chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses were given after expiration date; the vial was initially stored in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator). On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that there was a confusion between expiration date printed in the carton and expiration date when the QR code was scanned. The product did not underwent any temperature excursion. Patient did not experienced any adverse event. Date the vial was initially stored in the refrigerator: 29-OCT-2021.   This case was linked to MOD-2022-491837 (Patient Link).
After receiving the 2nd dose, it caused a fibro-myalgia flare with increased pain all over my body. I called my doctor and she increased my gabapentin mg, that I was already taking. The increase helped.
Headache, Myalgia, SORE ARM AND NECK Narrative:  1/25: pt experienced sore arm and neck. On 1/26 she experienced muscle aches and migraine. On 1/28 she had a headache.
Swelling, soreness and heat at injection site, starting 4 hours post injection, continued more than 48 hours post injection
ACHE IN SHOULDER BLADES AND IN ARM; CHILL TO THE BONE; DIZZY; SLIGHT HEADACHE; EXHAUSTED; SLEEPY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chill to the bone. On MAR-2021, the subject experienced dizzy. On MAR-2021, the subject experienced slight headache. On MAR-2021, the subject experienced exhausted. On MAR-2021, the subject experienced sleepy. On 08-MAR-2021, the subject experienced ache in shoulder blades and in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chill to the bone, dizzy, slight headache, exhausted, sleepy and ache in shoulder blades and in arm was not reported. This report was non-serious.
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient started getting side effect. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of started getting side effect: not reported.
Little headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Little headache) and MYALGIA (Body ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Had heart attack a year ago). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, ATORVASTATIN and OLMESARTAN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HEADACHE (Little headache) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Little headache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-382241, MOD-2021-382303 (Patient Link).
sick for almost 10 DAYS; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for almost 10 DAYS) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ILLNESS (sick for almost 10 DAYS). At the time of the report, ILLNESS (sick for almost 10 DAYS) had resolved.            No concomitant medication information was provided.  No treatment medication were provided.
When sleeve was rolled up to give 2nd injection of the Covid Pfizer vaccine on 2/11/2021 (Rt arm where 1st one was given), the administering noticed a 1/2 golf ball sized soft lump located centrally in his right deltoid.  I spoke with pt and he was completely unaware of the lump and states that he has no pain  or discomfort at all.  He plans to have his PCP look at it at his next physical appt which is in April.  He will seek medical attention sooner if it increases in size or becomes painful.
There have been no adverse events reported by the patient. However, the vaccine was stored in the freezer upon its arrival to our clinic site on 7/20/21 until 8/10/21 when we learned that the vaccine should have been stored in the refrigerator at temperatures between 36-46 degrees farenheit.  Therefore, the vaccine has no efficacy.
Pt was admitted to the hospital 4/26 with fatigue and dyspnea and tested positive for COVID (non ICU)
He had covid in November 2020 and was hospitalized and went to rehab to start walking again, after treatment walked out of rehab. After receiving the vaccine the next day couldn't get out of bed and was very weak and could not walk.  Went to the hospital and was there 4-5 days and sent home for physical therapy at home and still cannot walk more than 4-5 feet with out a walker.  All of this after  1st dose of Moderna, he can no longer walk.
She could not walk; feet were hurting; Extremelly ill; fever (unknown); chills; Severe body pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)) and CHILLS (chills) in a 34-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.     The patient's past medical history included COVID-19.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)), CHILLS (chills) and MYALGIA (Severe body pain). At the time of the report, GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)), CHILLS (chills) and MYALGIA (Severe body pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that he side effects of the vaccine were worst than the Covid-19 disease. Concomitant medications were not provided. Treatment information was not reported.
I developed tinnitus approximately 1 hour after having the extra dose flu vaccine for adults 65 at my pharmacy. I had an appointment with ENT today and he stated the vaccine could have contributed to development of the tinnitus. I thought it should be reported as the tinnitus is very distressing and I am now being treated for it.
Patient received the vaccine on 7/23/2018 and then the next day mom called to report of left arm very painful and headache for 3 days straight.
SORE/TENDER/PAINFUL TESTICLES; HEADACHE; SORENESS AT ARM WHERE INJECTION ADMINISTERED; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced soreness at arm where injection administered. On 13-APR-2021, the subject experienced sore/tender/painful testicles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and soreness at arm where injection administered on APR-2021, and the outcome of sore/tender/painful testicles was not reported. This report was non-serious. This case, from the same reporter is linked to 20210430095 and 20210438566.
