chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021 at 4:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 4:32 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 55.60 at administration of 02-Mar-2021 and 55.67 at administration of 30-Mar-2021. Concomitant products were not provided. On 02-Mar-2021, at 09:00 A.M., the temperature recorded was 27 degree Fahrenheit, at 10:00 A.M, the temperature recorded was 29 degree Fahrenheit, at 11:00 A.M., the temperature recorded was 32 degree Fahrenheit, at 12:00 P.M., the temperature recorded was 33 degree Fahrenheit, at 02:00 P.M., the temperature recorded was 35 degree Fahrenheit, at 03:00 PM., the temperature recorded was 36 degree Fahrenheit and vial was initially oved to the fridge on 24-Feb-2021 and beyond use date was 26-Mar-2021. Product moved to clinic on 02-Mar-2021. On 30-Mar-2021 at 09:00 A.M., the temperature recorded was 33 degree Fahrenheit and vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021. Product moved to clinic on 30-Mar-2021. Vial was stored on cooler 1, on 02-Mar-2021, Excursion duration At 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM: 36, 2 PM: 35, 3 PM: 36, 4 PM: 37, 5 PM: 37. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported. This case was linked to MOD-2022-566976 (Patient Link).
Patient tested positive for COVID on 09/18/2021. Symptoms started on 09/14/2021. She had congestion, runny nose, cough, left ear pain.
Patient is a 11y.o. female who complains of  rash. She got Tdap, menactra 12/30. That night started with little rash on forehead. Itchy and spread across face. 12/31 very itchy, spreading down neck. Used some hct.   Examined 1/4/2021. Rash does not come and go. Remains on face. Now nose, eyelids, ears, chin. Some bumps on arms.    Did not eat today, but feeling fine. No runny nose or cough, no sore throat, no abdominal pain or diarrhea.  Sleeping fine.
About two days after receiving my vaccine, I started developing Left S.I. pain. It was getting worse and worse, so on Tuesday, I had a Virtual Appointment with my PCP. I was given Cyclobenzaprine to help with the pain. It did help somewhat. I was taking that with ibuprofen and acetaminophen.
the patient received improperly stored vaccine; This spontaneous report was received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant medication.     On an unknown date, the patient was vaccinated with an improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) one dose (lot # S003865 and expiration date 08-AUG-2020) (strength, dosage schedule and route of administration were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 32.5 Fahrenheit for 8 hours. The vaccine did not have a previous temperature excursion and the call was because of data logger.
This case was reported by a physician via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was past the 6 month interval for the second dose, which led to incomplete course of vaccination. The patient recently presented with shingles in the face and head area. The reporter did not provide any further information and did not refuse to be contacted about the case.
On the first day, in the night, the injection area was sore and red. On the second day, there was a baseball size red area around the injection site that was swollen and warm with a hard lump under he skin. By the afternoon, my whole body and joints were painful and I had a fever of 102 even after taking ibuprofen. On the third day, the redness and swelling had spread up to my armpit and down past my elbow. It was painful like a bruise and hot like a sunburn. I talked to a medical professional and was prescribed an antibiotic. Also took ibuprofen and benadryl and iced the area. By the fourth day the redness had still spread and swelling continued. By the 5th day (today) the redness and swelling and warmth and pain had finally started to reverse.
symptoms building slowly, but eventually sending me to ER with:  flank pain (right side) and weakness (walking up even slight inclination difficult)  lower back pain, with some lumbar spinal disk herniation (MRI)  numbness and tingling in fingers Muscle pain and aches (without injury)  muscle fatigue  general malaise and lack of energy some sore throat joint pain without swelling or redness and some headaches  later: pain in left shoulder (where shot was given); MRI showed:  lots of inflammation in many places  various partial tears + rotator cuff injury without obvious reasons Crepitus or crackling sensation in joints and spine, moderate joint effusion  fight/flight reaction of nervous system  generally: apparent irregular auto-immune responses leading to various forms of inflammation and other things on May 3, 2022, I tested positive for COVID 19
PATIENT RETURNED TO PHARMACY AFTER RECEIVING VACCINE APPROX 5 MINUTES PRIOR STATING SHE FELT LIGHT HEADED AND HAD AN UNUSUAL TASTE/COLDNESS IN HER MOUTH.  SHE SAT DOWN FOR 10-15 MINUTES UNTIL THE FEELING SUBSIDED THEN LEFT.
24 hrs after getting injection,  stated running fever of 99. Chills, body aches and pains in the joints
Shivers; Fatigue; Blood pressure 154/127; This case was reported by a consumer via interactive digital media and described the occurrence of shivers in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced shivers, fatigue and blood pressure increased. On an unknown date, the outcome of the shivers, fatigue and blood pressure increased were unknown.   It was unknown if the reporter considered the shivers, fatigue and blood pressure increased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine. The reporter stated that after recieving shingles vaccine he/she experienced shivers, fatigue and his/her blood pressure was 154/127. The patient wanted to know was it normal. Additional supportive information: Follow-up would not possible as no contact details were available.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 26-MAR-2019, the patient was vaccinated with an expired dose of VAQTA, intramuscular, lot # R010368, expiration date 25-MAR-2019 for prophylaxis (dose was not reported) (expired product administered). The outcome of the event expired product administered was not reported.
