chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13May2021 14:00 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PMDD" (unspecified if ongoing); "Seasonal allergy" (unspecified if ongoing), notes: cipro, tequin, seasonal and other allergies like ingredients in makeup; "other allergies like ingredients in makeup" (unspecified if ongoing), notes: cipro, tequin, seasonal and other allergies like ingredients in makeup; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination. The patient took concomitant medications. Past drug history included: Ciprofloxacin, reaction(s): "Allergy", notes: cipro, tequin, seasonal and other allergies like ingredients in makeup; Tequin, reaction(s): "Allergy", notes: cipro, tequin, seasonal and other allergies like ingredients in makeup. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation. The following information was reported: HYPERHIDROSIS (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "sweating profusely"; PAIN (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "body aches"; CHILLS (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "chills"; FATIGUE (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "severe tiredness"; HEADACHE (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "headache"; LETHARGY (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "lethargic"; CONFUSIONAL STATE (non-serious) with onset 14May2021 11:00, outcome "recovered with sequelae", described as "confusion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: diagnosed with covid-19, notes: Prior to vaccination. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Gastrointestinal disorder, Irritable bowel syndrome
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 12:00 (Lot number: EW0179) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergies: Shell fish" (unspecified if ongoing). Concomitant medication(s) included: AZOR [ALPRAZOLAM]. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EW0179, administration time: 12:00 PM, vaccine location: Left arm), administration date: 18May2021, when the patient was 64 years old, for COVID-19 immunisation, reaction(s): "Moderate Stomach cramps", "Nausea", "diarrhea", "Severe Fatigue", "IBS symptoms after first". The following information was reported: FATIGUE (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "severe fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "Moderate Stomach cramps"; NAUSEA (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "nausea"; DIARRHOEA (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "diarrhea/loose stools"; IRRITABLE BOWEL SYNDROME (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "IBS symptoms"; GASTROINTESTINAL DISORDER (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "GI symptoms". The events "severe fatigue", "moderate stomach cramps", "nausea", "diarrhea/loose stools", "ibs symptoms" and "gi symptoms" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea. Additional information: Zofran was taken as treatment for nausea. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021723359 similar report from same reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 12:00 (Lot number: EW0179) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergies: Shell fish" (unspecified if ongoing). Concomitant medication(s) included: AZOR [ALPRAZOLAM]. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EW0179, administration time: 12:00 PM, vaccine location: Left arm), administration date: 18May2021, when the patient was 64 years old, for COVID-19 immunisation, reaction(s): "Moderate Stomach cramps", "Nausea", "diarrhea", "Severe Fatigue", "IBS symptoms after first". The following information was reported: FATIGUE (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "severe fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "Moderate Stomach cramps"; NAUSEA (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "nausea"; DIARRHOEA (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "diarrhea/loose stools"; IRRITABLE BOWEL SYNDROME (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "IBS symptoms"; GASTROINTESTINAL DISORDER (non-serious) with onset 08Jun2021 12:00, outcome "not recovered", described as "GI symptoms". The events "severe fatigue", "moderate stomach cramps", "nausea", "diarrhea/loose stools", "ibs symptoms" and "gi symptoms" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea. Additional information: Zofran was taken as treatment for nausea. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021723359 similar report from same reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Irritable bowel syndrome, Nausea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 12:00 (Lot number: EW0179) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Shell fish" (unspecified if ongoing). Concomitant medication(s) included: AZOR [ALPRAZOLAM].The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "recovered" (2021), described as "Moderate Stomach cramps"; NAUSEA (non-serious), outcome "recovered" (2021), described as "nausea"; DIARRHOEA (non-serious), outcome "recovered" (2021), described as "diarrhea"; IRRITABLE BOWEL SYNDROME (non-serious), outcome "recovered" (2021), described as "IBS symptoms"; FATIGUE (non-serious), outcome "unknown", described as "severe fatigue". The events "moderate stomach cramps", "nausea", "diarrhea", "ibs symptoms" and "severe fatigue" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea.Additional information: Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received treatment with Zofran for nausea. Follow-up attempts were completed. No further information was expected.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Arrhythmia
