, armpit, left breast, and forearm. Six days after injection several spots developed on my neck, face, bilateral arms, breast, and scalp. Two weeks after injection I have spots all over my body including hands, face, scalp, feet, legs, trunk, back, and bilateral arms. These spots range from 3 cms to about 2 inches in diameter, they are circular, raised, red, and have areas of white flakey skin that peels off and grows back inside the spots. They are itchy, burn sometimes, and are visually unappealing. The injection site is still swollen, red, raised, and has shed about 5 layers of skin. Since the start of the rash 24 days ago I have not shaved or used any type of razor, have not changed detergents, have only used Dove white unscented bar soap, have not changed shampoos or lotions, have not changed my eating habits, have not changed any medication, and basically to sum it up I have not brought anything new to my body besides my vaccines. I was given Terbinafine HCL 250mg tablets and Clotrimazole cream on 8/31 and have been using them with no relief of symptoms. The rash has not subsided since using the medication and multiple new spots have occurred. An aerobic culture was taken from the injection site and sent by Dr. that resulted in no growth. I contacted the Health Department, talked to 4 different people, and was told "this is normal" by each one. This is clearly not normal.
Pt exp stiff neck p/1st dose of Engerix-B & then exp sore neck & cervical adenopathy devel in PM p/2nd dose;
Guillian- Barre Syndrome was diagnosed based on nerve conduction studies; respiratory failure; leg weakness; This is a literature report.  A 75-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "diabetes mellitus" (ongoing); "Crohns disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "unknown", described as "Guillian- Barre Syndrome was diagnosed based on nerve conduction studies"; RESPIRATORY FAILURE (medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "unknown"; MUSCULAR WEAKNESS (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "leg weakness". The patient underwent the following laboratory tests and procedures: Nerve conduction studies: Guillian-Barre Syndrome was diagnosed. Therapeutic measures were taken as a result of guillain-barre syndrome.  Clinical course: Patient with hypertension, diabetes mellitus and Crohn's disease developed leg weakness, complicated by respiratory failure, three days after her first dose. Guillian-Barre Syndrome was diagnosed based on nerve conduction studies. She received PLEX followed by IVIG. She can now ambulate with a walker. These cases raise concern that mRNA vaccinations may be associated with neurologic complications due to heightened immune reactivity.; Sender's Comments: Based on the available information in the case, the causal association between the events Guillian- Barre Syndrome, respiratory failure, muscular weakness and the suspect drug BNT162B2 cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200110398 Same article/durg and different patient/event;
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 81-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 16-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, route of administration, anatomical location, expiry date and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805519 was crossed linked to the original case 201804863 due to same reporter.
COVID-19 test is positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 test is positive) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included ISOTRETINOIN and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 12-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 COVID-19 (COVID-19 test is positive). At the time of the report, COVID-19 (COVID-19 test is positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 24-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 63 year old male patient. On 11-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On 24-SEP-2013, the patient experienced two blisters on his head that looked like mosquito bites and about four blisters near the injection site, that also looked like mosquito bites. The outcome of two blisters on his head that looked like mosquito bites and four blisters near the injection site, that also looked like mosquito bites were unknown. Additional information has been requested.
Headache; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 4th January 2022, 1 days after receiving Shingrix, the patient experienced headache and pain in arm. On 5th January 2022, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the headache and pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022046148  Additional details were provided as follows: The case was self reported by the patient. The patient received first dose of Shingrix vaccine and day after she got her first Shingrix vaccine, she had a headache and arm soreness in the arm she got her vaccine in (right arm). The patient reported that, headache only lasted about a day and the sore arm lasted about a week. The reporter did not consent to follow up.  This case was linked with US2022046148 reported by same reporter for same patient for second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046148:Same reporter.
headaches around the forehead after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches around the forehead after the 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches around the forehead after the 1st dose). At the time of the report, HEADACHE (headaches around the forehead after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient was scheduled to receive 2nd shot after 4 weeks on 27Apr2021.
