chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID fully vaccinate, admitted and positive for COVID and given remdesivir
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Narrative:  Patient received first booster on 2/17/22 and reported to his team provider at his visit on 3/3/22 that he developed cold sores around his mouth and inside his nose after receiving this vaccine. No such reaction reported for his first or second dose in the series. Unsure if patient has ever experienced cold sores before. Patient reported self treating with ketoconazole cream he had at home. Cold sores resolved.
Age: 68.0
Sex: M
Vaccine: FLUA4
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Narrative: Patient also received dexamethasone 10mg IV and epinephrine 1M injection. Patient released home after observation with Epi-Pen. No further incident reported.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Seen today for swelling & Redness L.T. - Kinrix 10mmx85mm - itchy R.T. Proquad 35mmx30mm initially hot and hard day after vaccine given 6/10/22 - seen today 6/13/22
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Immediate post-injection reaction, Joint range of motion decreased, Neck pain
Clinical narrative: Started w/pain in the arm (left) immediately after the shot. Progressed to neck and Headache. Patient has had pain in the arm that the vaccine was given on for 4 month now. Patient takes tylenol & tramadol for pain. The pain causes a lot of discomfort and also decreased Range of motion
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Started w/pain in the arm (left) immediately after the shot. Progressed to neck and Headache. Patient has had pain in the arm that the vaccine was given on for 4 month now. Patient takes tylenol & tramadol for pain. The pain causes a lot of discomfort and also decreased Range of motion
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: R thigh on Thursday 9th had redness & swelling 60x40mm No pain - used warm compresses
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Cellulitis, Hypoaesthesia, Immunoglobulin therapy, Pain, Therapy non-responder
Clinical narrative: The patient needed 1200 units (8ml) of HRIG administered around the would cat bit wound after the surgeon had completed the washout due to a cellulitis caused by the cat bit. All 8ml were injected into the right wrist/lower right arm area around the wound. The patient was complaining of numbness in the thumb and extreme pain 10/10 that was not relived with narcotic use.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Influenza like illness, Mobility decreased, Movement disorder, Paraesthesia
Clinical narrative: tingling; numbness; very hard to move around, hard time getting out of bed, walking to the bathroom and back to bed; feel feverish; flu-like symptoms; mobility issues kicked in; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4437960.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunization. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 23Mar2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 14Apr2021, outcome "not recovered", described as "feel feverish"; INFLUENZA LIKE ILLNESS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "flu-like symptoms"; MOBILITY DECREASED (non-serious) with onset 14Apr2021, outcome "not recovered", described as "mobility issues kicked in"; MOVEMENT DISORDER (non-serious) with onset 14Apr2021, outcome "not recovered", described as "very hard to move around, hard time getting out of bed, walking to the bathroom and back to bed"; PARAESTHESIA (non-serious), outcome "not recovered", described as "tingling"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "numbness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 23Mar2021, and 14Apr2021, patient started therapy with Pfizer Covid Vaccine for unknown indication. On 14Apr2021, it was reported that patient experienced, reaction to the second Covid shot: feel feverish and flu-like symptoms, mobility issues kicked in, tingling, numbness. He described the mobility issues as very hard to move around, hard time getting out of bed, walking to the bathroom and back to bed. Covid and negative antibody test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: tingling; numbness; very hard to move around, hard time getting out of bed, walking to the bathroom and back to bed; feel feverish; flu-like symptoms; mobility issues kicked in; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4437960.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunization. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 23Mar2021, when the patient was 60-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 14Apr2021, outcome "not recovered", described as "feel feverish"; INFLUENZA LIKE ILLNESS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "flu-like symptoms"; MOBILITY DECREASED (non-serious) with onset 14Apr2021, outcome "not recovered", described as "mobility issues kicked in"; MOVEMENT DISORDER (non-serious) with onset 14Apr2021, outcome "not recovered", described as "very hard to move around, hard time getting out of bed, walking to the bathroom and back to bed"; PARAESTHESIA (non-serious), outcome "not recovered", described as "tingling"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "numbness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 23Mar2021, and 14Apr2021, patient started therapy with Pfizer Covid Vaccine for unknown indication. On 14Apr2021, it was reported that patient experienced, reaction to the second Covid shot: feel feverish and flu-like symptoms, mobility issues kicked in, tingling, numbness. He described the mobility issues as very hard to move around, hard time getting out of bed, walking to the bathroom and back to bed. Covid and negative antibody test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging, Nerve conduction studies