Clinical narrative: anaphylactic reactions; heart arrhythmia; Initial information was received on 23-Nov-2021 regarding an unsolicited valid serious case from social media via consumer/non-healthcare professional.  This case involves a patient (demographics unknown) who experienced anaphylactic reactions (anaphylactic reaction) and heart arrhythmia (arrhythmia) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious anaphylactic reaction (anaphylactic reaction) and heart arrhythmia (arrhythmia) (unknown latency) following the administration of INFLUENZA VACCINE.   The reporter stated that he/she will never take this poison again.   These events were assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the events.  The reporter did not report causality of events with suspect.  At time of reporting, the outcome of the events was unknown.  Information on the batch number for this case was requested.; Sender's Comments: This case involves a patient (demographics unknown) who experienced anaphylactic reaction and arrhythmia after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Autoimmune disorder, Malaise
Clinical narrative: autoimmune disease consistent with those symptoms; Initial information was received on 24-Nov-2021 regarding an unsolicited valid serious social media case from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who had autoimmune disease consistent with those symptoms (autoimmune disorder)  after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date in 2003, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination. Patient almost immediately started having symptoms.  On an unknown date in 2004,  the patient was diagnosed with a serious autoimmune disease consistent with those symptoms (autoimmune disorder) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Patient still has that condition. Patient would rather have had the sniffles, and if memory serves,  still got sick anyways.  Patient think there's something sinister going on with these vaccines, and the fraud, and lies they are fed about the corona virus disease (COVID) vaccine only serves to reinforce the idea that patient may be right.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.  Information on batch number is requested.; Sender's Comments: This case concerns a patient (unknown demographics) who had autoimmune disorder after vaccination with  INFLUENZA VACCINE (unknown manufacturer).The time to onset is unknown. However, there is no further information regarding patient's medical condition at the time of vaccination, concomitant medication(s) and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Sleep disorder
Clinical narrative: Had interrupted sleep the entire time; Congestion; Bad cold; Sore throat; This spontaneous case was retrieved on 27-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1774802-1), reported by other non-healthcare professional and concerned an adult patient, of an unreported age and gender. The patient's medical history and concomitant medications were not reported. The patient had a flu shots for 25 years with no adverse event reported.On an unspecified date in 2021, reported as earlier this year, the patient was vaccinated with non-company co-suspect Covid 19 vaccine (brand not specified; indication, dose, route of administration, anatomical location: not reported). The batch number was not reported.On 22-Sep-2021, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location: not reported) for prophylactic vaccination. The batch number was not reported.On an unspecified date in 2021, reported as following friday, an unknown amount of time after receiving influenza virus vaccine polyvalent and non-company co-suspect Covid 19 vaccine, the patient developed sore throat, bad cold, congestion and had interrupted sleep the entire time. It was unknown if the patient experienced any additional symptoms or events.The details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of initial reporting, the patient had not recovered from all events. The reporter assessed the events as related to influenza virus vaccine polyvalent. The patient stated that got a flu shot for 25 years and never had this problem.The case was assessed as non-serious.Company comment: A patient was vaccinated with the suspect product influenza virus vaccine polyvalent and non-company co-suspect Covid 19 vaccine. Within one week the patient developed sore throat, nasopharyngitis, congestion and had interrupted sleep the entire time. Causality is confounded by concurrent administration of co-suspect vaccine. Causality for sleep disorder is assessed as not related based on biological implausibility. Based on plausible time relationship causality for the remaining events is assessed as possibly related.; Reporter's Comments: The patient stated that got a flu shot for 25 years and never had this problem. Sender's Comments: A patient was vaccinated with the suspect product influenza virus vaccine polyvalent and non-company co-suspect Covid 19 vaccine. Within one week the patient developed sore throat, nasopharyngitis, congestion and had interrupted sleep the entire time. Causality is confounded by concurrent administration of co-suspect vaccine. Causality for sleep disorder is assessed as not related based on biological implausibility. Based on plausible time relationship causality for the remaining events is assessed as possibly related.
