chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 71-year-old female patient who received SHINGRIX (batch number P3777, expiry date unknown). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included CARAFATE. On 9th March 2018, the patient received SHINGRIX .5 ml. On 9th March 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness and pain in arm. On 10th March 2018, the patient experienced injection site pain. On an unknown date, the outcome of the tiredness, pain in arm and injection site pain were recovered/resolved. The reporter considered the tiredness, pain in arm and injection site pain to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included vitamins (nos). The patient reported that after receiving the SHINGRIX vaccine she had soreness at the injection site and the patient was also tired and her arms were sore and achy. At the time of reporting, the side effect of the patient had fully resolved. The patient went to bed at 7:20 pm after that weekend but her tiredness has since resolved and she was back to exercising.
patient states left upper arm became swollen went to emergency room.  States ER staff told him he had cellulitis
Raynaud's syndrome; This spontaneous case was reported by a consumer and describes the occurrence of RAYNAUD'S PHENOMENON (Raynaud's syndrome) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced RAYNAUD'S PHENOMENON (Raynaud's syndrome). At the time of the report, RAYNAUD'S PHENOMENON (Raynaud's syndrome) outcome was unknown.            Concomitant product use was not provided by the reporter.  On an unknown date, the patient had Raynaud syndrome. No treatment information was provided. The reporter's causality for the event(s) of Raynaud syndrome with Humira (adalimumab) was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.      Reporter did not allow further contact
Pt complained of sore throat and swelling throat with dysphagia. No constitutional, allergy or URI symptoms. Started upon arising this am. Similar occurrence reported after 1st shot but wasn't seen by MD. Mild tonsilar pillar redness without edema / pus. 2+ cobblestoning.
"felt good"; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION ("felt good") and PYREXIA (fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included IXEKIZUMAB (TALTZ) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced FEELING OF RELAXATION ("felt good"). 08-May-2021, the patient experienced PYREXIA (fever). At the time of the report, FEELING OF RELAXATION ("felt good") outcome was unknown and PYREXIA (fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Ibuprofen.
fluid retention in my fingers (both hands); fluid retention increased; PIP (proximal interphalangeal) pain (both hands) if I moved my fingers too quickly. Then came DIP (distal interphalangeal) pain (both hands) if I moved my fingers too quickly; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot Number: ER8734) via an unspecified route of administration on 05Apr2021 at 09:30 (at the age at vaccination of 64-year-old) in left arm as dose 2, single for covid-19 immunization. The patient's medical history and known allergies were reported as none. The patient had not received any concomitant medications including other medications within 2 weeks. Patient didn't receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with covid-19 and post-vaccination, the patient was not tested for covid-19. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot Number: EN6205) via an unspecified route of administration on 15Mar2021 at 09:30 (at the age at vaccination of 64-year-old) in left arm as dose 1, single for covid-19 immunization and experienced fluid retention in fingers (both hands) on 22Mar2021. His thumbs seem ok. Fluid retention first occurred about 1 week after first dose, but he did not associate it with the vaccine since he was expecting an immediate reaction (which he did not had), local pain at injection site (which he did not have) nor did he have other reported general symptoms. On an unspecified date in Apr2021, about a week after the second dose the patient experienced fluid retention increased, and patient started experiencing PIP (proximal interphalangeal) pain (both hands) if patient moved the fingers too quickly. Then came DIP (distal interphalangeal) pain (both hands) if patient moved the fingers too quickly. On 18May2021, patient discovered a website that said to contact patient's doctor if patient had swelling in patient's finger. He contacted the banner health nurse line on 19May2021 and reported the events. They advised him to see a doctor if he had red streaks in hands/arms or if hands felt hot. He reported that he did not. Currently he had fluid retention every morning when he woke up which somewhat subsides during the day. He was very concerned. The patient did not receive any treatment for the events. Outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
3 patients were given full dose as a booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (3 patients were given full dose as a booster) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (3 patients were given full dose as a booster). On 02-Nov-2021, ACCIDENTAL OVERDOSE (3 patients were given full dose as a booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported   This case was linked to MOD-2021-162950 (Patient Link).
