chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Full body rash; This is a spontaneous report received from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6202, Dose number: 1) via an unspecified route of administration on the left arm on 25Feb2021 at 17:30 as single dose for COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Medical history included asthma. The patient was not allergic to any medication, food, or other products. Concomitant medications were not reported. On 26Feb2021, a day after receiving vaccine, the patient experienced full body rash. Upon consultation with the doctor regarding the event, the patient was prescribed Prednisone pack and a steroid shot was administered. The patient stated that, the steroid shot effect reduced within one day and rash went away with prednisone pack. But after completing Prednisone pack, rash returned a couple of days later. Treatment with second prednisone pack was started which was not working as well as first pack. The clinical outcome of the event rash all over was not resolved. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist via company representative refers to a 40 year (reported as early 40s) old female patient. Pertinent medical history was unspecified by reporter. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (intramuscular, dose, route of administration and anatomical location was unknown). Concomitant medications were unspecified by reporter. On an unknown date the patient experienced severe swelling at injection site with painful redness. The outcome of the events was unknown. The causality was unknown. No additional information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Vaccine administered, upon review of vaccine administration patient had stated this was first dose of covid vaccine, however patient was fully vaccinated with moderna prior to receiving 1 dose of Pfizer. Pharmacy was unaware of moderna vaccination at time of administration of Pfizer . No Adverse event from administration was reported.  Received a total of 3 covid vaccines ( two moderna and one Pfizer) outside of current guidelines.
A non-serious report of "gave patient expired FLUMIST" was received from a nurse concerning a four year old male patient. On 30-Dec-2008, the patient received expired FLUMIST (expiration date not reported). There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow-up information received on 04-Aug-2009 included Product complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 13 customers not in some medications errors that occurred shortly after the product expired.
Patient had previously received the Janssen (J&J) vaccine at Pharmacy on 3/9/2021.  This violates the EUA for both vaccine parameters.
Redness at site that evening. Pt went to facility on 3/26/13 at 21:30 with swelling of (R) arm around site and nausea. Pt given BENADRYL and Ranitidine. Pt discharged 3/26/13 at 22:06.
Blood blister under tongue, Petechia in spots on skin, Blood donation on 4/29 - difficult to stop bleeding from both finger stick (iron check) and from left arm which was used for donation.
COVID-19 pneumonia requiring inpatient hospitalization despite three COVID mRNA vaccinations; COVID-19; This is a literature report.  A 51-year-old male patient received BNT162b2 (BNT162B2), 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: "never smoker" (unspecified if ongoing); "vasculitis" (unspecified if ongoing); "interstitial lung disease" (unspecified if ongoing), notes: on 4-5L of oxygen; "nausea" (unspecified if ongoing), notes: for 2 days; "fever" (unspecified if ongoing), notes: for 2 days. Concomitant medication(s) included: AZATHIOPRINE; PREDNISONE; NINTEDANIB; IMMUNOGLOBULIN I.V. Past drug history included: Rituximab for interstitial lung disease, notes: 1000 mg x 2 doses every 6 months with last infusion one month prior to presentation. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), outcome "unknown", described as "COVID-19 pneumonia requiring inpatient hospitalization despite three COVID mRNA vaccinations"; COVID-19 (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: positive; positive; positive; Blood creatinine: normal; Blood lactate dehydrogenase: 318 IU/l, notes: elevated; Blood lactic acid: 3.5 mmol/L, notes: elevated; Blood pressure measurement: normotensive; Body temperature: afebrile; Carbon dioxide: 34; Chest X-ray: patchy filling opacities and low lung volumes; Forced expiratory volume: 1.28 L, notes: 39% predicted; Forced vital capacity: 1.60 L, notes: 37% predicted; Haemoglobin: normal; Heart rate: 110, notes: Unit: BPM; Exam: notable for a cough, wheezing, and tachypnea; Platelet count: normal; Pulmonary function test: unchanged; SARS-CoV-2 test: positive; White blood cell count: 5.3 x10 3/mm3. Therapeutic measures were taken as a result of covid-19.; 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 events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
massive headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (massive headache) in a 68-year-old male patient who received mRNA-1273 for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (massive headache). At the time of the report, HEADACHE (massive headache) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications included unspecified blood pressure medications. Treatment information was not provided.   This case was linked to MOD-2021-100546 (Patient Link).
