chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 10:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:12 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 67.64 years for dose administered on 03-Mar-2021 and 67.72 years for dose administered on 31-Mar-2021.  Concomitant products were not provided.  On 03-Mar-2021 vials were moved to clinic. On 24-Feb-2021 the vaccines were moved to fridge. On 03-Mar-2021, the vial underwent the excursion on the following timings: at 10 AM temperature was 34. The vaccine beyond use date was reported as 26-Mar-2021.  On 31-Mar-2021 vials were moved to clinic. On 30-Mar-2021 the vaccines were moved to fridge. On 31-Mar-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 32. The vaccine beyond use date was reported as 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Initial arm soreness; exactly 1 week later arm became even more sore at injection site and is very itchy, hard  knot. Worse at 1 week than day 1-day 6. Not improving. site is warm.  additionally muscle and joint aches developed around day 5-7
BELLS PALSY,  GIVEN 4 RX., LEFT EYE VISION ,COULD NOT EAT, SEVERE PAIN ON LEFT SIDE OF FACE AND BEHIND THE LEFT EAR. STILL HAVE PAIN. EYE STILL SWALLON.  NUMBNESS HAS SOMEWHAT GONE AWAY A LITTLE.
weakness; headache; sore arm with lump; 102 degree F fever; Flu-like symptoms; night sweats; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), NIGHT SWEATS (night sweats), ASTHENIA (weakness), HEADACHE (headache) and PYREXIA (102 degree F fever) in a 68-year-old patient of an unknown gender 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 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), NIGHT SWEATS (night sweats) and PYREXIA (102 degree F fever). On an unknown date, the patient experienced ASTHENIA (weakness), HEADACHE (headache) and INJECTION SITE INDURATION (sore arm with lump). On 28-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ASTHENIA (weakness), HEADACHE (headache) and INJECTION SITE INDURATION (sore arm with lump) had resolved. At the time of the report, NIGHT SWEATS (night sweats) and PYREXIA (102 degree F fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
BOOSTER DOSE WAS GIVEN FROM AN EXPIRED BOTTLE FROM PREVIOUS DAY ( 12/11/2021 )
Mild hives treated with BENADRYL 6.25mg Q4hr prn.
I couldn't lift my arm after a few hours, the pain went to my neck and shoulder. It has been over 7 days and my arm still hurts to raise it. My neck is still stiff and my shoulder still hurts.
Patient reported discomfort in throat and light-headedness while in the post-vaccination observation area after receiving the 2nd dose of Pfizer Covid Vaccine. Benadryl 25 mg oral solution was administered by mouth.  Patient reported resolution of symptoms by the time of exiting the facility.
Information has been received from the authors in a literature article concerning a 48 year old father with MMR vaccine (manufacturer unknown) route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at health care agency or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency, which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at health care agency using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (H), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
tight in chest, unable to get a deep breath, feeling of lump in throat when attempting to take deep breath, irregular heartbeat
Feels like her face is swollen; Feels liker her neck is swollen; Difficulty swallowing; "gurgled speech"; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Feels like her face is swollen), SWELLING (Feels liker her neck is swollen), DYSPHAGIA (Difficulty swallowing) and DYSARTHRIA ("gurgled speech") in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced SWELLING FACE (Feels like her face is swollen), SWELLING (Feels liker her neck is swollen), DYSPHAGIA (Difficulty swallowing) and DYSARTHRIA ("gurgled speech"). At the time of the report, SWELLING FACE (Feels like her face is swollen), SWELLING (Feels liker her neck is swollen), DYSPHAGIA (Difficulty swallowing) and DYSARTHRIA ("gurgled speech") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: follow up received on 01-JUN-2021 Contains NNI
Dizziness, nausea, fatigue, fever, chills, muscle soreness, pain in left hand, swollen and painful armpit.
Left hand pain at injection site,limited mobility due to pain left arm. No infection. No brachial plexus weakness or injury but also could be neuritis. Too early to tell as she has pain and weakness is sec to pain or real neuritis, unknown. Start ibuprofen 800 mg tablet 1 tablet 3 times a day as needed for 7 days. Start predniSONE 10 mg tablet 1 tablet every day for 5 days.
Approximately 30 minutes post vaccination, patient experienced metallic taste in mouth. Complained of tongue feeling strange, limbs feeling strange.  Vital signs:  tachycardia, mildly hypertensive. (102-108 BPM, 138/90).  Glucose 100.
arm is puffed up and swollen; significant pain in arm and underarm is significantly sore; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is puffed up and swollen), PAIN IN EXTREMITY (significant pain in arm and underarm is significantly sore) and PAIN (soreness) in a 5-day-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and GABAPENTIN for an unknown indication.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm is puffed up and swollen), PAIN IN EXTREMITY (significant pain in arm and underarm is significantly sore) and PAIN (soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm is puffed up and swollen), PAIN IN EXTREMITY (significant pain in arm and underarm is significantly sore) and PAIN (soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.      Treatment details included paracetamol and ibuprofen. Upon internal review on 21 Jun 2021, the patient age is captured as unknown due to unclear information in source document.
paralyzed after the second dose/paralyzed from the waist down; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient was paralyzed after the second dose/paralyzed from the waist down on an unspecified date. It was reported that, Caller stated nothing against Pfizer, but he knew someone who was paralyzed after the second dose. The outcome of the event was unknown.    Follow-up attempts are completed; information about lot/batch number cannot be obtained.
