chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wiped out; shakes; left arm, lower abdomen and both hips ached; felt hot and cold; left arm, lower abdomen and both hips ached; Fever; left arm, lower abdomen and both hips ached; little headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), ABDOMINAL PAIN (left arm, lower abdomen and both hips ached), FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold), PAIN IN EXTREMITY (left arm, lower abdomen and both hips ached) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 08-Apr-2021, the patient experienced TREMOR (shakes), ABDOMINAL PAIN (left arm, lower abdomen and both hips ached), FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold), PAIN IN EXTREMITY (left arm, lower abdomen and both hips ached), PYREXIA (Fever), ARTHRALGIA (left arm, lower abdomen and both hips ached) and HEADACHE (little headache). On 09-Apr-2021, the patient experienced FATIGUE (wiped out). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Apr-2021, TREMOR (shakes) and FEELING OF BODY TEMPERATURE CHANGE (felt hot and cold) had resolved. On 09-Apr-2021, HEADACHE (little headache) had resolved. At the time of the report, ABDOMINAL PAIN (left arm, lower abdomen and both hips ached), PAIN IN EXTREMITY (left arm, lower abdomen and both hips ached), PYREXIA (Fever), ARTHRALGIA (left arm, lower abdomen and both hips ached) and FATIGUE (wiped out) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Patient received Tylenol treatment for Fever and Aches  No concomitant medications provided.   INC.-MOD-2021-072901:First dose case
This spontaneous report as received from a consumer, as part of a marketing research conducted by Observant LLC refers to her child who was a 14 year old female patient. The patient was vaccinated with GARDASIL (Lot#, dose/frequency, route unspecified) in June 2012, then the patient experienced muscle pain at dose on an unknown date in 2012. Subsequently patient recovered with sequelae. The reporter felt that unspecified adverse event at dose was non-serious and it was related to the therapy with GARDASIL. Patient's sister experienced muscle pain at dose post vaccine of GARDASIL (MARR# 1210USA002222). Additional information has been requested.
18 hours after receiving the 2nd shot I had extreme chills and joint pain. The next day I felt fine. I have a lingering effect in the joints of 2 of my fingers on my right hand. My ring finger is the worst, and will often curl on its own,and is very swollen feeling and painful at times
Patient experiencing arm pain & soreness after receiving vaccine. Was put on a MEDROL Dose Pak and helped while she was on it. Now pain seems to be returning. Same problem I have had with other patients receiving the AFLURIA.
arm started to itch; large red patch; swelling and it is extending down the arm; Slight burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm started to itch), VACCINATION SITE ERYTHEMA (large red patch), PERIPHERAL SWELLING (swelling and it is extending down the arm) and BURNING SENSATION (Slight burning sensation) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication.     Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm started to itch), VACCINATION SITE ERYTHEMA (large red patch), PERIPHERAL SWELLING (swelling and it is extending down the arm) and BURNING SENSATION (Slight burning sensation). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (arm started to itch), VACCINATION SITE ERYTHEMA (large red patch), PERIPHERAL SWELLING (swelling and it is extending down the arm) and BURNING SENSATION (Slight burning sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Syncope immediately following vaccine administration.  No loss of consciousness, oriented, alert, responding appropriately to questions.  Described "seeing spots in front of eyes, cold feeling".  Pt denied nausea.
tightness in my chest; fatigue; brain fog; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2021 as dose 1, single (Lot number: EW0164) at the age of 21 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety", start date: 2017 (ongoing); "Depression", start date: 2017 (unspecified if ongoing); "ADHD", start date: 2017 (unspecified if ongoing); "Hives Edema", start date: Jul2021 (ongoing); "Angioedema", start date: Sep2021 (ongoing). Concomitant medication(s) included: ZYRTEC HIVES RELIEF oral taken for urticaria, start date: Jul2021 (ongoing); XOLAIR taken for angioedema, start date: Oct2021 (ongoing); SINGULAIR taken for urticaria, start date: Dec2021 (ongoing); ALLEGRA oral taken for urticaria, start date: Jul2021 (ongoing). The following information was reported: FEELING ABNORMAL (non-serious) with onset 23Apr2021, outcome "unknown", described as "brain fog"; FATIGUE (non-serious) with onset 23Apr2021, outcome "unknown"; CHEST DISCOMFORT (non-serious) with onset 23Apr2021, outcome "recovered" (23Apr2021), described as "tightness in my chest".  Additional information: Did the patient provide information to you regarding the reported adverse event(s) With the use of the product: Yes. If yes above, do you consider the Pfizer product had a causal effect to the adverse event: Yes. Are you willing to be contacted again by Pfizer on the reported adverse event(s): Yes. Vaccine Facility Type Hospital. Vaccine Administered at Military Facility: No. PRIOR VACCINATION (within 4 weeks): None.  No follow-up attempts are possible. No further information is expected.
Patient received the vaccine and was waiting in the waiting area. Approximately 5-6 minutes later he blacked out and fainted on the floor. He said he was stressed about the vaccine and also had not ate. We called 911 and the paramedics checked all the vitals and everything was okay. He left with his friend and was feeling better.