Acting fatigued, delirious (Mental Status changes/saying very bizarre things), dragging feet, pale, did not want to trick or treat very far, felt warm but looked pale, put to bed only 30 minutes later than normal with halloween & was asleep instantaneously. 1 hour later heard crying, not sure if missed this earlier. Found son to be crying/sobbing in bed and shaking but unarousable. Btwn me and his father, rubbing his back, and removing his pajamas and getting him to the ER, he was unarousable for a good estimated 40 minutes. When he did open his eyes he screamed about his mouth hurting and continued to cry. He appeared flushed, also said his head hurt (I assumed this from crying). We were able to get him under control at the ER with popsicles and DVD after some time. He was found to actually be afebrile. His strep test came back negative. He has never done anything like this before. He is always a very healthy child. He had not had any complaints prior. He does get the croup typically one time per year but other than that he does not even pick up the common cold so I thought he was a good candidate for the live attenuated virus. Not being able to arouse him while he cried and also his mental status changes/early evening drowsiness was a very scary experience.
Approximately 10 days after the vaccination. the lymph node in the armpit enlarged to size of an apple, but CT shows it as 1.9cm Nov 10 2019. Several days later, the water broke from that lymph node, it was leaking 2-3 days and later subdued in size and pain. Reduced to size 0.9 cm PET scan 12/26/2019.
Severe local reaction. Redness, pain & swelling from top of left shoulder to 4" above elbow - swelling is all around the arm into the armpit area.  Fingers on left hand tingling and numb (on & Off)
Moderna Dose Number: 2; Pfizer / BioNTech Dose Number: 3; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "broken arm" (unspecified if ongoing), notes: Currently recovering from broken arm. The patient had no known allergies. Concomitant medication(s) included: OXYCODONE, start date: 15Nov2022, stop date: 21Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna Dose Number: 2; Pfizer / BioNTech Dose Number: 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 for which included PF-07321332, ritonavir (PAXLOVID) from 06Dec2022 to 11Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Stomach problems; Intestinal problems; Diarrhea; Bad headaches; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), ABDOMINAL DISCOMFORT (Stomach problems), FUNCTIONAL GASTROINTESTINAL DISORDER (Intestinal problems), DIARRHOEA (Diarrhea) and HEADACHE (Bad headaches) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting). On 29-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems), FUNCTIONAL GASTROINTESTINAL DISORDER (Intestinal problems), DIARRHOEA (Diarrhea) and HEADACHE (Bad headaches). At the time of the report, PAIN IN EXTREMITY (Arm was hurting), ABDOMINAL DISCOMFORT (Stomach problems), FUNCTIONAL GASTROINTESTINAL DISORDER (Intestinal problems), DIARRHOEA (Diarrhea) and HEADACHE (Bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment product information was not provided.
This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included migraine. On 24 September 2009 at 13:59 the subject received unspecified dose of FLULAVAL (0.5 ml, route unknown), and experienced vaccine exposure during pregnancy. No details regarding the pregnancy were available at the time of reporting. Follow-up was received from the reporter on 20 October 2009: The subject's estimated due date was on 03 January 2010. The pregnancy was ongoing with no complications at the time of this report. Follow-up informant was received on 30 April 2010 via healthcare professional. The reporter indicated the adverse event was a result of suspected transmission of an infectious agent via a medicinal product however the pregnancy was by normal conception. On an unspecified date in April 2010, at unspecified gestation age, the subject gave birth to a male live infant who was considered full term. The infant was delivered by normal vaginal delivery, weight 7 pounds 4 ounces; length and Apgar score were not provided. The healthcare professional considered vaccine exposure during pregnancy to be clinically significant. Follow-up information also indicated the vaccination date was 22 September 2009 as opposed to previously reported 24 September 2009.
Pt stated 15 min post vaccine, started having tightness of chest on left side and difficulty breathing, lightheaded and nausea. Pt was given 25mg Benadryl.
Swollen, red, hot, tender upper  arm surrounding injection sites on L arm - 2 visible sites on L arm below deltoid muscle 1 inch apart.  Temp 99.8
Erythema localized swelling at site, approximately 3 inch diameter area noted. Cool compresses & BENADRYL used to treat.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 32 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin", notes: known allergies: Augmentin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (18Dec2022) Positive, notes: positive test two days after ending full Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given for COVID 19 treatment. Return of COVID symptoms and positive test two days after ending full Paxlovid treatment.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Presented to hospital with progressively worsening SOB, tested positive for covid-19. CXR showing Covid PNA. Admitted for acute respiratory failure with hypoxia secondary to Covid-19, AKI on CKD-4. Patient was transferred on 1.30.22 for worsening renal function and dialysis needs. Oxygen requirements remained consistently high through entire length of stay - unable to wean off. Was transferred to ICU for hypotensive shock, chest/abdominal wall hematoma development while on Heparin gtt. Family agreed to comfort care on 2.8.22. Patient was not a candidate for Remdesivir due to renal function. Treated with IV Steroids and Baricitinib at hospital.
