chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little cold, but not too bad; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 27-Oct-2020.  This case is linked to cases 2020SA305230 and 2020SA305527.  This case involves a patient of an unknown age who had a little cold, but not too bad (Nasopharyngitis) when the patient received INFLUENZA VACCINE>  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination   On an unknown date (latency unknown) after administration of INFLUENZA VACCINE, patient experienced little cold, but not too bad (Nasopharyngitis). The patient got the cold before INFLUENZA VACCINE settled in the two weeks duration and was feeling much better at the time of this report.  No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as recovering, at the time of reporting.  There will be no information regarding the batch number for the case.
Patient received a sub-optimal COVID-19 vaccine due to a storage and handling error. Vaccine was stored in a regular freezer prior to being refrigerated and then administered. The requested that a form be submitted for this patient.
I've been woken up every two hours with leg cramps; sleepiness; sore arm; muscle aches; chills; pain went to my wrist/pain went to my knee (had a knee replacement in 2019); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain went to my wrist/pain went to my knee (had a knee replacement in 2019)), MUSCLE SPASMS (I've been woken up every two hours with leg cramps), SOMNOLENCE (sleepiness), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Symptomatic treatment.    No medical history was reported.  Concomitant products included ALLOPURINOL for Uric acid, LISINOPRIL, ROSUVASTATIN and METOPROLOL for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced PAIN (pain went to my wrist/pain went to my knee (had a knee replacement in 2019)), SOMNOLENCE (sleepiness), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and CHILLS (chills). On 18-Mar-2021, the patient experienced MUSCLE SPASMS (I've been woken up every two hours with leg cramps). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY NIGHTTIME) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (pain went to my wrist/pain went to my knee (had a knee replacement in 2019)), MUSCLE SPASMS (I've been woken up every two hours with leg cramps), SOMNOLENCE (sleepiness), PAIN IN EXTREMITY (sore arm), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown.             She was told not to take any anti-inflammation   Reporter did not allow further contact
Fever; Headache; Chills; This case has been initially considered invalid as there is no indication that the patient experienced an adverse event under the suspect product BNT162B2. Upon receipt of follow-up information on 07Jun2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer . A 73-years-old female patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular, administered in left arm on 25Feb2021 09:40 (Batch/Lot Number: EN6200, expiration date was not reported) as single dose for COVID-19 immunization at hospital. Medical history included: covid-19 from Mar2020 (she had the virus back in Mar2020). The patient's concomitant medications were not reported. The patient previously received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular, administered in right arm on 04Feb2021 09:40 (Batch/Lot Number: EL1283, expiration date was not reported) as single dose for COVID-19 immunization at hospital. On 25Feb2021, the patient experienced fever, headache and chills. The patient reported that she had a reaction to both shots but was not critically ill. The patient underwent lab tests and procedures which included: on 23Mar2020 POC Rapid Flu A+B was negative, on 03Nov2020 mammogram showed no malignancy, on 08Jul2020 sars-cov-2 antibody test was positive and showed antibodies, on 12Nov2020 sars-cov-2 antibody test was negative and on 23Mar2021 sars-cov-2 antibody test was positive. Outcome of the events was reported as recovered on 27Feb2021.
DTaP, PCV and Comvax given SQ, instead of IM. Site of DTaP administration with 5 inches of induration/erythema.  Plan to repeat administration of Hep B.
Significant pain in arm and under area of injection. Continuous pain that interferes with daily activities and sleep. Feels like a bee sting. Arm feels swollen. Arm is warm with increased pain to touch. Pain has continued for more than 12 hours.
received / first dose / on Nov 12, 2020 / dose received today count as the 2nd dose?; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose received on 12th November 2020).   On 9th August 2021, the patient received the 2nd dose of Shingrix. On 9th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter stated that, the patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. The reporter follow up via an email. This case was linked with case US2021168421, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168421:Same reporter
Pfizer was stored incorrectly. Mother is informed that the vaccine that patient received is considered invalid and would need revaccinated if she chooses to do so.
Trouble with memory; Depressed; Eyes do not feel right; Throat hurts; Sweats; hot flashes; nausea; headache; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Trouble with memory), DEPRESSION (Depressed), OCULAR DISCOMFORT (Eyes do not feel right), OROPHARYNGEAL PAIN (Throat hurts) and HYPERHIDROSIS (Sweats) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included ATORVASTATIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (Trouble with memory), DEPRESSION (Depressed), OCULAR DISCOMFORT (Eyes do not feel right), OROPHARYNGEAL PAIN (Throat hurts), HYPERHIDROSIS (Sweats), HOT FLUSH (hot flashes), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever). At the time of the report, MEMORY IMPAIRMENT (Trouble with memory), DEPRESSION (Depressed), OCULAR DISCOMFORT (Eyes do not feel right), OROPHARYNGEAL PAIN (Throat hurts), HYPERHIDROSIS (Sweats), HOT FLUSH (hot flashes), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            It was reported that the adverse events lasted for about a month, even though dates were not provided  Concomitant medications also included: Blood pressure medications  Treatment information was not reported   This case was linked to MOD-2021-281438 (Patient Link).
