chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tremendous pain in both arms for 36-48 hours after second shot; Fever for 36-48 hours after second shot; Chills for 36-48 hours after second shot; Headache for 36-48 hours after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tremendous pain in both arms for 36-48 hours after second shot), PYREXIA (Fever for 36-48 hours after second shot), CHILLS (Chills for 36-48 hours after second shot) and HEADACHE (Headache for 36-48 hours after second shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pneumonia and Cancer.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Tremendous pain in both arms for 36-48 hours after second shot), PYREXIA (Fever for 36-48 hours after second shot), CHILLS (Chills for 36-48 hours after second shot) and HEADACHE (Headache for 36-48 hours after second shot). In April 2021, PAIN IN EXTREMITY (Tremendous pain in both arms for 36-48 hours after second shot), PYREXIA (Fever for 36-48 hours after second shot), CHILLS (Chills for 36-48 hours after second shot) and HEADACHE (Headache for 36-48 hours after second shot) outcome was unknown.            No concomitant medications reported.  No treatment information was reported by reporter.    This case was linked to MOD-2021-297516, MOD-2021-297591 (Patient Link).
Fever , swollen at the injection point, hives around infected area still swollen treating the temperature  with Tylenol and Motrin also a warm compress on the swollen injection site
Fever for one and a half days, reaching 104.3 degrees; lethargy; fussiness; lack of appetite; no bowel movements for a day, reduced urination; treated with infant Motrin.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Shingrix (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 14th May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2018, 1 day after receiving Shingrix, the patient experienced shingles and sickness. In May 2018, the outcome of the shingles and sickness were recovered/resolved. The reporter considered the shingles and sickness to be probably related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on the left arm. The health care professional reported that the patient experienced shingles on her arm. It occurred further down, not at the injection site. The patient also felt sick. The adverse events were resolved in 1 week. This case has been linked with US2018102494, reported by the same reporter.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This was linked with Case ID 2018SA286240, 2018SA286241, 2018SA286245, 2018SA286242, 2018SA286244 and 2018SA286233. This case involves a female patient (age not reported) who experienced redness and swelling that warm to the touch, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 09-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U1982AA via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious significant local redness and swelling that warm to the touch three days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was redness and swelling that warm to the touch. No corrective treatment was received. The event outcome was reported as Unknown. List of documents held by sender: none.
Arm was sore but had chills that were so bad I went home from school.  I had 3 coats and a heavy blanket on for most of the next day until the chills broke about 2:00 a.m.
Patient experienced chills, body aches, and headache for the first 48 hours after vaccination. Lump developed over left clavicle and plans to see provider for evaluation.
Oct90 10 out of 59 pts were found to have either insuff or neg antibody levels during post serology testing for anti HBs.  (see EBU910168, EBU910170 - EBU910172 - EBU910177)
10/19 8pm Red blotches appeared over entire body - very itchy, skin turned purple till 10/24.  I took oral BENADRYL 25 mg every 2 hours. 10/21 11AM MD administered CALDRONE shot. 10/26 rash gone mostly. 11/15 still some rash.
No Side effects after the first dose.  The second dose a few days later caused extreme heart palpitations that are currently still happening occasionally, persistent insomnia for 10 months, hair loss 3 months post vaccine and is currently still occurring, and ocular migraines with blurred visions that resolved after 9 months later post vaccine.
Bone Aches, Muscle Aches, Vomiting, Chills, Tiredness, Sever Stomach Ache, Could not get out of bed, Diarrhea, The worst Pain I have ever felt in my life.
Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (under treatment for this illness).    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was undergoing treatment for HIV. Medications reported included atorvastatin, tivicay and descovy.   Patient did not have any known allergies.   This case was linked to MOD-2022-475923, MOD-2022-476325, MOD-2022-476437 (Patient Link).
Pain in upper left arm (felt like arm was punched), severe circular bruise approx. 2" diameter at injection site.
Chills and low grade fever everday since I got vaccine. Temp running 99.3-100
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition and medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified) that underwent a supported temperature excursion. No adverse experiences reported. No further information provided. No product quality complaint reported. This is one of several reports received from the same reporter. Additional information has been requested.
Intense itching of the arm and shoulder. Started approximately 40 minutes after injection. Patient was given Benadryl 50mg and observed for an additional 40 minutes. No trouble breathing and no swelling occurred. Patient is following up with PCP.
I felt like my throat was closing up and I had a lot of pressure in my throat and chest and felt like I couldn't breathe.  I used my mother's albuterol asthma inhaler and took allergy medication, which didn't help much. Then I feel asleep (passed out?) and didn't wake up until the next day. My throat still felt tight but I was able to breathe the next day.