ACHY BONES FEELING THROUGH THE SKIN; HEART RATE ELEVATED; FREEZING; CHILLS; FEVER AT 101.1; 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, route of admin not reported, and batch number: 180980 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced achy bones feeling through the skin. On 08-APR-2021, the subject experienced heart rate elevated. On 08-APR-2021, the subject experienced freezing. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever at 101.1. Laboratory data (dates unspecified) included: Fever (NR: not provided) 101.1, 100.7, Heart rate (NR: not provided) 95, and Heart rate high (NR: not provided) 114. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, achy bones feeling through the skin, heart rate elevated, and fever at 101.1, and the outcome of freezing was not reported. This report was non-serious. This case, from the same reporter is linked to 20210417646.
This spontaneous report was received from a pharmacist referring to a 67 year old female patient. The patient had none concomitant medication, pertinent medical history or drug reactions or allergies. On 19-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# reported as: N016106, expiration date reported as: 16-NOV-2018), intramuscularly (frequency was unspecified) for prophylaxis. On that same date at night, the inside of her injected arm was red, warm, and tight. The patient did not receive any treatment for her conditions. It was reported that no laboratory diagnostics were performed, that the patient sought for medical attention with the reporting pharmacist, that intervention to prevent serious criteria was not necessary, that the patient was not hospitalized and that the patient's conditions were not life threatening. No product quality complaint was involved. At the time of the report, the outcome of injection site movement impairment, injection site warmth and injection site erythema was reported as not recovered. The relatedness assessment between PNEUMOVAX 23 and the aforementioned adverse events was not provided. Lot# N016106 was verified to be an invalid lot number for PNEUMOVAX 23.
Information has been received from a physician concerning an 18-week-old patient who on 22-FEB-2007 was vaccinated PO with the second 2.0 ml dose of Rotateq (Lot #656103/1166F) (1st dose administrated on 08-DEC-2006). The physician reported that on 23-FEB-2007, the patient developed bloody stool. The patient was taken to the Emergency Room (ER) and was discharged with a negative outcome. The patient subsequently recovered. Upon internal review, bloody stool was determined to be an other important medical event. Additional information has been requested.
Information has been received from a physician concerning a 9 year old female patient who on 10-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot # not reported) and fainted right after reported noted that "patient's eyes rolled back" as she fainted. On 09-NOV-2010, the patient received her second dose of GARDASIL (Lot # not reported) and her blood pressure went from 103/64 to 94/64 to 88/53. At the time of the report the patient was being observed in office. The patient's outcome was not reported. Patient did not seek medical attention. No further information is available.
pt recvd vax; 24 hrs later, devel  cellulitis at inject site;
fever to 5 days p/vax began exp extreme pain & stiffness in the rt shoulder & the surrounding area;presently exp pain;
It was reported that a female pt received a Fluzone SV '99-'00 vaccination on 10/30/99. Reportedly, the pt developed a 6cm reddened area at the injection site.
Fever. Fatigue. Swelling, redness and warmth around inj site.
Narrative: Verbal report received months after injection of occurrence that lips were raised, dry, and tingling after Moderna COVID Vaccine first dose, Urgent Care visit occurred, and patient reported receiving a steroid injection and symptoms ceased. Second dose was not administered.
6 days after PREVNAR, MMR, VARIVAX, Hep A - uncontrollable crying, persistent.
Redness in the area of injection; Very hard to the touch in the area of the injection; Swelling at the site of injection; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Very hard to the touch in the area of the injection), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041l20a and 041l20a) for COVID-19 vaccination.     Concurrent medical conditions included Sclerosis multiple. Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALINE [SERTRALINE HYDROCHLORIDE]), NORTRIPTYLINE, SUMATRIPTAN, OCRELIZUMAB, HYDROXOCOBALAMIN ACETATE (V12) and ZOLPIDEM for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PYREXIA (Fever). On 10-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE INDURATION (Very hard to the touch in the area of the injection). 10-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Swelling). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; MORINDA CITRIFOLIA (MORIN [MORINDA CITRIFOLIA]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE INDURATION (Very hard to the touch in the area of the injection), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
At day 8 post vaccine I have redness, itching and warm skin at the injection site.
At 3:15pm immun were administered. Pt walked across room and was standing when pt yelled out for mom. Fell straight back hit head, eyes open, stiff but shaking. About a minute later pt came to disoriented to time and place. Doctor assessed ordered pt not to be moved and 911 was called. B/p 100/72. Pt was taken to ER.
This spontaneous report was received from a Registered Nurse referring to an 8 week old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 05-OCT-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ per oral route (dose, dose number, frequency, and anatomical location were unknown) with lot # N030364, and expiration date 06-MAR-2018 for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 13.3 °C degrees Celsius for 1 hour and 17 minutes. There was a digital data logger involved, but there was no previous temperature excursion reported. No adverse effects were reported. Sender's Comments: US-009507513-1810USA004400.
Inflamed at site of injection, large swollen area at site of injection, edema filled area at site of injection
A Moderna Bivalent booster was ordered for this patient. She received the incorrect formulation and incorrect dose of Moderna bivalent vaccine for her age group and vaccination status. The vaccine administered was the dark blue vial with gray band and she was given 0.5ml of vaccine. However, she should have received a 0.2ml dose from the dark pink vial with yellow band. As far as this writer and the health center knows, she has not experienced any adverse symptoms or reactions after this incorrect vaccination was administered. She did receive a Tdap vaccine at the same time.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Mild
This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a female patient of an unspecified age. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper. One of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. The doses from the 4 affected MDV that were leaking were administered. On 01-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234, expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019, FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. The reporter assessed this case as non-serious. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.