Clinical narrative: Nasal Swab : postive; Nasal Swab : positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 16-year-old male patient received BNT162b2 (COMIRNATY), on 06Aug2021 at 17:00 as dose 1, single (Lot number: EW0168), in right arm and on 27Aug2021 at 04:30 as dose 2, single (Lot number: EW0168) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebral Palsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amitriptyline, reaction(s): "known allergies: Amitriptyline"; Hydroxyzine hcl, reaction(s): "known allergies: hydroxyzine Hcl". Prior to the vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: COVID-19 (medically significant) with onset 29Oct2021, outcome "unknown", described as "Nasal Swab : positive"; VACCINATION FAILURE (medically significant), outcome "unknown", described as "Nasal Swab : postive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2021) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828805 Same patient and drug, different event separated in time;
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Dysphagia, Fatigue, Gait inability, Headache
Clinical narrative: Nasal Swab : postive; Nasal Swab : positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 16-year-old male patient received BNT162b2 (COMIRNATY), on 06Aug2021 at 17:00 as dose 1, single (Lot number: EW0168), in right arm and on 27Aug2021 at 04:30 as dose 2, single (Lot number: EW0168) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebral Palsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amitriptyline, reaction(s): "known allergies: Amitriptyline"; Hydroxyzine hcl, reaction(s): "known allergies: hydroxyzine Hcl". Prior to the vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: COVID-19 (medically significant) with onset 29Oct2021, outcome "unknown", described as "Nasal Swab : positive"; VACCINATION FAILURE (medically significant), outcome "unknown", described as "Nasal Swab : postive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2021) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828805 Same patient and drug, different event separated in time;
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Myalgia, Pain in extremity, Polyneuropathy, SARS-CoV-2 test
Clinical narrative: Nasal Swab : postive; Nasal Swab : positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 16-year-old male patient received BNT162b2 (COMIRNATY), on 06Aug2021 at 17:00 as dose 1, single (Lot number: EW0168), in right arm and on 27Aug2021 at 04:30 as dose 2, single (Lot number: EW0168) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebral Palsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amitriptyline, reaction(s): "known allergies: Amitriptyline"; Hydroxyzine hcl, reaction(s): "known allergies: hydroxyzine Hcl". Prior to the vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: COVID-19 (medically significant) with onset 29Oct2021, outcome "unknown", described as "Nasal Swab : positive"; VACCINATION FAILURE (medically significant), outcome "unknown", described as "Nasal Swab : postive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2021) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828805 Same patient and drug, different event separated in time;
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: Nasal Swab : postive; Nasal Swab : positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 16-year-old male patient received BNT162b2 (COMIRNATY), on 06Aug2021 at 17:00 as dose 1, single (Lot number: EW0168), in right arm and on 27Aug2021 at 04:30 as dose 2, single (Lot number: EW0168) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebral Palsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amitriptyline, reaction(s): "known allergies: Amitriptyline"; Hydroxyzine hcl, reaction(s): "known allergies: hydroxyzine Hcl". Prior to the vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: COVID-19 (medically significant) with onset 29Oct2021, outcome "unknown", described as "Nasal Swab : positive"; VACCINATION FAILURE (medically significant), outcome "unknown", described as "Nasal Swab : postive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2021) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828805 Same patient and drug, different event separated in time;
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab : postive; Nasal Swab : positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 16-year-old male patient received BNT162b2 (COMIRNATY), on 06Aug2021 at 17:00 as dose 1, single (Lot number: EW0168), in right arm and on 27Aug2021 at 04:30 as dose 2, single (Lot number: EW0168) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebral Palsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amitriptyline, reaction(s): "known allergies: Amitriptyline"; Hydroxyzine hcl, reaction(s): "known allergies: hydroxyzine Hcl". Prior to the vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: COVID-19 (medically significant) with onset 29Oct2021, outcome "unknown", described as "Nasal Swab : positive"; VACCINATION FAILURE (medically significant), outcome "unknown", described as "Nasal Swab : postive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2021) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200828805 Same patient and drug, different event separated in time;
