chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain shoots all the way down to her fingers and all the way up to the side of her neck/ screams in pain/ cries in pain/ pain comes and goes,feels like this pain after the vaccine is bringing back all of the hurt from the accident; veins in that area are sticking out more/are popping out; putting the arm high hurts; pain in the arm,right arm (same arm of the second injection) started hurting suddenly; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain shoots all the way down to her fingers and all the way up to the side of her neck/ screams in pain/ cries in pain/ pain comes and goes,feels like this pain after the vaccine is bringing back all of the hurt from the accident), VASODILATATION (veins in that area are sticking out more/are popping out), VACCINATION SITE MOVEMENT IMPAIRMENT (putting the arm high hurts), PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE PAIN (pain in the arm,right arm (same arm of the second injection) started hurting suddenly) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 034C21A.) for COVID-19 vaccination.     The patient's past medical history included Automobile accident in 1971, Multiple fractures (In a road accident, every bone in the body was fractured) in 1971 and Coma (ended up in coma after accident) in 1971.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in the arm). In August 2021, the patient experienced PAIN (pain shoots all the way down to her fingers and all the way up to the side of her neck/ screams in pain/ cries in pain/ pain comes and goes,feels like this pain after the vaccine is bringing back all of the hurt from the accident), VASODILATATION (veins in that area are sticking out more/are popping out), VACCINATION SITE MOVEMENT IMPAIRMENT (putting the arm high hurts) and VACCINATION SITE PAIN (pain in the arm,right arm (same arm of the second injection) started hurting suddenly). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) in August 2021 for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (pain shoots all the way down to her fingers and all the way up to the side of her neck/ screams in pain/ cries in pain/ pain comes and goes,feels like this pain after the vaccine is bringing back all of the hurt from the accident), VASODILATATION (veins in that area are sticking out more/are popping out), VACCINATION SITE MOVEMENT IMPAIRMENT (putting the arm high hurts), PAIN IN EXTREMITY (pain in the arm) and VACCINATION SITE PAIN (pain in the arm,right arm (same arm of the second injection) started hurting suddenly) outcome was unknown.            No concomitant medication was provided.
Headache, nausea and sore arm.  All night shivers and body ached with nerve zings and diarrhea. When I woke up morning following vaccine, tingly lips and severe nerve pain up and down legs. Legs kept giving way with step and  could not lift leg high enough to enter vehicle. At the time of writing this 94PM the day after the vaccine ( approx 35 hours after vaccine) nerve pain is much less, very tired/ slept most of the day,  nerve pain in legs, hips, back is much less. Stomach issues still persist.
This case was reported by a physician and a nurse and described the occurrence of myopathy in a 54 year old male subject who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. On an unspecified date  years ago the subject received unspecified doe of Lymerix unknown. Previously the subject had taken cholesterol and medications but they were discontinued. On an unspecified date after vaccination with Lymerix, the subject experienced elevated liver enzymes, myopathy, elevated creatinine phosphokinase and an abnormal electromyography. The nurse considered that these events were life threatening. At the time of reporting the outcome of the events was unspecified. The nurse considered that the events were probably related to treatment with Lymerix.
Vertigo NOS on 2020-12-17, Adverse effect of other vaccines and biological substances, initial encounter on 2020-12-17.
I had a severe 2-3 month arthritis flare after my 2nd dose of the Moderna vaccine so I was waiting for a long time to get my booster. I got an IV infusion 1.5 days prior to my booster that included 1000ml saline, high dose vitamin C, high dose magnesium, B complex and taurine. I took vitamin A and D sublingual and BCQ for 4 days prior and continue to take them daily. Reduced my sugar intake and drink a lot of water a day hoping to not have a reaction to the booster. I didn't have any same day or that week response to the vaccine. Prior to the vaccine and booster, I consider my RA in remission. January 1-3, 2022, I began having a small amount of muscle tightness, joint pain and inflammation. On January 6, 2022, I started having a strong Ankylosing Spondylitis arthritis flare: much inflammation in my AS areas - inflammation on top of my sacrum, my sacroiliac joints, my lumbar spine and around both of my hip joints (my hip joints aren't generally part of my AS inflammation areas). I have nerve pain radiating from my spine around my torso and down to my legs, especially on my left side. My muscles will spasm in response to the inflammation. The inflammation, nerve pain causes so much pain that my pain levels will be 8/10 and I cannot work in this condition since my job is manual labor.  I take a prescribed anti-inflammatory as much as I can, but it hurts my stomach. I take muscle relaxants and pain medication for the pain. I ice the areas that are inflamed. I apply topical Traumeel to the areas. I go about every 6 days to get vitamin injections including Traumeel, 400mg magnesium, vitamin B complex, tuarine, L-carnitine for the pain and spasm muscles. 6 days later, my inflammation, pain, nerve pain, stiffness increases again. Then I get another round of vitamin injections.
slept from Friday pm through Saturday about 2pm,exhausted, slept until 10am Sunday.   nightmares, minor sweating. on Sunday began nausea, headache, neck and shoulder aches, fluish, minor sore throat. knew I would sleep heavily again and did.