Age: 49.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Muscle spasms
Clinical narrative: Arm twitches/she was experiencing some muscle twisting in the arm she got Flucelvax vaccine; This spontaneous case was received on 27-Oct-2021 from pharmacist (reference number: SEQW21-04647) and concerned a 49-year-old, female patient.The patient's medical history and concomitant medications were not reported.On 08-Oct-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, arm) for influenza prophylaxis. The batch number reported was 308477 and expiry date: 30-Jun-2022.On the same date, the patient was vaccinated with non-company co-suspect COVID-19 vaccine (brand not specified; anatomical location: arm, dose, route of administration and indication: not reported). The batch number was not reported. The patient got vaccines in separate arms.On the same day, after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient's arm twitched and she was experiencing some muscle twisting in the arm she got Flucelvax vaccine. The patient did not receive any treatment measures.The outcome of the event was unknown.The reporter did not provide a causality assessment. The case was assessed as non-serious.Company comment: On the same day, after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient's arm twitched. As reported the patient experienced some muscle twisting in the arm where she got Flucelvax vaccine. Considering suggestive time relationship and biological plausibility, causal role of the suspect vaccine is assessed as possibly related. Sender's Comments: On the same day, after receiving Flucelvax Quadrivalent and non-company co-suspect Covid-19 vaccine, the patient's arm twitched. As reported the patient experienced some muscle twisting in the arm where she got Flucelvax vaccine. Considering suggestive time relationship and biological plausibility, causal role of the suspect vaccine is assessed as possibly related.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Balance disorder
Clinical narrative: Balance was off/balance problems; This spontaneous case from was received on 27-Oct-2021 from other non-healthcare professional (consumer) via Communications (reference number: SEQW21-04665) and concerned a 73-year-old, female patient.  The patient's concurrent condition included high blood pressure and cellulitis. The patient's concomitant medications included unspecified blood pressure medicine, COVID-19-vaccine (brand not specified) and unspecified eye drops, both used for unreported indication.   On 21-Oct-2021, at 10:15 a.m., the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 312869 and expiry date: 30-Jun-2022.  On the same day, after receiving Fluad Quadrivalent, at 06:00 p.m., the patient noticed she was having balance problems/balance was off, had to hold on to things when she got up to walk in her apartment and that lasted through the night. The patient did not receive any treatment measures.  On 22-Oct-2021 (reported also as '25-Oct-2021' as discrepant information), about 24 hours after, the patient's symptom disappeared.  The reporter did not provide a causality assessment. The patient was taking eye drops at the time and thought maybe it could be them.  Company comment: A 73-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed a balance disorder. No alternative aetiology was provided. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: The patient was taking eye drops at the time and thought maybe it could be them.; Sender's Comments: A 73-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed a balance disorder. No alternative aetiology was provided. Based on plausible time relationship, causality is assessed as possibly related.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large Lymphnode swelling  under right arm/arm pit area (injection arm)
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Dyspnoea
Clinical narrative: Mild shortness of breath, starting 2 days after vaccine
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein normal, Full blood count normal, Gout, Metabolic function test, Pruritus
Clinical narrative: Gout Flare treated with PO prednisone and resolved 2 weeks after immunization.  Erythematous Skin Rash on bilateral lower extremities which spread superiorly up body to include groin and chest one week after immunization; significant pruritis  and rash ongoing now for over one month - treated with topical steroid, antihistamine and referred to specialist
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Red blood cell sedimentation rate normal
Clinical narrative: Gout Flare treated with PO prednisone and resolved 2 weeks after immunization.  Erythematous Skin Rash on bilateral lower extremities which spread superiorly up body to include groin and chest one week after immunization; significant pruritis  and rash ongoing now for over one month - treated with topical steroid, antihistamine and referred to specialist
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Achy; Headachy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and HEADACHE (Headachy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced PAIN (Achy) and HEADACHE (Headachy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Achy) and HEADACHE (Headachy) outcome was unknown.            Patient also reports being on 2 or 3 daily regular medications before the vaccine. Patient reports similar late onset reactions from the second dose.   This case was linked to MOD-2021-046491 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Contusion, Dizziness, Dry eye
