chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia oral, Illness, Tongue discomfort
Clinical narrative: lower lip intermediately numb; burning in left thigh; burning throughout different part of my body; I am so sick; tongue felt a burning sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old patient received bnt162b2 (BNT162B2), administration date 12May2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 immunisation. The following information was reported: TONGUE DISCOMFORT (non-serious) with onset 12May2021, outcome "recovered" (May2021), described as "tongue felt a burning sensation"; BURNING SENSATION (non-serious) with onset 13May2021, outcome "unknown", described as "burning in left thigh; burning throughout different part of my body"; ILLNESS (non-serious) with onset 13May2021, outcome "unknown", described as "I am so sick"; HYPOAESTHESIA ORAL (non-serious) with onset 16May2021, outcome "unknown", described as "lower lip intermediately numb".  Additional information: Patient (Pt) received second dose of the Pfizer COVID Vaccine on Wednesday, 12May2021 and Pt started experiencing symptoms on 13May2021 and wanted to find out if this was normal. Actually the first symptom after the couple of hour of shot my tongue felt a burning sensation then it went away it was temporary and the next day when Pt woke up had burning in left thigh and since then Pt was so sick, experiencing temporary burning throughout different part of body and today (at the time of reporting, 16May2021) having lower lip intermediately numb and so was it something heard of.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pain in extremity
Clinical narrative: very sore arm; swollen lymph nodes; felt sick; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Dec2020 (Lot number: Ej1685) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Jan2021, outcome "not recovered", described as "very sore arm"; LYMPHADENOPATHY (non-serious) with onset 19Jan2021, outcome "not recovered", described as "swollen lymph nodes"; MALAISE (non-serious) with onset 19Jan2021, outcome "not recovered", described as "felt sick". The events "very sore arm", "swollen lymph nodes" and "felt sick" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, lymphadenopathy, malaise. Additional information: First dose, she had a very sore arm and swollen lymph nodes and felt sick for weeks, second dose she had the same symptoms but also since second dose, she has had severe joint pain in almost every joint of her body that would not go away. Have now been on multiple vitamins and medications to help with this and still they hurt everyday terribly. AE resulted in doctor or other healthcare professional office/clinic visit. Treatment after the first dose, she was put in medications to help prevent same symptoms with second dose. No covid prior vaccination. No covid tested post vaccination. Known allergies to Penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device date was reported as 19May2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021574729 same reporter/patient/vaccine, different dose
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Vomiting every 30 minutes for 9 hours; Abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14May2021 15:30 (Lot number: EWO173) at the age of 13 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: DULOXETINE. Past drug history included: Augmentin, reaction(s): "known_allergies: Augmentin"; Cefuroxime, reaction(s): "known_allergies: Cefuroxime". The following information was reported: VOMITING (non-serious) with onset 18May2021 12:00, outcome "recovering", described as "Vomiting every 30 minutes for 9 hours"; ABDOMINAL PAIN (non-serious) with onset 18May2021 12:00, outcome "recovering", described as "Abdominal pain". The events "vomiting every 30 minutes for 9 hours" and "abdominal pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vomiting, abdominal pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Also Prior to vaccination, he was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  Additional information: Reporter is a consumer who is asking if diarrhea is a known reaction to the second dose of the Pfizer-Biontech covid19 vaccine? If so, how long would the symptoms last, up to a week?. Reporter said she "had a friend who experienced it, too".  Her friend said "the shot was great" then a few days later she "encountered" the diarrhea. She told her friend it may also be a stomach bug. Reporter was a consumer speaking about the Pfizer-Biontech Covid19 vaccine. She stated that she's glad she got the Pfizer product, and "I think Pfizer's been one of the better ones. Reporter heard people were having a much harder time with Moderna!"   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 64-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed tinnitus and fatigue (felt exhausted), with outcome of unknown. Additional information: After the administration of the first dose of the Pfizer COVID-19 vaccine, patient developed tinnitus and felt exhausted. He received the second dose on March 26. His physician gave him steroids for the management of the tinnitus, and it did not work. His specialist told him she saw the same symptoms in other 6 patients. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021578448 same reporter/drug/event for different patients.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Feeling abnormal, Hypoaesthesia, Joint swelling, Peripheral coldness
