chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: did not feel too great; felt drained; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel too great) and FATIGUE (felt drained) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 19-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (did not feel too great) and FATIGUE (felt drained). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (did not feel too great) and FATIGUE (felt drained) outcome was unknown.            Concomitant medication included birth control.   This case was linked to MOD-2021-006655 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient administered with a booster dose instead of a full 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient administered with a booster dose instead of a full 3rd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Transplant. Concurrent medical conditions included Immunocompromised (due to a transplant).   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient administered with a booster dose instead of a full 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient administered with a booster dose instead of a full 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. HCP did not have any details on transplant. No treatment medication reported by reporter.
Sex: F
Vaccine: PNC13
Symptoms: Animal bite
Clinical narrative: got bit by a dog; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumovax (she received her first Pneumovax dose), administration date: 19Oct2020, for immunization; Moderna covid vaccine (she received the Moderna Covid vaccine back in Feb and March.), administration date: Feb2021, for immunization; Moderna covid vaccine (she received the Moderna Covid vaccine back in Feb and March.), administration date: Mar2021, for immunization; Rabies shot (back in April and got a rabies shot), administration date: Apr2021, for immunization. The following information was reported: ANIMAL BITE (non-serious) with onset Apr2021, outcome "unknown", described as "got bit by a dog". Therapeutic measures were taken as a result of animal bite.  Additional information: caller reported that after getting the Moderna Covid vaccine she got bit by a dog and had to get a rabies shot.Caller was unsure which Pneumovax brand she had received (either Prevnar 13 or PPSV23). Spoke from Prevnar 13 Vaccination Schedule for Adults 18 Years of Age and Older. Prevnar 13 is administered as a single dose. During this call the caller also asked if this agent had any information on rabies vaccines stating that she got bit by a dog a couple of months ago, back in April and got a rabies shot (unsure if it was a Pfizer product).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I missed 6 month deadline for second shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable. The patient missed 6 month deadline for second shot of Shingles vaccine, which led to incomplete course of vaccination.  The patient was asking could he/she still get second shot of Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Almost killed me. Was down for about 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were reported as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient stated that he/she received first dose of Shigles vaccine and almost fainted when he/she was told 200 dollars and plus the so called no side effects almost killed him/her. The patient was down for about 4 days. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th March 2022, the patient received Shingles vaccine. In March 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received shot on Friday on an unknown arm.  The patient got covered 100 percent by insurance.  The patient experienced just a sore arm at injection site. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm for several days -was not able to lie on the arm that received the shot; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient had pain in arm for several days after one shot and was not able to lie on the arm that received the shot. The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Injection site nodule, Oral mucosal blistering, Oral pain, Pruritus
Clinical narrative: Mouth pain; tooth pain; Dysphagia; blisters on top of mouth; painful blister; itch over majority of body; Nodule at injection site; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site nodule in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2022, the patient received the 1st dose of Shingrix. On 10th March 2022, 1 days after receiving Shingrix, the patient experienced fever. On 14th March 2022, the patient experienced injection site nodule. On 15th March 2022, the patient experienced localized itching. On 17th March 2022, the patient experienced blistering of mouth and pain. On 18th March 2022, the patient experienced oral pain, toothache and dysphagia. On an unknown date, the outcome of the injection site nodule and localized itching were recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the blistering of mouth, pain, oral pain, toothache and dysphagia were not recovered/not resolved.   It was unknown if the reporter considered the injection site nodule, fever, localized itching, blistering of mouth, pain, oral pain, toothache and dysphagia to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient. The patient received Shingrix in the right arm. After receiving Shingrix, the patient experienced fever. The fever lasted approximately two days.  Five days after receiving Shingrix, the patient experienced nodule on the right arm at the injection site. The nodule was still present but was gradually getting smaller. Six days after receiving Shingrix, the patient experienced an itch over the majority of their body including on the arms, legs, back, and head. The itch was ongoing but gradually improving.  Eight days after receiving Shingrix, the patient experienced blisters on the top of the mouth and blisters were painful.  Nine days after receiving Shingrix, the patient experienced mouth and tooth pain they believe was associated with the blisters.  Nine days after receiving Shingrix, the patient experienced difficulty in swallowing. The consent to follow up was given Vaccine was administered by pharmacist.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Toothache