W/in 48 hrs p/vax periods of crying, anorexia, sleepiness & would stare off in a daze. 4 days p/immun, babysitter reported infant had loose stools, spitting up, irritability & insomnia. Staring episodes stopped improving w/no tx.
Fever, chills, body aches within 6 hours of first shot lasting 24 hours. Nausea, head ache, dizziness starting 36 hours after first shot.
10 hrs later - arm sore. Next AM - warm feeling T-100 lump. Felt achy & slight nausea. Extremely tired. Redness in arm 2". 2 days later diarrhea.
Information has been received from a physician concerning a 15 month old male with an allergy to amoxicillin who on Jan 11 2005 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot 649977/0706P). The physician indicated that the child was given the adult vaccine accidentally. Shortly after the vaccination the patient developed fever and irritability. Medical attention was sought. The physician indicated that the fever irritability lasted for several days. On Jan 21 2005, the patient recovered. No further information is available.
I started feeling bad on July 20, 2021. Ended up in ER July 27, 2021 and again July 31.  Could not move air through my lungs. Was taken by ambulance on the 31st to the Hospital.  Symptoms similar to Covid.
Muscle Pain in arm where patient received the shot.  Pain continues 2 weeks later, and has impaired use of the arm.
Nurse needed stability information or their 0.5 mL Fluzone Quad vaccines that experienced multiple temperature excursions ranging from 5-10 minutes/No AE; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case mentions a nurse needed stability information for their 0.5 ml fluzone quad vaccines that experienced multiple temperature excursions ranging from  5-10 minutes/no AE [Product storage error] for vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot no : UT6654JA, expiration date- 30-Jun-2016) and (lot no : UT6657NA, expiration date- 30-Jun-2016).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  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.
Foggy feeling; headache; body aches; low grade fever; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient (no pregnancy) received bnt162b2, via an unspecified route of administration at site of right arm at 15:45 on 14Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced foggy feeling, headache, body aches and low grade fever at 12:00 on 18Dec2020. No treatment received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Patient began reporting of a tingling sensation in right arm approximately 15 minutes after vaccine administration in the right arm.  Patient denied shortness of breath, chest pain, palpitations. Patient encouraged to wait in observation room for another 10-15 minutes with enhanced monitoring by MAs and RNs, patient agreed and complied to plan.  Patient reported continuation of tingling sensation in right arm with noticeable tingling sensation beginning in left arm and lips as well.  Vital signs taken on patient at 1300: BP: 165/84, HR 78, O2 100% on RA.  Proceed out called, team arrived and transported patient to ED for further evaluation.   In ED, patient was observed for few hours, and was discharged home.
Information has been received from a Pharm D. and a physician concerning a male with no known allergies and a history of abnormal sized pupils of unknown origin at 3 months of age who on 09/27/2001 was vaccinated with MMR II. On 09/27/2001, the pt was concomitantly vaccinated wit poliovirus vaccine inactivated in the other arm. It was reported that 2 minutes after the pt received MMR II vaccine, the mother felt the child tingling and his eyes rolled back. He had a clonic tonic seizure with back arched and arms raised over his head. The seizure lasted 30 seconds. The child was administered Tylenol, and his temp was 97. The child recovered from the incident and the diagnosis was questionable seizure or vasovagal response. It was reported that all previous immunizations were pretreated with Tylenol except for the immunization on 09/27/2001. On 06/19/2001, the pt was in his "normal state" of health. Upon internal review, the pt's grand mal convulsion was considered an other medical event. Additional info has been requested.  Follow up on 07/17/2003: "No additional information is expected."
Student Nurse gave vaccines to young patient.  Vaccines were meant to be given to a 4yr old child.  The student got confused.  She thought that she had the right patient.  This patient needed shots but not the vaccines given.  No adverse effects.
