chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature that product was out of range at 9 C time exposed to temperature was30 minutes or less/ NO AE; Initial information received on 26-May-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information.  This case involves a 6-years-old female patient who received 0.5 mL (VERO) [IPOL] (frequency: once, strength: standard, batch number: R1F801M and expiry date: 28-Sep-2021 via intramuscular route in left deltoid) which was exposed to 9 degree Celsius for 30 minutes and less was given post a temperature excursion that made the vaccine not useable  (product storage error) on 18-Mar-2021 for prophylactic vaccination  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  No other vaccines received by patient.  It was potential medication error case due to incorrect product storage.  Excursion occurred on 09-Mar-2021. that the excursion was spotted during an audit of temperatures from a data logger; that three consumers received the vaccine; and that with further verifying dates and times of vaccine administration only two consumers received the vaccine. The clinic calling the manufacturer for guidance. Caller is requesting temperature excursion information for the vaccine.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: patient only received a 0.3 ml dose due to a defective syringe with no AE; patient only received a 0.3 ml dose due to a defective syringe with no AE; Initial information regarding an unsolicited valid non-serious was received from a Pharmacist via Medical Information (Reference number- 00618533) and transmitted to Sanofi on 27-May-2021.  This case involves a patient with unknown gender received a 0.3 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site (underdose) for prophylactic vaccination due to a defective syringe (syringe issue) on an unknown date.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   The reporter asked should the patient be revaccinated.  It was an actual medication error case due to vaccine underdose and syringe issue (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Ipol dose was given to a child with no ae; Initial information regarding an unsolicited valid non-serious was received from a Physician via Medical Information (Reference number- 00620475) and transmitted to Sanofi on 28-May-2021.  This case involves a 7 years old male patient who received a expired dose of suspect IPV (VERO) [IPOL] (lot R1B251M and expiry date: 12-Mar-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 28-May-2021.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   The reporter asked how to proceed.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Fluid retention, Oedema, Palpitations
Clinical narrative: After my first and second Moderna shots my heart raced and 3 weeks after the second shot I started to retain body fluid from heart failure and Edema. also my mother died 3 weeks after her first Moderna shot and also my aunt (her sister) died 3 weeks after her Moderna shot.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest X-ray normal, Chills, Cough, Dyspnoea
Clinical narrative: Chills and shaking 05/27/2021 Cough, fatigue, pain in legs 05/27/2021-05/30/21 I slept nearly all day 05/31/21- 06/02/21 Difficulty breathing + coughing 06/05/21-06/07/21 Fever, pounding headache, Shortness of breath, pain in arms 06/08/2021 Shortness of breath, pain in abdomen, headache, nose feels like it?s underwater, nauseous 06/09/2021
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Nausea, Pain in extremity
Clinical narrative: Chills and shaking 05/27/2021 Cough, fatigue, pain in legs 05/27/2021-05/30/21 I slept nearly all day 05/31/21- 06/02/21 Difficulty breathing + coughing 06/05/21-06/07/21 Fever, pounding headache, Shortness of breath, pain in arms 06/08/2021 Shortness of breath, pain in abdomen, headache, nose feels like it?s underwater, nauseous 06/09/2021
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Somnolence, Tremor
Clinical narrative: Chills and shaking 05/27/2021 Cough, fatigue, pain in legs 05/27/2021-05/30/21 I slept nearly all day 05/31/21- 06/02/21 Difficulty breathing + coughing 06/05/21-06/07/21 Fever, pounding headache, Shortness of breath, pain in arms 06/08/2021 Shortness of breath, pain in abdomen, headache, nose feels like it?s underwater, nauseous 06/09/2021
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria, Immune-mediated neuropathy, Proteinuria, Pyrexia, Urine analysis
Clinical narrative: Proteinuria about 0.5g/L. Hematuria about 200 ery/uL. Fever of 100.5F oral. Malaise. Patient has had similar proteinuria and hematuria in response to viral infections (influenza) before but it had resolved and not been seen in the last year prior to the vaccination. Suspected mild IgA nephropathy but not confirmed. Fever and malaise resolved in 36 hours. Hematuria resolved in about 4 days and proteinuria in about 6 days. No treatment other than tylenol for fever.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Food allergy, Throat tightness
Clinical narrative: Tight throat developed within minutes of shot. When eating later in the day, chest pain as food might have been having difficulty going down. Both symptoms lasted all day but were better the next day.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 7 days after vaccine around where injection was given is now red, swollen, itchy and hot to the touch
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Myalgia
Clinical narrative: Headache, myalgia, elevated heart rate up to 55 bpm above baseline
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: Increased frequency of seizures
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Electrocardiogram, Fatigue
Clinical narrative: Roughly two days after the second Pfizer shot my arm muscle was sore, but then I started having lightheadedness and dizzy spells along with severe fatigue. I've been to several doctors since.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Urine analysis
Clinical narrative: Roughly two days after the second Pfizer shot my arm muscle was sore, but then I started having lightheadedness and dizzy spells along with severe fatigue. I've been to several doctors since.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Glossodynia, Mobility decreased, Pain in extremity
Clinical narrative: Arm hurt, could barely move it. Then he got the chills and a fever, and really tired. Hours later, he said his tongue started to hurt.  I tried to log this on the daily check in but by the time I clicked on the link it said it expired - 12 hours after receiving  - why wouldn't they give you 24 hours?
