chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nerve pain with no histrory; unexplained bruising; swelling; circulation problems; MRI abnormal (L5, SI, lowerback); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2022 at 15:00 as dose 3 (booster), single (Lot number: FM0698) at the age of 38 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Inflammation" (unspecified if ongoing); "Nerve pain" (unspecified if ongoing). Concomitant medication(s) included: MOTRIN [IBUPROFEN] taken for pain, inflammation, start date: Apr2021 (ongoing); CYMBALTA taken for neuralgia, start date: Apr2021 (ongoing); LORAZEPAM taken for anxiety, start date: Apr2021 (ongoing); PREDNISONE taken for inflammation, start date: Feb2022, stop date: Mar2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 03:00 PM, Site and route of injection: # hospital, Anatomical Site and route of injection: # hospital, Intramuscular, Batch/Lot number: ER8279), administration date: 09Apr2021, when the patient was 37-year-old, for COVID-19 immunization, reaction(s): "Nerve pain with no history", "Unexplained bruising", "Circulation Problem", "swelling"; BNT162b2 (DOSE 2, SINGLE, Time: 03:00 PM, Site and route of injection: # hospital, Anatomical Site and route of injection: # hospital, Intramuscular, Batch/Lot number: EW0172), administration date: 30Apr2021, when the patient was 37-year-old, for COVID-19 immunization, reaction(s): "Blood high(lipo protein)".  The following information was reported: ARTHROPATHY (non-serious) with onset 04Mar2022, outcome "unknown", described as "MRI abnormal (L5, SI, lowerback)"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain with no histrory"; CONTUSION (non-serious), outcome "unknown", described as "unexplained bruising"; SWELLING (non-serious), outcome "unknown"; PERIPHERAL VASCULAR DISORDER (non-serious), outcome "unknown", described as "circulation problems". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not had covid-19, prior vaccinations within 4 weeks.Booster dose was administered due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications).  No follow-up attempts are possible. No further information is expected.
ITCHY SITE is the main complaint.   1.  Immediately after injection the site stung a LOT for about 10 minutes 2. Day of injection I developed a hot, hard, painful spot (2" by 1.5") which became slightly itchy after a couple days. Felt like a spider bite.  3. Day 5 red spot was gone, although it was still a little painful and hard.  4. Day 8  Intense itching started right at the site, about 1cm surrounding it. Thought it was a bug bite. 5. Day 9 Woke up with the same big red spot as on Day 1 (2" x 1.5" around injection site), but now it's itching intensely. It is hard, swollen, and itchy, but not really painful. It feels like a huge hive.
This spontaneous report as received from a Registered Nurse refers to unknown demographics. The Patient's medical history and current conditions are not reported. On 30-SEP-2014, the patient was inadvertently administered (Oka/Merck) VARIVAX instead of ZOSTAVAX. The patient experienced no adverse effects. Product quality complaint was not reported. The outcome of the events is unknown. Additional information is not expected.
Brain fog and fatigue, increased from first; Brain fog and fatigue, increased from first; Brain fog and fatigue, increased from first; Chills; shortness of breath with exertion; Palpitations; Paresthesias to bilateral hands and right foot/leg; Weakness to bilateral hands; This is a spontaneous report received from a contactable nurse (who is also the patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ELB9B2, expiry date: unknown), intramuscular on the left arm, on 16Jan2021 12:00, at single dose, for COVID-19 immunization, at the hospital. Medical history included myelitis transverse from 2015, and depression. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. There were unspecified concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date: unknown), intramuscular on the left arm, on 26Dec2020 11:30, for COVID-19 immunization and the patient experienced paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. The patient did not receive other vaccines in four weeks. On 17Jan2021 at 07:00 (also reported as "12-18 hours after injection"), the patient experienced paresthesias to bilateral hands and right foot/leg; weakness to bilateral hands; brain fog and fatigue, increased from first; chills and shortness of breath with exertion; and palpitations. The events palpitations and shortness of breath with exertion were noticed on day 6 resulting to emergency room visit. It was also reported that the events resulted to emergency room and physician office visits. No treatment was given for the events. The patient was tested for COVID-19 post vaccination via nasal swab with negative result on 22Jan2021. The outcome of the events was recovering (improved gradually).
Extremely high heart rate from a heart rate at rest. One incident resulted in my almost passing out and throwing up. This happened about three different times.  My significant other was going to the hospital but I asked him not to take me.
