chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received  on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
soreness in his hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in his hand".  Additional information: It was also reported that the reporter also mentioned all of his 4 COVID 19 vaccines have been from Pfizer, and with the previous ones he did not have any reaction at all, just soreness in his hand.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever 100-100.5 3 days swelling 2-6 days herpes simplex lower lip for 5 days, glossitis, stomatitis, and gingivitis 5 days. Feeling of choking especially when sleeping. Apnea episodes. TX  Tepid spraying, Aspirin, pain reliever, warm drinks, rest.
Tolerated past immunizations without difficulty. With Anthrax (1) vaccine, noted some site soreness starting p.m. of vaccination and continuing for 4-5 days. Had pre-treated with MOTRIN 800 mg and continued MOTRIN x 2 days post-vaccination. No significant redness, warmth or nodules at vaccination site. Describes pain as dull, aching pain surrounding vaccination site which seemed to resolve by 5th day post-vaccine. However, on 17 Sep, SM reports pain returned, but was more intense (up to 8/10 on pain scale of 0-10). Also on 17 Sep, noted swelling of R) upper arm and noted the pain more with reaching movements, adduction across chest, and with pressure applied around vaccine site (not extending to shoulder or across chest, but below vaccine site to about 1-2" above elbow). No other vaccines were received in that arm on 8 Sep. SM denies any recent or previous injuries, trauma or surgeries of R) UE. Noted some fatigue the first few days following vaccine receipt, which has improved. Noted generalized body aches and joint pains over first few days, which receive within 5-7 days. No Pruritus in area of vaccine site, no localized erythema, no red streaking, and no nodule at vaccine site - exam essentially normal except for pain to palpation and ROM limited due to pain.
Patient states that the next day she started to feel itchy and notice hives on the back both arms, abdomen and the back of the right leg.  Mother was notified and brought patient to the clinic on 08/26/2003.  No medication given at home.  MD prescribed atarax 10mg 1tsp by mouth of 6 hr x3 days.  04/26/2003
Received the 1 shot of SHINGRIX on Friday afternoon, came in Monday afternoon saying that on Sunday she started noticing a rash on her trunk area, Monday she came in and was referred to md, who diagnosed rash as shingles.
Arm pain/soreness/induration/stiffness - Tylenol; early onset within hours  Chills - onset ~18hrs, lasted 2 hours Muscle aches - onset 18hrs, lasted about a day Joint pain - onset 24hrs, lasted about 1/2 day Fatigue - onset 12 hours, worsened after 48 hours Nausea - onset after 72 hours
Information has been received from a health professional concerning a 12 month old female who in approximately 2/03 at the age of 12 months, was vaccinated with a second dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # 642826/0250M). ON 4/15/02 at the age of two months, the patient was vaccinated with the first dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # 638838/1759K). In approximately 6/02 at the age of four months, the patient was vaccinated with a dose of Haemophilus B conjugate vaccine (lot # 636470/0707K). The reporter indicated that the patient has since had HIB with the date of onset reported as 2/21/03, at which time the patient went to the emergency room. The patient had a blood culture that was positive for Haemophilus influenza type B. It was noted that treatment was required for the event and that the patient recovered. Upon internal review, Haemophilus influenza type B was determined to be an other important medical event (OMIC). Additional information has been requested.  Follow up on 06/30/2003: "Information has been received from a registered nurse concerning a 12 month old female who on 09/18/2002 was vaccinated with a second dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast)(Lot # 642826/0250M).  On 04/15/2002, at the age of two months, the patient was vaccinated with a first dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast)(Lot # 638838/1759K) at a health department.  On 06/18/2002, at the age of four months, the patient was vaccinated with a dose of Haemophilus B conjugate vaccine (lot # 636470/0707K) at a health department.  The reporter indicated that the patient "has since had Hib" with the date of onset reported as 02/21/2003, at which time the patient went to the emergency room.  On 02/24/2003 the patient had a blood culture that was positive for Haemophilus influenza type b.  It was noted that treatment and a prescription drug were required for the event and that the patient recovered.  A product quality complaint was not involved.  Follow up information was received from an epidemiologist which indicated that on 02/21/2003 the patient developed lung congestion and was hospitalized.  Haemophilus influenza was isolated from a blood culture.  The patient subsequently recovered.  Upon internal review, Haemophilus influenza type B was determined to be an other important medical event. (OMIC)  No further information is expected."
SOB, Wheezing  pt on home O2, Pt family member positive with covid
"Covid arm"  Red, warm raised area on left arm deltoid area where shot was given.  apprx. size 3"x 5" .  Bright red like area was slapped, warm to touch, not itchy nor painful. No fever.  A blobby circular pattern, not symmetrical.
The day after receiving immunization pt had a lot of redness and pain at injection site. Saw Dr on 6/9/17 and was prescribed Azithromycin for possible cellulitis. Symptoms were resolved by 6/12/17.