Clinical narrative: Mouth pain; tooth pain; Dysphagia; blisters on top of mouth; painful blister; itch over majority of body; Nodule at injection site; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site nodule in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2022, the patient received the 1st dose of Shingrix. On 10th March 2022, 1 days after receiving Shingrix, the patient experienced fever. On 14th March 2022, the patient experienced injection site nodule. On 15th March 2022, the patient experienced localized itching. On 17th March 2022, the patient experienced blistering of mouth and pain. On 18th March 2022, the patient experienced oral pain, toothache and dysphagia. On an unknown date, the outcome of the injection site nodule and localized itching were recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the blistering of mouth, pain, oral pain, toothache and dysphagia were not recovered/not resolved.   It was unknown if the reporter considered the injection site nodule, fever, localized itching, blistering of mouth, pain, oral pain, toothache and dysphagia to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient. The patient received Shingrix in the right arm. After receiving Shingrix, the patient experienced fever. The fever lasted approximately two days.  Five days after receiving Shingrix, the patient experienced nodule on the right arm at the injection site. The nodule was still present but was gradually getting smaller. Six days after receiving Shingrix, the patient experienced an itch over the majority of their body including on the arms, legs, back, and head. The itch was ongoing but gradually improving.  Eight days after receiving Shingrix, the patient experienced blisters on the top of the mouth and blisters were painful.  Nine days after receiving Shingrix, the patient experienced mouth and tooth pain they believe was associated with the blisters.  Nine days after receiving Shingrix, the patient experienced difficulty in swallowing. The consent to follow up was given Vaccine was administered by pharmacist.
Age: 15.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix instead of IPV vaccine; 16 year old was administered Pediarix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th March 2022, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 17th March 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 15 years old patient was administered Pediarix intramuscularly into her left arm when she was intended to receive IPV vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.  No further information reported. Follow-up consent to contact was not asked.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash; This literature-non-study case was reported in a literature article and describes the occurrence of RASH (Skin rash) in a 62-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   LITERATURE REFERENCE: Moderna COVID-19 vaccine induced skin rash. Vis J Emerg Med;25:101108     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Skin rash) (seriousness criterion hospitalization). At the time of the report, RASH (Skin rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered RASH (Skin rash) to be related.    No concomitant and treatment medication were reported.  Company Comment: This literature non-study case concerns a 62-year-old, male patient with no reported medical history, who experienced the unexpected, serious (hospitalized) event of Rash. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature non-study case concerns a 62-year-old, male patient with no reported medical history, who experienced the unexpected, serious (hospitalized) event of Rash. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis with thrombocytopenia syndrome
Clinical narrative: Vaccine-Induced Thrombotic Thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Vaccine-Induced Thrombotic Thrombocytopenia) in a 34-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Vaccine-Induced Thrombotic Thrombocytopenia) (seriousness criterion medically significant). At the time of the report, THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Vaccine-Induced Thrombotic Thrombocytopenia) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Vaccine-Induced Thrombotic Thrombocytopenia) to be related.    Concomitant medication information wasn't reported.  The patient was managed conservatively with steroids. Steroids and intravenous immune globulin therapy have been reported in the literature. This report highlights that VITT should be considered in the differential diagnosis for patient presenting with increased bruising in the setting of recent COVID-19 vaccine administration.  Company comment-This is a literature case concerning a 34-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious (Medically Significant), AESI event of Thrombosis with thrombocytopenia syndrome at an unknown interval after first and second dose of mRNA-1273 vaccine administration. It was reported that patient presented with easy bruising and thrombocytopenia following completion of the two-dose Moderna COVID-19 vaccine, suspicious for a diagnosis of VITT. The patient was managed conservatively with steroids, The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature case concerning a 34-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious (Medically Significant), AESI event of Thrombosis with thrombocytopenia syndrome at an unknown interval after first and second dose of mRNA-1273 vaccine administration. It was reported that patient presented with easy bruising and thrombocytopenia following completion of the two-dose Moderna COVID-19 vaccine, suspicious for a diagnosis of VITT. The patient was managed conservatively with steroids, The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cutaneous vasculitis
