chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Swelling of eyelid
Clinical narrative: Numbness on the left side of my face, puffy eyelid
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Injection site swelling, Pyrexia
Clinical narrative: Fever, fatigue, swollen at injection site
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Underdose
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Complete dose was administered on 9-19-22
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Underdose
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse event had been reported. Correct dose was administered on 09-18-22
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse event had been reported and correct dose was administered on 09-17-22.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: My son was registered to receive the second dose in his MODERNA Covid-19 series. We confirmed this with the person at the registration desk. After receiving our vaccines, I looked at his vaccine card and noted that the Pfizer sticker was present, not Moderna, indicating he had in fact been given Pfizer instead. My appointment confirmation, and confirmation with the woman registering us--both indicate our need for the second Moderna vaccine in our series.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient has not yet returned for full dose
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported.  Full dose was administered on 9-20-22
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient received full dose on 9-17-22
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Dizziness, Dizziness postural
Clinical narrative: Headaches, dizziness, lightheaded after standing up, shortness of breath, high blood pressure, fatigue, brain fog, chest pain
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Fatigue, Feeling abnormal, Headache
Clinical narrative: Headaches, dizziness, lightheaded after standing up, shortness of breath, high blood pressure, fatigue, brain fog, chest pain
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Headaches, dizziness, lightheaded after standing up, shortness of breath, high blood pressure, fatigue, brain fog, chest pain
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient has not yet returned for the full dose.
Age: 62.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient has not yet returned for full dose.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.25ml as a dose instead of the 0.5ml. Patient was informed of the situation and will receive the 0.5ml dose 8 weeks after the 0.25 ml (non-qualifying) dose,  as were the instructions per the CDC for such an event.
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient received full dose on 9-16-22
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient has not yet returned for full dose.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Underdose
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient has not yet returned for full dose.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, Vaccination error
Clinical narrative: Patient and I made an appointment at the Pharmacy to receive her Pfizer Covid-19 vaccination. Patient has not been vaccinated for Covid-19 before and signed up to get the first of the primary shots. When he finished administering the shot, I asked him to schedule the 2nd dose. He looked at me weird and said there wasn?t one and then he realized the error. He gave her the Bivalent Booster shot instead of the Pfizer original one. SHE HAS NOT BEEN PREVIOUSLY VACCINATED! There was no checking of vaccine cards or anything (she doesn?t have one anyway/never vaccinated). He then said he needed to call the CDC and Pfizer right away to find out how to proceed. He also mentioned to me that the boxes look similar between the primary vaccine and the booster one - his mistake Ugh. My daughter had to get the Covid-19 vaccine for her class at school, and this better not prevent that. Also, I am worried about if my daughter will have a reaction to a booster that was given without getting the Covid-19 primary series or vaccinations. He said the CDC and Pfizer told him she is fully vaccinated with only getting the Bivalent booster, but that there were not studies on reactions with only getting the booster. He also mentioned he sent a report to VAERS as well. I need answers as to the reason that you must be vaccinated previously before getting boosters and if this will affect my daughter, patient as far as health, vaccine cards, etc.
Age: 79.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Product preparation error
Clinical narrative: The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse events had been reported. Patient received full dose 9-19-22.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Fall, Headache, Laboratory test, Musculoskeletal disorder
Clinical narrative: Received vaccine on Friday and woke up Monday morning @4am to use the restroom and when stood up R leg gave out and I fell to the floor. It took several minutes before I was able to have strength on R leg to stand. Following that I have had on and off pains in calf area of R leg with constant dull headache mainly on R side.
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Received vaccine on Friday and woke up Monday morning @4am to use the restroom and when stood up R leg gave out and I fell to the floor. It took several minutes before I was able to have strength on R leg to stand. Following that I have had on and off pains in calf area of R leg with constant dull headache mainly on R side.
Age: 19.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Day after shot, injection site became very red and swollen. Two days after, large redness around the injection that has been spreading since. Visited urgent care, was put on antibiotics as a precaution. Was told to take Benadryl as well.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary pain, Injected limb mobility decreased, Limb discomfort, Pain, Peripheral swelling
Clinical narrative: Very painful swelling of the right armpit starting 10-12 hours after receiving the vaccine. Pain is manageable with ibuprofen, but difficult to tolerate without pain reliever. Swelling is significant enough along with pain that lowering right arm is difficult and very uncomfortable.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: Vaccine given IM using 25g, 1 inch needle into (L) deltoid, needle was withdrawn and area bled, bandage was applied, area immediately began to swell and turn red, Dr. was notified, bandage was removed and wiped with alcohol pad, area had stopped bleeding so bandage was left off, pt was observed for 15 minutes, redness measured 5.4 mm x 4.8 mm, swelling measured 4.5 mm x 3.5mm x 0.3mm, pt advised to apply cold compress and call or RTC if worsening symptoms or concerns.
