chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report was received from a nurse and refers to a 30 year old female patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. On 05-FEB-2018, the patient was vaccinated with VARIVAX injection, subcutaneously (dose, strength, frequency were not reported) (lot # N021720, expiration date on 10-AUG-2019) for "vaccination". Concomitant therapy included sterile diluent. On 20-FEB-2018, the patient was examined by an unspecified obstetrics and gynecology physician. The patient was pregnant. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not reported. No treatment was given. No lab diagnostics were performed. The patient sought medical attention.
Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (Lot # K008931, expiry04-MAR-2017; strength, dosage, frequency and route unspecified). The vaccines were exposed to -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: Pt is a 91 male who died on 05/09/2021 w/h/o CKD, GERD, HLD, and HTN. Pt received Moderna Covid-19 vaccination 2/2 on 02/08/2021. Pt died on 05//09/2021 at hospital. Unlikely Moderna Covid-19 vaccine caused/contributed to pt death.
Patient has pain in her arm.  It was sore the days following the vaccine and never improved for two weeks so the patient went to the Dr and the Dr gave a steroid.
8 years ago I had a chip in my left elbow.  Some constant pain, Could not bend without massive pain, could not touch face, dress myself etc.  Saw physician, lasted two weeks.  2 days after vaccination in left shoulder similar symptoms again in left elbow for the first time since the 8 year old event.  Getting better on tumeric and ibuprofen, not well yet.   Will visit DR if trend worsens.
Patient stated that she felt weak and had a headache after receiving the vaccine. Patient get dizzy if she moves around for to long Patient said leg feels heavy when she walks.
Second vaccine due 4/20/21, offender received vaccine 4/15/21.
Frozen left shoulder after about a month of second doze Pfizer COVID 19 vaccination. My doctor recommended physical therapy, which may also have contributed to in addition to COVID-19 vaccination; COVID-19 vaccination in raising my blood pressure; Left shoulder and arm as well is also experiencing a weakness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9265), via an unspecified route of administration, administered in Arm Left on 05Feb2021 11:45 (at the age of 56-year-old) as dose 2, single for covid-19 immunisation. The patient other medical history was reported as none and concomitant medications were not reported. Patient did not have any known allergies. Patient was not pregnant at the time of vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in Arm Left on 15Jan2021 10:30 (at the age of 56-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine in four weeks and did not have any other medications in two weeks. Patient did not have COVID prior vaccination and COVID was not tested post vaccination. The patient experienced frozen left shoulder after about a month of second doze Pfizer COVID-19 vaccination in Mar2021. Her doctor recommended physical therapy, which may also have contributed to in addition to COVID-19 vaccination in raising her blood pressure and ended up taking blood pressure medicine. Left shoulder and arm as well was also experiencing a weakness. The patient underwent lab tests and procedures which included blood pressure measurement: raising my blood pressure on an unspecified date. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment in the form of physical therapy and high blood pressure medicine. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Felt like a pulled muscle on friday and saturday after my shower on sunday at 6pm the pulled muscle shot turned into a rash
expired vaccine was administered; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered) and PAIN IN EXTREMITY (sore arm) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered) and PAIN IN EXTREMITY (sore arm). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Treatment medication reported includes Tylenol.
Wide raised rash on outer part of elbows and outer part of knees. Blotches and spots down legs to ankles and down arms to wrists; Wide raised rash on outer part of elbows and outer part of knees. Blotches and spots down legs to ankles and down arms to wrists; SARS-COV-2 infection; This is a spontaneous report from a contactable consumer (patient). A 36-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0170), via an unspecified route of administration, administered in left arm on 01May2021 15:00 as dose 1, single  (at the age of 36-years-old) for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ibuprofen (ADVIL 12 HOUR); paracetamol (TYLENOL); zinc chloride; ergocalciferol (VIT D); ascorbic acid (VIT C). The patient did not have any other vaccine if four weeks. There were no known allergies. On 09May2021 19:00, the patient experienced wide raised rash on outer part of elbows and outer part of knees, blotches and spots down legs to ankles and down arms to wrists. On 03May2021, the patient had sars-cov-2 infection. The patient received Benadryl and inch cream as treatment for the adverse events.On 03May2021, the patient underwent sars-cov-2 nasal swab test (Rapid) which was positive. The patient did not have covid prior vaccination but was tested positive for covid post vaccination. The case was assessed by reporter as non-serious. The outcome of covid-19 was unknown and the outcome of all the other events was recovered.   Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
Narrative:  82 year old male, received first dose of COVID-19 vaccine (Moderna) on 2/3/2021. PMH significant of Alzheimer's dementia. Seen on 2/10/2021 by neurology for history of possible myoclonic jerks for 2 years. Prescriber levetiracetam, which improved jerk-like movements. Admitted 2/13/2021 to ED due to decreased ability to perform activities of daily living. Re-admitted 2/16/2021 due to decreased appetite x 6 days, decreased urination and stooling. Switched to palliative care 2/17/2021. Patient expired 2/28/2021 at 9pm.