This is pre-exposure prophylaxis for animal control.  Patient has allergy to doxycycline which caused GI upset/vomiting.  She stated after the rabies injection she felt well however when she got home she felt fatigued.  The next day at work she began having vomiting episodes and headache.  She was sent home from work.  She stated her symptoms have lessened today.  she denies any SOB/Chest pain (does have acid reflux).  Temp is 98.9, BP 107/75, HR 82
March 8: 6pm: chills, body muscle aches, headache 7pm: fatigue had to lie down 11pm: fewer chills, a little spine pain (maybe caused by inflammation?)  March 9: Noon: Only sore throat, which went away after drinking and eating
itchy eyes, swollen tongue and throat. To ED for IV benedryl and PO prednisone
This spontaneous report as received from an immunization coordinator (also reported as vendor) refers to patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with M-M-R II (unknown route, dose and strength) lot # K026366 with expiration date of 15-DEC-2016. Concomitant medications were not reported. No adverse effects were reported. There was no quality complaint involved. Additional information has been requested.
Suffering from a migraine; Slight headache; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 06Feb2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). In Feb2021, the patient was suffering from a migraine; and had a slight headache. The outcome of the events, 'migraine' and 'slight headache', was unknown.  Information on lot/batch number has been requested.
blurred vision; joints hurt; High pressure (went up repeatedly); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High pressure (went up repeatedly)), VISION BLURRED (blurred vision) and ARTHRALGIA (joints hurt) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure since an unknown date.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced HYPERTENSION (High pressure (went up repeatedly)). On an unknown date, the patient experienced VISION BLURRED (blurred vision) and ARTHRALGIA (joints hurt). At the time of the report, HYPERTENSION (High pressure (went up repeatedly)) had not resolved and VISION BLURRED (blurred vision) and ARTHRALGIA (joints hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Blood pressure measurement: 6.11 left the hospital with a pressure of 6.11 but in the night it rose from 9 to 25.. On 25-Jan-2021, Computerised tomogram: normal. On 26-Jan-2021, Blood pressure measurement: 22 pressure went up to 22. On 27-Jan-2021, Blood pressure measurement: 23.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient take Medication for the pressure
Nausea and vomiting for 7 days straight, fever of 102 for 3 days, extreme chills and sweats to the point of vomiting more, headaches for all 7 days, went to ER on day 4 for dehydration and vomiting doctor took X-ray and gave nausea medicine.
death J18.9 - Pneumonia, unspecified organism shortness of breath chest pain
Vomiting x 5 days. Given ZOFRAN IM. and ZOFRAN 3mg oral solution. Sent to Emergency Dept. rec. ZOFRAN IV, and IV fluids.
04/19/06 immunization, 4/20/06 arm red, swollen treated with Cipro and Prednisone, 4/24 resolved.
Contracted COVID-19 while travelling. Symptoms started 09/13/2022. Sore throat, congested sinuses, tiredness, slight body aches, slight headache. Called Dr. when returned home on 09/15/2022. He prescribed Pavlovid 300-100 mg pack (EUA), a five day course. Symptoms abated almost immediately and were gone by the end of the course.
I had no adverse reactions to my 1st dose, 2nd dose given on 4/7/21 , within hours of receiving  had  extreme heart racing, sweats, chills, body aches, fever.  The heart racing lasted 2-3 days and was non stop
This case was reported by a consumer via call center representative described the occurrence of generalized muscle aches in a 64-year-old male patient who received SHINGRIX. Concomitant products included lisinopril, calcium and fish oil. In February 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 15 hrs after receiving SHINGRIX, the patient experienced generalized muscle aches, shivering and headache. The patient was treated with meloxicam. On an unknown date, the outcome of the generalized muscle aches, shivering and headache were recovering/resolving. The reporter considered the generalized muscle aches, shivering and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient never had a reaction to a vaccine in the past. The patient was also receiving multivitamin as concomitant drugs. On 28th February 2018 at 15:00, the patient received the SHINGRIX vaccine in the left deltoid and did not have any immediate side effects. On 1st March 2018 at 06:00, the patient woke up in the morning and had myalgia/muscle aches all over his body. The muscle aches improved as he started moving around. The patient also developed a mild headache and shivering. The patient had a prescription for Meloxicam and took a dose on the reporting date morning and the symptoms were beginning to resolve.
expired dose of Engerix-B was administered to a patient.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HBV (Engerix B) (batch number 39T22, expiry date 07-SEP-2023) for prophylaxis.   On 11-OCT-2023, the patient received Engerix B. On 11-OCT-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B was administered to a patient.).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 Pharmacist called to report an expired dose of Engerix-B was administered to a patient inadvertently, which led to expired vaccine used. No side effects reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. No additional information provided.
