chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a sore arm; a little bit tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number: EP7533, and expiry date were not reported), via an unspecified route of administration, on 23Apr2021 at the age of 72 years as dose 1, single and on 14May2021 (Lot number: EW0158) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "a sore arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "a little bit tired".  No follow-up attempts are possible. No further information is expected.
Pt described myalgia-like pain at site of vaccination. Soreness never went away since initial shot.
I got the vaccine around 12:35 on 12/29/2020. Around 3 in the morning I started having sever body aches. Now its 12/30/2020 7:32 in the morning, I have sever body pain, Dont have fever but I feel very warm, My hands are very warm it feels like I have a high fever, chills and very tired with no energy. It feels like I have flu.
Received vaccine on 10/5. Felt some tenderness on shoulder on 10/6. Morning of 10/7 woke up to a lump the size of a large grape just above the right collar bone. Get another under right arm pit. Confirmed with urgent care it was a reaction from vaccine and something was going on with my lymph nodes. Seen by primary care physicians office and confirmed infection in my lymph nodes. Also informed a reaction from vaccine again but was informed it is known to happen. Discovered another lump in my neck at time of visits. Prescribed antibiotics and doctor ordered CBC testing.
9:05 PATIENT FEEL SHAKY. ATIENT SOME CANDY 9:15 PATIENT STATES SHE FEELS BTTER AND SHE IS NOT "SHAKY"
Patient was administered expired vaccine/ no AE; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00655521) and transmitted to Sanofi on 24-Jun-2021.  This case involves a one-year-old female patient who was vaccinated with 0.5 mL (once) dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ316AAB, expiry date 08-Jun-2021) via intramuscular route in left vastus lateralis on 24-Jun-2021 for prophylactic vaccination and reported that patient was administered expired vaccine with no adverse event (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  Caller wanted to know if the product was still active or do the patient need to be re-vaccinate.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no 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 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.
No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to a 4-months-old female patient (previously considered non-valid).  On 17-JAN-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength not reported) lot # 1660685 with expiration date on 21-MAR-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.; Sender's Comments:  US-009507513-2003USA001374: US-009507513-2003USA001376: US-009507513-2003USA001375: US-009507513-2001USA006732: US-009507513-2003USA001378: US-009507513-2003USA001379:
Patient developed ataxia, left-sided weakness, was admitted to hospital 9/13/2010. She ultimately had acute respiratory failure related to her weakness. Weakness was progressive, imaging (MRI) with possible demyelinating process.
patient tested positive in a routine test for placement at a sub acute rehab facility. Patient is asymptomatic 11/2/21. Lot number was not recorded for the second dose in her medical record.
Severe Vomiting; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe vomiting.   The patient's medical history was not provided.  No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced severe vomiting and was hospitalized for two weeks.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, severe vomiting, was not reported.; Reporter's Comments: This spontaneous report concerns a female patient who experienced a serious event of severe vomiting. The event of occurred on an unknown date after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-Unknown).  Treatment and outcome are unknown. There is not enough information of assess the causal association between he reported event and the administration of mRNA-1273 vaccine as critical details such as the date of treatment, onset of the event, patient's medical history including exclusion of other triggers cannot be established. Main field defaults to possibly related'
This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient intended to be vaccinated with a dose of ZOSTAVAX (route, dose, lot # and expiration date unknown), at the ZOSTAVAX vaccination clinic, however, the pharmacist was uncertain whether the patient had received a valid dose of ZOSTAVAX. Recently the patient came to the pharmacy, stating that on different unspecified dates, the patient developed 8 to 10 separate cases of shingles. No lab diagnostics studies were performed and no treatment was given for the event. The patient had an active case shingles at this time of reporting. The causal relationship between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information is not expected, as there is no consent to contact the pharmacist.
Chest to feel tight; Asthmatic reaction; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest to feel tight) and ASTHMA (Asthmatic reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Chest to feel tight) and ASTHMA (Asthmatic reaction). At the time of the report, CHEST DISCOMFORT (Chest to feel tight) and ASTHMA (Asthmatic reaction) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.