Flu-like symptoms - fever, chills, nausea, headache, weakness, which lasted for about 24 hours. Pain, hotness, hardness and redness at injection site, which lasted for four days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL9263), on 10Feb2021 as dose 2, single (Lot number: EM9809) and on 09Oct2021 as dose 3 (booster), single (Lot number: EW186) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "nightmares" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Allergy: sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: SEASONIQUE, start date: 01Oct2004, stop date: 06Aug2022; ADDERALL, start date: 01May2015, stop date: 08Aug2022; WELLBUTRIN XL, start date: 01Nov2017, stop date: 10Aug2022; PRAZOSIN, start date: 03Sep2012; ARMOUR THYROID, start date: 01Mar2015. Past drug history included: Bactrim ds, reaction(s): "Known allergies: Bactrim DS"; Zinc oxide, reaction(s): "Known allergies: Zinc oxide". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient received Other medication in 2weeks.Patient received Paxlovid for COVID 19 treatment , Started on 10Aug2022 and stopped on 15Aug2022.Pateint reported that "Very horrible flavor in the mouth that was bitter or staled, that would not go away even if brush teeth or tongue, eat or drink it stayed. It even woke her up in the middle of the night. It won't let her fill it out below but the side effect lasted until a little after therapy ended, after around a day (Tuesday after finishing the day before). She still cannot taste or smell 30% of things but she don't know if it's from COVID or the drug.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events (VACCINATION FAILURE, COVID 19 )cannot be completely excluded.
"feeling like coming down" for a short period of time; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 31Jan2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, the patient experienced "feeling like coming down" for a short period of time. It was reported that patient wanted to know if there was any safety information or recommendation for her situation. she is not sure if the vaccine is working, she was in contact with her daughter for 5 days. Wants to know how to participate as part of the clinical trials of the vaccine. The patient underwent lab tests and procedures which included covid antigen test which resulted as negative. The outcome of event was unknown.  Information about lot Batch requested  Follow-up attempts are completed. No further information is expected.
ED note: Patient here with allergic reaction to her second covid vaccination. She denies respiratory symptoms or distress. No throat closure or swelling. Benadryl given while in ambulance and she states that does make her tired. Will give steroids and monitor. Labs obtained that was unremarkable.  Monitored patient. She is feeling much better after steroids given today. Discussed will give medrol dose pack for home in case needs to continue treatment. Discussed that she doesn't need to take Benadryl unless start to have more severe reaction since she gets tired with medication. She can also continue zyrtec or claritin. Vitals have remained stable. Continues to have respiratory symptoms. Feel that she is safe for discharge. She is to return to ED if develop any further concerns. She is agreeable with plan and states ready for discharge. .
His left leg was swollen from the knee to hip 2 x the right leg. Evaluated by physician and will use warm compress.
Left arm swollen, painful, red. Fatigue, headache, nausea, vomiting, chills, decreased appetite.
Arm swelling, redness and heat at injection site,  swelling of lymph nodes under left arm, swelling at elbow and forearm
This case was reported by a lawyer and described the occurrence of fainting episode in a 33-year-old female subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included automobile accident, foot fracture and shoulder pain. Concurrent medical conditions included back pain. On 12 July 1999 and 25 August 1999 the subject received 1st dose and 2nd dose of LYMERIX (unknown). According to an interview between the subject and attorney(s), on 12 July 1999, less than one day after the first vaccination with LYMERIX, the subject experienced fainting episode (attributed to lightheadedness after blood was drawn prior to receiving LYMERIX. A "few days" after the second vaccination with LYMERIX, in August 1999, the subject developed flu-like symptoms (including "severe" vomiting). In the winter of 1999/2000, she developed joint pain, lightheadedness, and "numbness on exertion". In approximately 2002/2003, she developed swollen glands, fatigue, achiness, diarrhea, muscle pain, muscle twitching, cognitive problems (difficulty with concentration, memory, and word recall), and sleep disturbance. In approximately 2003 she experienced chest fluttering, chest pain, facial numbness, burning sensation, migraine, eye pressure, and light sensitivity. Treatment included PLAQUENIL, glucosamine chondroitin, and antibiotics, as well as massage therapy and chiropractic treatment. This case was assessed as medically serious by GSK. At the time of reporting the events, with the exception of fainting spell and flu-like symptoms, were unresolved.
A patient received improperly stored vaccine; This spontaneous report was received from nurse referring to a 6-months-old patient of unknown gender. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.  On 03-SEP-2021, the patient received a dose of an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot # 1691301, expiration date 12-DEC-2021) orally for prophylaxis.  Temperature was 14.2 C during a time frame of 3 hours and 15 minutes, previous temperature excursion reported was 17.5 C for 8 hours.