Extreme sore/pain in left arm injection site. Couldn't lift arm above chest height. Fever of 101 started about 8pm day after injection. Broke during the night. Arm is very sore at the time of writing this two days to the hour. Was unable to go to work today.
pt recv vax JAN96 & 4JUN96 pt devel lesions, described as looking like bug bites/pimples;pt had one lesion on forehead, one on lt arm & 3-4 on torso;MD did not feel that pt had chicken pox;
Patient given vaccine past it's BUD of 7/22/2022 - no know reaction
The patient received a expired dose of PENTACEL vaccine (with no reported adverse event); Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Agency (Reference number- 00653447) and transmitted to Sanofi on 23-Jun-2021.  This case involves patient with unknown demographics who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [expiry date: 13-June, lot number and other dosing details were not reported] on 22-Jun-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, family history and concomitant medications were not reported.  It was a case of actual medication error due to expired vaccine used. (Latency: on the same day)  It was reported that, line was disconnected before reporter could gather demographic information.  At the time of report, no adverse event was reported.  At time of reporting, the outcome was of event reported as unknown.  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.
Redness, swelling, itchiness, and sensitivity around injection site, roughly 2 inches in diameter. Developed around 20 hours after injection.
Information has been received from a mother concerning her approximately 24 month old son with no known allergies and a history of infantile asthma and ear infections who was vaccinated with a first and second dose of MMR II on 5/9/02 (lot 637986/0155L) and 5/15/02 (lot 0557M, invalid for this product), respectively. There was no concomitant medication. Subsequently, the child "developed autism between the 24-27th month of the MMR vaccinations." As of 11/21/02, at the time of report, the child was 30 months old. Unspecified medical attention was sought. Upon internal review, the pt's autism was determined to be an other important medical event (OMIC). Additional ifo has been requested. Additional information was received from manufacturer and was assigned manufacturer report number HQ5919127DEC2002. It noted that concomitant vaccinations included hepatitis B vaccine recombinant (yeast) and varicella virus vaccine (live). This originally reported by consumer. Upon internal review, the pt's autism was determined to be an other impotant medical event.
Next day aches, flu-like symptoms.  Heartburn several weeks after shot, doctor believes it may be pregnancy-related heartburn. Swollen ankle (one broken in childhood) around time of heartburn.  First dose 6 weeks, second at 10. Third pregnancy, healthy so far, due date November 13th 2021.  Was told to take pepsid for heartburn
Pt was very nervous about vaccine, concerned about getting Bell's Palsy. Mom and brother got it. She complains of right shoulder and neck pain almost immediately after vaccine administration. Within approx. 15 mins, complains of jaw and ear pressure sensation, headache and tongue feeling funny all on right side. Client stated that she still felt symptoms prior to leaving. She stayed about 1 hour. She will take Benadryl and call dr. Advised to speak to allergist or to take J& J vaccine due to the facial side effects. Followed up with Pt at 6:26 pm she still is having right side facial pain, jaw, eye, neck and back of her head and tongue. Follow up the next day 5/05/21 complains of being light headed and pain in right side of head but has lessened, tongue is still sore. 5/06/21 at 1237pm, having lots of nausea and bowel movements these last 2 days. She said she was going to call her PCP.
Information regarding PREVNAR was received from a healthcare professional regarding a patient who received a dose of PREVNAR exposed to "too cold" temperatures on an unspecified date. On an unspecified date, the patient received a dose of PREVNAR that was exposed to "too cold" temperatures. No adverse event was reported. The reporter was unable to specify the number of patients who experienced this event. The out-of-range variances in the temperature occurred over the past three years. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
- Left arm pain at site of injection. Could not lift my arm for 2 days. - Paresthesia on Ankle and shin bone area of Left leg. Feels like anesthetized and have loss of sensitivity. This has been going on for 3-4 days already.
pt recv vax 2OCT95 & 3OCT95 devel a hive-like rash on neck which progressed to a gen body rash;dermatologist dx rash as eczema;tx w/steroid cream;
Fever; Fatigue; Joint pain; Headache; This is a spontaneous report from a contactable consumer (patient's co-worker). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included had the COVID-19 virus 3 weeks before getting the COVID-19 Vaccine in 2020. The patient's concomitant medications were not reported. The patient had a lot of side effects after taking the COVID-19 vaccine: fever, fatigue, joint pain, and headache on unknown date. The outcome of events was unknown.  Information requested on Lot/ Batch number has been requested.
