chrisvoncsefalvay/vaers-outcomes huggingface dataset:
area is blistering; the area was "swollen 3x the size and was hot to the touch"; the area was" swollen 3x the size and was hot to the touch; the patient was experiencing redness, swollen, and soreness at the injection site; the patient was experiencing redness, swollen, and soreness at the injection site; the patient was experiencing redness, swollen, and soreness at the injection site; the patient is also "extremely tired"; This spontaneous report as received from the patient's wife concerning to a 70 year old male.  The patient's pertinent medical history included stevens-johnson syndrome and penicillin allergy. The concomitant medications included unspecified medications for high blood pressure and cholesterol.  On 19-JUN-2020 at 11:00, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot # S033790 has been verified to be a valid lot number, expiration date 02-AUG-2021, in the right arm, for prophylaxis (dose and route of administration were not reported).  Later, on the same date at 23:00, the patient was experiencing redness (vaccination site erythema), swollen (vaccination site swelling), and soreness at the vaccination site (vaccination site pain). On 20-JUN-2020, reported as the next day, the area was swollen 3x the size (extensive swelling of vaccinated limb) and it was hot to the touch (vaccination site warmth). As of 22-JUN-2020 (reported as today), the area was blistering (vaccination site vesicles), but swelling was reduced, and it was no longer warm to the touch. Therefore, physician was contacted via telephone and it was recommended icing every few hours and taking ibuprofen, every 4 hours. As a result of this experience, the patient was also "extremely tired" (fatigue). The patient underwent quarterly unspecified lab tests and blood work. At the time of reporting, the patient was recovering from extensive swelling of vaccinated limb, vaccination site pain, vaccination site swelling, vaccination site erythema and vaccination site vesicles, the paharmacist also reported that the patient's arm was starting to heal. The outcome of vaccination site warmth was recovered. The outcome of fatigue was unknown.    The causality relatedness between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S033790; expirationdate: 02-AUG-2021; deviceage and unit: 0 ; operatorofdevice: Pharmacist; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Left arm sore, blotchy red and swollen, warm to touch with swelling traveling down to elbow.
I experienced leg and side cramps that has been very severe. I still have those episodes with a lingering pain afterwards.
This case was reported by a nurse via other manufacturer and described the occurrence of pain in arm in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the pain in arm, swelling arm and erythema of extremities to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The case was received from other manufacturer's medical representative, who provided the information reported by the nurse. The nurse reported that patient received Shingrix and experienced painful and red swelling on the arm. No additional information was provided. This case has been linked with case US2018GSK148210, reported by the same reporter.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 04-OCT-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II, subcutaneously (lot number M001200 with an expiration date on 28-AUG-2016, albumin status was rHA). No adverse effect was reported. Additional information has been requested.
Had swollen mouth and tongue since first MMR shot on 11-12-2009.  Mouth and tongue grew considerably more swollen, including throat.  Difficulty breathing on day #5 of second MMR shot.
A report was received from a health care professional on 2/16/04 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 12/5/03. On 12/5/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
7-2-09 - Leg, knee pain. 7-3-09 - Numbness, low grade temp, chills - saw MD - labs done - tested neg for strep/flu - sore throat. 7-4-09 - No strength - edema of neck - trouble walking - blurry vision. 7-5-09 - Seen in ER - IV fluids, BENADRYL, EKG, CAT scan, thyroid level done, CXR.