Presented to ED on 5/10/2021 with abdominal pain, nausea, vomiting, marked leukocytosis of 30K with left shift. Admission screening PCR for COVID-19 Positive.    No known history of COVID-19 in the past, no known contact with a person positive for COVID-19
unknown if the product was expired on 05Mar2021, or if it will be expiring on 03May2021.; had a little growth on his upper back/felt a lump; oozing a bit; This is a spontaneous report from a contactable consumer or other non hcp. A 82-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN6199, Expiry date: 05Mar2021) via an unspecified route of administration, administered in arm Left on 06Mar2021 as DOSE 1, SINGLE for covid-19 immunization. No other vaccines on the same day as the COVID vaccine. Medical history and concomitant medications was none. Patient reported that, he received the first dose (of the Pfizer covid vaccine) on Saturday (06Mar2021) and after the first dose (he) noticed a growth on upper back (06Mar2021), oozing a bit. He stated he only noticed when (he) took off his shirt at night and had a spot on it, then felt a lump and it was wet a little bit. Also reported that, the growth did ooze a little bit (an unknown date in Mar2021), and it was still there. patient was wondering if other people have reported this as a side effect of the product. Also reported that, It was unknown if the product was expired on 05Mar2021, or if it would be expiring on 03May2021. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to unspecified number of 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 improperly stored PNEUMOVAX 23 (unknown strength and dose) lot # K0088409 and expiry date of 04-MAR-2016. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
3/14/08 - Runny nose, cough, fever (100-102 F), rash (chest then face - torso - arms and legs). 3/16/08 - Taken to Urgent Care - told it was chicken pox - no treatment. 3/19/08 - Rash disappears along with fever (never crusts). 3/23/08 - Fever returns (100-101 F) - nose still running. 3/24/08 - Doctor diagnosis otitis medial - Amoxicillin given.
extreme neck pain; redness all the way down the arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (extreme neck pain) and ERYTHEMA (redness all the way down the arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 NECK PAIN (extreme neck pain) and ERYTHEMA (redness all the way down the arm). At the time of the report, NECK PAIN (extreme neck pain) and ERYTHEMA (redness all the way down the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported   No treatment information was provided
Pain in the left arm, arm is frozen can not move right or left, numbness throughout arm and in hand.
I was having excessive water retention and not feeling  well and had general malaise. Major Bloating issue and decided to contact my doctor, on 12/9 visited with doctor and was given more blood pressure medicine based on blood panel. Doctor ordered some lab work 12/10 and had blood drawn and multiple panels were done. After this, a new blood panel was ordered on 12/22 where Renal Artery Stenosis was discovered and was put on a beta blocker Metoprolol and, at first, did not yield result desired. After trying again was sent for another blood panel 02/02, where some good progress was noted. On 02/07 had a physical and it was determined to change my HBP med to a Calcium channel blocker and so far yielded good results. My numbers are no where near what they were before the booster. Bloating is down, thankfully and I feel much better but it is a work in progress.
Dizziness, profuse sweating, cold chills, ear ringing, light headedness, uncontrollable shaking, and nausea 5 minutes after first dose of Pfizer vaccine. Subsided after 25 minutes. Dizziness continues 3 days after vaccination. Muscle spasms in left thigh muscle, brain fog, and tiredness continue.
Runny nose approximately 10 hours-no sx at 24 hrs. Hives (2) approximately 13 hours-significant improvement at 24 hrs. Patient initiated Tx with 1% hydrocortisone cream to hive on leg-resolved at 24 hours-no Tx to facial hive at 24 hours-pt reports improvement at 24 hours. Initiated tx with 10 mg loratadine and 1% hydrocortisone for facial hive.
1 of 3 pts vaxed from the same vial who exp edema & redness @ inj site w/in 24hrs p/vax; pt had rxn the size of a grapefruit;no cultures taken;not cellulitis;treated w/cold packs;pt recovered
Chills, total body aches, headache, weakness for 24 hours. Took tylenol and ibuprofen for aches.
Approx. 1 hr. after getting vaccine, didn't feel well - specifically: * pain and stiffness that slowly spread down left arm (below injection site) * headache * low-grade fever during night, then sweating * waves of nausea the following day * diarrhea also following day Felt OK approx. 32 hrs. after injection
he received the 2nd dose outside of the recommended time frame; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose outside of the recommended time frame) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose outside of the recommended time frame). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the 2nd dose outside of the recommended time frame) had resolved.            no concomitant medications are reported.
11 Mar 2020: slight pain at the left arm at the shot location 12 Mar 2020: Tiredness, fatigue, fever like but temperature was ok, different taste in mouth (flu like symptoms) 13 Mar 2020: Pressure in left eye. Hurt a little when eye was pressed 14 and 15 Mar 2020: Slight puffiness under left eye. Huts a little when puffiness is pressed
Temp 100-101 Sun and Mon in bed, asleep, for Sun and Mon, Body aches.
Fatigue the day after increased and progressed to weakness and confusion for the week following the vaccine, culminating in Emergency Department visit with hypercalcemia and acute kidney failure and subsequent 9 day hospitalization.