I had earaches, headaches, I went to the doctor. I discussed my symptoms, not testing was done at this time. They felt that I did have an infection, I was given a prescription of Amoxicillin to take to help clear up what was going on in head. I am feeling better, still a little sore, I do feel like I am on the mend.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZOA) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 18-NOV-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Patient received the Janssen COVID-19 Vaccine EUA April 12, 2021 and later that evening started developing severe abdominal pain that would not go away.  Following day it was still there, so we took her to the Emergency Room where after an abdominal cat scan she was diagnosed with mesenteric adenitis.  They gave her total to manage the pain and sent her home to let the symptoms subside hopefully after a few days.  Today she is better, but very tired.
Client presented to the vaccination site on 1/19/2022. The client reported that she received a 1st and 2nd dose of Pfizer COVID vaccine. Client reported hives, rash, and itching all over her body accompanied by a scratchy throat immediately after both Pfizer doses that lasted until she took Benadryl. Lead RN submitted a medical consult via text message requesting to proceed with the COVID vaccine Janssen. Per MD, approval to proceed with COVID vaccine Janssen was obtained from medical consult team via text message. Client received COVID vaccine Janssen Lot# 1855191 on 1/19/2022. The client did not report any symptoms during the 30-minute observation period. Lead RN educated client on possible adverse reactions, when to seek medical care and to register. The client left the vaccination site at 15:15 with a steady gate.
He recently had an injection in his left arm 1 week ago for the shingles vaccine.  He states he has had some fatigue and malaise associated with that in the initial 2-3 days after, but that has resolved.  He is not any fevers he is aware of, and no other medication changes.  He has decreased his exercise secondary to the pain and wonders what else he can do for this.  He is not having any vision or hearing changes, neck pain, chest pain, shortness of breath, lightheadedness, dizziness, or abdominal pain at this time. Appears to be a cellulitis
Swelling, redness, and itching near injection site.  Nausea, low grade fever, diarrhea x 1, vomiting x 1, body aches.
This spontaneous report as received from a nurse refers to a 6 month old female patient. The patient's current conditions or medical history were not reported. On 19-AUG-2013, the patient was vaccinated with a dose of VAQTA (dose, route, indication, lot and expiration date were not provided). No adverse effect reported. At the time of the report the outcome was unknown. Additional information has been requested.
12 inch long hive area near injection site; Bruising around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising around injection site) and VACCINATION SITE URTICARIA (12 inch long hive area near injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Bruising around injection site). On 29-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (12 inch long hive area near injection site). On 31-Mar-2021, VACCINATION SITE URTICARIA (12 inch long hive area near injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruising around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Event occurred after 2nd dose. Patient was diagnosed with COVID-19. Casirivimab and Discharged home.
0.5ml vial of menquadfi reconstituted with 0.5ml sterile water was administered to a patient with no reported adverse event; Initial information was received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age/gender patient who received 0.5ml vial of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] reconstituted with 0.5ml sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 24-Jul-2023, a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection at dose of 0.5 ml (lot number, strength, expiration date, route, administration site: Unknown) for Immunization (immunisation) reconstituted with 0.5ml sterile water was administered to a patient with no reported adverse event (product preparation issue) (latency: same day). Information on the batch number was requested.  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event 0.5ml vial of menquadfi reconstituted with 0.5ml sterile water was administered to a patient with no reported adverse event.  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 guidelines. 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.
I am the physician assistant who saw patient on 3/27/12 for a rash that could be varicella.  She has reported that her daughter had varicella vaccine and other vaccinations one week ago.
This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose at 60 years and had pain in arm, refer case US2021AMR264864). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose 4months apart from 1st dose and his/her arm hurt. The patient truly believed that it was better than suffering with shingles. The follow-up could not be possible as no contact details were available; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR264864:Same reporter.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/12/21 2nd dose02/07/21 Diagnosed covid positive:08/25/21 Symptom onset:08/17/21 Exposure:Home Symptoms:fever,cough,fatigue,muscle aches, loss of smell/taste,sorethroat, nausea, runny nose,HA
Very bad nausea; Dizziness; This is a spontaneous report received from a non-contactable consumer. A 20-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 30Mar2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient was allergic to iodine. Concomitant medications were not reported. Prior to the 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 four weeks prior to the COVID-19 vaccine. On an unknown date in Mar2021, the patient experienced very bad nausea and dizziness. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events nausea and dizziness was resolved with lasting effects on unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient with h/o chronic vomiting x 5 months.  Work up in progress by MD.  Likely unrelated to vaccine.  EMS called and evaluated.  Patient declined transport.
Developed swelling, redness of right deltoid area. Appears to have surrounding bruising. Denies any arthralgia or decreased ROM. Complaints of right sided jaw ache. No noted lymph node swelling.  Patient used ice to the area and will utilize Ibuprofen and continue with as needed Claritin.