Clinical narrative: Did not go into detail about what kind of reaction she was having; feels like a guinea pig and says this is "bullcrap."; That night her feet started feeling really cold; Having an unusual sensation from her ankles down; Her feet are swollen and and it feels like she has wet socks on; it feels like she has wet socks on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chiari I malformation" (unspecified if ongoing); "also had a stent put in her kidney", start date: 2007 (unspecified if ongoing); "VP shunt" (unspecified if ongoing); "Pseudotumor" (unspecified if ongoing), notes: a pseudotumor that had to be untethered on both side of her spine. The patient's concomitant medications were not reported.  The following information was reported: ADVERSE EVENT (non-serious), outcome "unknown", described as "Did not go into detail about what kind of reaction she was having"; PERIPHERAL COLDNESS (non-serious) with onset 05May2021, outcome "unknown", described as "That night her feet started feeling really cold"; HYPOAESTHESIA (non-serious) with onset 05May2021, outcome "unknown", described as "Having an unusual sensation from her ankles down"; JOINT SWELLING (non-serious) with onset 05May2021, outcome "unknown", described as "Her feet are swollen and and it feels like she has wet socks on"; SENSORY DISTURBANCE (non-serious) with onset 05May2021, outcome "unknown", described as "it feels like she has wet socks on"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels like a guinea pig and says this is "bullcrap."  Additional Information: No PQC Present. Unaddressed medical questions were referred or forwarded to Medical Information.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: Did not go into detail about what kind of reaction she was having; feels like a guinea pig and says this is "bullcrap."; That night her feet started feeling really cold; Having an unusual sensation from her ankles down; Her feet are swollen and and it feels like she has wet socks on; it feels like she has wet socks on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chiari I malformation" (unspecified if ongoing); "also had a stent put in her kidney", start date: 2007 (unspecified if ongoing); "VP shunt" (unspecified if ongoing); "Pseudotumor" (unspecified if ongoing), notes: a pseudotumor that had to be untethered on both side of her spine. The patient's concomitant medications were not reported.  The following information was reported: ADVERSE EVENT (non-serious), outcome "unknown", described as "Did not go into detail about what kind of reaction she was having"; PERIPHERAL COLDNESS (non-serious) with onset 05May2021, outcome "unknown", described as "That night her feet started feeling really cold"; HYPOAESTHESIA (non-serious) with onset 05May2021, outcome "unknown", described as "Having an unusual sensation from her ankles down"; JOINT SWELLING (non-serious) with onset 05May2021, outcome "unknown", described as "Her feet are swollen and and it feels like she has wet socks on"; SENSORY DISTURBANCE (non-serious) with onset 05May2021, outcome "unknown", described as "it feels like she has wet socks on"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels like a guinea pig and says this is "bullcrap."  Additional Information: No PQC Present. Unaddressed medical questions were referred or forwarded to Medical Information.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: Severe chest pain for 24 hours
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: severe excruciating disabling chest pain lasting about 24 hours
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Death, Dizziness
Clinical narrative: On 10/1 she received a 3rd COVID-19 vaccination (Pfizer) in her left arm at a local pharmacy.  About 3 hours after the shot she began to feel dizzy and dry heaves. She continued to feel unwell experiencing weakness, GI upset, myalgia, headache and stomachache. Her family contacted her doctor and about 18 hours after the shot she was taken to the Emergency Department.  En route to the hospital, she became unresponsive in PEA arrest.  At the ED she was found to be hypothermic, hypoglycemic and hyperkalemic.  She was admitted to the intensive care unit and later diagnosed with aspiration pneumonia.  She died in the hospital on 10/13/21.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hyperkalaemia, Hypoglycaemia, Hypothermia, Intensive care
Clinical narrative: On 10/1 she received a 3rd COVID-19 vaccination (Pfizer) in her left arm at a local pharmacy.  About 3 hours after the shot she began to feel dizzy and dry heaves. She continued to feel unwell experiencing weakness, GI upset, myalgia, headache and stomachache. Her family contacted her doctor and about 18 hours after the shot she was taken to the Emergency Department.  En route to the hospital, she became unresponsive in PEA arrest.  At the ED she was found to be hypothermic, hypoglycemic and hyperkalemic.  She was admitted to the intensive care unit and later diagnosed with aspiration pneumonia.  She died in the hospital on 10/13/21.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Myalgia, Pneumonia aspiration, Pulseless electrical activity, Retching