Age: 6.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: incorrect moderna vaccine given for age
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anti-GAD antibody, Type 1 diabetes mellitus
Clinical narrative: Development of  type 1 diabetes
Age: 5.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Started with Rash on both feet 9/19/22 Diffuse urticaria w/o Respiratory Involvement.
Age: 37.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Gave extra dose of PCV13. Recieved dose 6 weeks ago.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: All the COVID stuff like vertigo, mucus, etc. + lower back spasms stopped; All the COVID stuff like vertigo, mucus, etc. + lower back spasms stopped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "All the COVID stuff like vertigo, mucus, etc. + lower back spasms stopped". Clinical course: The patient stated, "I developed lower back spasms, came out of nowhere I also experienced constipation a lot. Visited physical therapist. Then it stopped. All the covid stuff like vertigo, mucus etc and lower back spasms stopped! I feel fine. What an ordeal. Though I'm scared to get the 2nd booster."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200059492 same patient and drug, different dose and event;
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging normal, Photophobia, Tic
Clinical narrative: involuntary vocal and motor tics; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 at 13:00 as dose 2, single (Lot number: FW0196) at the age of 35 years, in left arm for covid-19 immunisation. The patient's family history included: "family history of cancer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer , Prev dose brand unknown=False , Prev dose lot number=FF2587 , Prev dose lot unknown=False , Prev dose administration date= 30Aug2021, Prev dose administration time=01:00 PM, Prev dose dose number=1 , Prev dose vaccine location=Left arm), administration date: 30Aug2021, when the patient was 34-year-old, for Covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: TIC (hospitalization) with onset 30Sep2021, outcome "not recovered", described as "involuntary vocal and motor tics". The patient was hospitalized for tic (hospitalization duration: 1 day(s)). The events "involuntary vocal and motor tics" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Nov2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of tic. Clinical course: Almost immediately after the vaccine was administered, started experiencing involuntary vocal and motor tics, at first small but has steadily grown and become quite severe over the past couple of months. Tics seem to be triggered by sources of bright light and only disappear after prolonged absence of light. Adverse event start date: 30Sep2021. AE resulted in hospitalization: 1. treatment ae was Yes. Ae treatment was resperidone, guanfacine. Adverse event stop date: 09Sep2022. covid was tested post vaccination.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tic
Clinical narrative: involuntary vocal and motor tics; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 27Sep2021 at 13:00 as dose 2, single (Lot number: FW0196) at the age of 35 years, in left arm for covid-19 immunisation. The patient's family history included: "family history of cancer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer , Prev dose brand unknown=False , Prev dose lot number=FF2587 , Prev dose lot unknown=False , Prev dose administration date= 30Aug2021, Prev dose administration time=01:00 PM, Prev dose dose number=1 , Prev dose vaccine location=Left arm), administration date: 30Aug2021, when the patient was 34-year-old, for Covid-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: TIC (hospitalization) with onset 30Sep2021, outcome "not recovered", described as "involuntary vocal and motor tics". The patient was hospitalized for tic (hospitalization duration: 1 day(s)). The events "involuntary vocal and motor tics" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Nov2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of tic. Clinical course: Almost immediately after the vaccine was administered, started experiencing involuntary vocal and motor tics, at first small but has steadily grown and become quite severe over the past couple of months. Tics seem to be triggered by sources of bright light and only disappear after prolonged absence of light. Adverse event start date: 30Sep2021. AE resulted in hospitalization: 1. treatment ae was Yes. Ae treatment was resperidone, guanfacine. Adverse event stop date: 09Sep2022. covid was tested post vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Renal pain
Clinical narrative: My kidneys hurt . very painful; Urinating a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2022 at 11:45 as dose 4 (booster), single (Lot number: gh9694) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. Past drug history included: Pfizer / biontech, start date: 06Jul2021, stop date: 06Jul2021, for Covid-19 immunization, reaction(s): "Covid-19", notes: Dose Number: 1, Batch/Lot No: ew0178, Location of injection: Arm Left; Pfizer / biontech, start date: 23Aug2021, stop date: 23Aug2021, for Covid-19 immunization, reaction(s): "Covid-19", notes: Dose Number: 2, Batch/Lot No: fd8448, Location of injection: Arm Left; Pfizer / biontech, start date: 24Jan2022, stop date: 24Jan2022, for COVID-19 Immunization, reaction(s): "Covid-19", notes: Dose Number: 3, Batch/Lot No: 331308a, Location of injection: Arm Left. The following information was reported: RENAL PAIN (life threatening) with onset 16Sep2022 at 18:00, outcome "not recovered", described as "My kidneys hurt . very painful"; POLLAKIURIA (life threatening) with onset 16Sep2022 at 18:00, outcome "not recovered", described as "Urinating a lot". Therapeutic measures were not taken as a result of renal pain, pollakiuria.