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm hurt, could barely move it. Then he got the chills and a fever, and really tired. Hours later, he said his tongue started to hurt.  I tried to log this on the daily check in but by the time I clicked on the link it said it expired - 12 hours after receiving  - why wouldn't they give you 24 hours?
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Confusional state, Dyspnoea, Heart rate increased, Hypertension
Clinical narrative: Injection site swollen around my back arm and armpit, small hive left inner elbow, increased heart rate, blood pressure was 183/110. Was hard to breathe, clammy, faint, confused, and panicky. Left arm went numb. I went to hospital twice, and clinic twice due to the symptoms coming and going.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site swelling, Panic reaction, Syncope, Ultrasound scan
Clinical narrative: Injection site swollen around my back arm and armpit, small hive left inner elbow, increased heart rate, blood pressure was 183/110. Was hard to breathe, clammy, faint, confused, and panicky. Left arm went numb. I went to hospital twice, and clinic twice due to the symptoms coming and going.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Injection site swollen around my back arm and armpit, small hive left inner elbow, increased heart rate, blood pressure was 183/110. Was hard to breathe, clammy, faint, confused, and panicky. Left arm went numb. I went to hospital twice, and clinic twice due to the symptoms coming and going.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient received the first dose of GARDASIL 9 in 2016; This spontaneous report was received from a patient of unknown age and gender referring himself/herself. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  In 2016, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not provided) 1 time dose for prophylaxis.         On 07-JUN-2021, the patient inquired if hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dosing schedule was needed to be restarted (inappropriate schedule of product administration).
Sex: F
Vaccine: VARCEL
Symptoms: Autoimmune thyroiditis, Incomplete course of vaccination
Clinical narrative: Hashimoto's disease; missed for second dose; This spontaneous report was received from a physician referring to a 20 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On an unknown date, the patient was vaccinated with 1 out of the 2 required doses of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were not provided) 0.5 milliliter for prophylaxis.         On an unknown date, the patient was diagnosed with Hashimoto's disease and had never had her second dose of varicella virus vaccine live (oka/merck) (VARIVAX).  The outcome of Hashimoto's disease was not recovered. The causality between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.   Upon internal review, Hashimoto's disease was determined to be medically significant.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This case was received via VAERS (Reference number: 1151220) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no treatment medication reported. There was no concomitant medication reported.  The patient had a seizure about 10 minutes after the vaccine was given.  She had reported to us ahead of time that she has a seizure disorder.  Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's underlying condition of seizure disorder remains a confounder. Further information can't be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's underlying condition of seizure disorder remains a confounder. Further information can't be requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Got shingles vaccine / my arms are in pain since then; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine few months ago and experienced pain in arm. The follow up would not be possible as no contact details available.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the maladministration of Infanrix in a 7 year old male patient.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Sales representative that maladministration of Infanrix in a 7 year old male patient which led to inappropriate age at vaccine administration. No further details were provided at the time of the call. No more details about the vaccine or the patient were provided at the time of the call. The reporter mentioned the health care professional (HCP) who told her about the adverse event consented to follow-up by email.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Feeling hot, Injected limb mobility decreased, Muscle injury, Pain in extremity
Clinical narrative: swollen from her elbow to her shoulder; had arm pain/  her arm is still hurting; her arm is still hurting, hot; 25G needle was used by the office which she believes may have caused a muscle injury.; , and lost the use of her arm for 5 days,; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injected limb mobility decreased, pain in arm, extremities hot feeling of and muscle injury. The patient was treated with ibuprofen and lidocaine (Lidocaine Patch). On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm, extremities hot feeling of and muscle injury were not recovered/not resolved and the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injected limb mobility decreased, pain in arm, extremities hot feeling of and muscle injury to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received 1st dose of shingrix and experienced  arm pain, and lost the use of her arm for 5 days, her arm was still hurting, hot and swollen from her elbow to her shoulder. The reporter informed that 25g needle was used by the office which she believed might had caused the muscle injury. The patient took medication Ibuprofen 800 mg every 4 hours and put a Lidocaine patch on her arm for pain relief. The reporter consented to follow up
Age: 66.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid component of Menveo vaccine; received only the liquid component of Menveo vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date unknown) for prophylaxis.   On 1st May 2021, the patient received Menveo. On 1st May 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the liquid component of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The batch number was reported as AMXA38OA and was updated to AMVA380A, as per sales data sheet. The reporter consented to follow up.