Clinical narrative: Leukocytoclastic Vasculitis rash; This literature-non-study case was reported in a literature article and describes the occurrence of CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis rash) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis rash) (seriousness criterion medically significant). At the time of the report, CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis rash) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered CUTANEOUS VASCULITIS (Leukocytoclastic Vasculitis rash) to be related.    Concomitant, treatment medication information wasn't reported.  In our case report, we build on those findings with one of the first documented examples of vaccination-induced vasculitic rash in a previously asymptomatic patient.  Company comment: This literature case concerns a 59-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected AESI of Cutaneous vasculitis unspecified days after second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature case concerns a 59-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected AESI of Cutaneous vasculitis unspecified days after second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Poor quality product administered, Product temperature excursion issue, Pyrexia
Clinical narrative: they (mom patient) had fever, body aches and fatigue; they (mom patient) had fever, body aches and fatigue; they (mom patient) had fever, body aches and fatigue; two doses of the vaccine was drawn into syringes last Thursday, 31Dec2021 and stored in the refrigerator but the doses were only administered today, 04Jan2022.; two doses of the vaccine was drawn into syringes last Thursday, 31Dec2021 and stored in the refrigerator but the doses were only administered today, 04Jan2022.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 41 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 04Jan2022 09:37 (Lot number: FJ1620) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01, Lot number: FJ1620, Route of administration: IM, Anatomical site of injection; left arm), administration date: 11Dec2021, for COVID-19 immunization. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 04Jan2022, outcome "unknown" and all described as "two doses of the vaccine was drawn into syringes last Thursday, 31Dec2021 and stored in the refrigerator but the doses were only administered today, 04Jan2022."; PYREXIA (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 01Feb2022, outcome "recovered" (2022) and all described as "they (mom patient) had fever, body aches and fatigue".  Additional information: Reporter called to ask about the Pfizer COVID 19 vaccine purple cap. She stated that two doses of the vaccine was drawn into syringes last Thursday, 31Dec2021 and stored in the refrigerator but the doses were only administered on 04Jan2022. She stated that 41 year old female received the doses. She wanted to know if the dose was still valid. Patient had a routine appointment for her check up on 01Feb2022 and reported to the physician that had fever, body aches and fatigue. It might have been from the expired vaccine or normal reaction. Patient had recovered.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200009167 same reporter/product, different patient/event
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash macular
Clinical narrative: rash in the arm of the shot/Rash is red blotchy; Rash is red blotchy and hurts to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 20:00 (Batch/Lot number: unknown) at the age of 12 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Allergy to trees" (unspecified if ongoing); "sports induced asthma" (unspecified if ongoing); "Known Allergy: Peaches and Mangos" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: RASH MACULAR (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "rash in the arm of the shot/Rash is red blotchy"; PAIN (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "Rash is red blotchy and hurts to touch". Therapeutic measures were taken as a result of rash macular, pain.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No Covid prior vaccination and no covid tested post vaccination. Other medications in two weeks was Multi Vitamin Zyrtec Flonase. On 15Jan2022, night at 7pm he was complaining of a rash in the arm of the shot. Shot was given at to left arm. Rash was at bottom of arm. Rash was red blotchy and hurted to touch. AE treatment: Benadryl.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Off label use, Pain in extremity, Poor quality product administered, Product preparation issue, Product use issue
Clinical narrative: arm was sore; they do have a Pfizer Covid-19 vaccine that was not diluted properly and it was administered to a patient; they do have a Pfizer Covid-19 vaccine that was not diluted properly and it was administered to a patient; Product use for unapproved combination; Off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 21 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 19Jan2022 09:00 (Lot number: FJ1620) as dose 3 (booster), single for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), intramuscular, administered in deltoid right, administration date 19Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOESTRIN taken for contraception, start date: Sep2020 (ongoing). Vaccination history included: Bnt162b2 (1st), administration date: 29Mar2021, when the patient was 21 years old, for Covid-19 immunization; Bnt162b2 (2nd), administration date: 19Apr2021, when the patient was 21 years old, for Covid-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT PREPARATION ISSUE (non-serious) all with onset 19Jan2022, outcome "unknown" and all described as "they do have a Pfizer Covid-19 vaccine that was not diluted properly and it was administered to a patient"; PRODUCT USE ISSUE (non-serious) with onset 19Jan2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 19Jan2022, outcome "unknown", described as "Off label use"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore". Additional information: Prior vaccine in four weeks: None. For concomitant Tdap reason for use: Administered same day as 3rd Pfizer vax and the route of administration is IM RD. Patients Medical History Familial PKSD Ongoing. Medication improperly diluted Not diluted Enough.Confused w/syringe chance for diluted instead of 1.8 ml to dilute I used 0.18 ml. No pt day of a next day sand she was fine her arm was sore but started no more expected she was instanced to cast if she expected Amy adverse effect a reiterated that she was fine w/pt again today 16Feb2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (23Feb2022): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non HCP letter sent that included: Updated Information Included: New event, Reporter Information slide #2 Added, Other Relevant History, Vaccine Facility Information, concomitant medication.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Salivary hypersecretion