Fever, aches, chills, nausea, and fatigue for 2 weeks, nausea and fatigue have persisted for 4 weeks now..
Case number PHEH2015US019336, is an initial spontaneous report received from a nurse on 24 Sep 2015. This report refers to a 16 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 15 Aug 2015 which was stored on incorrect temperature of (34.0 degrees Fahrenheit, and 50.2 degree Fahrenheit 48-120 hours). No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 13 November 2015 from the nurse: Reporter stated that patient did not experience any adverse events and she was doing fine. Follow-up information received on 25 November 2015 from the nurse: Concomitant products included Tdap (batch number: C4730A4). The patient's vaccination status was current. The patient received the 1st dose of MENVEO (intramuscular) .5 ml on the right deltoid. The patient's details (height and weight) were provided.
Immediately after vaccination, while still in vaccination chair, patient became diaphoretic and said he was going to pass out.  Patient was given juice and peanut butter crackers.  Patient stayed in observation 30 minutes, stated feeling better.  Patient left fairgrounds.
pt recv vax & devel reactionary rash;@ time of report 2nd dose of vax had not been given;
Pt was given an expired dose. Dose expired on 12/7/22.  Pt was given the Pentacel vaccine on 12/8/22, which was expired by one day.  Pt experienced no s/s, called mom the next day patient continued to have no adverse signs or symptoms.
After a few days a rash broke out on my right lower side. It appeared to look like shingles. Itching and slightly painful. Still there after 13 days but getting better the first two days I was dizzy and was in pain from the shot, 4-weeks later. I still have most of the rash - Pain is almost gone.
red blotches and streaks on left inner thigh; Streaks on left inner thigh; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches and streaks on left inner thigh) and RASH (Streaks on left inner thigh) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RASH MACULAR (red blotches and streaks on left inner thigh) and RASH (Streaks on left inner thigh). At the time of the report, RASH MACULAR (red blotches and streaks on left inner thigh) and RASH (Streaks on left inner thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
Patient received covid vaccine on 07/31/2021 around noon.  States saw a little redness the following morning.  This morning woke up and was a lot of redness around injection site with tenderness, warmth, skin feels a little firm.  Upper arm is achey. Received Moderna Vaccine - this is her second vaccine.  States with first vaccine had a delayed reaction about 1 week later which was fairly mild.  Was more concerned this time as it is more red, firm and painful.  Has not been applying anything or taking anything for symptoms.
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 30-SEP-2022, 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 serval reports from the same reporter.
This spontaneous report was received from a physician assistant via a company representative concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with dose 2 of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date (reported as longer than 6 months ago), the patient fainted and upon hitting the floor, the patient may have had a seizure after receiving her dose 2 of GARDASIL. The patient did not seek any medical attention. It was unspecified if the patient was treated or if any lab tests were performed. The outcome of the events were unknown. The relatedness for the events was unknown for GARDASIL. Upon internal review, the event seizure was considered as medically significant. Additional information has been requested.
fully vaccinated, booster 8/16/21. Vaccine breakthrough 10/15/21
Moderna vaccine was administered, reported by patient ? NO LOT NUMBER WERE SUPPLIED  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/5/2021 OVARIAN CANCER, UNSPECIFIED SIDE
SWOLLEN, RED, PAINFUL ARM, MINOR BLISTERING THAT DEVELOPED WITHIN 3 DAYS OF DOSE. PATIENT APPLIED ICE AND TOOK IBUPROFEN. AGREED WITH TREATMENT, ADVISED PT COULD ALSO TAKE BENADRYL
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-052992 (Patient Link).