Child received vaccines on 9/21/07 child brought to ER in full arrest 9/22 late /9/23 early am ---> died report of autopsy pending.  12/18/07 Reviewed autopsy report which reveals COD as SIDS.  Patient co-sleeping w/parent in twin size bed. Found unresponsive w/blood in nose when parent awoke.
On Saturday March 27,2021 the patient was fine on the actual day of second shot which she received at approximately 11:30am. The next day she had a fever of 102, chills, body aches, and severe  headache. Tylenol was given with little relief. Symptoms persisted until Monday morning and she reported feeling ?much better.? On Tuesday 3-30-21 at about 3pm she passed out n was taken to an urgent care center where a CT scan of the head was done and was negative. She was discharged to home. The next morning she felt ok but as the day went on she developed facial drooping and slurred speech. She was taken back to the ER and admitted where she remains. An MRI confirmed an ischemic stroke on 4-1 -2021
10/11/02 woke up from sleep crying. L arm red, swollen with lump. Taken to instacare, dx. cellulitis. Rx with Cephalexis.
side effects; 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 VACCINATION COMPLICATION (side effects) 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Under 18 years of age vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age vaccine administered) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age vaccine administered). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   After the vaccination no adverse events were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received No new information added.
The patient experienced no symptoms; Nurse reports that "on 7/27/2020 a patient was administered an improperly stored dose of PROQUAD"; This spontaneous report as received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 27-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dosage regimen was not provided), lot # T001187, expiration date: 11-JUL-2021, administered subcutaneously as prophylaxis. The vaccine was administered with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # S038697 and expiration date 10-AUG-2022).  The improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced a temperature of 28.4 degree Fahrenheit (°F) , for a 6 hours and 38 minutes time frame. The vaccine was not exposed to any previous temperature excursions and the call was made due to a data logger. The patient did not experience any symptoms.
Ongoing Hospitalization, currently day 4 in ICU.  Shortness of breath during dialysis treatment, given supplemental oxygen and admitted to intensive care unit. Placed on BiPAP for hypoxia, then Vapotherm 25L and 75% FiO2. 5 ays of remdesivir, dexamethason
Nasal congestion and acute hearing loss left ear noted after vaccine  Vaccine given at Pharmacy
Details of Hospital Stay   History of Present Illness  The patient is a 79-year-old woman with a past medical history of hypertension, hypothyroidism, lumbar compression fracture, hiatal hernia, metastatic adenocarcinoma primary lung to bone and question liver, on immunotherapy pembrolizumab started 12/3/2019, changed to osimertinib, right leg superficial thrombosis, on Xarelto presented to hospital on 3/10/2020 with complaints of 2 months duration shortness of breath, worsened over a 4-day period. She was admitted to the hospital with a diagnosis of acute respiratory failure with concerns of acute PE. For all details regarding the patient's initial presentation please refer to history and physical exam dated 3/10/2021.
Follow up received from the physician provided information regarding serotyping. Information regarding Prevnar was received from a physician regarding a 4 year old male patient who developed pneumococcal bacteremia. At 12 months of age, the patient received the fourth dose on 6/11/01. The patient has no relevant medical history. Indication for Prevnar was immunization. Product was administered on 6/11/01. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 5/20/04, a 4 year old male patient developed pneumococcal bacteremia and was hospitalized. He was discharged from the hospital on 5/23/04. The reporter indicated that the patient has recovered. The reporter indicated that he has been unable to obtain serotype information for this patient. The reporter stated that the hospital worked with the local health department to forward isolates to the CDC. However, whenever the reporter calls the local health department, they have no information to provide him. No additional information was available at the time of this report.
Around 10/19/10 patient came in with a sore arm. Nothing looked red or infected. On 10/29/10 patient's live in boyfriend called stating that his girlfriend's arm was still sore when she lays down.
Localized area of redness, induration and tenderness (5-6 cm in diameter) at site of MMRV in (R) thigh. Otherwise well - no other rash, fever - developed 24 hours after injection and unchanged at 48 hours.