arm soreness; joint pain; Malaise; 19 to 20 days post 1st vaccine fever; chills; extreme fatigue; shortness of breath; pain when taking a deep breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6204; Expiration Date: 03Jun2021), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 (at the age of 66-year-old) as 1st dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, polymyalgia rheumatica. Patient is allergic to clindamycin, fortaz, sulfa. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not tested positive since vaccination. Patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications received in two weeks was reported as too many to list. On 25Mar2021 06:00, 19 to 20 days post 1st vaccine, the patient experienced fever, chills, extreme fatigue, shortness of breath, pain when taking a deep breath. On an unknown date patient experienced arm soreness, joint pain, malaise. Consumer stated that she was not sure if she was experiencing side effects from her vaccine or not which is why she didn't go to the website. she was wondering if you are seeing any cases of 3 weeks out 24 hours of fever, malaise, fatigue. she was supposed to get her second one tomorrow and she was feeling better now, but yesterday she was running a 100 temperature, she had joint pain and it just knocked out, it was about 24 hours and now its over. When confirmed that the consumer wanted to know about the side effects from the COVID 19 Vaccine, consumer stated that Yeah, have you heard about that. When confirmed if the consumer had any side effects from the first shot, consumer stated that she was not sure if this is or not, all she had was some arm soreness and fatigue directly from the first vaccination. This is almost 3 weeks and she had this almost 24 hour thing just out of nowhere. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Mar2021, fever: 100 on 25Mar2021. Therapeutic measures were taken as a result of events included antibiotics and steroids. The outcome of the events were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning a female patient who on unspecified dates, was vaccinated with GARDASIL. The consumer reported that she was speaking with another mother who stated her daughter was experiencing terrible headaches since receiving GARDASIL. Outcome was not reported. No further information is available.
Whole-body aches / Muscle pain; seems to have a fever; Chills; Fatigue; Arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt a little), MYALGIA (Whole-body aches / Muscle pain), PYREXIA (seems to have a fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012220A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt a little). On 22-Jan-2021, the patient experienced MYALGIA (Whole-body aches / Muscle pain), PYREXIA (seems to have a fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm hurt a little), MYALGIA (Whole-body aches / Muscle pain), PYREXIA (seems to have a fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Pt was provided with incorrect dose of vaccine. Was given 1.0 mL rather than 0.5 mL.
Started on day 8 of Injection became very sore, itchy and hard. A red rash,ring appeared around injection. Into day 6 and still same symptoms.
Localized swelling, tenderness, erythema at the injection site the day following the injection. Redness/swelling roughly the size and shape of a small egg. Also experienced severe thoracic back pain, likely a muscle spasm--although it is questionable this is a reaction to the vaccine.
Patient was given an undiluted dose of pfizer pediatric vaccine- so too high of a dose. They were informed the same day but have not reported any symptoms to us this far.
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   It was unknown if the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains Non significant information.
pt recv vax 13OCT98 & 15OCT c/o soreness under arm-radiated to back (lt side);saw MD 19OCT;also x-ray of lungs;
Very swollen lymph node above left colar bone; same side that the COVID-19 vaccine was injected. It?s been a month and it hasn?t gone down at all. The lymph node is about the size of a penny, it?s hard but moves.