Headache, continuous since vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache, continuous since vaccination) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache, continuous since vaccination). At the time of the report, HEADACHE (Headache, continuous since vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment medication not provided.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. Previously administered products included ZOSTAVAX (received many years before the time of reporting) and SHINGRIX with an associated reaction of injection site pain (received 1st dose refer case US2018GSK196387). On 17th October 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 18th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, dizziness, esotropia, agitation, tiredness, fever and nausea. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, dizziness, esotropia, agitation, tiredness, fever and nausea were recovering/resolving. It was unknown if the reporter considered the injection site pain, dizziness, esotropia, agitation, tiredness, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient experienced strong adverse eves after receiving SHINGRIX. The patient had more pain at the site of injection, low grade fever, dizzy, nausea, very agitated, feels profoundly tired and profoundly fatigued. The patient also noticed that her eyes keep crossing, but she did not know if it was because of being so tired. All symptoms started the second day after the vaccine. On the day of reporting the patient felt 80 percent better.
pt rcvd vax; pt devel soreness & swelling at injection site; pain on left arm , shoulder & neck; pt exp headache;
Got the second dose of a covid shot. The very next day I was having chronic shoulder pain, numbness, etc that radiates into my chest breastbone area.
Patient self-reported to the hospital's electronic  ADR reporting system.  In her own word, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21, the injection site became swollen , itchy, and painful.  The following day, under my armpit was swollen and painful.  This lasted for 5 days".
Pt recvd 3 doses of Engerix-B & did not respond;
Experienced severe swelling from elbow and all of upper arm. Had to be taken to the emergency room, diagnosed as an allergic reaction to the vaccine. Required couple days in the hospital. Patient was on blood thinner Warfarin and doctors diagnosed as her having internal bleeding after the vaccination.
Went from feeling fine to almost immediately freezing, fatigued, with a fever. Fever varied for two days between 100.5-101.9. Alternated between hot and cold. Headache for 3 days. Body weakness as well as pretty intense pains kind of randomly throughout my body. At this point those symptoms are mostly better.  My armpit however is swollen and hurts to push on as well as just laying on that side, moving my arm, etc. I?m reading this is lymph node swelling but it?s never happened to me before and fairly uncomfortable.
The patient developed a large welt on the left arm at the injection site with erythema of the surrounding area. The patient was treated with Benadryl and ice was applied.
Moderna COVID-19 Vaccine EUA Friday  2/12/2021 at 10:00 am, six and a-half days later my upper right arm suddenly became itchy, like a bite. When I looked at it later in the day, I saw a 2-inch pink/red circle at the injection site. During that day my arm evolved to being happy with simple muscle massage and did not need to be scratched any more. I used a topical OTC antihistamine twice a day for 3 days. Approaching day 4 of my shot, I can see a very faint pink circle.
Inflamed red area with streaking below & beside small pox vaccination area. Area noted 8/2/12, saw ER MD 8/2/12. C/O of fatigue and aching under axilla, on ABX.
Developed abdominal pain 4/7. Diagnosed with acute appendicitis 4/9 and underwent laparoscopic appendectomy 4/9. Also incidentally noted to have complex cystic pancreatic tail mass up to 8.3 cm with 7mm and 4mm RLL subsolid lung nodules. Patient has been discharged after appendectomy, and further workup of the pancreatic mass is planned. The appendicitis AE is resolved, but the pancreatic mass and lung nodules (likely not related to vaccine) are ongoing at this time.
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug reactions were not reported. On an unknown date patient received first and second dose of GARDASIL (dose, frequency, therapy route, lot#, expiry date unspecified). On 14-AUG-2014, patient was due for this third dose of GARDASIL. Reporting nurse stated that the patient was in the office on 15-DEC-2014 to receive the third dose of GARDASIL "which is now 4 months delayed". No adverse effects were reported. Outcome of the event was not reported. No product quality complaint (PQC) was reported. Reporter considered the event to be not related to GARDASIL. Additional information has been requested.
pt recvd vax; devel burning itchy, flushing over nose & cheeks which lasted for 1 wk along w/ fever of 100.3, maculopapular rash; joint ache & aching muscles;