Significant arm swelling and pain, fatigue lasting overnight into the next day. Arm pain remained 2 days
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 6-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 12-NOV-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
swelling of her ovaries; hot to the touch; on the opposite side, so the right side, on her lower back in that area it was also swollen and hot to the touch; This is spontaneous report from a contactable consumer(patient) reported for herself. A 46-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot Number: Unknown) as SINGLE DOSE, dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced swelling of her ovaries, hot to the touch, on the opposite side, so the right side, on her lower back in that area it was also swollen and hot to the touch, all on 18Mar2021 with outcome of not recovered. Patient has received both the first and second dose of the Pfizer Covid Vaccine. Stated she got her second dose yesterday and with both dose of the vaccine, she had swelling of her ovaries and they were hot to the touch. Stated it was more on the right than the left. Stated it was worse the first time. States on the opposite side, so the right side, on her lower back in that area it was also swollen and hot to the touch. The patient experienced events after first dose from 18Mar2021 and recovered on 20Mar2021, experienced same events after second dose on 08Apr2021 and ongoing. Time of Onset (24-hour clock) reported as noticed it this morning and got up around 05:40. The events reported as non-serious.  No Emergency Room visit. No Physician Office visit, stated she worked for a dentist and she consulted with her and the dentist said to watch it and wait 48 hours. Treatment received included Ibuprofen.   No follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.
On Saturday, 02/06/2021, evening around 6:00 PM, intense pruritus developed on right arm around injection site on right arm. Some warmness was also noted. The pruritus continued on Sunday and Monday. On Monday, 02/08/2012, evening, a small area of erythema was noted. On Tuesday morning, 02/09/2021, a large firm, bright erythematous plaque was visible.  The plaque was warm and sensitive to touch. The pruritus had decreased. As of Thursday, 02/11/2021, the erythema  has only slightly decreased.
Said it felt sore until today; His tongue is really red and it is stinging; Lost his taste; His tongue started to hurt; Bad headache; Tongue turned bright red; His doctor believes that his tongue has a yeast infection; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6206 and expiration date: Not available), via an unspecified route of administration in the right upper arm on 08Mar2021 as a single dose for COVID-19 immunisation. The patients medical history included heart problems, cirrhosis of the liver, has less than 50% of his lung capacity, high blood pressure and high cholesterol, cancer and 3 heart attacks and he is on pace maker. The patients family history included heart attack, cancer, heart failures, lung cancer, heavy smokers, acute respiratory failure, his sister died undergoing a cardio test, his brother had rheumatic fever and everything. The patient had no prior vaccine in 4 weeks. On 08Mar2021, the patient experienced slight headache on the day of vaccination and on 09Mar2021, he had a bad headache. On 11Mar2021, the patients tongue started to hurt and on 12Mar2021, his tongue is really red, and it is stinging. In 2021, his doctor believes that his tongue has a yeast infection. The events did not result in a visit to Emergency Room or Physician Office. The clinical outcome of the event bad headache was Recovered/Resolved, the patients tongue started to hurt, and his tongue is really red and it is stinging was Not Recovered/Not Resolved, whereas for other events it was unknown. The patient wanted to know if this is a normal reaction to the vaccine or if the vaccine interacted with some of the medications he is currently taking. Consumer said that some of his medications give him a dry mouth, so he wants to know if the vaccine somehow interacted with his medications. He has been through pandemics before, he remembers the swine flu. He had to see a doctor over there and he was asked if he had ever had any problems with vaccines before and he said that when he took the swine flu vaccine, shortly after he doze out, he didn't ever pass out, but he did run off the road because he was dizzy.  Information on Lot/Batch number was available. Additional information has been requested.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4222859-00 (RA), US-PFIZER INC-202200047448 (Pfizer). A 45 year-old female patient received bnt162b2 (BNT162B2), subcutaneous, administration date 27Aug2021 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single, subcutaneous, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single and subcutaneous, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis; methotrexate (METHOTREXATE) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: FOLIC ACID. The following information was reported: IMMUNISATION (medically significant) with onset 27Aug2021, outcome "unknown", described as "Booster"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 27Nov2021, outcome "unknown" and all described as "COVID-19"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss"; STOMATITIS (non-serious), outcome "unknown", described as "sores mouth"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "bnt162b2 via subcutaneous". The action taken for adalimumab was unknown. Additional information: Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Hair Loss, Covid-19, Sore Arm And Fatigue After All Covid Vaccine onset in 2021, Mouth Sores and Sore Arm And Fatigue After All Covid Vaccine onset in 2021 was not provided. The reporter causality for event Fatigue, Sores mouth, Sore arm was not reported and for hair loss and COVID-19 reported as not related with suspect BNT162B2. The reporter causality for event Fatigue, Sore arm was not reported, Sores mouth hair loss was reported as probable and COVID-19 it was not related with suspect Methotrexate. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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.