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, Fatigue, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a patient via other manufacturer Pfizer concerned a 45 year old male. Initial information was processed with the additional information received on 10-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, hypertension, anxiety, avocado allergy and tree nuts allergy. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022, expiry: unknown) dose was not reported, 1 total, administered on 08-MAR-2021 at 15:00 in left arm for prophylactic vaccination. Age at time of vaccination 44 years old. The patient additionally received non-company suspect vaccine included: Moderna (Spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: 939902, expiry: unknown) dose was not reported, administered on 25-OCT-2021 at 15:00 in left arm for prophylactic vaccination. Concomitant medications included fluticasone propionate/salmeterol xinafoate (Wixela). On 27-FEB-2022, the patient experienced first Covid symptoms. On 02-MAR-2022, patient tested positive for Covid, thus patient had confirmed Covid-19 infection (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). Laboratory data included: COVID-19 virus test Positive. The patient received Paxlovid from 02-MAR-2022 to 07-MAR-2022 for Covid-19 treatment. On 08-MAR-2022, patient's symptoms were largely gone except post Covid tachycardia, shortness of breath and fatigue (dose number in series 2). On 10-MAR-2022, Laboratory data included: COVID-19 virus test Negative. On 13-MAR-2022, patient lost sense of smell. Laboratory data included: COVID-19 virus test Positive. The action taken with Covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from confirmed Covid-19 infection on 02-APR-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235175. Sender's Comments: V0: 20220617454- Covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure .The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: This spontaneous report received from a patient via other manufacturer Pfizer concerned a 45 year old male. Initial information was processed with the additional information received on 10-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, hypertension, anxiety, avocado allergy and tree nuts allergy. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022, expiry: unknown) dose was not reported, 1 total, administered on 08-MAR-2021 at 15:00 in left arm for prophylactic vaccination. Age at time of vaccination 44 years old. The patient additionally received non-company suspect vaccine included: Moderna (Spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: 939902, expiry: unknown) dose was not reported, administered on 25-OCT-2021 at 15:00 in left arm for prophylactic vaccination. Concomitant medications included fluticasone propionate/salmeterol xinafoate (Wixela). On 27-FEB-2022, the patient experienced first Covid symptoms. On 02-MAR-2022, patient tested positive for Covid, thus patient had confirmed Covid-19 infection (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). Laboratory data included: COVID-19 virus test Positive. The patient received Paxlovid from 02-MAR-2022 to 07-MAR-2022 for Covid-19 treatment. On 08-MAR-2022, patient's symptoms were largely gone except post Covid tachycardia, shortness of breath and fatigue (dose number in series 2). On 10-MAR-2022, Laboratory data included: COVID-19 virus test Negative. On 13-MAR-2022, patient lost sense of smell. Laboratory data included: COVID-19 virus test Positive. The action taken with Covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from confirmed Covid-19 infection on 02-APR-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235175. Sender's Comments: V0: 20220617454- Covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure .The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This spontaneous report received from a patient via other manufacturer Pfizer concerned a 45 year old male. Initial information was processed with the additional information received on 10-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, hypertension, anxiety, avocado allergy and tree nuts allergy. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022, expiry: unknown) dose was not reported, 1 total, administered on 08-MAR-2021 at 15:00 in left arm for prophylactic vaccination. Age at time of vaccination 44 years old. The patient additionally received non-company suspect vaccine included: Moderna (Spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: 939902, expiry: unknown) dose was not reported, administered on 25-OCT-2021 at 15:00 in left arm for prophylactic vaccination. Concomitant medications included fluticasone propionate/salmeterol xinafoate (Wixela). On 27-FEB-2022, the patient experienced first Covid symptoms. On 02-MAR-2022, patient tested positive for Covid, thus patient had confirmed Covid-19 infection (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). Laboratory data included: COVID-19 virus test Positive. The patient received Paxlovid from 02-MAR-2022 to 07-MAR-2022 for Covid-19 treatment. On 08-MAR-2022, patient's symptoms were largely gone except post Covid tachycardia, shortness of breath and fatigue (dose number in series 2). On 10-MAR-2022, Laboratory data included: COVID-19 virus test Negative. On 13-MAR-2022, patient lost sense of smell. Laboratory data included: COVID-19 virus test Positive. The action taken with Covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from confirmed Covid-19 infection on 02-APR-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235175. Sender's Comments: V0: 20220617454- Covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure .The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A 66-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset Apr2021, outcome "unknown", described as "hair started to fall out at an alarming rate". Additional information: The patient reported that she had since lost 50% of her hair mass. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, HPVX