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My kidneys hurt . very painful; Urinating a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2022 at 11:45 as dose 4 (booster), single (Lot number: gh9694) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. Past drug history included: Pfizer / biontech, start date: 06Jul2021, stop date: 06Jul2021, for Covid-19 immunization, reaction(s): "Covid-19", notes: Dose Number: 1, Batch/Lot No: ew0178, Location of injection: Arm Left; Pfizer / biontech, start date: 23Aug2021, stop date: 23Aug2021, for Covid-19 immunization, reaction(s): "Covid-19", notes: Dose Number: 2, Batch/Lot No: fd8448, Location of injection: Arm Left; Pfizer / biontech, start date: 24Jan2022, stop date: 24Jan2022, for COVID-19 Immunization, reaction(s): "Covid-19", notes: Dose Number: 3, Batch/Lot No: 331308a, Location of injection: Arm Left. The following information was reported: RENAL PAIN (life threatening) with onset 16Sep2022 at 18:00, outcome "not recovered", described as "My kidneys hurt . very painful"; POLLAKIURIA (life threatening) with onset 16Sep2022 at 18:00, outcome "not recovered", described as "Urinating a lot". Therapeutic measures were not taken as a result of renal pain, pollakiuria.
Age: 54.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Pollakiuria, Renal pain
Clinical narrative: My kidneys hurt . very painful; Urinating a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2022 at 11:45 as dose 4 (booster), single (Lot number: gh9694) at the age of 54 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. Past drug history included: Pfizer / biontech, start date: 06Jul2021, stop date: 06Jul2021, for Covid-19 immunization, reaction(s): "Covid-19", notes: Dose Number: 1, Batch/Lot No: ew0178, Location of injection: Arm Left; Pfizer / biontech, start date: 23Aug2021, stop date: 23Aug2021, for Covid-19 immunization, reaction(s): "Covid-19", notes: Dose Number: 2, Batch/Lot No: fd8448, Location of injection: Arm Left; Pfizer / biontech, start date: 24Jan2022, stop date: 24Jan2022, for COVID-19 Immunization, reaction(s): "Covid-19", notes: Dose Number: 3, Batch/Lot No: 331308a, Location of injection: Arm Left. The following information was reported: RENAL PAIN (life threatening) with onset 16Sep2022 at 18:00, outcome "not recovered", described as "My kidneys hurt . very painful"; POLLAKIURIA (life threatening) with onset 16Sep2022 at 18:00, outcome "not recovered", described as "Urinating a lot". Therapeutic measures were not taken as a result of renal pain, pollakiuria.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Musculoskeletal stiffness, SARS-CoV-2 test
Clinical narrative: Neck and shoulder stiffness; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck and shoulder stiffness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MCOA) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck and shoulder stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck and shoulder stiffness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had no allergies.  The patient never tested positive for COVID-19.  Patient received 14 different medications but not specified the names.   Treatment: Spray for insect bites.   This case was linked to MOD-2022-645125, MOD-2022-645288 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mass, Pruritus
Clinical narrative: Neck and shoulder stiffness; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck and shoulder stiffness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MCOA) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck and shoulder stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck and shoulder stiffness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had no allergies.  The patient never tested positive for COVID-19.  Patient received 14 different medications but not specified the names.   Treatment: Spray for insect bites.   This case was linked to MOD-2022-645125, MOD-2022-645288 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Neck and shoulder stiffness; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Neck and shoulder stiffness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MCOA) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck and shoulder stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Neck and shoulder stiffness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had no allergies.  The patient never tested positive for COVID-19.  Patient received 14 different medications but not specified the names.   Treatment: Spray for insect bites.   This case was linked to MOD-2022-645125, MOD-2022-645288 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: sick; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 10Mar2021, when the patient was 68-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE), administration date: 31Mar2021, when the patient was 68-year-old, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: It was reported the patient was supposed to get her second booster last Tuesday (as of report) but she was sick. Caller stated that starting on 01Sep2022 through 04Sep2022, patient ran a really high fever 101-103.1, but that was with the Covid, not from the Paxlovid. Stated when patient runs a high fever, she usually felt weak for a few days after but these side effects are really bad.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 10Mar2021, when the patient was 68-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE), administration date: 31Mar2021, when the patient was 68-year-old, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: It was reported the patient was supposed to get her second booster last Tuesday (as of report) but she was sick. Caller stated that starting on 01Sep2022 through 04Sep2022, patient ran a really high fever 101-103.1, but that was with the Covid, not from the Paxlovid. Stated when patient runs a high fever, she usually felt weak for a few days after but these side effects are really bad.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Foreign travel, Gait disturbance, General physical health deterioration, Impaired work ability
