chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she reacted to the adhesive on the tape and developed blister; She had a little fatigue but she had that before; This spontaneous report was received on 09MAY2019 from a health professional. A 35-year-old female patient, developed a reaction distal to the injection site following the administration of ACAM2000.   On 26APR2019, the patient received ACAM2000 (lot# unknown) in her right upper arm. An occlusive dressing was placed on over the injection site. When the patient was seen on 07MAY2019, the patient was noted to have reacted to the adhesive on the tape and developed blisters. The blisters were healing and now looked like an abrasion. There were no subsequent blisters other than at the inoculation site. On the same date, distal to the vaccination site, the area was red, warm and swollen similar to cellulitis. The patient was not washing the area and had no fever, but experienced little fatigue which she had before. The patient stated that the redness spread within a couple of hours. According to the reporter, the outcome at the time of the report was that the redness was nearly gone and the reaction improved.   According to the reporter, the reaction was localized, not systemic and could either be from the tape of the ACAM2000.   Treatments included intramuscular(IM) Ancef and Oral Keflex to treat the possible cellulitis. Patient stated that the redness spread within a couple of hours and on follow up on 09MAY2019 redness had almost gone. Outcome at the time of report was Improved( Redness nearly gone).  Patient's medical history: None  Allergies included Hives with penicillin.  Concomitant medications: None  Company Comment:  The reaction describes a satellite lesion with possibly robust take that the Company considers possibly related to ACAM2000 and not to the tape. Satellite lesions is a common post vaccination complication and sometimes it is associated with erythema and edema similar to the reaction described by the reporter. Fatigue is not assessable and relationship to ACAM is not possible to determine as the patient had fatigue before.
Patient reports a rash at injection site that was first noticed today.  Reports tender to touch and mild pruritus.  Reports rash is localized to right upper arm and extends about 1 inch from injection site. Reports she felt a little "agitated" a couple of days post vaccination but cut down on coffee and issue resolved. Patient stated 2 days ago on Tuesday started feeling tired with cough and wheezing (denies asthma history).   RN informed patient that respiratory symptoms are not a side effect of the vaccine and she should call her primary care doctor for an evaluation and testing for COVID-19 infection.
As I drove away after getting the vaccine, I had some very sharp pain in my stomach. It came back the next day but not since then. I woke up during the night with chills and a severe headache which lasted 36 hours. Ten to twelve days after the shot I had extreme fatigue and head pain. It was above my right ear almost to my temple and goes toward the top of my head which was  a very sharp pain that lingered. These head pains last hours at a time and feels like the veins in my head are aching. They were daily all day for two weeks but now they are more intermittent. Nothing I took helped with the pain. They are not like headaches. On 04/17/2021 I woke up during the night with a sharp pain in my head. I went to the ER and they did a MRI but they did not find anything. The sharp pains lasted the next two days. My doctor said that the shot had triggered Cranial Neuralgia. I may have to take some medication to calm the nerves down.  I still had the pain in my head today which is four weeks after the vaccine. I am also worried about the extreme fatigue which makes me feel like falling asleep at my desk.  Some days it is worse than others. I had Covid-19 in April of 2020 and had fatigue for six months.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age. The patients' medical history and concurrent conditions were not reported. On an unknown dates, in August 2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (lot # M00462, expiry date 03-MAR-2018). The vaccines were stored at a temperature excursion between 9°C to 25°C for a cumulative total of 6 hours and 35 minutes (first for 4 hours and 33 minutes and then for 2 hours and 2 minutes) (incorrect product storage). It was called because of a data logger. No adverse effects were reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of three reports from the same reporter source (linked to cased #s 1708USA009475 and 1708USA010055). Additional information has been requested. Lot # M00462 is an invalid lot # for RECOMBIVAX HB. Sender's Comments: US-009507513-1708USA009475: US-009507513-1708USA010055.
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 66 years old male patient whose lymph glands, saliva glands and tear ducts were burning and were on fire, had sweating, vomiting and soreness that happens with injections, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza USP Trival A-B High-Dose Subvirion Vaccine (lot number not reported) via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious lymph glands, saliva glands and tear ducts were burning and were on fire (pain), sweating (hyperhidrosis), vomiting and soreness that happens with injections (vaccination site pain) 5-6 hrs following the administration of Influenza USP Trival A-B High-Dose Subvirion Vaccine. No lab data was reported. Final diagnosis vaccination site pain, vomiting, sweating and burning pain. The patient was treated with BANOPHEN. The outcome was reported as Unknown for all the events. List of document held by sender: None.
pain in shoulder; chills; fatigue; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. It was reported that caller wondering how long virus lives outside of the body airborn/surfaces. Caller stated that he had pain in shoulder, chills and fatigue after receiving vaccine. Outcome of the events were unknown.  Information on the Lot/Batch number has been requested.