Symptoms: Attention deficit hyperactivity disorder, No adverse event, Underdose
Clinical narrative: an inadvertent administration of 0.2 mL of the orange cap formulation of the vaccine; Blood pressure elevated; lipids were still elevated; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 09Jun2022 as dose 3 (booster), 0.2 ml single (Lot number: FL8094, Expiration Date: 31Aug2022) at the age of 12 years, in right deltoid for covid-19 immunisation; hpv vaccine (HPV VACCINE), on 09Jun2022 as dose number unknown, single (Lot number: U032681, Expiration Date: 26Oct2023) intramuscular, in left deltoid. The patient's relevant medical history included: "Vitamin D deficiency" (ongoing); "Hyperlipidemia" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (NDC, LOT, EXP: Unknown, Patient received these doses at withheld), administration date: 31Dec2021, when the patient was 11-year-old, for COVID-19 Immunization; BNT162b2 (10mcg 0.2ml, assuming it was also the orange cap, NDC, LOT, EXP: Unknown, Patient received these doses at withheld), administration date: 08Nov2021, when the patient was 11-year-old, for COVID-19 Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 09Jun2022, outcome "unknown", described as "Blood pressure elevated"; PRODUCT USE ISSUE (non-serious) with onset 09Jun2022, outcome "unknown", described as "an inadvertent administration of 0.2 mL of the orange cap formulation of the vaccine"; HYPERLIPIDAEMIA (non-serious) with onset 09Jun2022, outcome "unknown", described as "lipids were still elevated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not visit emergency room/physician office. The patient did not receive prior vaccine within 4 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200829475 same reporter/drug/event, different patient;
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, HPVX
Symptoms: Blood pressure increased, Blood pressure measurement, Hyperlipidaemia, Lipids, Product use issue
Clinical narrative: an inadvertent administration of 0.2 mL of the orange cap formulation of the vaccine; Blood pressure elevated; lipids were still elevated; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 09Jun2022 as dose 3 (booster), 0.2 ml single (Lot number: FL8094, Expiration Date: 31Aug2022) at the age of 12 years, in right deltoid for covid-19 immunisation; hpv vaccine (HPV VACCINE), on 09Jun2022 as dose number unknown, single (Lot number: U032681, Expiration Date: 26Oct2023) intramuscular, in left deltoid. The patient's relevant medical history included: "Vitamin D deficiency" (ongoing); "Hyperlipidemia" (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (NDC, LOT, EXP: Unknown, Patient received these doses at withheld), administration date: 31Dec2021, when the patient was 11-year-old, for COVID-19 Immunization; BNT162b2 (10mcg 0.2ml, assuming it was also the orange cap, NDC, LOT, EXP: Unknown, Patient received these doses at withheld), administration date: 08Nov2021, when the patient was 11-year-old, for COVID-19 Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 09Jun2022, outcome "unknown", described as "Blood pressure elevated"; PRODUCT USE ISSUE (non-serious) with onset 09Jun2022, outcome "unknown", described as "an inadvertent administration of 0.2 mL of the orange cap formulation of the vaccine"; HYPERLIPIDAEMIA (non-serious) with onset 09Jun2022, outcome "unknown", described as "lipids were still elevated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not visit emergency room/physician office. The patient did not receive prior vaccine within 4 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200829475 same reporter/drug/event, different patient;
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Dehydration, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: Patient reports having a "low grade fevers" only exceeding 100 degress once. Patient reports the fevers occuring about twice a week leading to fatigue, tiredness, and cramping due to dehydration from the fever as well as accosiated headaches. patient reports the symptoms have continued since the last vaccination. Patient reported no symptoms like this after the first 3 doses and is following up with her regular physcian monday 6/13/2022. Patient called the pharmacy 6/10/22
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: Patient reports having a "low grade fevers" only exceeding 100 degress once. Patient reports the fevers occuring about twice a week leading to fatigue, tiredness, and cramping due to dehydration from the fever as well as accosiated headaches. patient reports the symptoms have continued since the last vaccination. Patient reported no symptoms like this after the first 3 doses and is following up with her regular physcian monday 6/13/2022. Patient called the pharmacy 6/10/22