Breakthrough case admission after 2 vaccines Moderna 3/14/21 Lot# 007B21A;  Moderna 4/14/21 Lot# 043B21A
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 10Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 29Mar2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Recurrent breast cancer" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE; AREDS; VITAMIN D [VITAMIN D NOS]. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Pcn carbocaine, reaction(s): "Known allergies: PCN carbocaine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (04Jul2022) Positive; (07Jul2022) Negative; (09Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, on 28Jun2022 patient received drug Paxlovid for the treatment of COVID-19 and with drawn on 03Jul2022. It was also reported that, patient took paxlovid Day 1-5 tested positive Day 6, tested negative Day 9, Symptoms of headache, runny nose and constant cough returned on Day 11 Tested positive Day11.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Received flu vaccine 11/8/13 at approx 0730, at employee's end of shift, went home to bed, woke up about 2 hrs later. Reports trouble breathing, itching and hives. Called at 1100 to employee health, was instructed to seek care. Husband took her to urgent care at 1400. Treated with epinephrine, steroids, and pain med.
Very soon after the RZV shot, started to feel shoulder stiffness, rapid heart beat, feeling hot in my face.  As the day continued, started to feel a little dizzy and tired.  By evening I was not well at all.  Fever hot, feeling nausea, bad headache, Insomnia, some shivering.  Could not fall asleep.  Very weak when try to get up.  Unable to go to work this work.  No energy.  No strength.  Still feel some headache.  My ears are ringing.  Pulse is still a little fast.  Cannot sleep.
Chills; low grade fever 99.4 orally; fatigue; weakness; This is a spontaneous report from a contactable Physician. A 77-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported),  via an unspecified route of administration on an unspecified date at single dose (2nd dose) for covid-19 immunization.  Medical history included high cholesterol and has no known allergies.  The patient's concomitant medications were not reported.  The patient had her first dose on left arm of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot no. EJ1685) at 12:00 on 22Dec2020 but had slight discomfort site injection and occasional soreness site injection over the subsequent 3 weeks. For vaccine dose 2, it was reported that after 30-36 hr, patient developed chills, low grade fever 99.4 orally, fatigue, weakness and took ibuprofen. She slept normal by 42 hrs and no further complications. The outcome of events recovered on unspecified date. The facility where the most recent COVID-19 vaccine was administered was in a school clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Information about lot/batch number has been requested.
Up to 15 of their patients who are immunocompromised received booster doses of the Moderna Covid-19 Vaccine over the last few months instead of full 3rd doses; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Up to 15 of their patients who are immunocompromised received booster doses of the Moderna Covid-19 Vaccine over the last few months instead of full 3rd doses) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Up to 15 of their patients who are immunocompromised received booster doses of the Moderna Covid-19 Vaccine over the last few months instead of full 3rd doses). At the time of the report, ACCIDENTAL UNDERDOSE (Up to 15 of their patients who are immunocompromised received booster doses of the Moderna Covid-19 Vaccine over the last few months instead of full 3rd doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 15-Feb-2022, case MOD-2022-484085   became invalid as they were no patient identifier reported . Therefore , this case will be logically deleted from the safety database.  No concomitant medications details were reported. No treatment information details were reported.
Patient told us she has anxiety about immunization.  5 minutes post vaccine she felt hot and nauseated. Gave patient a water and lowered to floor and elevated feet.  Applied ice to groin, neck and chest.  After 15 minutes patient was able to sit up in chair and was no longer feeling nauseated or diaphoretic.  BP: 124/90 P: 60 R: 16.   Patient discharged 35 minutes post vaccine.
A cluster of three adult patients, with no illness at the time of vaccination, had received intramuscular injections of FLUZONE SV 2007-2008, lot number U2438AA, on 18 October 2007. In the evening of the same day, the patients experienced fevers of 102 degrees Farenheit, stomach pain, and chills. Treatment included ibuprofen and liquid diet. At the time of this report, the event was still resolving, and the patient had not recovered. A corrective version was created with the same latest received date as the previous version (19 October 2007) for the sole purpose of adding to the narrative and the main screen (linked cases structure field) that the reporter for this case is the same as for cases 2007-03588, 2007-03589, and 2007-03590. No other relevant medically significant information was added to this case.
Received expired first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).
under 18; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (under 18) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (under 18). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (under 18) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Moderna COVID-19 Vaccine EUA Per first aid provider at vaccine POD: Chief Complaint: lips tingling, no swelling or rash noted, patient monitored for 30 minutes, medical options of Benadryl discussed, patient refused, symptoms resolved, patient instructed if symptoms reoccur to take Benadryl per package directions, seek medical help if symptoms persist or other symptoms develop.