This case was reported by a consumer and described the occurrence of vesicular rash in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced vesicular rash, itchy rash and pain. On an unknown date, the outcome of the vesicular rash, itchy rash and pain were not recovered/not resolved. It was unknown if the reporter considered the vesicular rash, itchy rash and pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient reported that approximately 14 days after she was given the injection of the vaccine she developed a shingles-type rash from the middle of her abdomen to the middle of her back. It itches and was painful. The patient reported that it seems to be no relief in sight. The patient wanted to know would this happen with her second injection to be given on 22nd December 2018.
Client received a 3rd Hep-B. She complained of nausea and feeling dizzy around 09:05 to 09:10. She was monitored, vitals stable at 108/60, 72 pulse and RR 20-24. At 09:40, she became unresponsive. She was given .5cc epinephrine SC in left arms. Also reports difficulty breathing and swallowing.
Patient' s mom called 2/21/12. Stated daughter received shots (Var, Tdap, meningitis) on 2/16/12. Had hives 2/17/12, "swollen shoulder", "no fever". Hives have resolved, continues with slight swelling on arm. Patient is in school today.
On 3/24, onset of light internal pressure in left chest area. Over next 2 days, pressure increased.  During the following 2 days, pain changed to a sharp constant pain in same area with onset of shortness of breath.  On Friday 3/29, pursued medical attention with Dr. visit and was admitted to hospital for evaluation and treatment of new-onset Atrial Fibrillation.
Patient reported having redness, tenderness  and some itch at injection site the next day after vaccination was given. Then yesterday, patient noticed rash, itchiness and redness all over body.
Painful, swollen, fever, achy, fatigue. ER visit x 2 with antibiotics administered.
mom states 4 hr post injections 13jun97 pt became pale, limp & had decreased resp rate; pt taken by squad to hosp; parents decided to come to another hosp for Dr. to check
Patient and her grandmother request Covid Booster (Bivalent) I took patient label to the Pharmacy (at this facility the Pharmacist draws up the medication/vaccines and hands it to the  nurse) to request the vaccine. I request child 10 year old Pfizer Bivalent vaccine. Patient label given to the Pharmacist, Pharmacist drew up vaccine and placed label on syringe.  She placed vaccine color coated in orange with Pfizer PEDS C19 VAX Bivalent (AGE 5-11) on syringe under patient label. I went to room patient was in with grandmother (guardian) verified the patient by Name and DOB per policy and I administered vaccine IM in Left Deltoid.  I went back to chart the vaccine in the computer and that is when I noticed that the grandmother COVID vaccine and the Patient had the same lot number.  Appeared Pharmacist had drawn up both vaccines from same vial.
tired; This is a spontaneous report from a contactable healthcare professional, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at an unknown age) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced felt really tired. The outcome of the event felt really tired was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145089 same drug/patient, second dose/different AE
PANS; strep throat twice. Unexplained upper respitory infection. Night terrors. Sleep walking. Personality change. Urinary issues. Attachment issues. Appetite change. Headaches. Body weekness. Aggression.
5mins p/vax pt in wating area, came to mom & collasped in lap; eyes rolled back in head as collasped;observed limp in mothers arms as carried back to clinic room;pale & limp gray color to lips, sweaty or clammy; lethargic
We had an 18 year old today on private insurance who needed his 2nd Hep A vaccine. The only pediatric dose we had was from State. Our provider stated that it was ok to use the Private Adult dose since he was 18 years of age.
The day after my flu shot, noticed severe pain in my shoulder while picking up a bottle of laundry detergent. I also noticed limited mobility in the shoulder. The pain (both while the shoulder is in motion and while still) and the limited range of motion remain to this day.
Rheumatoid arthritis flare up/AFFECTING SHOULDER JOINTS; ARTHRITIS IN HAND; Feels bad; Skin thinning of; Blister; get rips really easily; This is a solicited report based on information received by Pfizer. A contactable consumer (patient) reported that a 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for rheumatoid arthritis. The patient had immune compromised since childhood, prior to taking adalimumab. She had hand surgery due to arthritis. The outcome for surgery was reported as recovered and causality was reported as no reasonable possibility. BNT162B2 vaccine caused her a slight flare up of rheumatoid arthritis which affected the shoulder joint and she felt bad for couple of days. Her skin was getting thin and not regenerating like it should. It get rips really easily and gets blisters. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The outcome of events was unknown.   The reporter's assessment of the causal relationship of the events with the suspect product 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.  The reporter's causality for the event(s) of arthritis in hand, felt bad, blister and rheumatoid arthritis flare up affecting shoulder joints was not provided. the reporter's causality for the event(s) of skin was thinning not regenerating/skin rips really easily with HUMIRA (adalimumab) was a reasonable possibility. (privacy) opinion is that there is no reasonable possibility that the events of arthritis in hand, felt bad, skin was thinning not regenerating/skin rips really easily, blister and rheumatoid arthritis flare up affecting shoulder joints are related to HUMIRA (adalimumab).; Sender's Comments: Based on the current available information, the events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. Concomitant using HUMIRA (adalimumab) may provide a plausible alternative explanation for the events.  The case will be reassessed if additional information becomes available.