Clinical narrative: On 10/1 she received a 3rd COVID-19 vaccination (Pfizer) in her left arm at a local pharmacy.  About 3 hours after the shot she began to feel dizzy and dry heaves. She continued to feel unwell experiencing weakness, GI upset, myalgia, headache and stomachache. Her family contacted her doctor and about 18 hours after the shot she was taken to the Emergency Department.  En route to the hospital, she became unresponsive in PEA arrest.  At the ED she was found to be hypothermic, hypoglycemic and hyperkalemic.  She was admitted to the intensive care unit and later diagnosed with aspiration pneumonia.  She died in the hospital on 10/13/21.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: On 10/1 she received a 3rd COVID-19 vaccination (Pfizer) in her left arm at a local pharmacy.  About 3 hours after the shot she began to feel dizzy and dry heaves. She continued to feel unwell experiencing weakness, GI upset, myalgia, headache and stomachache. Her family contacted her doctor and about 18 hours after the shot she was taken to the Emergency Department.  En route to the hospital, she became unresponsive in PEA arrest.  At the ED she was found to be hypothermic, hypoglycemic and hyperkalemic.  She was admitted to the intensive care unit and later diagnosed with aspiration pneumonia.  She died in the hospital on 10/13/21.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Endotracheal intubation, Hypoxia, Inappropriate schedule of product administration
Clinical narrative: Patient fully vaccinated with Pfizer on 9/17/21 and 10/25/21. Diagnosed with COVID on 11/1/21 and received monoclonal antibodies on 11/5/21. Admitted to hospital for COVID on 11/5/21-11/19/21. Patient chronically immunosuppressed on long term solu-medrol. Patient re-admitted to hospital with severe hypoxia requiring immediate intubation upon arrival. Patient deceased on 12/7/21.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Constant ringing in both ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 04May2021 17:30 (Lot number: ER8735) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 12May2021, outcome "not recovered", described as "Constant ringing in both ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: 8 days after receiving 1st vaccination shot I developed constant ringing in both ears which is still ongoing as of today, 19May2021. Hospitalization Prolonged: No. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient was not received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Otitis media, Otitis media acute, Pyrexia, Rash
Clinical narrative: My Medical Assistant accidentally gave MMRV plus Varicella instead of MMR plus varicella, resulting on extra dose of varicella vaccine  Child started having high fevers up to 103 three days after immunizations. I saw baby in clinic and diagnosed with viral URI and bilateral acute otitis media, started on antibiotic (cefdinir), offered Covid 19 and flu testing which parents refused.  Baby presented on 12/22/21 with widespread rash. Parents were concerned about varicella. Provider thinks maybe viral rash vs delayed reaction to antibiotic. Rash compeletly resolved
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Viral upper respiratory tract infection, Wrong product administered
Clinical narrative: My Medical Assistant accidentally gave MMRV plus Varicella instead of MMR plus varicella, resulting on extra dose of varicella vaccine  Child started having high fevers up to 103 three days after immunizations. I saw baby in clinic and diagnosed with viral URI and bilateral acute otitis media, started on antibiotic (cefdinir), offered Covid 19 and flu testing which parents refused.  Baby presented on 12/22/21 with widespread rash. Parents were concerned about varicella. Provider thinks maybe viral rash vs delayed reaction to antibiotic. Rash compeletly resolved
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Blood test, Chest X-ray, Computerised tomogram, Dyspnoea
Clinical narrative: Pt. states that after receiving the 3rd dose of Moderna 11/22/2021, started experiencing symptoms 11/23/2021 of a rash developing on both legs (self-treated with Cortisone Cream Steroid) lasting 1 hr. 12/2021 estimated 2 weeks after initial dose experienced shortness of breath, nausea, and loss of consciousness. Emergency Room visit 12/2021, O2 low, pulse low reading, kept for observation.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Heart rate, Hypersensitivity, Mobility decreased, Nausea
Clinical narrative: Pt. states that after receiving the 3rd dose of Moderna 11/22/2021, started experiencing symptoms 11/23/2021 of a rash developing on both legs (self-treated with Cortisone Cream Steroid) lasting 1 hr. 12/2021 estimated 2 weeks after initial dose experienced shortness of breath, nausea, and loss of consciousness. Emergency Room visit 12/2021, O2 low, pulse low reading, kept for observation.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Speech disorder, Wheezing
Clinical narrative: Pt. states that after receiving the 3rd dose of Moderna 11/22/2021, started experiencing symptoms 11/23/2021 of a rash developing on both legs (self-treated with Cortisone Cream Steroid) lasting 1 hr. 12/2021 estimated 2 weeks after initial dose experienced shortness of breath, nausea, and loss of consciousness. Emergency Room visit 12/2021, O2 low, pulse low reading, kept for observation.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Dyspnoea, Heart rate decreased, Loss of consciousness
Clinical narrative: Pt. states that after receiving the 3rd dose of Moderna 11/22/2021, started experiencing symptoms 11/23/2021 of a rash developing on both legs (self-treated with Cortisone Cream Steroid) lasting 1 hr. 12/2021 estimated 2 weeks after initial dose experienced shortness of breath, nausea, and loss of consciousness. Emergency Room visit 12/2021, O2 low, pulse low reading, kept for observation.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Nausea, Oxygen saturation decreased, Rash
Clinical narrative: Pt. states that after receiving the 3rd dose of Moderna 11/22/2021, started experiencing symptoms 11/23/2021 of a rash developing on both legs (self-treated with Cortisone Cream Steroid) lasting 1 hr. 12/2021 estimated 2 weeks after initial dose experienced shortness of breath, nausea, and loss of consciousness. Emergency Room visit 12/2021, O2 low, pulse low reading, kept for observation.