Clinical narrative: salivating a lot and her mouth is running a lot and doesn't stop; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 5-year-old female patient received bnt162b2 (BNT162B2), administration date 08Jan2022 (Batch/Lot number: unknown) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "heart condition" (unspecified if ongoing), notes: Verbatim: heart condition. There were no concomitant medications. The following information was reported: SALIVARY HYPERSECRETION (non-serious) with onset 09Jan2022, outcome "not recovered", described as "salivating a lot and her mouth is running a lot and doesn't stop".  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Urticaria
Clinical narrative: I search and I found person with the same hives due vaccine allergies.; I search and I found person with the same hives due vaccine allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "I search and I found person with the same hives due vaccine allergies."; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "I search and I found person with the same hives due vaccine allergies".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A 26 year-old female patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 26 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "hives". The event "hives" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of urticaria.  Additional information: The patient had autoimmune disorder, had both Pfizer Covid vaccines, last March-April. She had been wanting a booster, but was concerned as she had reaction three days after second vaccine. She broke out in head to toe hives, with some appearing as very large welts, which were hot to touch, which lasted ten-twelve days. She went to urgent care at the time. They did not seem to know much about it. Benadryl was given. Her neurologist was made aware but also, had no recommendations.  Follow-up attempts made; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have had fibromyalgia for 20 years, With the first shot I felt good for five days, with the second shot four days, and with the booster it was all gone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 77 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Oct2021 10:00 (Lot number: FF2590) at the age of 77 years as dose 3 (booster), single, intramuscular, administration date 08Feb2021 (Lot number: EL9266) as dose 2, single and intramuscular, administered in arm right, administration date 21Jan2021 17:00 (Lot number: EL8982) as dose 1, single for covid-19 immunisation. Relevant medical history included: "fibromyalgia", start date: 2001, stop date: 17Oct2021, notes: have had fibromyalgia for 20 years; "Polymyalgia", start date: 2017 (ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have had fibromyalgia for 20 years, With the first shot I felt good for five days, with the second shot four days, and with the booster it was all gone".  Additional information: The Patient had fibromyalgia for 20 years, Patient is now 77 years old, and with the booster shot the disease totally went away. With the first shot it felt good for five days, with the second shot four days, and with the booster it was all gone. The patient received the 4th booster dose on 23Feb2022, 01PM (Lot number: FK9729 ). No Prior vaccination (within 4 weeks), No Concomitant drug.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pruritus
Clinical narrative: horrible itching; it is so bad that it effects my daily life.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "horrible itching"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "not recovered", described as "it is so bad that it effects my daily life.". The events "horrible itching" and "it is so bad that it effects my daily life." were evaluated at the physician office visit.  Additional Information: Subject: Patient Assistance, Customer Verbatim: Hello, I have had horrible itching without a rash since my covid vaccine. I have seen doctor after doctor and nothing. it is so bad that it effects my daily life. Wondering who to contact with Pfizer to find out if there have been any other reports of this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (04Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Pain
Clinical narrative: my arthritis is 100% worse; My pain is debilitating and has been since I received the vaccinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "my arthritis is 100% worse"; PAIN (non-serious), outcome "unknown", described as "My pain is debilitating and has been since I received the vaccinations".  Additional Information: Since patient received Covid 19 vaccinations patients arthritis was 100 percentage worse. In fact, patient had Rheumatologist checking on more information about this and primary. As of the point where patient fear may be disabled at a much earlier age in life. The patients pain was debilitating and had been since received the vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Around the 1 minutes, her daughter felt pounding and palpitations; Around the 1 minutes, her daughter felt pounding and palpitations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Dec2021 (Lot number: FF2593) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), PALPITATIONS (non-serious) all with onset 10Dec2021, outcome "recovered" (10Dec2021) and all described as "Around the 1 minutes, her daughter felt pounding and palpitations".  Additional information: Parent stated that for the first dose they were supposed to wait for like 1 minutes. Around the 1 minutes, her daughter felt pounding and palpitations. At that time, it only lasted about 12 minutes and went away and her daughter didn't think anything of it.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration, Neutrophil count, White blood cell count, White blood cell count decreased