08/11/2022 thought that I had allergies. 08/13/2022: I did come down with major symptoms these included, coughing, congestion, low grade fever. 08/14/2022 molnupiravir shot given at emergency clinic. Symptoms went away after the shot in about 2-3 days. Afterwards I was then clear and COVID-19. However the following Friday I was not feeling well and I became positive again for COVID-19. I was suggested to come in and they tested me again and I was positive for COVID-19 again. They believe that I had a rebound case of COVID-19 and it came with a mild cough, sore throat, and respiratory issues but nothing very severe. I am still having lingering symptoms as well.
fever, nausea, vomiting x3, bilateral lower extremity numbness and weakness with falls, hematemesis x3 episodes, headache. 2 days later, fatigue, fever, nausea persist
Information has been received from a nurse practitioner concerning a female who on 23-JUL-2007 was vaccinated with a single dose of Zostavax (Oka/Merck). On 22-SEP-2007 or 23-SEP-2007 the patient developed a "very mild case of shingles". Medical attention was sought and the nurse practitioner visually confirmed and diagnosed the patient with shingles. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Follow up information on 25-SEP-2007 indicated that the office was not able to provide a specimen for VZV analysis. Follow-up information concerning an 83-year-old retired, registered nurse with no know allergies and a childhood history of chickenpox, who on 23-JUL-2007 was vaccinated intramuscularly with her first dose of 0.7 milliliters in the right deltoid with Zostavax vaccine (Oka/Merck) (lot# 658081/0743U). Concomitant medications included calcium with vitamin D and "non-contributing" medications. 61 days post vaccination, the patient developed a vesicular rash with seven lesions on her left posterior thigh (dermatome S-1). Treatment included "famvair" 500 milligrams #21, PO TID, for 7 days with resolution noted. There was no fever (maximum temperature of 98.4 degrees PO) and mild pain symptoms (rated a 3-4 on a scale of 0 to 10 with 0 being the least) were noted. It was also reported that there was no recent exposure to chickenpox or herpes zoster, a direct fluorescent antibody was not done, no specimen was collected for PCR and no photos were taken. Additional information is not expected.
a patient was inadvertently vaccinated with an expired dose of Typhim Vi with no AE; Initial information was received on 22-Jul-2021 regarding an unsolicited valid non-serious case from pharmacist via call center via Regulatory authority (Reference number- 00693193).  This case involves a 57-year-old female patient who vaccinated with an expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  The patient's past medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 21-Jul-2021, the patient received a 0.5 mL dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number : R2A252M and expiry date : 11-May-2021) via an intramuscular route in the right deltoid for prophylactic vaccination (expired product administered).  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported that, "pharmacist reported that She requested guidance on how to proceed. the pharmacist stated that she will re-vaccinate the patient."  At the time of reporting, no adverse event was reported.  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 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.
This spontaneous report as received from a licensed Nurse practitioner refers to a 22 years old (currently 26 years old) female patient. The patient was vaccinated with a first, second dose of, third and fourth dose respectively of VARIVAX (Merck) (dose, route of administration and anatomical location were not reported) on 11-JUN-1987, 13-MAR-1991, 12-AUG-2008 (lot no 1521V, exp. date 19-SEP-2009) and 20-SEP-2012 (lot number [H011553]) is an invalid lot number for VARIVAX (Merck), exp date 11-JUN-2014). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that her daughter received 4 doses VARIVAX (Merck) because her titers were negative. The patient had titers drawn in 2008 and in 2012. No treatment information was reported. the outcome of titers were negative is unknown. The relatedness for titers were negative is unknown for VARIVAX (Merck). Additional information has been requested.
At time of first dose I was 19 weeks pregnant. I began getting a headache about 30 minutes after vaccination. I remained hydrated with water and Gatorade. Headaches would go from mild to causing dizziness and nausea- they NEVER went away between shots. Tylenol lessened them, but did not remove.  At time of second dose I was 23 weeks pregnant.  Approximately 2 weeks after shot and headaches are beginning to fade to 3-5 days a week instead of daily. The intensity is also not as severe. Blood pressure was monitored between injections by OBGYN and Perinatal centers for routine appointments- no noticeable increase.  Pregnancy due date 1/15/2022.
Chills, disoriented, nausea, extreme fatigue, fever nightmares, head ache, teeth ache, muscle ache