Clinical narrative: dizziness/very dizzy, every day; back was hurting; could not walk properly; fallen a lot; arm and leg were hurting/hurting for a few days; body was aching; body feels very weak/weak legs; dry eyes; nostrils hurt; arms was swollen; Bruised; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/very dizzy, every day), DRY EYE (dry eyes), NASAL DISCOMFORT (nostrils hurt), PERIPHERAL SWELLING (arms was swollen) and CONTUSION (Bruised) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OTIC21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janssen (Patient received 1 dose of the Janssen vaccine on 13MAR2021 (lot number 1805018)) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced DRY EYE (dry eyes), NASAL DISCOMFORT (nostrils hurt), PERIPHERAL SWELLING (arms was swollen) and CONTUSION (Bruised). On an unknown date, the patient experienced DIZZINESS (dizziness/very dizzy, every day), BACK PAIN (back was hurting), GAIT DISTURBANCE (could not walk properly), FALL (fallen a lot), PAIN IN EXTREMITY (arm and leg were hurting/hurting for a few days), PAIN (body was aching) and ASTHENIA (body feels very weak/weak legs). The patient was treated with PARACETAMOL (TYLENOL A) for Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness/very dizzy, every day) had not resolved, DRY EYE (dry eyes), NASAL DISCOMFORT (nostrils hurt), PERIPHERAL SWELLING (arms was swollen), CONTUSION (Bruised), BACK PAIN (back was hurting), GAIT DISTURBANCE (could not walk properly), FALL (fallen a lot), PAIN IN EXTREMITY (arm and leg were hurting/hurting for a few days) and PAIN (body was aching) outcome was unknown and ASTHENIA (body feels very weak/weak legs) had resolved.            No Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: non signi follow-up appended(MOD21-167761- was an initial Document, but the case was created from Followup doc (MOD21-167786) so the version (MOD21-167761) was made as Non signi follow up)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, Nasal discomfort, Pain, Pain in extremity
Clinical narrative: dizziness/very dizzy, every day; back was hurting; could not walk properly; fallen a lot; arm and leg were hurting/hurting for a few days; body was aching; body feels very weak/weak legs; dry eyes; nostrils hurt; arms was swollen; Bruised; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/very dizzy, every day), DRY EYE (dry eyes), NASAL DISCOMFORT (nostrils hurt), PERIPHERAL SWELLING (arms was swollen) and CONTUSION (Bruised) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OTIC21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janssen (Patient received 1 dose of the Janssen vaccine on 13MAR2021 (lot number 1805018)) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced DRY EYE (dry eyes), NASAL DISCOMFORT (nostrils hurt), PERIPHERAL SWELLING (arms was swollen) and CONTUSION (Bruised). On an unknown date, the patient experienced DIZZINESS (dizziness/very dizzy, every day), BACK PAIN (back was hurting), GAIT DISTURBANCE (could not walk properly), FALL (fallen a lot), PAIN IN EXTREMITY (arm and leg were hurting/hurting for a few days), PAIN (body was aching) and ASTHENIA (body feels very weak/weak legs). The patient was treated with PARACETAMOL (TYLENOL A) for Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness/very dizzy, every day) had not resolved, DRY EYE (dry eyes), NASAL DISCOMFORT (nostrils hurt), PERIPHERAL SWELLING (arms was swollen), CONTUSION (Bruised), BACK PAIN (back was hurting), GAIT DISTURBANCE (could not walk properly), FALL (fallen a lot), PAIN IN EXTREMITY (arm and leg were hurting/hurting for a few days) and PAIN (body was aching) outcome was unknown and ASTHENIA (body feels very weak/weak legs) had resolved.            No Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: non signi follow-up appended(MOD21-167761- was an initial Document, but the case was created from Followup doc (MOD21-167786) so the version (MOD21-167761) was made as Non signi follow up)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: dizziness/very dizzy, every day; back was hurting; could not walk properly; fallen a lot; arm and leg were hurting/hurting for a few days; body was aching; body feels very weak/weak legs; dry eyes; nostrils hurt; arms was swollen; Bruised; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/very dizzy, every day), DRY EYE (dry eyes), NASAL DISCOMFORT (nostrils hurt), PERIPHERAL SWELLING (arms was swollen) and CONTUSION (Bruised) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OTIC21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Janssen (Patient received 1 dose of the Janssen vaccine on 13MAR2021 (lot number 1805018)) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced DRY EYE (dry eyes), NASAL DISCOMFORT (nostrils hurt), PERIPHERAL SWELLING (arms was swollen) and CONTUSION (Bruised). On an unknown date, the patient experienced DIZZINESS (dizziness/very dizzy, every day), BACK PAIN (back was hurting), GAIT DISTURBANCE (could not walk properly), FALL (fallen a lot), PAIN IN EXTREMITY (arm and leg were hurting/hurting for a few days), PAIN (body was aching) and ASTHENIA (body feels very weak/weak legs). The patient was treated with PARACETAMOL (TYLENOL A) for Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness/very dizzy, every day) had not resolved, DRY EYE (dry eyes), NASAL DISCOMFORT (nostrils hurt), PERIPHERAL SWELLING (arms was swollen), CONTUSION (Bruised), BACK PAIN (back was hurting), GAIT DISTURBANCE (could not walk properly), FALL (fallen a lot), PAIN IN EXTREMITY (arm and leg were hurting/hurting for a few days) and PAIN (body was aching) outcome was unknown and ASTHENIA (body feels very weak/weak legs) had resolved.            No Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: non signi follow-up appended(MOD21-167761- was an initial Document, but the case was created from Followup doc (MOD21-167786) so the version (MOD21-167761) was made as Non signi follow up)