This spontaneous report was received from a female consumer of unknown age reporting on herself who on unspecified date was vaccinated with a dose of ZOSTAVAX (dose, Lot # and route were not reported). No concomitant medications were reported. The consumer reported that she was diagnosed with chickenpox after receiving ZOSTAVAX on unspecified date. The patient refused to provide any further information regarding the AE. Patient's outcome was reported as recovering. It was unspecified if the patient sought medical attention. The causal relationship between ZOSTAVAX and the event was unknown. Additional information is not expected.
Takotsubo cardiomyopathy; This is a literature report for the following literature source(s). A 65-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: STRESS CARDIOMYOPATHY (medically significant), 1 day after the suspect vaccine administration, outcome "unknown", described as "Takotsubo cardiomyopathy". Patient had chest pain, myalgia, nausea, and headache as symptoms. The patient underwent the following laboratory tests and procedures: Electrocardiogram: abnormal. Therapeutic measures were taken as a result of stress cardiomyopathy and included aspirin, atorvastatin, lisinopril, and metoprolol succinate as treatment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported event (Stress Cardiomyopathy) cannot be excluded. No alternative causes were identified as per the available information. Case will be reassessed upon receipt of additional information
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA308764, 2018SA308765, 2018SA308766, 2018SA308767 (same reporter). This case involves 16 year old patient (gender unknown) who was vaccinated with dose of FLUZONE HIGH DOSE (Batch number, Expiry date, dose in series and site of administration was not reported) on an unknown date instead of FLUZONE QUADRIVALENT. Patient medical history and concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was unknown if the patient experienced any adverse events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
elevated heart rate; extreme muscle soreness; Cold Chills; all of a sudden becomes super cold; mild headache off and on; sinus congestion off and on; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In June 2022, the patient received Shingles vaccine. In June 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced heart rate increased, muscle soreness, chills, coldness general, headache and sinus congestion. On an unknown date, the outcome of the heart rate increased, muscle soreness, chills and coldness general were unknown and the outcome of the headache and sinus congestion were not recovered/not resolved.   It was unknown if the reporter considered the heart rate increased, muscle soreness, chills, coldness general, headache and sinus congestion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The case was reported via interactive digital media. The reporter was patient's wife. The patient got the vaccine last week and had elevated heart rate, extreme muscle soreness, cold chills and all of a sudden becomes super cold, mild headache off and on and sinus congestion off and on.
On 07/14/2000, the patient developed chickenpox that consisted of less than 30 lesions over her entire body and the patient was afebrile. The patient sought unspecified medical attention. Follow up information from a physician indicated that the patient's symptoms included "scattered, small, vesicular lesions on a red base on the patient's trunk and face." The patient was diagnosed with "possible varicella versus other viral exanthema." Subsequently, the patient recovered.
2/4/2023 I started with headaches in the right occipital lobe. I have had MRA, CT  and find no growth or other issues. I have unexplained headaches that come and go in the back of my head. I go back in two weeks for a check up.
I had the same reaction for both doses: I was sick for two days, I had extreme sweating all night for two days, I had extreme body pain for two days, I felt dizzy/confused, and I had extreme injection site pain and swelling for three days. The reaction from this shot was worse than when I had COVID-19, twice.   There were nights after the first dose but before the second dose that I woke up sweating. I still feel confused at times.
Notified by girlfriend.  Patient woke up this morning with arm  soreness. States temperature 102.3 this am. Instructed to call primary care.  Instructed patient could have COVID or flu not related to shot.  Waited 30 minutes post vaccination, without complication.
A report was received from a healthcare professional on 10/15/2003 concerning a group of vaccinees of unknown demography who received an accidental overdose of Fluvirin on approximately 8 October 2003. On approximately 8 October 2003 a group of vaccinees were inadvertently administered 1ml Fluvirin instead of the recommended dose of 0.5ml.  No adverse events were reported in relation to the overdosing. There was insufficient information to determine the reporter's causality assessment. Update 1, 17 November 2003 Follow up information received from a healthcare professional indicated that possibly 19 vaccinees inadvertently received 1ml Fluvirin. Follow up pending.
Patient described a migraine she had the evening after the vaccine was administered. It did not go away. Her doctor prescribed ibuprofen 800mg three times daily and the migraine went away after a couple of days.
Right thigh red, swollen, 20cm x 12cm induration - minimally tender.
Per nursing report: "took 2nd dose of Moderna Monday  [5/10] to left deltoid. C/o headache yesterday [5/11] and today [5/12] c/o  chills, sore to move and left arm soreness."
pt recv vax; scarring of lt anterior leg area; pt referred to plastic surgeon by MD;
Soreness, Redness, Itching, and Warm at the place and around the place the shot was given.  Patient contacted on 09/27/10 and 09/28/10 at 2:00PM.  Itching and soreness resolving.  Patient states she is feeling better and stable.
This case was reported by a healthcare professional and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with Havrix (GlaxoSmithKline). On an unspecified date the subject received 1st dose of Havrix (1 ml, unknown). At an unspecified time after vaccination with Havrix, the subject experienced nonspecific reaction. It was reported the immunization series was discontinued and/or delayed. No other information was provided. At the time of reporting the outcome of the event was unspecified.
Pt developed shingles in the axillary dermatome on 7/14/01. Pt had possible exposure to varicella. Pt's recovery was complete after 2 days of Prelone.