Age: 56.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Burning sensation, Electromyogram, Hypoaesthesia, Inflammation, Magnetic resonance imaging head
Clinical narrative: Severe pain, numbness, tingling of both hands and up the arms. Blood work, MRI of head and C-spine, EMG & NCS
Age: 56.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Magnetic resonance imaging neck, Nerve conduction studies, Orthosis user, Pain, Sleep disorder
Clinical narrative: Severe pain, numbness, tingling of both hands and up the arms. Blood work, MRI of head and C-spine, EMG & NCS
Age: 56.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Blood test, Electromyogram, Hypoaesthesia, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Severe pain, numbness, tingling of both hands and up the arms. Blood work, MRI of head and C-spine, EMG & NCS
Age: 56.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Nerve conduction studies, Pain, Paraesthesia
Clinical narrative: Severe pain, numbness, tingling of both hands and up the arms. Blood work, MRI of head and C-spine, EMG & NCS
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 11 year old female received 1st dose of Pfizer covid 19 vaccine and was inadvertently administered 12+ dose of Pfizer instead of 5-11 year old dose.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 11 year old female received 1st dose of Pfizer covid 19 vaccine and was inadvertently administered 12+ dose of Pfizer instead of 5-11 year old dose.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Hemiplegia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: patient stated tingling in lips began soon after injection, although she did not report at the time. Within 5 days she had developed facial Bell's Palsy which is mostly resolved after 28 days.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: patient stated tingling in lips began soon after injection, although she did not report at the time. Within 5 days she had developed facial Bell's Palsy which is mostly resolved after 28 days.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Paraesthesia oral
Clinical narrative: patient stated tingling in lips began soon after injection, although she did not report at the time. Within 5 days she had developed facial Bell's Palsy which is mostly resolved after 28 days.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Inappropriate schedule of product administration, Oedema peripheral
Clinical narrative: 12 year old given Moderna booster 0.25ml.  Next day complaints of axillary swelling, axillary pain, chills.  Side effects resolve within 3 days.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Oedema peripheral, Product administered to patient of inappropriate age
Clinical narrative: 12 year old given Moderna booster 0.25ml.  Next day complaints of axillary swelling, axillary pain, chills.  Side effects resolve within 3 days.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: difficulties walking up stairs and sometimes just walking; weakness in both of my legs mostly below my knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 11:45 (Lot number: EW0175) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (feeling sick, dose 1, Administration time: 03:45 PM, Vaccine location: Right arm, Lot number: ER8733), administration date: 02Apr2021, when the patient was 51 years old, for Covid-19 Immunization, reaction(s): "Feeling sick", "Body Aches", "Headache", "Fatigue".  The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "difficulties walking up stairs and sometimes just walking"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered", described as "weakness in both of my legs mostly below my knees". Therapeutic measures were not taken as a result of gait disturbance, muscular weakness.  Additional information included: Received the second dose and felt fine for the first couple of days, then I started to experience weakness in both of my legs mostly below my knees. I experience this daily to the point I have difficulties walking up stairs and sometimes just walking. Prior to receiving the vaccine I consider myself to be in reasonably good shape physically, I could walk many miles without any issues including hiking up mountains..    No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: difficulties walking up stairs and sometimes just walking; weakness in both of my legs mostly below my knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 11:45 (Lot number: EW0175) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (feeling sick, dose 1, Administration time: 03:45 PM, Vaccine location: Right arm, Lot number: ER8733), administration date: 02Apr2021, when the patient was 51 years old, for Covid-19 Immunization, reaction(s): "Feeling sick", "Body Aches", "Headache", "Fatigue".  The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "difficulties walking up stairs and sometimes just walking"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered", described as "weakness in both of my legs mostly below my knees". Therapeutic measures were not taken as a result of gait disturbance, muscular weakness.  Additional information included: Received the second dose and felt fine for the first couple of days, then I started to experience weakness in both of my legs mostly below my knees. I experience this daily to the point I have difficulties walking up stairs and sometimes just walking. Prior to receiving the vaccine I consider myself to be in reasonably good shape physically, I could walk many miles without any issues including hiking up mountains..    