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Fatigue, Headache, Lethargy, Muscle spasms
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: Patient reports having a "low grade fevers" only exceeding 100 degress once. Patient reports the fevers occuring about twice a week leading to fatigue, tiredness, and cramping due to dehydration from the fever as well as accosiated headaches. patient reports the symptoms have continued since the last vaccination. Patient reported no symptoms like this after the first 3 doses and is following up with her regular physcian monday 6/13/2022. Patient called the pharmacy 6/10/22
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Additional Details: Patient reports having a "low grade fevers" only exceeding 100 degress once. Patient reports the fevers occuring about twice a week leading to fatigue, tiredness, and cramping due to dehydration from the fever as well as accosiated headaches. patient reports the symptoms have continued since the last vaccination. Patient reported no symptoms like this after the first 3 doses and is following up with her regular physcian monday 6/13/2022. Patient called the pharmacy 6/10/22
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Burning when the vaccine went in that ran down her arm and lasted a couple seconds.; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Burning when the vaccine went in that ran down her arm and lasted a couple seconds.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (Burning when the vaccine went in that ran down her arm and lasted a couple seconds.). On 28-Feb-2021, VACCINATION SITE PAIN (Burning when the vaccine went in that ran down her arm and lasted a couple seconds.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took first dose of Moderna vaccine and had no problems and after second dose patient experienced burning when the vaccine went in that ran down her arm and lasted a couple seconds and patient thought that it was because the person giving the injection did not let the alcohol dry completely before giving the shot. Patient took other medications on an unspecified date but none of them are blood thinners. Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2022-587136 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Burning when the vaccine went in that ran down her arm and lasted a couple seconds.; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Burning when the vaccine went in that ran down her arm and lasted a couple seconds.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (Burning when the vaccine went in that ran down her arm and lasted a couple seconds.). On 28-Feb-2021, VACCINATION SITE PAIN (Burning when the vaccine went in that ran down her arm and lasted a couple seconds.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took first dose of Moderna vaccine and had no problems and after second dose patient experienced burning when the vaccine went in that ran down her arm and lasted a couple seconds and patient thought that it was because the person giving the injection did not let the alcohol dry completely before giving the shot. Patient took other medications on an unspecified date but none of them are blood thinners. Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2022-587136 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: When the caller received first, second and booster dose Pfizer Covid Vaccine, with all of the doses, the caller kind of had a rash on stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "When the caller received first, second and booster dose Pfizer Covid Vaccine, with all of the doses, the caller kind of had a rash on stomach".  Additional information: The patient started taking Paxlovid yesterday night, 01JUN2022 and took second dose of Paxlovid this morning, 02JUN2022. The patient started having a rash all on stomach and both arms on 02Jun2022. When the patient received first, second and booster dose Pfizer Covid Vaccine, with all of the doses, the patient kind of had a rash on stomach. The patient stated her doctor already told her to stop it, and to take antihistaminic, she just wanted to know if there's something similar because it was basically the same reaction in both, rash in her stomach and arms. Patient hesitant to get the second booster because this always happen, even with this medicine, patient just wanted to know if Paxlovid and the Pfizer Covid Vaccine have a similar ingredient in both that could cause the patient to be allergic, a similar component, maybe the same family or source so that she can bring this information to her allergist. She stated took Paxlovid this morning, but since she was allergic she cannot take it anymore, patient wanted to know if there any reactions between Paxlovid and Advil Cold and Sinus.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: When the caller received first, second and booster dose Pfizer Covid Vaccine, with all of the doses, the caller kind of had a rash on stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "When the caller received first, second and booster dose Pfizer Covid Vaccine, with all of the doses, the caller kind of had a rash on stomach".  