Clinical narrative: PAIN IN RIGHT LEG JOINTS; This spontaneous report received from a consumer concerned a 40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy and physically active individual with no notable medical history prior to receiving the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, administered on 11-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 40 years old. No concomitant medications were reported. On 2021, the patient experienced pain in right leg joints. Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in right leg joints was not reported. This report was non-serious. This case, involving the same patient is linked to 20220938918.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Laboratory test, Polyarthritis
Clinical narrative: PAIN IN RIGHT LEG JOINTS; This spontaneous report received from a consumer concerned a 40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy and physically active individual with no notable medical history prior to receiving the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, administered on 11-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 40 years old. No concomitant medications were reported. On 2021, the patient experienced pain in right leg joints. Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in right leg joints was not reported. This report was non-serious. This case, involving the same patient is linked to 20220938918.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: PAIN IN RIGHT LEG JOINTS; This spontaneous report received from a consumer concerned a 40 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was healthy and physically active individual with no notable medical history prior to receiving the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, administered on 11-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 40 years old. No concomitant medications were reported. On 2021, the patient experienced pain in right leg joints. Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in right leg joints was not reported. This report was non-serious. This case, involving the same patient is linked to 20220938918.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: left side of her neck was swollen/glands on that side that are swollen; She says that it seems like it may be the glands on that side that are swollen; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (left side of her neck was swollen/glands on that side that are swollen), LYMPHADENOPATHY (She says that it seems like it may be the glands on that side that are swollen), CHILLS (chills) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 001L21-2A, 009021A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included Injury (some preexisting damage in arm. It possibly could have been due to the previous injury.). Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE and INFLUENZA VACCINE (experienced similar event with Flu shot). Past adverse reactions to the above products included Chills with INFLUENZA VACCINE; and Fever with INFLUENZA VACCINE. Concurrent medical conditions included Sjogren's syndrome (from 15 years), Drug allergy (Dicyclomine) and Allergy to antibiotic (Ciprofloxacin). Concomitant products included LEVOTHYROXINE, ALENDRONATE SODIUM (ALENDRONATE), LORAZEPAM, ESTRADIOL, AMLODIPINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2022, the patient experienced CHILLS (chills) and PYREXIA (fever). On 15-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWELLING (left side of her neck was swollen/glands on that side that are swollen) and LYMPHADENOPATHY (She says that it seems like it may be the glands on that side that are swollen). At the time of the report, SWELLING (left side of her neck was swollen/glands on that side that are swollen) and LYMPHADENOPATHY (She says that it seems like it may be the glands on that side that are swollen) outcome was unknown and CHILLS (chills) and PYREXIA (fever) had resolved.            Patients height was reported as 147.3 cm. The patient experienced a similar event in the past with flu shot. It was reported that the previous Moderna COVID-19 vaccines has made patient really sick. Patient had never been diagnosed with/ tested positive for COVID-19. No vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek any medical care No treatment drug details was reported.   This case was linked to MOD-2022-646746, MOD-2021-272492 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: left side of her neck was swollen/glands on that side that are swollen; She says that it seems like it may be the glands on that side that are swollen; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (left side of her neck was swollen/glands on that side that are swollen), LYMPHADENOPATHY (She says that it seems like it may be the glands on that side that are swollen), CHILLS (chills) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 001L21-2A, 009021A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included Injury (some preexisting damage in arm. It possibly could have been due to the previous injury.). Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE and INFLUENZA VACCINE (experienced similar event with Flu shot). Past adverse reactions to the above products included Chills with INFLUENZA VACCINE; and Fever with INFLUENZA VACCINE. Concurrent medical conditions included Sjogren's syndrome (from 15 years), Drug allergy (Dicyclomine) and Allergy to antibiotic (Ciprofloxacin). Concomitant products included LEVOTHYROXINE, ALENDRONATE SODIUM (ALENDRONATE), LORAZEPAM, ESTRADIOL, AMLODIPINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2022, the patient experienced CHILLS (chills) and PYREXIA (fever). On 15-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWELLING (left side of her neck was swollen/glands on that side that are swollen) and LYMPHADENOPATHY (She says that it seems like it may be the glands on that side that are swollen). At the time of the report, SWELLING (left side of her neck was swollen/glands on that side that are swollen) and LYMPHADENOPATHY (She says that it seems like it may be the glands on that side that are swollen) outcome was unknown and CHILLS (chills) and PYREXIA (fever) had resolved.            Patients height was reported as 147.3 cm. The patient experienced a similar event in the past with flu shot. It was reported that the previous Moderna COVID-19 vaccines has made patient really sick. Patient had never been diagnosed with/ tested positive for COVID-19. No vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek any medical care No treatment drug details was reported.   This case was linked to MOD-2022-646746, MOD-2021-272492 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: Aches; Moderna 4th dose and covid 19 booster taken on 4-APR-2022 (same day); This spontaneous case was reported by a patient and describes the occurrence of PAIN (Aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 4th dose and covid 19 booster taken on 4-APR-2022 (same day)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE for an unknown indication.    Concurrent medical conditions included Allergy (No drug).   On 04-Apr-2022, the patient received third dose of COVID-19 VACCINE (unknown route) 1 dosage form. On 04-Apr-2022 at 8:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 4th dose and covid 19 booster taken on 4-APR-2022 (same day)). On an unknown date, the patient experienced PAIN (Aches). At the time of the report, PAIN (Aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 4th dose and covid 19 booster taken on 4-APR-2022 (same day)) outcome was unknown.            It was reported that concomitant medication included patient took flu vaccine on 09-SEP-2022 on arm.  It was reported that patient was not diagnosed with COVID-19, before and after administration of COVID-19 Vaccine.  No treatment medication were reported.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: Aches; Moderna 4th dose and covid 19 booster taken on 4-APR-2022 (same day); This spontaneous case was reported by a patient and describes the occurrence of PAIN (Aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 4th dose and covid 19 booster taken on 4-APR-2022 (same day)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE for an unknown indication.    Concurrent medical conditions included Allergy (No drug).   On 04-Apr-2022, the patient received third dose of COVID-19 VACCINE (unknown route) 1 dosage form. On 04-Apr-2022 at 8:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 4th dose and covid 19 booster taken on 4-APR-2022 (same day)). On an unknown date, the patient experienced PAIN (Aches). At the time of the report, PAIN (Aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna 4th dose and covid 19 booster taken on 4-APR-2022 (same day)) outcome was unknown.            It was reported that concomitant medication included patient took flu vaccine on 09-SEP-2022 on arm.  It was reported that patient was not diagnosed with COVID-19, before and after administration of COVID-19 Vaccine.  No treatment medication were reported.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received the pediatric dose of the Pfizer-Biontech covid vaccine for the second dose instead of the toddler dose at around 10am. Parent was contacted around 3pm when the error was noticed by afternoon pharmacist. At the time no side effects noted, but was counseled on what to watch for in case of reaction. Pediatrician was also notified of the error.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: Pruitis
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discomfort, Flushing
Clinical narrative: At 1:20pm Patient felt a little flushed and felt little pressure like face is blowing up. Vital was taken BP:150/83, HR:73, Oxygen:97. No EMS. Patient report might have high blood pressure. Patient was observed another 10mins and nurse retake vital BP: 123/83. Patient felt better and cleared by nurse.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Headache, Injection site inflammation, Injection site paraesthesia, Lymphadenopathy
Clinical narrative: Paresthesias distal to injection site (ulnar nerve distribution): onset 6 hours after administration, fading alongside inflammation around injection site 18 hours after vaccination. Fever, headache, lightheadedness, nausea: onset 11 hours after administration, with nausea persisting until 30 hours post-vaccination. Neck pain, mild bilateral cervical adenopathy: onset 11 hours after administration, with right-sided neck pain persisting beyond all other symptoms (hour 128+ post-vaccination).
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Neck pain, Pyrexia, Ulnar nerve injury
Clinical narrative: Paresthesias distal to injection site (ulnar nerve distribution): onset 6 hours after administration, fading alongside inflammation around injection site 18 hours after vaccination. Fever, headache, lightheadedness, nausea: onset 11 hours after administration, with nausea persisting until 30 hours post-vaccination. Neck pain, mild bilateral cervical adenopathy: onset 11 hours after administration, with right-sided neck pain persisting beyond all other symptoms (hour 128+ post-vaccination).
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sleep-related event, Dyskinesia
Clinical narrative: Uncontrollable leg movement ?running movement? when asleep (occurred every minute for several hours).  Stopped if I woke up child.