chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 15-MAR-2018, the patient was vaccinated with an improperly stored dose of VAQTA lot # N019924 with expiration date of 02-SEP-2018 (strength, dose, route, and anatomical location were not provided) for prophylaxis. No adverse events were reported. The vaccine was exposed to a temperature range between 32°F up to 35°F (33.8°F), during a time frame of 24 hours, which was called by a data logger. No previous temperature excursions were reported. This is one of two cases from the same reporter.; Sender's Comments: US-009507513-1804USA006860:
Reported by pt arm became red and swollen with pain. Pt did not report reaction until 02/25/2005. Pt recovered but says arm still hurts at times.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received SHINGRIX for prophylaxis.  On 26th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th August 2018, several hours after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, pain in arm, fever, weakness and mental status changes. The patient was treated with non-drug therapy (Cold Pack). On 29th August 2018, the outcome of the erythema of extremities, swelling arm, pain in arm, fever, weakness and mental status changes were recovered/resolved.  The reporter considered the erythema of extremities, swelling arm, pain in arm, fever, weakness and mental status changes to be related to SHINGRIX. Additional details were reported as follows: At 11:00, the patient received SHINGRIX on the left arm. On the day of vaccination, by the evening, the patient's left arm was very red, swollen and painful. Less than day after vaccination, the patient was very feverish, weak and had an altered mental state. The patient used cold packs on the swelling and took a lots of showers to keep her fever down. On Wednesday evening, the symptoms had mostly resolved. The patient had decided not to receive the 2nd dose of SHINGRIX. The contact details of the physician was provided. The reporter had given consent to follow-up.
Phone report from mother.  Left arm swollen, red, hot to touch, itchy.  Swollen area is full circumference of arm and extends approximately 6 inches from top of deltoid to mid upper arm.  No fever.  Mother giving Tylenol and topical hydrocortisone.  Advised mother to contact pediatrician.  Mother called back on 10/14/2009 and stated patient had seen Dr. and was given an antibiotic. Redness and swelling is resolving.
3:42 pm Pt received vaccination, stood up and c/o of feeling light headed, dizzy and body tingles. He became diaphoretic, pale and warm. Vaccinator put ice pack to back of neck, brought to recovery area in wheel chair VS 120/78, HR 81 reg, resps 16 regular non labored, 96% O2 sat. gave water to hydrate. no c/o N/V Monitored for 30 min Pt state he felt better, tingles diminished, color came back to face, no more diaphoresis. Provided reassurance. Encourage hydration. V-safe site. Ok'd to leave site. RN 3/9/21 - called pt to check condition he stated he is doing very well. RN
7/28/2021 Started to feel weak, diaphoretic, sore throat, lightheaded. 7/30/2021 presented to ED with continued cough, sore throat and R leg pain. Had been out of town on trip two weeks prior.  Tested Covid-19 positive 7/30/2021. Due to immunocompromised status, did not qualify for remdesivir, decadron or tocilizumb. Placed on prophylactic heparin and given fluids and placed on O2. Was hypotensive and Benicar and HCTZ were held. Discharged 8/1/2021 in improved condition, without supplemental oxygen,  with the following dx: hypotension, AKI, Covid-19. Submitter does not have access to any further hospitalization information. If further follow up information is required, please contact the hospital.
I went to the pharmacy and I received the booster vaccine. I was the third one to get the shot that day. That evening I had to put ice on the injection shot due to being sore. After that it was kind of sore, it was tender. On Wednesday, I was feeling dizzy. I was taking Sudafed. I figured out that during this time period I was dealing with problems with my sinuses and teeth. I started the prescription on the afternoon on 09/24/2021, I also stopped the Sudafed. My jaw started to hurt again. I called my doctor and they advised that I need to come in to see him. The day before yesterday I woke up and I was dizzy. I took medication for dizziness. That helped with the dizziness. The next day was a little less. This morning was I have had very little. I have used Sudafed my whole adult life.
I was sleeping 16 to 17 hours a day. I have trouble breathing. I went to my doctor. She ran an EKG, abnormal results came back. They did a stress test and values test, normal result. It was difficult to stay awake and to keep food down.