Clinical narrative: she typically has a low WBC; 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 69 year-old female patient received bnt162b2 (BNT162B2), administration date 27Aug2021 (Lot number: FC3184, Expiration Date: 31Oct2021) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot FA7485, NDC unknown, expiration date 31Oct2021), administration date: 04Aug2021, when the patient was 68 years old, for COVID-19 Immunization. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "she typically has a low WBC". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller had called about the Pfizer Biontech vaccine. The caller had the first shot which was no issue. The caller had the second dose and she had a reaction. The caller was glad to have a reaction because she typically has a low WBC.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Rosacea
Clinical narrative: I experienced inflammation/rosacea issues on my face, especially around my cheekbones; I experienced inflammation/rosacea issues on my face, especially around my cheekbones; I experienced inflammation/rosacea issues on my face, especially around my cheekbones; I experienced inflammation/rosacea issues on my face, especially around my cheekbones; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jul2021 02:15 (Lot number: FA6780) at the age of 53 years as dose 2, single and administered in arm left, administration date 26Jan2022 10:15 (Lot number: PJ1614) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FW0181, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 28Jun2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: INFLAMMATION (non-serious), ROSACEA (non-serious) all with onset Jul2021, outcome "recovered" (Dec2021) and all described as "I experienced inflammation/rosacea issues on my face, especially around my cheekbones"; INFLAMMATION (non-serious), ROSACEA (non-serious) all with onset 28Jan2022, outcome "recovering" and all described as "I experienced inflammation/rosacea issues on my face, especially around my cheekbones". Therapeutic measures were not taken as a result of inflammation, rosacea, inflammation, rosacea.  Additional information: The patient has not been tested positive for covid post or prior to vaccination. It was reported that patient experienced inflammation/rosacea issues on his face, especially around my cheekbones. Patient don't have a history of skin issues. After his second dose, patient also experienced the same (much worse) issue; however, patient didn't recognize it was related to the vaccine until now. The previous case lasted from July through December before his skin returned to normal.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Chest pain, Chest wall mass, Limb mass
Clinical narrative: I have chest pain; lumps towards the chest; lumps towards the chest near my shoulders; and lumps towards the chest near my shoulders and my armpits; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: 26Mar2021, for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "I have chest pain"; CHEST WALL MASS (non-serious), outcome "unknown", described as "lumps towards the chest"; LIMB MASS (non-serious), outcome "unknown", described as "lumps towards the chest near my shoulders"; AXILLARY MASS (non-serious), outcome "unknown", described as "and lumps towards the chest near my shoulders and my armpits". The events "I have chest pain", "lumps towards the chest", "lumps towards the chest near my shoulders" and "and lumps towards the chest near my shoulders and my armpits" were evaluated at the physician office visit.  Additional Information: For 9 months patient had experienced the following side effects: Patient had chest pain and lumps towards the chest near his shoulders and his armpits. Patient has been going though doctors and specialists including cardiologists and patient want to know how to fix this.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Skin odour abnormal, Vaccination site inflammation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 28Jan2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "stroke" (unspecified if ongoing), notes: Verbatim: Stroke; "Seizures", start date: 2014 (unspecified if ongoing), notes: Verbatim: Seizures. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for Covid-19 immunization, reaction(s): "No adverse effect"; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for Covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: INJECTION SITE INFLAMMATION (non-serious) with onset 30Jan2021, outcome "unknown", described as "bump appearing on the injection site"; INFECTION (non-serious) with onset 30Jan2021, outcome "unknown", described as ""something black" came out and has a little odor to it."; SKIN ODOR ABNORMAL (non-serious) with onset 30Jan2021, outcome "unknown", described as "a little odor". Additional Information: This is Non Serious case. Reporter stated that he noticed a bump appearing on the injection site of his left arm a few days after he received his booster dose and this has happened at two different times. He said that the when he rubbed the bump, "something black" came out and has a little odor to it. A few days later when the caller was cleaning a little more came out of it, no more has come out since then. He also said that he was fine from his first two doses but for his booster dose, this particular bump with a black excretion and little odor appeared. The caller had just gone to his primary care provider before he took the booster shot. This bump wasn't on the caller's arm after the first two shots, it showed up after the third shot. It happened two times and hasn't come no more. When the caller wiped himself with a towel the paste came out and had a little odor. The caller smelled it and it had a light odor to it. The caller was in a panic because he had to take his medicine to his doctor and they said there shouldn't be any problems with them interfering with the vaccine. The caller took his medicine to his neurologist and they said there shouldn't be any conflict with the medicine and the shot. Then the caller took his shots. Reason for no lot number of Pfizer Covid vaccine was mentioned as, The caller does not have his vaccination card with him. Patient taking Pfizer Covid vaccine (Verbatim) because, every one was telling him to take. Additional Information for Other Conditions: The last one was in 2014. The lot number for [BNT162B2], was not provided and will be requested during follow up.