PATIENT EXPERIENCED SYNCOPE 15 TO 20 MINUTES AFTER SHOT WAS ADMINISTERED.  HELD AND COMFORTED UNTIL CONSCIOUSNESS WAS REGAINED.  OBSERVED FOR  ADDITIONAL 30 MINUTES BEFORE PATIENT LEFT AT HER OWN WILL
Limited range of motion. Numbness in the left hand. Sharp pain causing sleeplessness when moving.
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female with no medical history and drug reaction and allergies who on 08-JUN-2010 was vaccinated with the first dose of GARDASIL (lot number 665607/1332Y) and hepatitis A virus vaccine (unspecified). On 09-SEP-2010 the patient was vaccinated IM in the right arm with the second dose of GARDASIL (reported as lot # "0785Z" was a valid lot # for VARIVAX (Merck). On 21-SEP-2010 client came in for doctor visit stating she was having irregular periods. Urine pregnancy test taken and was positive (LMP: May-2010). Client estimated due date is 08-JAN-2011 (EDD: 08-JAN-2011). Nurse states client was not experiencing any problems. Follow-up information has been received from a registered nurse concerning the 16 year old female patient with anemia and no previous pregnancy who was vaccinated with the first dose of GARDASIL (lot number 665607/1332Y) on 08-JUN-2010, and the second dose (lot number 0785Z was not valid for GARDASIL, but valid for VARIVAX (Merck)) on 09-SEP-2010. During pregnancy, the patient was treated with prenatal vitamin tablet, once a day for pregnancy on 25-OCT-2010 (duration unknown), and ferrous sulfate 325 mg tablet, BID by mouth for anemia in October 2010 (duration unknown). On 28-SEP-2010, an ultrasound was performed for normal fetal survey and revealed a 25 and 3/7 week pregnancy. As for Maternal Serum Alpha-Fetoprotein Screening (MSAFP), it was stated "too late entry to care". Follow up information has been received from a registered nurse concerning the 16 year old female teen pregnant patient with anemia and no previous pregnancy who on 08-JUN-2010 was vaccinated with the first dose of GARDASIL (lot # not charted). During pregnancy, the patient was treated with prenatal vitamins tablet, once a day for pregnancy on 21-SEP-2010 (previously reported as 25-OCT-2010) (duration unknown), and ferrous sulfate tablet, twice a day for anemia on 25-OCT-2010 (duration unknown). On 28-SEP-2010, an ultrasound was performed for dating ultrasound, and revealed the estimated delivery date as 08-JAN-2011 (EDC: 08-JAN-2011) (it was also reported that the patient's LMP was in May 2010). The patient's prenatal care was ate, and started at 29 weeks gestation. On 03-JAN-2011). The baby's weight was 6 pound 10 ounces, length 19 inches, and Apgar score 9/9. There was no congenital anomaly or other complication or abnormality.
Large erythematous reaction about 150mm at site of injection.  Pain and itching. No elbow involvement. Right triceps.
Woke up at 2 am with severe chest pain.  Sweating, neck pain.  Felt as though I was having a heart attack.
This spontaneous report has been received from a registered nurse and referred to 3 patients of unknown ages and genders. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with the doses one of expired M-M-R II (strength, dose, and route of administration were not reported; lot number M032153 with an expiration date 22-APR-2017) for prophylaxis that were reconstituted with sterile diluent (MRK) (lot number and expiration date were not reported). There were no adverse effects reported. Additional information is not expected as there was no contact consent provided.
Pt recieved pfizer-BioNtech COVID-19 Vaccine mixed with the wrong diluent. It was mixed with sterile water instead of 0.9% NaCL (NS) and administered to the pt.  No adverse events reported or detected by patient Provider Dr. made aware. No further action warranted.   I called Pfizer to receive further instructions. Pfizer reported that they do not have information regarding sterile water as diluent. Instructed to report with Vaers.  Filled out a report with Pfizer.