Vomiting, severe nausea, extreme body and joint pain, headache, weakness, tired, unable to fully lift left arm
My 87YO father has always been fiercely independent and, up until March of this year, was the sole caregiver of my 86YO mother who suffers from dementia. Up until 2 years ago he was also the caregiver for my 57YO autistic brother. He has always been extremely healthy and his only hospitalization was a hip replacement on his 80th birthday. On Sunday afternoon, March 27th, I received a phone call from Dad, telling me that he was on the floor after falling. He told me that he couldn't move his arm or leg on his right side. I told him that he needed to hang up with me and call 911 because it sounded to me as if he was experiencing a stroke. I knew that time is of the essence with stroke victims.  My mind was racing as I hung up the phone. What could I do? I live in state and my parents are in other state. My mother cannot be left alone. I knew my father was going to the hospital. I checked flights and found one leaving within a couple of hours that would allow me to be at their house by 11:30pm. I arranged for my older brother, who has extreme health issues himself, to stay with my mother until I was able to arrive. My immediate thought was the COVID shot that my father had the previous month. I wondered if it could be related. My travel from city to other city were the longest six hours of my life. What on earth would we do? What was going to happen to my dad? How could we provide my mom with the care she requires? I prayed for God to heal my father and give us the wisdom required to navigate the maze that I could see unfolding before us.  On Monday morning, I took my mother to the hospital with me to see my dad. I discovered that my father had indeed suffered a stroke caused by a blood clot on the left side of his brain. Fortunately, the blockage was such that some flow had been allowed from his right side, so his speech or cognitive abilities had not been impaired. He was paralyzed on his right side, nonetheless. The week was a scramble as we tried to plan our bleak future. The only option seemed to be putting both of my parents in a care facility. I knew this would kill my dad, but I could think of no alternative. On April 1, my father was released to a care facility in a neighboring town. My mother was also moved to the same facility on the same day. My father received physical therapy and regained use of his arm. He can walk again, but drags his right foot. When he becomes tired he hast use a walker or risk falling.  It's not fair. My father has always been self-reliant, but must now depend on others for his care and the care of my mother. He's been robbed of precious time. The date of his stroke 03/28/2021 and it was caused by a cerebral venous thrombosis (CVT) resulting in complete paralysis on his right side, including his right leg and arm. Despite being in Rehab for 8 months, he still doesn't have use of his right leg
Asthma worsened greatly to the point where climbing stairs in my house is exhausting. Coughing fits and fatigue from very light physical tasks.
This spontaneous report as received from a registered nurse refers to an unknown age and gender patient. Pertinent medical history, drug reactions or allergies were not reported. On 21-JUN-2013, the patient was vaccinated with an improperly stored dose of VARIVAX, (dose was not reported), lot # H009635, expiration date: 09-MAY-2014. Concomitant medication was not reported. The reporter stated that VARIVAX was improperly stored from 03-JUN-2013 to 21-JUN-2013, and the total amount of time that the doses were above the recommended storage range of -15 Celsius (C) was 187.5 hours. Through most of the temperatures recorded in that time period were below -10C, there were three occasions where a highest temperature of 0C was recorded. The three temperature excursions were: 1). 88.5 hours to as warm as 0C, 2). 7.5 hours t as warm as -6C, and 3). 88.5 hours to as warm as -8C. No adverse effect had been observed or reported. This is one of four cases linked to the same reporter (MARR# 1310USA008540, 1310USA010121 and 1310USA010122). Additional information has been requested.
Patient received the Moderna 0.25 booster vaccine and was not eligible by age to receive this vaccine as she was 16 years 11 months old at time of vaccination. Her first two vaccinations were Pfizer. Mother thought she was eligible so brought her to the vaccine clinic. Per mother, patient was slightly dizzy and fatigued on 11/19/2021 the day after the injection and that symptoms resolved by evening of 11/19/2021.
Medication error. Patient is immunosuppressed, MMR and Varicella given. The patient reported the following post-vaccination symptoms on 10/7/2022: ? fever and fatigue that lasted 2 days post-vaccination ? redness on the left tricep (Varicela site) appeared 2 days post-vaccination and resolved within 3-4 days. ? pt denies current rash or redness at either injection site. No medical attention sought when patient was contacted about medication error.