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: NO OTHER AE; The caller said inadverntently administered a dose expired of GARDASIL 9; This spontaneous report has been received from a nurse, concerning patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, current conditions, previous drug reactions, or allergies.  On 11-FEB-2022, the patient was inadvertently vaccinated with one expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (lot number 1581027 has been verified to be a valid lot number, expiration date reported and established as 03-JUN-2021) (exact dose, route and anatomical location of administration were not reported) (expired product administered). No other adverse events (AE) reported (no adverse event), no temperature excursion occurred prior to administration.
Age: 6.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient was administered expired MMRII; This spontaneous report was received from medical assistance referring to a 6-year-old patient of unreported gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 10-FEB-2022, the patient vaccinated with expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) (Expired product administered) (subcutaneous injection, lot number T003384, expiration date: 28-JAN-2022, dose, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. There was no temperature excursion affected on measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II).   No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller reported GARDASIL 9 was involved in this possible excursion, and caller stated the GARDASIL 9 was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-FEB-2022, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, 0.5 milliliter, lot #U007667, expiration date: 23-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided) after a potential temperature excursion occurred. The data logger stopped recording for 24 hours, however, there were no specific temperatures to evaluate. The vaccine did not undergo previous temperature excursion. The patient did not experience any adverse event.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Gaze palsy, Inappropriate schedule of product administration, Seizure
Clinical narrative: Patient was administered GARDASIL 9 and then had a seizure for 30 seconds with his eyes rolling into the back of head; Patient was administered GARDASIL 9 and then had a seizure for 30 seconds with his eyes rolling into the back of head; This spontaneous report was received from a certified medical assistant referring to a male patient of unknown age. The patient had not concurrent conditions, pertinent medical history, and drug reactions/allergies. Concomitant therapies were reported as "other unspecified medication".  On 24-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, 0.5 milliliter, lot #T036812, expiration date: 28-APR-2023, administered intramuscularly as human papilloma virus (HPV) prevention.   On 15-FEB-2022, the patient was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage regimen, route of administration, lot# and expiration date were not reported), and then had a seizure for 30 seconds with his eyes rolling into the back of head; however, the patient remembered what was happening and stated that has never had a seizure before, and she also ate before coming to the clinic. No treatment was given for the events, and laboratories (unspecified) were performed (results not provided). At the time of the report, the outcome of the event was unknown.  The causal relationship between the events of seizure, eyes movement disorder, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  Upon internal review, the event of seizure was determined to be medically significant.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for Covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F, 302M208 and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive for Covid). The patient was treated with MOLNUPIRAVIR ongoing from 14-Feb-2022 for COVID-19, at a dose of every 12 hours. At the time of the report, COVID-19 (Positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications was reported.  Company Comment: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious, and AESI of COVID-19. The event occurred 3 months and 13 days after the third dose of mRNA-1273 vaccine. Primary vaccination against COVID-19 completed with mRNA-1273 vaccine, with and inappropriate schedule, as doses were given 66 days apart. Patient reports that he visited his doctor and tested positive for COVID-19. He was asymptomatic, and received treatment with molnupiravir. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-486840 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious, and AESI of COVID-19. The event occurred 3 months and 13 days after the third dose of mRNA-1273 vaccine. Primary vaccination against COVID-19 completed with mRNA-1273 vaccine, with and inappropriate schedule, as doses were given 66 days apart. Patient reports that he visited his doctor and tested positive for COVID-19. He was asymptomatic, and received treatment with molnupiravir. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Complications; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Complications) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Complications). At the time of the report, VACCINATION COMPLICATION (Complications) outcome was unknown.            