chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 booster doses of Moderna Covid-19 vaccine were given beyond 12 hrs., but less than 24 hrs. of exposure to room temperature) and PRODUCT STORAGE ERROR (Vaccine punctured on 04-May-2022 and administered on 05-May-2022, 23 hours and 2 minute after puncture) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-2022 at 9:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 booster doses of Moderna Covid-19 vaccine were given beyond 12 hrs., but less than 24 hrs. of exposure to room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine punctured on 04-May-2022 and administered on 05-May-2022, 23 hours and 2 minute after puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 booster doses of Moderna Covid-19 vaccine were given beyond 12 hrs., but less than 24 hrs. of exposure to room temperature) and PRODUCT STORAGE ERROR (Vaccine punctured on 04-May-2022 and administered on 05-May-2022, 23 hours and 2 minute after puncture) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provider by the reporter. Dose administered greater than 12(US)/24(CA) hours post puncture. The vial was initially stored in the refrigerator at 10:38 am on 04-May-2022. On 04-May-2022, at 10:58 am vial was first punctured. On 05-May-2022, at 09:40 am vaccine administered. The vial was stored in Room temp, out of direct light post puncture. The vial not underwent any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was reported as 23hrs 2 min, beyond 12 hours, but less than 24hrs of exposure to room temperature. No treatment drug were reported. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow up document contain no new information.
Approx. 1 hour, post vax, child cried inconsolably. Mom called us after 3 1/2 hours (at 16:30 PM). She was told to give Tylenol and call back within the hour. Pt continuing to cry until 20:00 when family sent to ER. Temperature was 100.4F. Child did not stop crying until 03:00.
Fever; really tired; Feeling cold; Cold sweat; Chills; This is a spontaneous report from a contactable consumer (Patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), Solution for injection, intramuscular, administered in Arm Right on 08Feb2021 09:15 (at the age of 69-year-old) as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. Patient did not receive any other vaccine with four weeks of COVID vaccine. On an unspecified date in Feb2021, the patient experienced fever, really tired, feeling cold and chills. It was reported that, it had been 11 days since she received the vaccine. She had the vaccine on 08 Feb 2021 and Friday, 19 Feb 2021, or maybe the day before that, she began to feel really tired. But she put it down to it being weather related because her area has had a month of rain and she was tired of it. By Friday night, she was feeling very cold, but she didn't think about taking her temperature then. Saturday, she woke up having hard chills which went on all day long. She couldn't get warm. That afternoon, she took her temperature and it was almost 102 degrees. She took Tylenol and drank fluids and stayed in bed. Her seat was wrapped in a heating pad, trying to get warm. Sunday morning, she broke out in a cold sweat and the fever broke. Feeling much better yesterday, then last night, just before dark, the fever came back. She explained it was not quite as much of a fever, but the fever and chills came back. This morning, her fever had broken and she was feeling much better. With the number of days that passed to start with, she thought "do you have COVID?", But in reasoning, she didn't have any respiratory symptoms and other things to her knowledge would indicate COVID. After speaking with her daughter and talking to her about it, her daughter told her "you have a reaction". The patient underwent lab tests and procedures which included body temperature: 102 degrees in Feb2021. She took Tylenol and drank fluids as a therapeutic measure to treat adverse events. The adverse event was not resulted into emergency room or physician office visit. No test was performed. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.
Patient given Tdap instead of DTaP.  Called CDC info line who advised that reimmunization not needed since this was 5th dose.
Administration Error, Incorrect mRNA COVID-19 vaccine product was administered as a 3rd dose booster instead of Bivalent.
>>MESSAGE (06/30/22 09:50 AM):  >> Mom called and stated pt. received vaccines last week. He developed a fever on Tuesday. Tmax 104.4, but stays around 100-101 with motrin and tylenol. She was wondering whether the MMR would cause this. I spoke w/ Dr. and reviewed this online and per website "around 7 to 11 days after the injection, babies or young children may feel a bit unwell or develop a high temperature for about 2 or 3 days."  Dr. recommended a covid test to be sure and to monitor for other symptoms in case it is not a vaccine reaction. Relayed this to mom and advised her to call us tomorrow if the fever has not broken.  I spoke w/ mom on 7/1/22 and she stated pt.'s fever has come down to 100.3 without Tylenol or Motrin. Advised to continue to monitor. If his fever resumes or he begins not feeling well over the weekend, advised to contact our after-hours line for further instruction.
Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; No adverse event; Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    This case contains information for the 03 out of 15 patients as described by the reporter.  No concomitant medication information was provided.  Beyond use date 08-Jan-2023, Administration dates are as follows: 09-Jan-2023 (2 patients), 11-Jan-2023 (4 patients) 12-Jan-2023 (4 patients) 13-Jan-2023 (3 patients). All the patients were 12 years and above, but HCP did not have the information if some of them were below 17 years old.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698566:Master case
Patient received a third dose of the Covid vaccine. His first two vaccines were Moderna. On 9/27 he was given a Pfizer additional dose by mistake. He was called and he is having no side effects that are out of the ordinary.
13 Nov developed numbness from buttocks to toes, muscle weakness made it hard to walk. Seen by ortho 19 Nov - EMG - "mild distal peripheral neuropathy, delayed peroneal motor latencies, and variable peroneal F waves.  12/4/07 Reviewed vax records which confirm lot # as reported.  12/11/07 Reviewed neurologist medical records which reveal patient initially seen 11/29/07 after experienced sudden loss of feeling from waist down approx 2 wks prior.  Had gradually improved prior to visit but still had some numbness & pain in calves & was noted to walk w/a waddling limp.  Tx w/steroids.  Returned to neuro 12/3/07 continuing to improve FINAL DX: atypical Guillain Barre syndrome vs. transverse myelitis, improving.
Patient received the Pfizer COVID-19 on 1/14/21 and 2/8/21 so was fully vaccinated when they tested positive on 9/2/21.
Severe arm pain: immediate and lingering post-admin 15 days. Soreness, inability to raise arm to full extent. Treating with OTC NSAIDS/TYLENOL.
I had a cough, and shortness of breath. I was having difficulty talking because I was so short of breath. I couldn't lay down at night because I was coughing so bad. I went to the doctor, and they ran some tests, and I ended up having Pneumonia. I was prescribed amoxicillin and doxycycline. I have to go back to the doctor on 1/20/23 for an X-Ray.
child was given the PENTACEL but it had reached -2 degree Celsius for 2 hours with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Pharmacist via Global Medical Information (Reference number- 00665902) and transmitted on 01-Jul-2021.  This case involves a child patient who was administered with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] but it had reached minus 2 degree Celsius for 2 hours (product storage error).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site for prophylactic vaccination (product storage error).   Cause of the excursion is unknown to reporter. HCP (Healthcare professional) states that the patient should get his shots again but the mother thinks it's too quickly, is there anything she should look out for? Should she bring her baby in so soon?  It was an actual medication error case due to product storage error temperature too low(latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
pt recv vax & joints ached-2months p/vax;pt devel migraines, eye sight failed;MRI poss tumor;brain biopsy inflammation of the brain;
Clinical team member administered the adjuvant only.  After realizing, she advised patient and then correctly mixed the shingrix with the adjuvant and administered the vaccine.  No immediate adverse symptoms.
Headache; Sore arm; Body aches; Chills; Low grade fever; Rash/hives on one finger of left hand; Rash/hives on one finger of left hand; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old non-pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in left arm on 26Mar2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient had been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Mar2021 at 12:15, the patient experienced headache, sore arm, body aches, chills, low grade fever, rash and hives on one finger of left hand. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The clinical outcome of the events headache, pain in arm, general body pain, chills, low grade fever, rash and hives was recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician regarding an 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with unidentified Merck hpv vaccine, GARDASIL or GARDASIL 9 valid lot# L043214 with expiration date 30-AUG-2017 (dosing details and route of administration unknown) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726: US-009507513-1701USA004566.