pt devel fever, dec appetite p/vax on 8JUL96;seen in ER on 9JUL96 for emesis adm r/o sepsis;in hosp no more emesis, fever dec, WBC count 11.4, feeding well;dx immun rxn;
bad rash on both of his arms and legs; itching/felt itchy; scabbed over; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 73-years-old via an unspecified route of administration, administered in Arm Right on 04Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood cholesterol from an unknown date (states that the only medication he had trouble with in the past, was on Statin for Cholesterol, but he was taken off of it). The patient's concomitant medications were not reported. The patient experienced rash that developed on his legs and arms on Feb2021 after receiving his first dose of the Pfizer-Biontech Covid19 vaccine. He states that he "felt itchy" on Feb2021 before the rash, and that it got so bad that it ended up "scabbed over" on Feb2021. This was a delayed reaction, it did not occur within the first hour after the vaccination. He wants to know if he should get the second dose of vaccine. His HCP told him if he does, he should get the dose at a hospital, just in case he needs medical intervention, and he is hesitant to go to a hospital during a pandemic due to the risk of Covid exposure. The patient reported a severe reaction he had from the first dose of the COVID vaccine. He had a bad rash on both of his arms and both legs. He states that it was probably four or five days later that he started itching, and then the rash just broke out suddenly. The patient was using a salve on the rash that was given to him by the doctor at the urgent care and with the salve, the rash is starting to disappear but it is still on his legs. He is considering not getting the second dose due to his reaction from the first. The patient was recovering from rash on both his arms and legs, while the outcome of the other events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt presents with urticaria on her legs approximately 20 min after her influenza injection. Within 5 minutes had widespread systemic urticaria and rash. Pt received 50mg po Benadryl. Pt transferred to an urgent care where she was monitored and received 25mg IM Benadryl. Pt d/c to home.
Received second Covid vaccine at ~1:45pm and was monitored x 15 minutes without difficulty. She reports that about 2:15pm while she was on her way home, she developed some chest fullness/tightness and some mild SOB. She returned to Vaccine clinic for evaluation. She was able to park and walk-in unassisted.  Denies throat itching/swelling No rash  Vitals:  Initial set 115/66, HR 70, RR 18, O2 sat 99% Continuous pulse oximetry with oxygen sats 99-100% and HR 70-75.    Gen: WDWN WF NAD, conversing easily without dyspnea.  CV: RRR no MGR Resp: CTA bilaterally, no increased WOB Skin: warm, dry, not diaphoretic, no rash  Neuro: afocal,MAE    Fingerstick glucose: 89    Monitored x 15 minutes with significant improvement and resolution of chest discomfort and SOB Discussed with medical director and transferred to employee health for additional 30 minutes of monitoring.  Monitored x 30 minutes in SEH.  Complete resolution of symptoms.  Vitals q 15 minutes x 2 @1513 133/69 HR 71 @ 121/65 HR 72  Cleared to return home. Discussed signs necessitating emergent treatment including chest pain, SOB, throat swelling/itching.
Pt came to or clinic and said he wanted a Janssen shot.  He did not tell us that he had already gotten the Pfizer shot on 4/1/21 and 4/24/21 -- when we processed the shot thru his insurance. it told us to use the same manufacturer as before . That's when we questioned him about the other covid shots he got which was not revealed to us before. He said technically he did not get any shots since it was more than 6 months ago.  He then started to say he has an underlying condtion and needed this shot. We told him he could have gotten the Pfizer shot in that case but it seems he came specially to get the Janssen shot and also said it was approved elsewhere.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received SHINGRIX for prophylaxis. On 23rd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, joint pain and fever. On an unknown date, the outcome of the injection site pain, muscle pain, joint pain and fever were recovered/resolved. It was unknown if the reporter considered the injection site pain, muscle pain, joint pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. Within 3 to 4 hours after receiving SHINGRIX, the patient experienced muscle aches, joint pain and a fever. There was soreness at the injection but it was minimal. The symptoms lasted for 24 hours. The reporter consented to follow up. For tolerance to second dose of SHINGRIX, refer case US2019GSK060256.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, and drug reactions/allergies were not provided. On unspecified date, the patient was inadvertently administered improperly stored Oka/Merck VARIVAX lot # R002054, expiration date 22-JAN-2020, N034559, expiration date 05-DEC-2019, N031938, expiration date 13-NOV-2019 (strength, dose, frequency and route were not provided). The excursion temperature was 6 to 14 degree Fahrenheit for 2 hours 10 minutes. There was no previously temperature excursion. The call was because of a data logger. Concomitant therapy included sterile diluent. The sterile diluent used to reconstitute the product was stored properly. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA010208.