Around 1315 Patient complains of throat tightness and difficulty swallowing. RN observation nurse reports to NP of patient's reaction. After assessing patient, NP administers Epi-Pen for continued throat tightness and difficulty swallowing. Patient symptoms subsided post administration of Epi-Pen. EMS were called but patient refused to be transported. Husband by her side. Educated patient of the importance for continued monitoring of symptoms and to call 911 ASAP. Patient verbalized understanding. Final V/S readings 117/78, P79, 18R, O2 96%,
Red, swollen at injection site. Affected area spread & worsened over the next 4 days after injection. Patient saw doctor & was prescribed KEFLEX.
10/21--Emp called to say she'd had a "weird reaction" to the seasonal flu vaccine. She "felt difficulty breathing,increasingly during the day." Used an inhaler, which she uses for excercise-induced asthma. She stated that helped. She said that overnight, she had bodyaches, chills/fever (did not take temp). The next morning, she awoke with swelling of her gums.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stage three kidney disease" (unspecified if ongoing); "Known allergies: Sulfa based drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The event was treated with Paxlovid from 25Dec2022 to 30Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a healthcare worker (reported also as radiology tech/vaccine coordinator) referring to an unspecified number of patients of unknown ages and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L048848 expiration date 09-AUG-2018) (lot # M006708 expiration date 02-JUN-2018) (dose and anatomical location were not reported). No adverse effects were reported. Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. With a data logger involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Localized erythema and edema at site of injection, deltoid, extending over entire area of upper arm with pruritis. Oral Benadryl subsided pruritis. Other symptoms lasted 7 days.
I developed severe headaches which turned into a lot of inflammation. There was nerve pain throughout my body. I wasn't able to sleep or eat for almost 7 days. I was experiencing nerve pain and tremors. They weren't continuous, but they would come and go. Inside I felt like there were quivering muscle sensations and weakness. The pain that was associated with the nerve pain would not go away. I have started to experience severe anxiety. I feel like I'm experiencing PTSD.
Approx. 5 hours post vac., c/o chills, shakey, difficulty breathing, reddened skin, tachycardia, hypertension. Vital signs 98.1, 130, 22, 160/110. Sent to ER and treated with Allegra D, Benadryl, Pepcid. Sent home, off of work 1 day.
This case was reported by a physician via sales rep and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX. On 30th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 30th April 2018, less than a day after receiving SHINGRIX, the patient experienced chills and headache. On an unknown date, the patient experienced fatigue. On 1st May 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the chills was unknown and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the chills, headache and fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced chills and headache which begun at night on the same day of vaccination. The headache lasted until the time of reporting. In 2018, less than a week after receiving SHINGRIX, the patient said she was very fatigued currently and would like to go home from work. The patient also stated that, the next time she gets SHINGRIX vaccine, she would do it on a Friday so she would not have to come to work the next day in case she experienced same reaction with the 2nd dose. The reporter agreed to be followed up.
First dose: about half a  hour after the administration I started to shake and my blood pressure rise a lot.  She was also short of breath.  Two days later she visited her cardiologist and the blood pressure was still high an she was retaining liquid, her legs was swollen.  Extreme tiredness and somnolence.  Second dose: Pain in the on the arm she was vaccinated.  The extreme tiredness and somnolence continued.  She also continue with the shortness of breath.
Fever, nausea, fatigue, and worsening dizziness after receiving three vaccines in one day, and admitted to the hospital  for acute febrile illness one day after vaccination.
Patient developed a headache and gastrointestinal symptoms 4 days after receiving the Moderna COVID-19 vaccine.  These symptoms lasted for over 4 days.  Subject is now stating she will not be getting 2nd dose of vaccine due to this
LEG SWOLLEN; CANNOT PUT PRESSURE ON FOOT,  WALKS ON TIP TOES; TENDERNESS ON OUTSIDE OF LEFT  LEG; PAINFUL KNEE/LEG; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure abnormal, knee disorder, and hand arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for hand arthritis, and acetylsalicylic acid.  On 10-APR-2021, the subject experienced leg swollen. On 10-APR-2021, the subject experienced cannot put pressure on foot, walks on tip toes. On 10-APR-2021, the subject experienced tenderness on outside of left leg. On 10-APR-2021, the subject experienced painful knee/leg. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No blood clots. On 20-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tenderness on outside of left leg, painful knee/leg, leg swollen, and cannot put pressure on foot, walks on tip toes. This report was non-serious.