Day 4 - large warm red spot on left arm below injection site Days 5-6 - eyes swollen halfway shut, general face swelling, redness, itching and burning
After our son had his shots at the 2 month appointment, he slept for a while, and woke up screaming. He was completely inconsolable for over 8 hours. We called the DR and took him to the emergency room, where they just said that it was a normal reaction. At 4 months, after receiving the DTaP again, the same thing happened. Ear piercing shrieking for over 8 hours. At his 6 month appointment, we opted out of the DTaP, he got other shots in the leg, and there was no crying other than the initial fit when he got the shot.
Mother of patient reports redness, swelling and pain in vaccinated arm. Mother gave ibuprofen to treat symptoms and pt states relief of pain.
1ST VACCINE WAS MODERNA GIVEN ON 3/12/21. 2ND VACCINE WAS PFIZER GIVEN ON 4/9/21.
Pt developed an injection site reaction at the site of the Prevnar shot and was seen by the physician on 4/22/00. The physician noted an area of redness measuring 1.5cm in diameter and induration measuring 2cm in diameter at the Prevnar injection site. The infant's parents were instructed to apply warm and moist compresses to the Prevnar site. The infant recovered. Follow up info received on 7/5/00 provided the pt's full name.
fell sick; (got ill )with a fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (fell sick) and PYREXIA ((got ill )with a fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced MALAISE (fell sick) and PYREXIA ((got ill )with a fever). At the time of the report, MALAISE (fell sick) and PYREXIA ((got ill )with a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
C/o right upper arm pain, pain at injection site and sting sensation and numbness involving the whole arm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 73 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3(booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID  19 and BNT162B2.
This spontaneous report as received from a healthcare worker refers to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not specified. On 17-SEP-2015, the patient was vaccinated with the expired dose of ZOSTAVAX injection, expiration date January 2015 (dose, route of administration and lot# were not reported). No adverse effects were reported. Additional information is not expected as no reporter contact information was provided.
pt recvd vax 14AUG95 & 5SEP95 & devel a severe cold w/cough;reporter also believed the pt had pox in throat;f/u pt's MD reported pt seen in clinic 13SEP95;15SEP95 mom stated pt devel low grade fever & looked like pt devel chicken pox
pt recvd vax & exp pain from shoulder up to neck; pt had f w/ t 101; exp flu-like symtoms of runny nose, h & stomach upset; pt also exp throat swelling & trouble talking;
temperature was up to a 101 / fever; she could not even move because it hurt when she moved; felt very bad / Feels horrible; Body ache; Chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient).  A 55-year-old female patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 11Jan2021 for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 11Jan2021 night she felt very bad with body aches and chills but then on 12Jan2021 she was not even able to go to the work. She was not going to go to work on 13Jan2021 and her temperature was up to a 101 and she could not even move because it hurt when she moved. Body aches, chills, fever, fatigue, she just said she just feels horrible. She took two Ibuprofen maybe 200 mg, so probably total of 400 mg of Ibuprofen. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F. However, that is not approved by agency for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Patient reports worsening pain in left arm after vaccine. Does not have full function or rotation of the arm and states that he "cannot sleep on that side, cannot lift it to shoulder height, and cannot drive with it." It has been ten days since the injection and he feels that it is getting worse.
BODY ACHES, CHILLS,HEADACHE, TEMPERATURE OF 100. STARTING AT 4AM ON THE 12/31/21 AND STILL HAVE THESE SYMPTOMS AT PRESENT WHICH IS 1/1/2022 AT 12NOON.  TOOK ADVIL , EXCEDRIN, EVERY 4 HOURS, FLUIDS, UNABLE TO SLEEP BECAUSE OF SYMPTOMS, EVEN WITH ADVIL.