Extreme feeling of hotness for first two days Extreme tightness in trachea on day after- re-emerging two days after Puffy feeling in ears - with whooshing feeling
shingles/ shingles outbreak; This case was reported by a physician via sales rep and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experience shingles, 2 days after receiving vaccine at pharmacy. The reporter reported that, the patient experienced outbreak on the same side of body as the injection. The reporter did not think that, the oubreak to be related to shingrix. The physician did not agree to be followed up.
DEATH Narrative:  no documentation regarding any immediate reaction after vaccine administration. 83 y.o. male with pmh severe pulmonary hypertension, s/p TAVR last year, severe asbestos related lung disease on chronic oxygen, recently started on palliative care. Was found by daugher deceased on the morning of 2/11/2021. Autopsy declined by family.
consumer inquired if there are any interactions between the 2 products/Possible vaccine and drug interaction; Experienced insomnia; Nausea; Shaking; This case was reported by a consumer via call center representative and described the occurrence of possible vaccine-drug interaction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included escitalopram (Lexapro) for anxiety disorder.   Concurrent medical conditions included anxiety disorder.   On 7th February 2022, the patient received the 1st dose of Shingrix. On 14th February 2022, the patient started Lexapro at an unknown dose and frequency. In February 2022, between 1 and 2 weeks after receiving Shingrix, the patient experienced drug interaction, insomnia, nausea and tremor. The action taken with Lexapro was unknown. On an unknown date, the outcome of the drug interaction, insomnia, nausea and tremor were unknown.   It was unknown if the reporter considered the drug interaction, insomnia, nausea and tremor to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose of Shingrix vaccine and then started Lexpro on 14th February 2022.  The reporter inquired if there were any interactions between the 2 products and stated that the side effects started after taking Lexpro.  The patient experienced insomnia, nausea and shaking.  The patient was referred to healthcare professional.  It was unknown if the reporter considered the insomnia, nausea and tremor to be related to Laxapro. The reporter consented to follow up to contact health care professional and consumer for follow-up.
Around 1030 PM on 3/12/2021 I woke up dry heaving. I then spent the night alternating between a cold sweat and a hot sweat. When I woke up on the morning of 3/13/2021 my whole body hurt. I felt as if I had been run over by a truck. My left arm was very sore from the injection. My left underarm hurt. Across my upper back was sore and tender. My chest felt tight. I was nauseous all day.    I took benedryl and Advil and slept most of the day.  By 5:00 PM on 3/13/2021 I was feeling better but still hurting. By 3/14/2021 the pain had mostly gone away, but my left underarm is still sore and I am still very tired
ROTATEQ that experienced a temperature excursion and was administered.; No side effects reported.; This spontaneous report was received from a medical assistant regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (strength, dosage regimen, lot #, and expiry date were not provided) (Product storage error). Lot number W0291190 is an invalid lot number for pentavalent (ROTATEQ) (expiration date was reported as 28-JAN-2024, conflicting information).  The improperly stored vaccine underwent a temperature excursion of 9.3 degrees Celsius (C) for 11 minutes with a previous excursion of 18.8 degrees Celsius (C) for 2 hours and 55 minutes. No side effects reported.  This is one of three cases received from the same reporter.; Sender's Comments:  US-009507513-2308USA005021: US-009507513-2308USA005116:
Vaccines done 10/22/07. Mom noted flecks of blood in stool, no other sx. Breast feeding, no formula.
Red, swelling, warm area bout 5x5 began about 12 hours after vaccine and slowly increased in size. Accidentally given a 3rd Hep A.
Patient received and completed Pfizer COVID vaccine series by different vendor on 6/16/2021 and 7/7/2021.  Patient then received another dose of Pfizer by us Physicians as listed on 8/12/2021.
A few days after vaccines, both wrists began to swell, ache and generate heat. About 7/18, some fingers (L) and (R) began to swell, stiffen and ache. Started taking 2 ALEVE in AM, 2 in PM. 7/23 stopped pilates started wearing wrist guards to limit movement. One finger turned purple and very swollen. Rt. wrist swelled to mid-forearm. Alternated heat and cool treatments-by 7/29 purple gone, swelling is subsiding. Worse morning and evening.
I noticed while showering approximately 10 days later that my hair started to fall out in clumps. Every time I brush my hair or wash it, I'm losing tons of hair. It is everywhere falling out just with the smallest touch.
Pt seen on 04/07/14 for WCC. Received HIB and PREVNAR in (R) superolateral thigh. RTC yesterday (04/28/14) with dimpling of fat in an area approx 6 cm x 2 cm. Flesh colored to ecchymotic at times. Mild induration in center.
EE received 2nd vaccine 1/20 0745 and began having s/s at 5pm: HA, nausea, fatigue, chills, body aches.