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: No Additional AEs or PQC reported.; expired dose of RECOMBIVAX administered to a patient; Information has been received from a nurse, referring to a 4 month old patient of unknown gender. Information of concurrent condition, medical history and concomitant therapy was not provided.      On 02-NOV-2021, the patient was vaccinated with expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (thimerosal-free) (strength unknown; lot# S022584 and expiration date 31-OCT-2021) 0.5 milliliter intramuscularly for prophylaxis (expired product administered).  No Additional no adverse event.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: pain at the injection site; swelling at inhection site; drained all of her mom's energy; lifeless; unable to lift her arm; This spontaneous report was received from a consumer concerning her mother, an 85 years old female patient. The patient's current conditions included penicillin allergy and sulfur allergy. No medical history or concomitant therapy was reported.   On 16-OCT-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and lot# were not reported) as prophylaxis.  On 17-OCT-2021 (reported as a day after the vaccine), the patient had severe pain and swelling at the injection site (vaccination site pain and vaccination site swelling). The patient was also unable to lift her arm (movement disorder) and had to sleep in a recliner because she was unable to lay on her arm. The reporter reported the vaccine drained all of her mom's energy (asthenia) and the patient was lifeless (feeling abnormal). The reporter spoke to her mother's physician and was told to ice the arm. No lab test was performed. On 09-NOV-2021, all the events were resolved. Action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not applicable.   The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was related as it was noted all the events were reaction to the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Age: 38.0
Sex: M
Vaccine: HPV4, HPV4, VARZOS
Symptoms: Testicular pain
Clinical narrative: near the end of December 2020 he began to experience urethra burning and testicular pain during ejaculation; near the end of December 2020 he began to experience urethra burning and testicular pain during ejaculation; chronic pelvic pain; prostatitis; near the end of December 2020 he began to experience urethra burning and testicular pain during ejaculation; He stated that he received 3 doses of Gardasil/Caller confirmed multiple times, and was adamant, that he received GARDASIL and not GARDASIL 9; This spontaneous report was received from 38 years old male patient, who was referring to himself. The patient's medical history included heart attack 10 years ago. His concomitant therapies included levofloxacin, cipro and other unspecified medications. His drug reactions/allergies included corticosteroids.    On 20-OCT-2020, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # T004598, expiration date was reported as June 2020, but upon internal validation was established as 30-JUN-2022 for prophylaxis (product administered to patient of inappropriate age). The patient confirmed multiple times, and was adamant, that he received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and not HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). On 25-NOV-2020, he received zoster vaccine live (ZOSTAVAX) lot # S039272 was confirmed to be valid, expiration date was reported as 20-JUN-2021, but upon internal validation was established as 30-JUN-2021 for indication of vaccination. Exact dose, anatomical location and route of administration were not reported for both vaccines.  Near the end of December 2020, the patient experienced urethra burning and testicular pain during ejaculation. His physician initially thought he had prostatitis but currently believes that he has had chronic pelvic pain.  On 29-DEC-2020, he was vaccinated with a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # T004598, expiration date was reported as June 2020, but upon internal validation was established as 30-JUN-2022 for prophylaxis. On 29-APR-2021, the patient was vaccinated with a third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # T030356, expiration date was reported as September 2022 and upon internal validation was established 30-SEP-2022 for prophylaxis. Exact dose, anatomical location and route of administration were not reported for both vaccines.  On an unknown date, the patient sought medical attention and received treatment: antibiotics and anti-inflammatory medication but continued to have symptoms. Also on an unknown date, Magnetic Resonance Imaging (MRI) of prostate and pelvis area, tests of urine and semen and tests for sexual disease were performed - all test were negative. The outcome of the events was reported as not recovered/not resolved.   The causality assessment between the events and the suspect therapy was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Tuberculosis
Clinical narrative: TUBERCULOSIS (TB); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced tuberculosis (TB). The action taken with covid-19 vaccine  was not applicable. The outcome of tuberculosis (TB) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211202026-covid-19 vaccine  -Tuberculosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: 7 STROKES; This spontaneous report received from a consumer via media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. Dose number series was 1.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter questioned "will it help me see my grandmother again" and added that her "grandmother got JANSSEN covid vaccine and had about 7 strokes in 3 months that ultimately took her life". On an unspecified date, the patient died from 7 strokes. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was fatal. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0- 20211203719-Covid-19 vaccine ad26.cov2.s-7 strokes. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: 7 STROKES