20 month old female received DTAP and HEPATIS A vaccines into the left and right thighs respectively on 19 Jun 2008. Some 24 hours later, the mother noticed increased redness and swelling over the left anterior-lateral thigh. The physician-father attempted to treat the "presumed infection" with a dose of Augmentin initially, and then later, a dose of Zithromax. The child was not febrile, anorectic, malaised or decreased in her activity. She was ambulating fine without complaints. The parents took the child to the clinic on 6/21/08 for evaluation. The pediatric attending saw the patient and admitted her to the ward with a diagnosis of "cellulitis". The child was discharged the following day, 22 June 2008, after a few doses of IV Clindamycin. 10/6/08-records received for DOS 6/21-6/22/08-DC DX: Cellulitis of left anterior thigh after immunizations. Presented to ED with C/O worsening erythema of left anterolateral thigh following vaccine immunization on 6/19/08. Site of vaccination appeared swollen and tender. Treated with IV antibiotics.
Slight headache, redness on arm, sore arm, chills (shivering) & mild fever, tiredness the following day.  Okay on second day.
Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 18-SEP-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which were improperly stored for 4 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
4/28/2021   Ms. was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  Feels a " burning sensation to her mid-chest".   Assessment : Time of assessment 1635. Alert and oriented. No redness , warmth, swelling or rash noted.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.  Water given,  1635- BP- 119/94, P- 101, O2- 100 % 1644- bp- 121/86, p- 91, o2- 100 %       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. She is instructed to follow up with PCP if issue becomes worse or for any concerns.       Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/28/2021  4:16 PM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8736   NDC: 59267-1000-2          Electronically signed by, RN at 4/28/2021  4:57 PM  Immunization on 4/28/2021   Detailed Report  Note shared with patient
High blood pressure; Pain in lungs; Dizziness; Headache; Tiredness; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), PULMONARY PAIN (Pain in lungs), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced HYPERTENSION (High blood pressure), PULMONARY PAIN (Pain in lungs), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, HYPERTENSION (High blood pressure), PULMONARY PAIN (Pain in lungs), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: NNI.
It was reported in a paper presented at a conference that a patient with HIV, AIDS-related virus, and history of ultrasound assisted liposuction of a buffalo hump who was vaccinated, twice in their lifetime, with pneumococcal vaccine 23 polyvalent developed pneumococcal pneumoni and pneumococcal bacteremia three months post the ultrasound assisted liposuction procedure. Concomitant therapy included antiviral therapy (unspecified). It was noted the patient was involved in a retrospective evaluation, which was done to evaluate the outcome of the treatment option, ultrasound assisted liposuction, used for treating fat maldistribution that leads to an enlargement of the dorsocervical fat pad, known as a buffalo hump. It was noted the patient tolerated the ultrasound assisted liposuction procedure well, and had initial partial reduction in buffalo hump size, but did not have full resolution of the buffalo hump. Follow up information received in a statement from the author reported, "These were not adverse events". Additional information was received via telephone correspondence from the author, a physician, who reported he did not know who was the manufacturer of the vaccine that had been administered to the patient, and that he would need to review the patient's chart to obtain more information. The physician reported that he was not implying the vaccine had anything to do with the patient's diagnosis of Pneumococcal Pneumonia or Bacteremia. Upon internal review pneumococcal pneumonia and pneumococcal bacteremia were determined to be an other important medical event (OMIC). The author of the paper also mentioned a second patient that had pneumococcal pneumonia and pneumococcal bacteremia following vaccination with pneumococcal vaccine 23 polyvalent. Follow-up info received in a statement from the author reported, "These were not adverse events."  A 15-day follow up report received 11/18/2003 adds: It was noted that the pt was involved in a retrospective evaluation, which was done to evaluate outcome of the treatment option, ultrasound assisted liposuction (UAL) used for treating fat maldistribution that leads to an enlargement of the dorsocervical fat pad, known as a "buffalo hump". It was noted the pt tolerated the ultrasound assisted liposuction procedure well, and had initial partial reduction in buffalo hump size, but did not have full resolution of the buffalo hump. Upon internal review pneumoccal pneumonia and pneumococcal bacteria were determined to be an other important medical event. The author of the paper also mentioned a second pt that had pneumococcal pnemonia and pneumococcal bacteremia following vacccination with pneumococcal 23 polyvalent (manufacture unknown) (WAES #0304USA02745).
Patient had outbreaks of hives on chest and wrist 5 minutes after Moderna vaccine which was given at 3.20pm Benadryl 0.5ml administered intramuscular to right arm.
Pt fainted few minutes after the shot. Though has a history of fainting before after shots.