Difficulty breathing, exhaustion, dizziness.  Went to bed at 8:30 pm, woke up at 10:30 pm and difficulty breathing and exhaustion had passed.  Dizziness was gone by the next morning.  Another woman who received the shot at the same clinic that morning reported the same symptoms.
Red cheeks - Red Flush; Headache; 42 day difference between doses; tongue swelled; lips felt swelled; taste altered but not gone, everything tasted salty,Unusal Tatse; redness in throat; I did not feel well; sore throat; mouth broke out with sores; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness in throat), MALAISE (I did not feel well), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (mouth broke out with sores) and FLUSHING (Red cheeks - Red Flush) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 029L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), PROBIOTICS NOS, LOVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TRAMADOL, CORTISONE ACETATE and LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (redness in throat), MALAISE (I did not feel well), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (mouth broke out with sores), SWOLLEN TONGUE (tongue swelled), LIP SWELLING (lips felt swelled), DYSGEUSIA (taste altered but not gone, everything tasted salty,Unusal Tatse) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (42 day difference between doses). On 01-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced FLUSHING (Red cheeks - Red Flush). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 22-Jan-2021, ERYTHEMA (redness in throat), MALAISE (I did not feel well), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (mouth broke out with sores), SWOLLEN TONGUE (tongue swelled), LIP SWELLING (lips felt swelled) and DYSGEUSIA (taste altered but not gone, everything tasted salty,Unusal Tatse) had resolved. On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (42 day difference between doses) had resolved. On 03-Mar-2021, FLUSHING (Red cheeks - Red Flush) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-JUN-2021 contains no significant information.
Sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore right arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. On 04-Mar-2021, VACCINATION SITE PAIN (Sore right arm) had resolved.            It was reported that patient was taking immunosuppressive medications.   This case was linked to MOD-2021-348356 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow up received included batch number of suspect drug and reporter address and updated start date of second dose.
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 5 months old (also reported as "6 months") patient of unknown gender. On 13-DEC-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# J013344, expiry date: 22-JAN-2015 as reported) (dose and frequency unspecified), route as intramuscular, at right leg. No adverse effect had been observed or reported. The patient did not seek medical attention. Additional information has been requested.
Child received Menactra 8/6/2009am. At 2am on 8/7/2009 became suddenly ill with a high fever, chills, rapid breathing, and bad nausea. Family gave ibuprofen and symptoms improved. Complained of soreness of deltoid muscle on 8/6/2009 evening and used ibuprofen.
Information has been received from a pharmacist referring to a 45 year old patient of unknown gender. patient's concurrent conditions, concomitant medication and medical history were not provided. On 23-MAR-2015 the patient was inadvertently vaccinated with a first dose of M-M-R II (subcutaneous, lot # J002866, 0.5ml once) that had expired on 12-MAR-2015. No adverse effect was reported. Additional information has been requested.
Urticarial rash within 10-15 minutes of vaccine administration. Epinephrine, Benadryl, Methylprednisone injection.  Nurse follow up on 09/10/04 states: "Fever."
Myalgia Narrative: Tight aching arm. Took Tylenol with some effectiveness.
I had loss of taste, slight fever; and I was fatigue. I had very bad muscle ache and coughing. Doctor provided me a 5 day prescription.
1. patient requested flu shot when he checked in  at the pharmacy and confirmed that he came in to get flu shot before we administered it. However, patient's wife indicated that both of them already had the flu shot this year and wanted to get Pfizer today afterwards. 2. we accidently administered Fluad when patient is 63 years old.  3. patient does not have any signs or symptoms of the adverse effect by the time they left the pharmacy.
ON 3/22/2021 PATIENT RECEIVED BOOSTER VACCINE TOO EARLY
Runny/stuffy nose, fever, headache, cough, fatigue, wheezing, lasted 17 days. Steroids and cough suppressants administered.
Had immunizations (PCV-7 & DTAP).  Left office 40 minutes later; while eating at McDonalds, developed hives-back of scalp, neck, chest, back.  Came to office about 15 minutes later.  Increasing hives breathing normally, lungs clear.  Mouth and talks, plays normally.  Urticarial leasions varying sizes as above itchiness.
On 9/9/2021, patient developed increased fatigue, headache, and sore throat as the initial symptoms. Sore throat progressed to the point where patient could no longer tolerate swallowing liquids. Patient never felt airway was at risk of being compromised. Fevers developed on 9/10/21 and have persisted, often being refractory to 500mg of Tylenol. Patient went to urgent care clinic believing this could be COVID (patient is ICU nurse that works in a COVID ICU) or strep throat. At the urgent care, rapid strep test was negative. Urgent care MD obtained a sample for a COVID 19 PCR test. In the afternoon of 9/10/2021 fevers elevated to a Tmax of 103.8. Overnight patient experienced chills, night sweats, headache, difficulty swallowing, and thick oral secretions. On the morning of 9/11/2021, patient elected to go to the ED because he felt very dehydrated but could not swallow water without choking. At the ED, several differentials were tested to include: peritonsilar abscess, strep throat, infectious mono, and CMV. All tests were negative. Patient given Augmentin to treat what appeared to be an infected left tonsil. Patient also received decadron to help ease swelling and pain of tonsil. Patient left tonsil is +4. Right tonsil is +2.