Swollen eyes; itchy eyes; watery eyes; allergic reaction; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Swollen eyes), EYE PRURITUS (itchy eyes), LACRIMATION INCREASED (watery eyes) and HYPERSENSITIVITY (allergic reaction) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts (Allergy to Brazilian nuts), Allergy to nuts (Allergy to Walnuts) and Fruit allergy (Allergy to Kiwi).    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced EYE SWELLING (Swollen eyes), EYE PRURITUS (itchy eyes), LACRIMATION INCREASED (watery eyes) and HYPERSENSITIVITY (allergic reaction). At the time of the report, EYE SWELLING (Swollen eyes), EYE PRURITUS (itchy eyes), LACRIMATION INCREASED (watery eyes) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient stated that on 11-JAN-2021 she used a collagen fill face mask and that her physician doesn't know if the vaccine or the face mask caused the reaction. Her physician gave her prednisone and Benadryl for the allergic reaction.
Actually I had adverse reactions to SHINGRIX on both shots in the series, given by the same clinic. I experienced headache, rapid heartbeat, dizziness, unusual fatigue, chills and shivering. After the first shot these symptoms lasted 2 days, after the second shot it lasted a full day. I drank fluids and rested.
Left upper arm with area of erythema, warmth, tenderness. Treated with KEFLEX 11/4/14.
Localized reaction on site of injection with warmth and redness.  Both feet and lower legs with erythematous macular rash with vesicles
Vaccination site pain; Suspected COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and SUSPECTED COVID-19 (Suspected COVID-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and SUSPECTED COVID-19 (Suspected COVID-19). The patient was treated with DENOSUMAB (PROLIA) at an unspecified dose and frequency and REPOSAL at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not resolved and SUSPECTED COVID-19 (Suspected COVID-19) was resolving.            No concomitant medicine were provided. There was no reported medical history. For HUMIRA, the reporter causality for the event of Vaccination site pain was a reasonable possibility. and for the event of Suspected COVID-19 was not 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.   Reporter did not allow further contact
I saw doctor on July 19th, 2021 for nasal congestion which I was getting a couple days prior. Saline nose spray, rotate Tylenol and ibuprofen to deal with any body aches or fever. Had upper respiratory congestion; but no fever. Doctor thought it was viral. It was the most sinus congestion and drainage from the nose, constantly blowing my nose. I have had colds before but this was uncommon in the extreme congestion I had. I had those symptoms the 16th (or a couple days before); missed work on the 16th and came back to work on July 22. It was the worse illness I had in years.
ErythemaMultiform, UrticariaPruritus, swelling, rash, itching, heat at injection site 5 days post injection Narrative:
Patient states she is having bad arm pain whenever she moves her arm. She is not limited in her movement, but states that it is painful and there is a red welt the size of a half dollar at the injection site. She states that the injection was administered halfway down her arm and not into the deltoid.
pt states myalgias beginning at right side of face and migrating up to left side of face and scalp which resolved spontaneously
2 days prior immun pt devel apparently moderate fever (temp not taken) which fluctuated; 7 days post vax pt exp loss of appetite was listless & c/o inability to walk; wrists, ankles & feet hurting; body was flaccid & abdo was distended;
Feeling a little "funky"; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling a little "funky") and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CLONAZEPAM and HYDROCHLOROTHIAZIDE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling a little "funky") and PYREXIA (Fever). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling a little "funky") and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
General achy muscle/bones same as after first injection.  With second injection had HIVES beginning about 18 hours after injection that continued for 5 days; now gone but residual rash and serious itching
Clinic note from 9/24-- "Pt got flu vaccine Friday morning. Friday evening, pt c/o pain and itching at site. Mom treated with tylenol. Saturday, Pt developed small bruising at puncture site with a small red ring around it. Pt still c/o itching and pain. Mom gave zyrtec, tylenol and applied ice. Saturday evening, the red ring was approx 2 inches big and mom called the RN line and was told to watch for 48 hrs and seek care if it was worse when she wakes up. On Sunday morning, area of redness was approx 5 inches and bruised area in the center was larger. Pt was seen at UC and was thought to have an injection site reaction as well as an infection and was started on Keflex. Mom continued with zyrtec, tylenol for comfort and applied ice and hydrocortisone. Pt took 2 doses of keflex on Sunday. Area looked alot better on Monday morning. Today in office, pt is much improved. Area appears normal - no swelling, redness, pain. Pt remained afebrile throughout weekend. This is pt's 4th year to get the flu vaccine. "
Morning after injection very sore arm, headache, dizziness, Fatigue, nausea, fever of 104.  2nd day after injection, headache, dizzy low appetite, no fever this morning
4/10 - after 4 hours, (14:00) felt hot and my face was in red color.  Generally OK 4/11 - Generally felt hot, red face, and then around 16:00, arm and let joins  started to ache and mild pain occurred. 4/12 - After having a dinner around 17:00, with in 30min, chest pain started at left chest.  felt more like heart burn sensation.                19:00 pain stopped by  drinking some hot tea.                22:00 took my meds, Brilinta, Carvedilol and Atorvastatin                 23:30 chest pain came back instead of left side, in the center of chest.  took some tums and drank some hot water                 26:00 no more pain and was able to go sleep. 4/13 - 07:00 no pain but off and on with discomfort in the chest area from last night chest pain.