Age: 16.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Wrong product administered
Clinical narrative: Patient received Bexsero on 08/14/2019 and Trumenba on 11/09/2020; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old patient who received Men B NVS (Bexsero) (batch number ABX797AA, expiry date 30th September 2020) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 14th August 2019, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th November 2020, the patient received TRUMENBA. In November 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: After receiving Bexsero, the patient received Trumenba on 9th November 2020, which led to interchange of vaccine products. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose during 2018 and 2nd dose was never administrated to patient; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got Shingrix shot #1 on 20-Jan-2020 / has not yet received shot #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 20th January 2020 intramuscularly in an unspecified arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter was the patient.  Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that,the patient had passed the 6 months window. The reporter did not want to share MD contact information. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hot flush
Clinical narrative: TIREDNESS/INTENSE FATIGUE; moderate flu symptoms; HOT FLASHES; SWEATS THROUGHOUT THE NIGHT; light sinus pain and pressure; slight joint pain; CHILLS/CHATTERING TEETH; light muscle pain; LIGHT PAIN IN MY ARM FROM THE INJECTION; moderate headache; moderate nausea; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy season. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced moderate flu symptoms. On MAR-2021, the subject experienced hot flashes. On MAR-2021, the subject experienced sweats throughout the night. On MAR-2021, the subject experienced light sinus pain and pressure. On MAR-2021, the subject experienced slight joint pain. On MAR-2021, the subject experienced chills/chattering teeth. On MAR-2021, the subject experienced light muscle pain. On MAR-2021, the subject experienced light pain in my arm from the injection. On MAR-2021, the subject experienced moderate headache. On MAR-2021, the subject experienced moderate nausea. On 13-MAR-2021, the subject experienced tiredness/intense fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from moderate flu symptoms, hot flashes, sweats throughout the night, light sinus pain and pressure, slight joint pain, chills/chattering teeth, light muscle pain, light pain in my arm from the injection, moderate headache, moderate nausea, and tiredness/intense fatigue on MAR-2021. The reporter causality and company causality between JNJ-78436735 and events moderate flu symptoms, hot flashes, sweats throughout the night, light sinus pain and pressure, slight joint pain, chills/chattering teeth, light muscle pain, light pain in my arm from the injection, moderate headache, moderate nausea, and tiredness/intense fatigue was possible. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Myalgia, Nausea, Night sweats
Clinical narrative: TIREDNESS/INTENSE FATIGUE; moderate flu symptoms; HOT FLASHES; SWEATS THROUGHOUT THE NIGHT; light sinus pain and pressure; slight joint pain; CHILLS/CHATTERING TEETH; light muscle pain; LIGHT PAIN IN MY ARM FROM THE INJECTION; moderate headache; moderate nausea; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy season. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced moderate flu symptoms. On MAR-2021, the subject experienced hot flashes. On MAR-2021, the subject experienced sweats throughout the night. On MAR-2021, the subject experienced light sinus pain and pressure. On MAR-2021, the subject experienced slight joint pain. On MAR-2021, the subject experienced chills/chattering teeth. On MAR-2021, the subject experienced light muscle pain. On MAR-2021, the subject experienced light pain in my arm from the injection. On MAR-2021, the subject experienced moderate headache. On MAR-2021, the subject experienced moderate nausea. On 13-MAR-2021, the subject experienced tiredness/intense fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from moderate flu symptoms, hot flashes, sweats throughout the night, light sinus pain and pressure, slight joint pain, chills/chattering teeth, light muscle pain, light pain in my arm from the injection, moderate headache, moderate nausea, and tiredness/intense fatigue on MAR-2021. The reporter causality and company causality between JNJ-78436735 and events moderate flu symptoms, hot flashes, sweats throughout the night, light sinus pain and pressure, slight joint pain, chills/chattering teeth, light muscle pain, light pain in my arm from the injection, moderate headache, moderate nausea, and tiredness/intense fatigue was possible. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: TIREDNESS/INTENSE FATIGUE; moderate flu symptoms; HOT FLASHES; SWEATS THROUGHOUT THE NIGHT; light sinus pain and pressure; slight joint pain; CHILLS/CHATTERING TEETH; light muscle pain; LIGHT PAIN IN MY ARM FROM THE INJECTION; moderate headache; moderate nausea; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy season. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced moderate flu symptoms. On MAR-2021, the subject experienced hot flashes. On MAR-2021, the subject experienced sweats throughout the night. On MAR-2021, the subject experienced light sinus pain and pressure. On MAR-2021, the subject experienced slight joint pain. On MAR-2021, the subject experienced chills/chattering teeth. On MAR-2021, the subject experienced light muscle pain. On MAR-2021, the subject experienced light pain in my arm from the injection. On MAR-2021, the subject experienced moderate headache. On MAR-2021, the subject experienced moderate nausea. On 13-MAR-2021, the subject experienced tiredness/intense fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from moderate flu symptoms, hot flashes, sweats throughout the night, light sinus pain and pressure, slight joint pain, chills/chattering teeth, light muscle pain, light pain in my arm from the injection, moderate headache, moderate nausea, and tiredness/intense fatigue on MAR-2021. The reporter causality and company causality between JNJ-78436735 and events moderate flu symptoms, hot flashes, sweats throughout the night, light sinus pain and pressure, slight joint pain, chills/chattering teeth, light muscle pain, light pain in my arm from the injection, moderate headache, moderate nausea, and tiredness/intense fatigue was possible. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Piloerection
Clinical narrative: EAR PAIN IN RIGHT EAR THAT COMES AS A STRONG AND QUICK PINCH, LIKE A NERVE PAIN, IT COMES IN TINY SHOCKS AND AFFECTS THE WHOLE AREA AROUND THE RIGHT EAR, AND THROUGH THE RIGHT TEMPLE; CHILLS; A STRONG HEADACHE; GOOSEBUMPS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUN-2021, the subject experienced goosebumps. On 01-JUN-2021, the subject experienced chills. On 01-JUN-2021, the subject experienced a strong headache. On 03-JUN-2021, the subject experienced ear pain in right ear that comes as a strong and quick pinch, like a nerve pain, it comes in tiny shocks and affects the whole area around the right ear, and through the right temple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear pain in right ear that comes as a strong and quick pinch, like a nerve pain, it comes in tiny shocks and affects the whole area around the right ear, and through the right temple, and the outcome of a strong headache, chills and goosebumps was not reported. This report was non-serious. This case, from the same reporter is linked to 20210612255.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Ischaemic stroke, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: its ischemic stroke; I was at store and passed out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ISCHAEMIC STROKE (its ischemic stroke) and LOSS OF CONSCIOUSNESS (I was at store and passed out) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 020B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR), ROPINIROLE, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]), FUROSEMIDE (LASIX [FUROSEMIDE]), QUETIAPINE FUMARATE (SEROQUEL), BUSPIRONE HYDROCHLORIDE (BUSPAR), ESTRADIOL and TRAZODONE for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced ISCHAEMIC STROKE (its ischemic stroke) (seriousness criteria hospitalization and medically significant) and LOSS OF CONSCIOUSNESS (I was at store and passed out) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 27-May-2021 due to ISCHAEMIC STROKE. The patient was treated with ALTEPLASE ongoing since an unknown date at a dose of Activase Alteplase. At the time of the report, ISCHAEMIC STROKE (its ischemic stroke) and LOSS OF CONSCIOUSNESS (I was at store and passed out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Computerised tomogram: abnormal (abnormal) ischemic stroke.. On 27-May-2021, Magnetic resonance imaging: abnormal (abnormal) ischemic stroke..         Patient was in Emergency room for 3 days and 2 days in ICU. patient was shifted to room and  1 day in regular room. In emergency room patient was prescribed with Activase Alteplase for treatment along with her daily medication. Company comment: Very limited information regarding this events has been provided at this time.  Further information can't be requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information can't be requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Groin pain, Thrombosis
Clinical narrative: Blood clots in her leg and lungs; She is black and blue; She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle; She also felt pain midway between her knee and ankle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots in her leg and lungs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Dyslipidaemia. Concurrent medical conditions included Blood pressure high, Depression, Acid reflux (oesophageal) and Allergy.  On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced GROIN PAIN (She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle) and ARTHRALGIA (She also felt pain midway between her knee and ankle). On 18-May-2021, the patient experienced THROMBOSIS (Blood clots in her leg and lungs) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CONTUSION (She is black and blue). The patient was hospitalized from 21-May-2021 to 22-May-2021 due to THROMBOSIS. The patient was treated with APIXABAN (ELIQUIS) on 22-May-2021 at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clots in her leg and lungs), CONTUSION (She is black and blue), GROIN PAIN (She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle) and ARTHRALGIA (She also felt pain midway between her knee and ankle) outcome was unknown.  The patient thought there were bug bites on her leg on 12-May-2021.   Treatment also included IV blood thinner while she was hospitalized.  The action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Staphylococcal infection