Had muscle fatigue and chills with low grade fever for 6-7 hours. The injection site started swelling Saturday afternoon and increased in size and redness very fast. I applied an ice pack and took an Advil. Sunday the injection site is still swollen.
5/23 dose given. 5/24 very sore/stiff..pt cont to exercise arm, later pain at touch. 5/25 no longer sore or stiff but redness starting about an inch below site and pooling/swelling in distal bicep area.  Pt reported to me today and will see dr tomorrow.
Severe Vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe vomiting. The reporter consented to follow up.
Atrial fibrillation.  Treated in the hospital with diltiazem fir approximately 4 hours. Sent Home one heart rate was below 100. A Fib resolved approximately two hours later
PT COMPLAINS OF ITCHING WITH EDEMA AND ERYTHEMA. HE WAS TREATED WITH BENADRYL, CALADRYL AND ALLEGRA.
Dry sore throat, ear aches, feeling hot and cold, and today - 1/14/2010 tightness in my chest. Also very tired.
Area around left deltoid became red, it was not itchy though. Also, lymph nodes in the left axilla became swollen. I noticed these symptoms about seven days after the vaccine was given to me.
Patient got hives, redness, and itching on both arms (more on the left arm)  starting the morning after receiving her second Shingrix vaccine.
Patient reported difficulty breathing, numbness / tingling; tongue swelling and itchy neck following vaccination.   Reported to have occurred within 5 to 10 minutes after 12.10.2021 dose.  Reported with prior doses as well.  Patient's words / communication to Allergist:  "I received my 3rd vaccine on Friday and I had another reaction to it. As before, I received the Pfizer vaccine and this time between 5-10 minutes after receiving the shot my tongue and lips started tingling then my tongue started swelling. I had taken benadryl right after I got the shot. But basically my symptoms matched what I reported to you when I saw you and when I messaged you after 2nd shot but with the added tongue swelling and lips tingling. So it appears that my reaction to the Pfizer shot is worsening."   Allergists response:  "In my experience, patients have similar symptoms with both the Pfizer and Moderna vaccines. Due to the risk of thrombosis, I do not recommend the Johnson and Johnson vaccine for someone your age.  In the future, I would recommend taking Benadryl before you get the vaccine. We could also consider adding Singulair (prescription) which can sometimes help. Please contact me before your next dose and I will prescribe this."  Patient description of concern with 2nd dose:  received the shot at 1:19pm At 1:30 the arm where I got the injection felt tingly and weirdly cool. Like there was an ice cube or an icicle along my arm. 1:35 the finger in my hands started tingling -- note: at 1:46 the finger tingling started to feel itchy under my finger nails like under the nail itself and not the ends of the fingers but on the pink above the moon. 1:43 my toes started tingling. 1:45pm  I started feeling chest tightness - it was fairly mild -- enough that I noticed it but not so bad that I was worried. Less tight than before, JSYK.  1:55pm I took 2 benadryl after talking with the RN and EMTs at the vaccine administration site.  2:02pm My tongue started to tingle and swelled slightly  2:19 pm My jaw and nose started to itch.  3:19pm All of the reactions subsided  3:30pm  Benadryl sleepiness overwhelmed me and I slept for about 6 hours until 9:30pm. When I woke, all was back to normal. Or at least my version of normal ^_^  Per the watch I wear which has a heart rate monitor, my heart rate was 85 BPM after the vaccine which is a slightly higher resting heartrate than normal Per the app it's between 69-73bpm. But it wasn't enough to concern me. I'm getting all of the fatigue, swollen lymph nodes, headache, and achy joints as before.  As a note: this is one of my allergy seasons. I am allergic to tree pollen. And well *gestures at the trees*. So it is possible that my immune system is just annoyed at life in general. I did go down with a chest/upper respiratory infection on Tuesday, but that's not unexpected. I get this about 3 times a year because of my allergies.