TC from patient 2:30 pm 4/17/08.  Received HPV, Menactra, and Tdap while in clinic.  Also received 1 gram Zithromax and 500 mg Cipro--client on no meds.  No chronic illness. No allergies.  No problem with childhood vaccines. C/o no rash, but tiching on upper abdomen, arms and neck since om 4/15/08. Also c.o nausea ans "stomachache"' No vomiting.
At injection site no redness or visible swelling, but when I touch it I can feel it is swollen directly underneath the spot where the vaccine was injected.
Moderna COVID-19 Vaccine dose given 15 days after the BUD for refrigeration
Slept a lot; wasn't able to each much; fever seems to come and go; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot), DECREASED APPETITE (wasn't able to each much), PYREXIA (fever seems to come and go), NAUSEA (nausea) and CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced HYPERSOMNIA (Slept a lot), DECREASED APPETITE (wasn't able to each much), PYREXIA (fever seems to come and go), NAUSEA (nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Joint ache, at an unspecified dose and frequency. On 23-Apr-2021, PYREXIA (fever seems to come and go), NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, HYPERSOMNIA (Slept a lot) and DECREASED APPETITE (wasn't able to each much) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2020, Body temperature: 100.7 f (High) high. On 20-Mar-2020, COVID-19: positive (Positive) Type of test nasal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: non significant follow up received on 23-MAY-2021 contains NNI On 24-May-2021: Significant follow up received om 24-MAY-2021, patient demographic details updated, dosage information was updated, events was updated, lab data was updated.
no adverse effects reported; The patient, who is pregnant, received a dose of Gardasil 9; This spontaneous prospective pregnancy report was received from a medical assistant via a company representative and refers to a 22 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-FEB-2019, the patient became pregnant.  On 14-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R011630, expiration date 12-DEC-2020 (dose, route and frequency were not reported) for prophylaxis (exposure during pregnancy).   It was stated that, at the time of vaccination, the patient was 33 weeks and 3 days of gestation. The patient's estimated delivery date (EDD) was reported as 01-DEC-2019. The pregnancy outcome was outcome pending. No adverse effects were reported.
Patient is being hospitalized for COVID-19 pneumonia. The patient has had a pulse ox reading in the low 90s and feels short of breath. She had a positive COVID-19 test collected on 3/16/21. She has fatigue and nausea/vomiting. The patient received Regeneron antibody infusion and dexamethasone. In ED, patient is requiring 2 L of O2 to maintain O2 saturation of 96%. Patient is being admitted.
Severe headache, acheing muscles, fever that spiked at 102.7 (21:00), nausea.
Diarrhea, nausea, body aches, headache, runny nose, low temperature. Ongoing at this time.
Vasovagal syncope. About 5 minutes after administration checked on patient and mom stated she was feeling really hot and nervous, she started looking pale. Suggested she lay down. At that time her eyes rolled back and she lost consciousness for about 2 seconds. We elevated her legs and she came to within seconds. We also gave her cold compresses and water once she returned consciousness. After time to recover her color returned and the patient was fine to sit and then stand. She had not had anything to eat and believe that could have been a contributing factor. We called EMS for her to be checked, they checked her BP and pulse where were normal and sent her home.
No adverse effects; A patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 09-JUL-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S009940, expiration date 04-OCT-2020, orally, for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 3 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.; Sender's Comments:  US-009507513-1907USA007439: US-009507513-1907USA007438:
Redness and itching to left arm that started approximately 30 minutes after administration. Redness and itching spread across body into a generalized rash. Itching to throat but no respiratory issues- no shortness of breath or trouble breathing. Took two Benadryl tablets and a Pepcid tablet around 745pm when I got home.
Numbness/tingling in bottom lip around 3 hours after shot, went away around 6 hours after shot  Woke up next day with significant muscle aches, fatigue mainly in my upper body (arms, neck, back). As the day progressed, dizziness and brief period of accelerated HR (have had incidents of elevated HR a couple months ago before receiving the vaccine)
Immediately bruised and swollen at injection site. Pain in shoulder blade numbness, tingling and burning. Went to hospital 10/21, given (10) pain pills.
booster was given to a child less than 18 without them meeting criteria.  (not immunocompromised).  Vaccine given at mothers request.  No adverse reaction to vaccine.
Pt received COVID-19 vaccine at 9:57am. Pt went to waiting area in front of pharmacy and sat down. Pt was on her phone when she said she felt like she started dreaming.  Her friend said her eyes rolled back and she threw her phone on the floor at 10:02am.  When I got to the patient a customer (nurse) was already assisting the patient. EMS and Code White were called at 10:03am. Pt was awake and aware of what was going on. She said she had no history or fainting or seizures. She did say that she normally had a lower blood pressure. Pt was sitting up but laid back down at 10:05am saying that she was having vision issues and feeling dizzy.  BP was 112/70 and HR 75 at 10:10am. EMS arrived at 10:12am and took over.  BP was still low at that time.  Pt denied going to the hospital and EMS left at 10:20am.  Pt stayed with friends until 10:40am. Pt left the store with 3 friends who had also received vaccine.