Patient inadvertently give 0.15 mL dose instead of required/recommended 0.3 mL dose. CDC contacted and advised to have patient return ASAP fto receive correct dosage. No adverse affects reported per patient. Patient returned 9/27/2021 and received 0.3 mL. dosage.
treatment of COVID-19; treatment of COVID-19; his is a spontaneous report received from a contactable reporter (other HCP). The reporter is the patient. A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (batch/lot number: unknown), in right arm for covid-19 immunization. The patient's relevant medical history included: "cardiac background" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: covid: negative, notes: Covid rebound 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included ZPack, Paxlovid with treatment start date 26Dec2022 and treatment stop date 31Dec2022.  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 the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Pt. states pain every since vaccine received. Pain in moving arm. Cannot use steering wheel. Cannot pick up 2 yr old. Had not taking anything. Recommended to take ibuprofen, ice, movement of arm and to see Dr.
Shortly  after midnight on 03/27/2021, I was feeling tired w/chills.  When I got up somewhere between 5-7 a.m. I had a migraine-like headache.  Felt very tired.  Body ached all over.  Temperature went from 99.1 to 103.4.  After I took Tylenol the temp went back down to 99s.  Chills and perspiration after the Tylenol.   Left arm was warm to touch and hard at the injection site with redness; approximate 3 inch diameter redness.   The arm remained the same for another 10 days.  Leaving a discoloration where the redness was, but no hardness.   Sunday, 03/27/2021 only a very mild headache.  Monday no symptoms at all.  None since then.
Jun 30, 2021 9:20pm Sharp Pain above left temple followed by complete numbness and tingling on right side of face.  Never slurred my speech, no palsy nor paralysis, only numbness and tingling that lasted for several days.  Felt a lot like your face feels after a dentist appointment as the Novacane wears off.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at the vaccination was not reported. The reporter collected adverse event report. The clinic manager asked the patient (staff member) what was experience with FLULAVAL immunization and the patient stated arm hurt for days following administration. The other reporter thought it was related to shot but one other patient commented that they thought administration technique of immunizer may have contributed. None of the immunizations led to hospitalization. This case has been linked to case US2017GSK182496 and US2017GSK183816, reported by same reporter for same event.
Nausea; More lethargic; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and LETHARGY (More lethargic) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (Pfizer vaccine 2nd dose) and Pfizer vaccine (Pfizer vaccine 1st dose). Past adverse reactions to the above products included Illness with Pfizer vaccine and Pfizer vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and LETHARGY (More lethargic). At the time of the report, NAUSEA (Nausea) and LETHARGY (More lethargic) outcome was unknown.            No concomitant medicine were provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided   Reporter did not allow further contact
Sore arm; Fever up to 101 degrees Fahrenheit; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK4176), via an unspecified route of administration in left arm, on 12Jan2021 at 12:15 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included colecalciferol (VITAMIN D). The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 21Dec2020 at 09:15 AM for COVID-19 immunization (left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 13Jan2021 at 05:00 AM, the patient experienced sore arm, fever up to 101 degrees Fahrenheit (F), and headache. No treatment was administered for the events. The patient underwent COVID-19 nasal swab test that was negative on 07Jan2021. The patient recovered from the events in Jan2021.
mom related by phone has fever & had convuls in morning went limp;to ER 13OCT95 discharged 15OCT95 had 1 sz in hosp;f/u 19OCT peds clinic translated by interpreters
Short term reaction (within 10 minutes of administration) red blotchy rash on neck and chest. Warm to touch. This is a common event for me and is believed to be related to the chronic hives. Did not happen on the second dose.   Longer term (started within a day, took months to recognize): significant worsening of existing diabetes insipidus that cleared up upon stopping all lithium. This was done in June.