Clinical narrative: out of the range of time for the second dose; Staph Infection in the nose; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Staph Infection in the nose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced STAPHYLOCOCCAL INFECTION (Staph Infection in the nose) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (out of the range of time for the second dose). On 01-Apr-2021, STAPHYLOCOCCAL INFECTION (Staph Infection in the nose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (out of the range of time for the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment with anti-biotic therapy was provided by the patient pertained to the events experienced.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: lost the hearing in her right ear; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS (lost the hearing in her right ear) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEAFNESS (lost the hearing in her right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (lost the hearing in her right ear) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 73 year old patient taking Adacel with no reported adverse event; Initial information was received on 24-May-2021 regarding an unsolicited valid non-serious case received from a consumer or other non-professional.  This case involves a 73 year old (unknown gender) patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age).   It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medications were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration. (latency same day)  It was unknown if there were laboratory data/results available.   At the time of report, no adverse event was reported.  It was unknown if the patient experienced any additional symptoms/events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 0.5
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given PENTACEL and a separate DTAP vaccine (INFANRIX) with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Physician via Medical Information (Reference number- 00613527) and transmitted to Sanofi on 24-May-2021.  This case involves a 6 months old male patient who received a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ390AAA and expiration date: 12-Oct-2021) via intramuscular route in the right thigh and a separate dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX] (lot number and expiry date were not reported) via unknown route at an unknown administration site (extra dose administered) for prophylactic vaccination on 24-May-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Immunisation.  The reporter asked for what to look out for and if the patient will be ok. They also questioned on the duplicate DTAP dose and what they need to do and what to expect.  It was an actual medication error case due to extra dose administered (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: F
Vaccine: DTAP, DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP accidentally grabbed Pentacel instead of Daptacel by mistake and administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious was received from other healthcare professional via  Medical Information (Reference number- 00620295) and transmitted to Sanofi on 28-May-2021.  This case involves an 18 months old female patient who was administered with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ389ABA and expiry date: 09-Oct-2021) via intramuscular route in the right thigh instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date were not reported) (wrong product administered) for prophylactic vaccination as administrator accidentally grabbed wrong vaccine by mistake on 28-May-2021.  The patient's medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant vaccinations included HEPATITIS A VACCINE (HEPATITIS A VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  The reporter asked if receiving the extra Ipol and ActHIB will harm the patient. Reporter also asked what side effects she should look out for. As it turned out it was also time for the ActHIB, however the next Ipol vaccine is not due until ages 4-6 years of age. They stated that Stated that a patient was given pentacel but the patient only needed the dTap.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Pruritus
Clinical narrative: Head hurts to touch getting itchy on arms legs and Buttocks  also arems sweeling
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at the injection site that was around 1 1/2  inches in diameter, warm to the touch, felt itchy and painful at times ; we treated it with ibuprofen and a cold compress/freezer pack