6 year old white female presents with temperature 101F-102F and spots, itching, starting on chest and back. Exposed to chickenpox, 1 week ago. Had vaccine 8/27/96. Discharged with 20 red spots 1mm X 1mm, 2mm X2mm vesicles on trunk and back, 1-2 on arms and legs approx. and 1 in vagina, itching. It is too early to tell.
After the first dose in October I was in a lot of pain and could not use arm for 2-3 days, but with second dose, I had a bad headache, pain in arm, left side of neck,, left shoulder as well as generalized pain all over, developed a fever (max reading taken 101.8) overnight with horrible shaking and chills all night. Nausea. Fever lasted over 24 hours with Tylenol controlling it. On Thursday, my fever hovered around 99 all day and still had headache. That day and all day Friday my arm had a large, red rash around injection site, was very swollen, hard, hot, itchy & painful.  Saturday I was extremely fatigued again.
RIGHT LEG AROUND AND ABOVE THE KNEE, SWELLING, PAIN AND FEELS HOT TO THE TOUCH
pt recv vax 19JUL96 & 27APR97 pt devel greater than 50 lesions;
Heart racing, fast pulse, heaviness in chest, light headed, short of breath, headache.  Lasted about an hour, drank  20oz of water and rested.
From an email received 08 April 2021-"My1st vaccination was on the 20th of March. On the 28th/29th (I?m not entirely certain which night it began), I woke up in the middle of night experiencing a pins and needles sensation in my lower legs. It was mild enough that I assumed I had just slept in the wrong position.  Over the course of the next several nights, the numbness and pins and needles sensation grew progressively worse. I was waking up several times throughout the night as a result and the numbness and tingling has spread to all four limbs (hips to toes, shoulders to fingers). The night of April 1st, the feeling had grown severe enough that I had trouble sleeping and was growing very worried about the symptoms. I didn?t have any symptoms during the day though, and that night the symptoms mostly went away. I still have the tiniest bit of mild tingling in my toes sometimes overnight, but otherwise I?m feeling just fine now."
Prior to vaccination, patient reported being afraid of needles and afraid of medical procedures.  Patient was advised to stay in the store for 15 minutes after vaccination to make sure he didn't have a reaction.  He left the pharmacy area to go to the deli, then returned to the pharmacy area about 5 minutes later and reported feeling very hot and light headed.  He appeared very pain and was sweating.  He did not report any shortness of breath, no tingling lips, and no tingling/scratchy throat.  He was given 25mg diphenhydramine and was advised to stay in the pharmacy for observation.  He reported feeling much better and thought  he was having anxiety and not a true reaction.
PATIENT COMPLAINED OF BEING IRRATABLE AND THE INABILITY TO SIT STILL. ALSO STATED WAS IN QUITE A BIT OF PAIN ALL OVER. STATED SHE WENT TO THE ER BECAUSE OF THE PAIN AND WAS PRESCRIBED TYLENOL #3. SHE WENT TO THE EYE DOCTOR A WEEK LATER ALSO. THIS PROVIDER STATED IT APPEARED SHE MAY HAVE HAD A SHINGLES OUT BREAK IN OR AROUND HER EYE. WAS PRESCRIBED VALTREX AND EYRTHOMYCIN TO COMBAT.
diffuse sensory and motor polyneuropathy; diffuse sensory and motor polyneuropathy; Information has been received from a lawyer, regarding a case in litigation, referring to a female patient (pt) of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.   On or about 05-FEB-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, anatomical location, strength, dose, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered diffuse sensory and motor polyneuropathy (peripheral sensory neuropathy and peripheral motor neuropathy). As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX) vaccine, symptoms have resulted in severe, serious, progressive, incurable and permanent personal injuries/ physical limitations not present prior to vaccination. The pt also experienced mental and emotional distress, significant conscious pain and suffering, loss of enjoyment of life, physical impairment and injury due to resulting physical limitations and seriousness of her condition.  At the reporting time, the outcome of the events was considered as not recovered. The lawyer considered the events to be related to Zoster Vaccine Live (ZOSTAVAX). The pt's experiences were considered to be disabling, due to permanent and incurable personal injuries.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 25-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 62-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. On 29th May 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced rash, blister and pain in arm. On an unknown date, the outcome of the rash, blister and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the rash, blister and pain in arm to be related to SHINGRIX. Additional details were provided as follows: At 09:43 AM, the patient received Shingrix on right arm. In 2018, the patient experienced six spots that she described as little blisters that hurt to the touch on the injection site arm. The reactions were reported to the pharmacist in the morning of reporting date. No additional details were available.
No additional AEs reported; Caller states her daughter received ROTATEQ and PEDVAX HIB Vaccines in 12/2021 that expired in 11/2021; This spontaneous report was received from the patient's concerning to her daughter a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in December 2021, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquidunk, expiration date: 15-NOV-2021 (strength, lot #, route of administration, and indication were not provided); and  hib vaccine conj (ompc) (PEDVAXHIB), (strength, formulation, lot #, route of administration, and indication were not provided).   In February 2021 the reporter states her daughter was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus B conjugate (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis. However, it was reported that, both vaccines were expired (on an unspecified date in November 2021) (expired product administered).