Additional information: The patient started taking Paxlovid yesterday night, 01JUN2022 and took second dose of Paxlovid this morning, 02JUN2022. The patient started having a rash all on stomach and both arms on 02Jun2022. When the patient received first, second and booster dose Pfizer Covid Vaccine, with all of the doses, the patient kind of had a rash on stomach. The patient stated her doctor already told her to stop it, and to take antihistaminic, she just wanted to know if there's something similar because it was basically the same reaction in both, rash in her stomach and arms. Patient hesitant to get the second booster because this always happen, even with this medicine, patient just wanted to know if Paxlovid and the Pfizer Covid Vaccine have a similar ingredient in both that could cause the patient to be allergic, a similar component, maybe the same family or source so that she can bring this information to her allergist. She stated took Paxlovid this morning, but since she was allergic she cannot take it anymore, patient wanted to know if there any reactions between Paxlovid and Advil Cold and Sinus.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Renal disorder
Clinical narrative: Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2021 at 11:00 as dose 1, single (Lot number: EW0167), in left arm and on 23May2021 at 11:00 as dose 2, single (Lot number: EW0185) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADDERALL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: Nasal swab.  clinical course: patient had no Known allergies, patient was no Covid prior vaccination, patient was tested post vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2021 at 11:00 as dose 1, single (Lot number: EW0167), in left arm and on 23May2021 at 11:00 as dose 2, single (Lot number: EW0185) at the age of 34 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADDERALL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: Nasal swab.  clinical course: patient had no Known allergies, patient was no Covid prior vaccination, patient was tested post vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 25May2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa" (unspecified if ongoing), notes: known allergies: Aspirin, sulfa, mariscos; "mariscos" (unspecified if ongoing), notes: known allergies: Aspirin, sulfa, mariscos. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Allergy", notes: known allergies: Aspirin, sulfa, mariscos. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022 at 23:00, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine. Patient did not take other medication in 2 weeks. Patient was treated with anti-viral Paxlovid for COVID-19 from 09Jun2022 to 10Jun2022 and had adverse events Urticaria, vomiting, diarrhea on 09Jun2022 11:00 PM. Outcome of the events was unknown and did not receive treatment for the events.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt received a full adult (0.5mL) dose of Moderna instead of the pediatric Pfizer vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fluid retention, Rash, Skin exfoliation, Swelling
Clinical narrative: Swelled up 30 pounds water weight, rashes began, skin started coming off my hands and fingers, diagnosed with SLE (Lupus)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus, Weight increased
Clinical narrative: Swelled up 30 pounds water weight, rashes began, skin started coming off my hands and fingers, diagnosed with SLE (Lupus)
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Shivering. Also tired, but that is probably because I walked 5+ miles today. I have a sore arm, but that was expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Joint swelling, Rash, Urine analysis
Clinical narrative: Major Rash to the lower legs and swelling in his ankles - Had to go to emergency  I have pictures but this site does not allow the upload of a doc
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional Adverse Event information provided; Expired "Hepatitis A" vaccine was accidentally administered; This spontaneous report was received from an executive referring to an unknown age and gender patient.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient has been accidentally vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (manufacturer unknown) (reported as a "Hepatitis A") (strength, dose, frequency, lot number, expiration date, route of administration, and anatomical injection site were not provided) (expired vaccine used).   No additional adverse event (AE) information was provided.  This case is non-valid due to the lack of patient identifiers.  Follow up information has been received on 13-JUN-2022, from a medical assistant. The case has now become valid as the patient was specified as 35-year-old, who was allergic to erythromycin. The patient has no past medical history and has no concomitant medications listed.  On 06-MAY-2022, expired hepatitis A vaccine inactivated (VAQTA) was administered in the left deltoid of the patient, by a trained medical assistant, at a private doctor's office and was purchased with private funds. The vaccine is not available for return.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: no adverse event; Expired VAQTA was administered to a patient; Ths spontaneous report has been received from a medical assistant, concerning a 44 year old patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 16-MAY-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) for prophylaxis lot #T036739  and expirationd ate reported as 22-APR-2022 (Strength, dose, frequency and route of administration was not provided). No additional adverse event was reported.