Area is warm; Palm sized redness at the injection site; Area is tender/Arm was achy; Was given by a pharmacist and she believes that he placed it too high; A spontaneous report was received from a health care professional concerning a 45 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site erythema, warmth and pain. she believes that the injection was placed too high.   The patient's medical history was not provided by the reporter. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of events, the patient received the first planned doses of mRNA-1273 (Lot number: unknown)in her left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021 the patient the injection was given by a pharmacist and she believes that he placed it too high. On 12 Jan 2021, the patient experienced a palm sized redness at the injection site, the area was warm and tender, arm was achy, and red.  Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event a palm sized redness at the injection site, the shot was given by a pharmacist and she believes that he placed it too high, the area was warm and tender, and arm was achy were  unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship for the other events cannot be excluded.  Causality for this medication error (suspected wrong technique in device usage process) is not applicable.
Patient presented to emergency department on 10/27/21 with resp distress. patient was admitted for further management of pneumonia. patient was found to be covid-19 positive on 10/22/2021. patient did requirement treatment for symptoms associated with covid-19 infection. Treatment included aggressive respiratory care, oxygen therapy, breathing treatments and other supportive measures. patient given dexamethasone, remdesivir. patient expired 10/31/2021 due to respiratory distress, acute hypoxemic respiratory failure secondary to covid 19
Client is a 33 y.o. female who received the Covid-19 Vaccine, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2613 on 3/18/2021. The patient experienced the following reaction(s) during the immediate of observation: 2:35pm Patient with witnessed syncopal episode during observation period. + head strike and loss of consciousness. Patient gained consciousness after about 30 seconds. No seizure activity noted. Denies SOB and difficulty breathing. Patient alert and verbal.  Patient was treated/managed as follows:  2:40pm VS BP 144/74, HR 99, RR 20, 99% on room air. Patient alert and oriented. C/o soreness to shoulder. Reports PMH psychogenic nonepileptic seizures induced by anxiety and stress, anxiety, and depression. 2:50pm VS BP 140/82, HR 87, RR 18, O2 sat 97% on room air. Patient reports mild headache and soreness to shoulder. 2:50pm 911 called. Patient given educational material regarding vaccine and advised to continue to self-monitor per the agency guidance. 3:17pm EMT arrived. VS BP 133/83, HR 83, RR 18, O2 sat 97% on room air. Patient reports feeling better. Patient refused transfer to hospital for further evaluation. 3:26pm Patient wheel chaired to car accompanied by mother, grandmother, and RN
This is a spontaneous report received from a noncontactable reporter other HCP. A 54-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD7218), at the age of 54, on Jan 12, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed pyrexia/fever, and nausea, onset Jan 2022, with outcome of unknown. Additional information: The case received via the regulatory authority reported as non-serious: no results in death, not life-threatening, no caused/prolonged hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect. No follow-up attempts possible. No further information expected.
chest tightness, felt like there was a heavy weight on me same effect after 2nd shot (Pfizer lot EWO162)- went to ER
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 04-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Patient states her arm started becoming really sore 2 hours after injections. Today left arm and left side of neck are swollen. patient rates pain as 9 out of 10 on pain scale. Patient is unable to lift arm. Patient states it looks like a vein in her neck is swollen and it hurts when she palpates it.
adverse events: throbbing headache, entire body ache, heart palpitations, nausea & vomiting, chills treatment: acetaminophen, rest, & continue to monitor
some sorenessin arm; Little rush; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some sorenessin arm) and RASH (Little rush) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (Hernia operation). Concurrent medical conditions included Bronchitis and COPD. Concomitant products included ALBUTEROL [SALBUTAMOL], IPRATROPIUM BROMIDE and RANIBIZUMAB (LUCENTIS) for an unknown indication.    On 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (some sorenessin arm) and RASH (Little rush). At the time of the report, PAIN IN EXTREMITY (some sorenessin arm) and RASH (Little rush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ, lot number not reported. No adverse effects reported. The outcome of incorrect product storage was unknown. This case is linked to 1508USA001517 as same reporter link. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm and erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced big red swollen arm after vaccination. The patient might not want to receive 2nd dose.
Vacc. given on 10/06/08 at 8.50 am. Moderate fever started same day after nap at 4.00 pm. 10/07/08 Fever climbed to 40 C on the next morning. Patient declined to eat much. Patient slept 7 hrs during day (instead of 2-3 hrs, although he had slept through  the night.) Called doc. office for advise as patient was  apathetic. Rec: Lower fever. I lowered fever with Ibprophen. 10/08/08 doctors office visit in the morning. Dr. examined child. Dr. said, that fever came to soon after shot. It might have other cause. No other cause was found (ears, throat, lungs, urine). Patient was released. I cont. to lower fever which still was in the 40 C without medication. Patient declined to eat much, was apathetic. 10/09/08 Patient was feeling worse. Whining, drinking but not eating much. Could hardly stay awake. After nap at 4.00 patient was suddenly feeling cold. Body temp droped to 34.8 C. Called office. Nurse said: "You measured wrong!" I said: "His hands and feet and face are kind of blue." On my way to ER at 6.30 pm he recovered suddenly. Started talking. Stared eating little. I didn't check him in although I was staying literally right in front of the hospital. In the late evening and drning the next day his recovery cont. No fever, feeling better.