Child received dose of recalled Hep Hib. 1/16/08-the parents called on 12/14/07 after learning about the HIB recall and stated that the child has not "seemed right since she got the shot."  The provider stated there was no specific complaint  and the child was healthy when he examined her after that.
COVID-19; COVID-19; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 84-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9261), on 17Feb2021 as dose 2, single (Lot number: EN6200) and on 25Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 83 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Oct2022 as dose 5 (booster), single (Lot number: 055F22B), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 08May2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "HLD" (unspecified if ongoing), notes: HLD; "fatty liver" (unspecified if ongoing); "Cataract" (unspecified if ongoing); "Hyperglycemia" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing); "Rhinitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: Sulfa (hives)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nexium, reaction(s): "Known allergies: Nexium (hives)". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08May2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Oct2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive; (13Oct2022) Negative, notes: Home test on 13Oct negative; (18Oct2022) Positive, notes: positive home COVID test on 18Oct2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient may have had COVID rebound after Paxlovid treatment. Upper respiratory symptoms, congestion, fatigue, sore throat started 07Oct2022. Home antigen COVID test positive 08Oct2022. Prescribed Paxlovid on 08Oct2022. No symptoms on 13Oct2022 after completing Paxlovid. Home test on 13Oct2022 negative.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events interchange of vaccine products, vaccination failure and covid-19 and BNT162B2.
on 1/13/2020 began that night with redness and swelling. allergic local reaction to either vaccine or adhesive from bandaid.
This spontaneous report received from a patient concerned a 64 year old male.The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and other pre-existing medical conditions included: The patient did not experience any body odor issue previously and no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient experienced bad smell like poop/sewerage around him.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from bad smell like poop/sewerage around him.This report was non-serious.
BURNING SENSATION OF THE MOUTH, ULCERS IN MOUTH, FEVER, CHILLS, BODY ACHES.
1150 2AUG94 pt given vax & APAP & pt began crying, face flushed, red areas on thighs @ inject sites;
The pt received immunizations at approx. 11:30. Per mom, the child was inconsolable from 12:00 until 20:00 that night.
pt called 6/22 complaining about body aches all over. she said arm hurts too and did not remember having these symptoms with the first shot. she had to travel right away,so not sure she had/had not symptoms with first one. advised pt to take tylenol 500 mg otc and will check back in 4 hrs,if no relief or worsening s/sx,to goto er. pt called back in the aft saying she felt much better. advised pt to continue apap twice daily till monday when she can get hold of her dr. tried calling pt again 6/23 but no answer.
Pt was given flu shot at clinic around 9am today at flu clinic. Pt returned to flu clinic around 1:30pm and that she had started to notice about an hour or two after she received her vaccine that she was itching on her face/neck and had some hives/rash on her arm and redness at the injection site. Left side of pt's face appeared to be slightly red on cheek and chin area where she had scratched and there was some redness at the injection site on left arm. No difficulty breathing observed and pt was alert and oriented. She states that she has never had any type of reaction in the past to the flu vaccine, gets them yearly and is not allergic to eggs. Pt was given 2 Benadryls, she has no drug allergies. Pt was instructed to return to clinic if any of her symptoms worsen after she takes Benadryls and was instructed not to drive due to side effects of Benadryls. She states she normally takes an anti-histamine every morning for allergies but did not take one this morning. She also asked if she would be exempt from receiving a flu vaccine in the future. I explained that flu medical exemptions are approved for severe anaphylactic reactions and an flu medical exemption form would need to be signed by an MD and would need medical records from treatment of the reaction. Pt did not return to flu clinic after Benadryl given.
shot #1 - sore arm following day shot #2 - sore arm started 4 hours later; 8 hours later started getting chills/sweats 12 hours profuse sweating, extreme chills, moderate fever, unable to stay asleep. Following day ~18hrs after shot, moderate body aches/fatigue. ~24hrs - trouble walking due to severe body aches/lethargy, severe headache, unable to focus (unsafe to drive)  ~36hrs - body aches started to subside, headache and inability to focus remained, nausea begins to set in, severe sweating and chills (soaked the sheets and bed as if 2 gallons of water dumped in). ~48hrs - headache starts to dissipate, fever, chills and sweating subsiding. ~60hrs - Feeling @ about 75% of normal ~72hrs - Slight headache remains, muscle aches are minimal. ~96hrs - at normal capacity
No treatment at this time because they're still figuring out a diagnosis. I have a palpable lump near my clavicle and sternum joint. There was a question whether it was cancer, but it is not. The end of the clavicle is enlarged and the tissue surrounding it is enlarged as well. It's about 3 by 4 inches. The surgeon noted the nerve of your larynx goes down the neck and goes back up and curves around the clavicle. The surgeon also noted that may be the reason for the weakness and hoarseness of my voice recently. I will be seeing a laryngologist on 05/16/2023. I have not been experiencing any pain. I still have swelling in the clavicle and my voice is still deep at this time.