This spontaneous report as received from a Certified Medical Assistant refers to 4 patients of unknown age and gender. On an unknown date (reported as during the month of June and July) the patients were vaccinated with an improperly stored PEDVAXHIB (dose, route and lot number were not reported). Concomitant medications were not reported. No adverse effects reported. This case is linked to case 1407USA013104 via same reporter link. Additional information is not expected.
Information has been received from the wife of a consumer concerning a 67 year old male who on 13-AUG-2007 was vaccinated with PNEUMOVAX 23 (Lot # not reported).  On 13-AUG-2007 post vaccination the patient developed hard swelling at the injection site, a rash, increased blood pressure, heart palpitations, trouble breathing and felt nauseous.  The patient had not sought medical attention.  At the time of the report the events persisted.  Additional information has been requested.
rotated eyes when shaking-arms stiffened & reached-shook, mumbled for 5min-vomited-taken to hosp ER given IV-T104 brought down to 100 2AM;slept then shaking;T104.4 given rocephin fever down;
high levels of esr and crp; high levels of esr and crp; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RED BLOOD CELL SEDIMENTATION RATE INCREASED (high levels of esr and crp) and C-REACTIVE PROTEIN INCREASED (high levels of esr and crp) in a  patient of an unknown age and gender 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 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 RED BLOOD CELL SEDIMENTATION RATE INCREASED (high levels of esr and crp) and C-REACTIVE PROTEIN INCREASED (high levels of esr and crp). At the time of the report, RED BLOOD CELL SEDIMENTATION RATE INCREASED (high levels of esr and crp) and C-REACTIVE PROTEIN INCREASED (high levels of esr and crp) outcome was unknown.            No concomitant medications were used. Treatment drugs used were unknown.
Swollen armpit; Swollen armpit causing pain when lifting arm; Armpit skin felt irritated; Severe headache; Rash on legs (appears like individual dots) not itchy; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received bnt162b2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: ER 8736), dose 2 via an unspecified route of administration, administered in left arm on 22Apr2021 at 09:00 (at the age of 50-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included heart murmur and penicillin allergy(Known allergies: penicillin) from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine includes received bnt162b2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in left leg on 18Mar2021 at 15:30 (at the age of 50-year-old) as DOSE 1, SINGLE for covid-19 immunisation. On 22Apr2021 at 09:15, the patient experienced swollen armpit causing pain when lifting arm, armpit skin felt irritated, severe headache, rash on legs (appeared like individual dots) not itchy. The events did not result in doctor or other health care professional office or clinic visit and emergency room department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen armpit causing pain when lifting arm, armpit skin felt irritated, severe headache, rash on legs (appeared like individual dots) not itchy was not recovered.  No follow-up attempts are needed. No further information is expected.
eczema are back; itching; minor rashes, rashes are back; This spontaneous case was reported by a patient and describes the occurrence of REBOUND ECZEMA (eczema are back), PRURITUS (itching) and RASH (minor rashes, rashes are back) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram once a day. In 2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On 27-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced REBOUND ECZEMA (eczema are back), PRURITUS (itching) and RASH (minor rashes, rashes are back). At the time of the report, REBOUND ECZEMA (eczema are back), PRURITUS (itching) and RASH (minor rashes, rashes are back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: showed 3 out of 20. In April 2021, SARS-CoV-2 antibody test: antibodies were low.         No concomitant medications were reported.It was reported that once patient started on Dupixent, it was amazing, felt 100 percent better but the dose was late so started having slight itching (pruritus) and minor rashes (rash), but they were minor and patient was 90 to 95 percent better since starting on Dupixent. Patient got booster dose of Moderna on 27-Aug-2021.Patient was advised to take 2 to 3 weeks before taking his Dupixent again, eczema and rashes disappeared 100%, now his rash (rash) and eczema (eczema rebound) are back, wanting to restart, and unsure if Dupixent shot made his antibodies low.  It was not reported if the patient received a corrective treatment for the events.  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.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of unknow age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 28-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location  and route of administration were not provided), as prescribed and/or administered by a healthcare provider at a physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider at an urgent care service, for shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome for herpes zoster was not reported.
Pt. stated she started feeling dizziness 5 mins. after getting vaccinated.  Seconds later she had a syncope episode for around 10 seconds.  At. 5:10 pm she was conscious and dizziness went away.  Vital signs were done BP101/60, R 19, O2 sat 100%, HR 62.  Pt stated, "I always have episodes of syncope when I get medical procedures,  This is not the first time."  At 5:25 pm pt stated she is feeling ok, pt is alert and oriented x4.  At 5:38 pm pt stated she wants to go home.  Pt. went home at 5:40 pm.