Vaccine was at room temperature for an undetermined amount of time / uncertain about the exact temperature or duration; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Herpes zoster (Shingrix) (batch number 7354R, expiry date 15th November 2022) for prophylaxis.   On 13th April 2021, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient brought Shingrix into the office from her pharmacy and vaccine was at room temperature for an undetermined amount of time which led to incorrect storage of drug. The vaccine was administered to patient. The reporter was asked was the vaccine efficacy affected, would we still consider this as Shingrix shot 1. Vaccine extended stability data provided but health care professional was uncertain about the exact temperature or duration. The health care professional  declined to provide patient demographics. The reporter consented to follow up.
1.5 weeks developed sinus infection leading to cellulitis in left eye, 1.5 weeks later hospital stay for 1week on broad spectrum antibiotics, came home 3 days, rushed back to hospital presented with pus on the brain , brain operation at local Hospital to wash brain, next day had a stroke in the right hemisphere, brain swelling and craniotomy to remove bone flap  to relieve swelling, coma for a month, rehabilitation, left arm contracted swallow issues, cognitive issues,had to learn to walk again, seizures
This spontaneous report as received from a medical assistant refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # L010143, expiration date: 24-SEP-2016 (therapy type, exact dose, route of administration and anatomical location were not provided). There were no adverse events reported. This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
Facility held offsite vaccine pod on 03/18/2021 and offered Janssen Covid19 vaccine. Pt. had reported past hospitalization due severe allergic reaction to Sulfa drug. She received the Covid vaccine at approximately 11:25 AM and was directed to waiting area where she would be watched for 30 minutes.  After 5 minutes, at approximately 11:30 AM, she alerted the waiting area monitor (who was an ER nurse) that she felt her throat was closing up and she was struggling to breathe. 911 was notified. BP was 140/82, P 80. EpiPen 0.3 mg ( Lot # 0FM411 Exp: 01/31/2022) administered left lateral thigh. Transported to local hospital ER.  Assessed, treated,  and released home
Information has been received from a nurse concerning a 20 year old female patient with an allergic reaction to Z-PACK and a history of migraines who on 10-FEB-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 659437/1266U). On 07-JUL-2009 the patient received the second IM, 0.5 ml dose of GARDASIL (lot number 662404/0312Y) and within one hour of the injection she developed a migraine that lasted for 24 hours. Concomitant therapy included TYLENOL. The patient called the office that day and told the nurse that she "was too sick to come back in". The patient was seen for a follow up appointment 2 days later, on 12-JUL-2009, and "she was fine". There were no lab diagnostics studies performed. Follow up information has been received from a Registered nurse who reported that the female patient who on 7-JUL-2009 was vaccinated IM with a second dose of GARDASIL (lot # 662404/0312Y) at 11:30 a.m into the left arm. The Registered nurse reported that on 07-JUL-2009, the patient experienced migraines, nausea, sore and numb arm at 12:30 p.m. At the time of the report, the patient recovered on 09-JUL-2009 (also reported by Registered nurse as 08-Jul-2009). Additional information is not expected requested.
Some hand, wrist swelling on opposing arm from vaccine, muscle aches, joint pain, excessive fatigue, shoulder pain.