After receiving the flu shot- dizziness, sweating, shaking, cold chills, fever, swollen cervical lymph nodes, malaise persisting for 48 hours plus.
Info. has been received from a registered nurse concerning a 6 mts old male with a "casien" allergy, eggs allergy and gluten allergy and a history of transient synovitis in March 01, and hospitalization for pneumonia in April 01. On 10/8/97 and on 3/13/98 the PT received a first (lot #624497/0923E) and second dose (lot #625399/1447E) of Hep B vaccine recombinant (yeast). Concomitant therapy on 3/13/98 included a dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus vaccine toxoid (Tripedia). Other concomitant therapy included cetirizine hydrochloride (ZYRTEC) prn. Subsequent to the vaccinations on 3/13/98 the PT developed a rash, 12 days duration. It was also reported that on 11/7/97 the PT was vaccinated with HIB conjugate vaccine (MSD) (lot #623260/0445E). On 1/13/98 the PT was vaccinated w/HIB conjugate vaccine (MSD) (lot# 624924/1112E), alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. On 10/8/98 the PT was vaccinated w/varicella virus vaccine live (lot #628027/1257H). It was also reported that on 12/18/98 the PT was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (MSD) (lot #628905/1362H) (diluent #629037/1521H). In June 99, the PT was diagnosed w/pervasive developmental disorder, autism (WAES #01110497). The PT was being followed by an MD at the time of this report. Add'l info has been requested.
Patient's arm became real red and warm. She didn't experience any itching until the evening of 5/16/17. The skin appears to be red and swollen and has spread over the last few days. It appears that she has had a minor allergic reaction becasue she has no other systemic symptoms.
Patient came in for second Moderna booster. Vaccinator administered Moderna  booster. On consent form he wrote age of 50 with a date of birth 03/27/1972. Later changed 1972 to 1974. Individual received last three vaccines from a different facility. LPN and I phoned individual to confirm and he stated" My sister corrected my date of birth as we both were in a rush. It was an honest mistake, I thought I corrected it on the form to reflect my age". No adverse reaction noted- no treatment needed.
knot; redness; soreness; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included intervertebral disc protrusion. Concomitant products included acetylsalicylic acid (Aspirin).   On 28th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced local swelling, erythema and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the local swelling was unknown and the outcome of the erythema was recovering/resolving and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the local swelling, erythema and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a knot and it was red and fading at the time of reporting. The patient also experienced pain that went away after the third day. The patient refused to provide any additional details.
pt recv vax 29SEP97 & 20NOV97 pt devel 20-30 lesions on back;pt was afeb;
Before giving his shot he denied any previous side effects from last vaccine and stated he did fine. He also voiced no complaints today. Pfizer vaccine Lot: EWO153 Exp: 07/21 administered at 1535. At approximately 1545 he got up from his chair and asked where the restroom was.  When he turned to go to the restroom he fell to the floor without bracing his fall. His head hit the floor and then ?bounced? and hit again. He appeared to be unconscious for about 30 seconds but was A&O to date, place, name when he woke up. He did say that he thought he lost consciousness at some point because he ?woke up with everyone standing over him?. When he fell he was diaphoretic and pale- I asked him if he was a diabetic and he states yes. He said he ate before coming and took ?8 units of insulin?. He also said his BG was 121 prior to eating- finger stick done at 1549- and was 88; which he states ?is not low for me?.  Doctor out to assess him and advised he needed to be evaluated by ER. The ambulance was called for him and his mother was notified.  While waiting for EMS he had trouble keeping his eyes open and his eyelids were fluttering, c/o his head hurting and being tired, he continuously yawned and rolled his tongue asking for water. 1559 EMS arrived and took over care of patient at this time.   VS post fall:   1548: 89/51; HR 52; 98%  1549: BG- 88  1551: 89/52; HR 50; 98%  1554: 83/47; HR 49; 98%  1557: ( Legs being elevated at this time) 108/64;  HR 59; 98%
Weakness / fatigue almost immediately, slept from 6pm to 9pm.  Woke up with severe chills / teeth chattering / uncontrollable shivering, my husband said my body was warm but I felt chilled to the bone.  Finally got warm enough to fall asleep around 2am.  The next day, more chills, headache, fatigue, and general malaise all day.  Started feeling better on the third day.  Today, tightness in right side of chest--not sure if related, will be calling the doctor.