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: aches and pains; some diarrhea; Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful; Huge bubble on the same side of my shot right above the clavicle/it's getting smaller; fever; severe headache; some nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains), DIARRHOEA (some diarrhea), LYMPHADENOPATHY (Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful), VACCINATION SITE SWELLING (Huge bubble on the same side of my shot right above the clavicle/it's getting smaller) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06G20A, 029A21A and P57F27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, 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 experienced PAIN (aches and pains), DIARRHOEA (some diarrhea), LYMPHADENOPATHY (Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful), VACCINATION SITE SWELLING (Huge bubble on the same side of my shot right above the clavicle/it's getting smaller), PYREXIA (fever), HEADACHE (severe headache) and NAUSEA (some nausea). At the time of the report, PAIN (aches and pains), DIARRHOEA (some diarrhea), LYMPHADENOPATHY (Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful), PYREXIA (fever), HEADACHE (severe headache) and NAUSEA (some nausea) outcome was unknown and VACCINATION SITE SWELLING (Huge bubble on the same side of my shot right above the clavicle/it's getting smaller) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow-up received on 29-Nov-2021 and contains significant information updated reporter details, patient demographics, vaccine details and events updated. On 30-Nov-2021: Follow-up information received was contain no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: aches and pains; some diarrhea; Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful; Huge bubble on the same side of my shot right above the clavicle/it's getting smaller; fever; severe headache; some nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains), DIARRHOEA (some diarrhea), LYMPHADENOPATHY (Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful), VACCINATION SITE SWELLING (Huge bubble on the same side of my shot right above the clavicle/it's getting smaller) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06G20A, 029A21A and P57F27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, 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 experienced PAIN (aches and pains), DIARRHOEA (some diarrhea), LYMPHADENOPATHY (Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful), VACCINATION SITE SWELLING (Huge bubble on the same side of my shot right above the clavicle/it's getting smaller), PYREXIA (fever), HEADACHE (severe headache) and NAUSEA (some nausea). At the time of the report, PAIN (aches and pains), DIARRHOEA (some diarrhea), LYMPHADENOPATHY (Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful), PYREXIA (fever), HEADACHE (severe headache) and NAUSEA (some nausea) outcome was unknown and VACCINATION SITE SWELLING (Huge bubble on the same side of my shot right above the clavicle/it's getting smaller) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow-up received on 29-Nov-2021 and contains significant information updated reporter details, patient demographics, vaccine details and events updated. On 30-Nov-2021: Follow-up information received was contain no new information.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Limb discomfort, Pain in extremity
Clinical narrative: Pain on his right arm starting from his palm all the way to his chest; Pain becoming tighter and heavier on his tricep area; Pain on his right arm starting from his palm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain on his right arm starting from his palm all the way to his chest), LIMB DISCOMFORT (Pain becoming tighter and heavier on his tricep area), PAIN IN EXTREMITY (Pain on his right arm starting from his palm) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced HEADACHE (Headache). On 26-Nov-2021, the patient experienced CHEST PAIN (Pain on his right arm starting from his palm all the way to his chest), LIMB DISCOMFORT (Pain becoming tighter and heavier on his tricep area) and PAIN IN EXTREMITY (Pain on his right arm starting from his palm). On 22-Nov-2021, HEADACHE (Headache) had resolved. At the time of the report, CHEST PAIN (Pain on his right arm starting from his palm all the way to his chest), LIMB DISCOMFORT (Pain becoming tighter and heavier on his tricep area) and PAIN IN EXTREMITY (Pain on his right arm starting from his palm) had not resolved.            Patient has no allergies.  Concomitant information was not provided.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Diarrhoea, Headache, Hot flush, Oropharyngeal pain
Clinical narrative: Sorethroat; Very hot face/ Hot flushes facial; Agitated; Diarrhea; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sorethroat), HOT FLUSH (Very hot face/ Hot flushes facial), AGITATION (Agitated), DIARRHOEA (Diarrhea) and HEADACHE (Severe headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sorethroat), HOT FLUSH (Very hot face/ Hot flushes facial), AGITATION (Agitated), DIARRHOEA (Diarrhea) and HEADACHE (Severe headache). At the time of the report, OROPHARYNGEAL PAIN (Sorethroat), HOT FLUSH (Very hot face/ Hot flushes facial), AGITATION (Agitated), DIARRHOEA (Diarrhea) and HEADACHE (Severe headache) outcome was unknown.            Patient is taking other medication. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after Moderna COVID-19 shot) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after Moderna COVID-19 shot). At the time of the report, VACCINATION COMPLICATION (side effects after Moderna COVID-19 shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment information was provided.