A report was received from an observational study. This is a safety study using Adenovirus Type 4 and Type 7 Vaccine. Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 685 patients exposed experienced symptoms involving skin; while 769 unexposed patients experienced SYMPTOMS INVOLVING SKIN. Of the exposed patients: Age: 29 were 18 years of age, 561 were between 19-24 years of age, 77 were between 25-29 years of age, 13 were between 30-34 years of age, 3 were between 35-39 years of age, and 2 were between 40-50 years of age. Gender: 220 were female, 465 were male. Of the 769 unexposed patients who experienced SYMPTOMS INVOLVING SKIN, 2 were 17; 49 were 18 years old, 584 were in the 19-24 year age range, 97 were in the 24-29 year range, 25 were in the 30-34 year range, 10 were in the 35-39 year range, and 2 were in the 40-50 year range. 244 were female, 525 were male.
Itchiness around injection site happened about 3 hours after injection. A couple hours afterwards, 5 hours after injection, the injection site was tender and hard to the touch. A 1 inch hard spot was observed by 7pm on daybed injection. The spot increased in size by 50% the next day and was noticeable under clothes. The area was red, hard, and tender. As of 2/13, the area is red, itchy, hard, and tender. The size has decreased by about 25%.
Pt recvd 1st dose of Hep B vax 26JUN91 & on 3JUL91 devel generalized red, pruritic rash; On 6JUL91 devel bumps around mouth; 2 days later started on medrol, DPH, Lidex; In AUG91 peeling all over;
Swelling, pain, redness, itching at injection site started several hours after injection.  Symptoms continue 2 days after injection.  No symptoms were noted with first injection, this was second Moderna Covid vaccination.
Pt vaccinated with DTP/OPV experienced irritable upon waking from nap. Temp 103-105. 10 days IV Antibiotic.
Dizziness observed after 2 weeks. Lightheadedness lasted brief time, less than a minute. ER visit confirmed no ruptured Aneurysm or stroke. Dizziness subsided after another week.
Case number PHEH2012US018900 is an initial spontaneous report received from a medical assistant on 18 Sep 2012: This report refers to a 24-year-old female patient. She was vaccinated with MENVEO, (batch number: unknown) intramuscularly in the previous week before the date pf reporting. On 18 Sep 2012 she notified the facility that she was 15-weeks pregnant. No adverse event was reported since administration of the vaccine. Follow up information received on 13 Aug 2013: Multiple attempts were made to obtain outcome of event without success. This case is considered lost to follow up.
This spontaneous report as received from a healthcare worker refers to a 2 month old patient of unknown gender. On 19-MAR-2014 the patient was vaccinated with ROTATEQ, lot # J003465, expiration date 04-AUG-2014 (dose not reported, dose in series unspecified) that was improperly stored at 52F on 15-JAN-2014 for 1 hour and at 33F on 19-MAR-2014 for 35 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
On about day 9 I noticed redness and warmth at the injection site.  It matches all the details I've seen on line for Covid Arm after the injection.  No itching or pain...just warm and red in a circle
doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen with no AE; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer non-healthcare professional and physician via Medical Information number: 00815008.  This case is linked to case 2021SA345065(CLUSTER).  This case involves a 74 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product storage error).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On 27-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ716AA and expiry date: 30-JUN-2022 via intramuscular route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to Product storage error temperature too low (latency: same day).  It was reported "The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time."  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 the guidelines. 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.
swollen @ inject site; redness that has moved downward; appearing as red streaks; no fever-arm not hot to touch;
12 hours after injection, I awoke with horrible chills. I was shaking so violently I woke myself and my husband. I proceeded to vomit four times. Since that time, I had a headache and general body aches. Exhaustion continues. I was unable to go to work today as I am so tired. I feel very foggy-headed.
Within 2 hours pain developed behind knees.  Difficult and painful to walk or climb stairs.  Managed to work that day but called doctor the next day and was referred to emergency room.  Pain has receded over time but still minor pain in right knee almost two months later.  Also developed low grade fever, runny nose, sore throat  01/24/2021. Symptoms lasted about 2-3 days .
Next day post vax, the injection site turned red and was the size of a penny. She had a headache, diarrhea, vomiting, and cold chills. Next day, the site was not red but was the size of a quarter with same symptoms; but later in the day started to get better.
12 hours post vaccination: Fever, chills, nausea, vomiting; resolved within 1 day.