No concomitant medication was reported. No treatment medications was reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: The patient also had a sore left injection site arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The patient also had a sore left injection site arm) and HEADACHE (Headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The patient also had a sore left injection site arm) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (The patient also had a sore left injection site arm) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2022-487475, MOD-2022-487384 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Doses administered to 3 patients after temperature excursion; Temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to 3 patients after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022 at 8:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered to 3 patients after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to 3 patients after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Doses administered after temperature excursion; Doses administered after temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after temperature excursion) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine was administered on left side intramuscularly.  No concomitant products were reported. No adverse event reported.  No treatment details were reported.  On Monday 07-Feb-2022 at 8:00 am, the digital readout on data logger reading -22.5 degree F for freezer and 19.9 degree F for refrigerator. Vaccine bottles from refrigerator had no signs of freeze, which meant no ice or crystallized solids in the vaccine bottle. The refrigerator temperature controller dial adjusted to 5 from initial number 7. No water bottles in refrigerator and frozen coolant packs in freezer at that time or any other times. At 9:11 am, refrigerator data logger reading was 27.7 degree F. Freezer data logger reading was -10.3 degree F. The temperature controller dial was on number 5. At 9:55 am on 07-FEB-2022, refrigerator data logger reading was 32.5 degree F and freezer data logger reading was -0.9 degree F.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago; Patient received vaccine from vial punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J121A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2022 at 10:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received Moderna Covid-19 vaccine from vial punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received first two Moderna COVID-19 vaccines at a different vaccination site. Date the vial initially stored in the refrigerator  was 07-Feb-2022, date and time the vial first punctured was16-Feb-2022 at 10 am. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range was 27 hours. The reporter was not aware of any adverse event complaints.  No treatment information was reported.   This case was linked to MOD-2022-487921, MOD-2022-487948 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash macular, SARS-CoV-2 test, Skin reaction, Urticaria
Clinical narrative: delayed on-site reaction; extreme chronic hives, It is pretty bad, Flare moments; random spots all over the body; Immunologist said that her T-cells were activated, it could be an extreme case of hypersensitivity; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (delayed on-site reaction), URTICARIA (extreme chronic hives, It is pretty bad, Flare moments), RASH MACULAR (random spots all over the body) and HYPERSENSITIVITY (Immunologist said that her T-cells were activated, it could be an extreme case of hypersensitivity) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 022C21A and 032B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu vaccine in November 2021. Past adverse reactions to the above products included No adverse event with flu vaccine.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, the patient experienced SKIN REACTION (delayed on-site reaction), URTICARIA (extreme chronic hives, It is pretty bad, Flare moments), RASH MACULAR (random spots all over the body) and HYPERSENSITIVITY (Immunologist said that her T-cells were activated, it could be an extreme case of hypersensitivity). The patient was treated with FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN REACTION (delayed on-site reaction), URTICARIA (extreme chronic hives, It is pretty bad, Flare moments), RASH MACULAR (random spots all over the body) and HYPERSENSITIVITY (Immunologist said that her T-cells were activated, it could be an extreme case of hypersensitivity) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2020, SARS-CoV-2 test: the result not reported The result not reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient height was reported as 5 feet and 5 inch. The patient had no allergies.  Concomitant medications reported were multivitamins and birth control arm implant.AE caused patient to seek medical care went to PCP and then to immunologist. Symptoms were pretty bad, with same intensity and in the same state. The patient did not experience the similar events in the past.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a 0.25ml dose of the vaccine four months after her second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a 0.25ml dose of the vaccine four months after her second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a 0.25ml dose of the vaccine four months after her second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a 0.25ml dose of the vaccine four months after her second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient was not immunocompromised back then, but at the time of reporting she was.  Treatment medication was not provided by the reporter.