Temperature excursion for PROQUAD, administered to patient; This spontaneous report was received from a registered nurse concerning a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), lot number X007358 with expiration date 08-SEP-2024 for prophylaxis (dose, administration route and anatomical location were not reported).  The administered dose had previous excursion of -14°C to -10°C (-13.8 C) for 0 hours 26 minutes and an additional one of -14°C to -10°C (-13.0 C) for 0 hours 18 minutes (improper storage of product in use).  At the reporting time, the patient's outcome was unknown.; Sender's Comments:  US-009507513-2310USA001447:Case # 02485005
Patient was given improper reconstitution of Smallpox (Acam 2000), was diluted with 0.7 ml of sterile water.  Patient does not have adverse reaction at this time.
About 10:30 at night I became very cold and my teeth started chattering (this has never happened to me before), I got a terrible headache, upset to stomach, sweating.  I WAS AFRAID I WAS  GETTING THE CORONAVIRUS. By 4:00a.m. , 6/13/20, I was not cold, no chattering teeth, but the rest of the day I did not feel good. My arm hurt almost immediately, and still hurts today.
Vomiting, extreme dizziness, headache, severe muscle pain, severe joint pain, involuntary convulsions, fever, chills, insomnia, enlarged painful lymph nodes.
Pericarditis.  Started with pain in right shoulder and trap area on Friday afternoon, started including significant chest pain, pain when breathing.  I recognized symptoms from having pericarditis 15 to 20 years earlier.  Went to Hospital emergency room, where pericarditis was diagnosed.
low back pain, b/l jaw muscle pain, right wrist/hand pain, and left foot/ankle/heel pain.  pain in his b/l hips, upper back/neck, and left hand, sore throat, as well as subjective fevers with an episode of night sweats. Pt with vague syndrome of nonspecific unilateral joint pain (R wrist, L foot, L ankle, L great toe pain) as well as low back and neck pain. Symptoms described as feeling muscle soreness as though he had conducted strenuous exercise, though he denies any such exercise. Events lasted for roughly three months with roving pains and symptoms.
No adverse event Covid 19 vaccine expired 10/27/2022 Given08-29-2022
NARRATIVE: Dizziness & Nausea Vomiting. She has been throwing up since receiving the injection @ 8AM. it is now 1456.
I stood up from a reclined position after having rested for an hour or so, and everything hurt. I had muscle aches and pains all over my body - just soreness everywhere. It was a familiar feeling I have experienced before while having the flu. I also felt very lethargic and these symptoms lasted approximately two and a half days, at which point upon waking up from sleep I felt completely fine. Everything was back to normal. No other symptoms, other than tired & body aches and soreness.
Approximately 6 months after I got my booster shot (Dose 3) I experienced the following symptoms: Body aches, congestion, Cough, Off and on headache, Fatigue. I called my doctor and was prescribed with Nirmatrelvir and Irtonabir. So far as of today I am still experiencing the same symptoms - I am feeling a bit better but still haven't fully recovered.
Pain in arm; Underdose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th July 2019, immediately after receiving Shingrix, the patient experienced pain in arm and underdose. On an unknown date, the outcome of the pain in arm and underdose were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: This pharmacist reported that the patient had pulled away from while being injected due to pain in their arm.  It was not pain from the needle being injected but was felt when the solution was being administered. The reporter consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Patient received vaccine at workplace at 10:20 am and returned to desk. At 10:30 am patient collapsed at desk and fell to the floor. Patient stated that she felt dizzy prior to fainting. Patient laid on back in chair for about 15 minutes until she felt normal.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 10:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:58 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 age of patient was provided as 21.30.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM and 10AM. temperature was 34 and 37 respectively. total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  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 Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
red sore throat; horrible night sweats-soaking the sheets; fever; chills; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (red sore throat), PYREXIA (fever), CHILLS , MYALGIA (body aches) and NIGHT SWEATS (horrible night sweats-soaking the sheets) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cardiac disorder NOS.    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 OROPHARYNGEAL PAIN (red sore throat), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and NIGHT SWEATS (horrible night sweats-soaking the sheets). At the time of the report, OROPHARYNGEAL PAIN (red sore throat), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and NIGHT SWEATS (horrible night sweats-soaking the sheets) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza: negative (Negative) negative. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Streptococcus test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.