chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She got COVID; She got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY), administration date 28Jun2021 (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "She got COVID". The reporter called on behalf of her mother to inquire regarding the second dose of the Pfizer Biontech COVID 19 vaccine. She stated her mother received the first dose of the Pfizer Biontech COVID 19 vaccine on 28Jun2021. She got COVID and was told by a Pharmacist not to come to get the second dose. Caller wanted to know if her mother should restart the vaccine series or to get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: had gotten Covid over holiday 2021 even though she was vaxxed and boosted (don't know what vaccine); had gotten Covid over holiday 2021 even though she was vaxxed and boosted (don't know what vaccine); had gotten Covid over holiday 2021 even though she was vaxxed and boosted (don't know what vaccine); This is a spontaneous report received from a contactable reporter (consumer) via portal. Other Case identifiers: US-PFIZER INC-202200015890 (Pfizer), US-PFIZER INC-202200015904 (Pfizer).  A female patient received BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Solution for injection), (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown," DRUG INEFFECTIVE (medically significant) and SUSPECTED COVID-19 (medically significant) both with onset Dec2021, outcome "unknown" and all described as "had gotten Covid over holiday 2021 even though she was vaxxed and boosted (don't know what vaccine)."  The batch/lot number for BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown) was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "got COVID". Patient was supposed to get her booster dose in Dec2021 but she got COVID. Reporter was asking what was the dosing schedule for the booster dose and caller mentioned that the CDC recommends people to get the booster dose after atleast 5 months if they receive the Pfizer primary series.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted Covid-19; contracted Covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "contracted Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: contracted covid-19, notes: Caller states they have contracted Covid-19 and have now fully recovered. Clinical course: The reporter had inquired about two kids, who were vaccinated with the pediatric formulation orange cap Pfizer BioNTech Covid-19 vaccine 3 weeks ago. The reporter stated that they have had contracted Covid-19 and have now fully recovered. Reporter would like to know if the second dose of the pediatric formulation Covid-19 vaccine should be administered on schedule or if the second dose should be delayed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: I don't know, she tested negative for COVID with almost like she had symptoms of one whole COVID, and its lasted for about three days; Headache; tired/fatigue; she couldn''t get out of bed; she is like completely bed within.; She was dizzy.; She have a cold; brain Fogg; she was completely disoriented, she couldn't function; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Lot number: TJ1620) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic cough" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: she had breast cancer like several years ago like probably 15-20 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "extreme fatigue", "brain Fogg"; Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "extreme fatigue", "brain Fogg". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 01Jan2022, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 01Jan2022, outcome "unknown", described as "tired/fatigue"; MOVEMENT DISORDER (non-serious) with onset 01Jan2022, outcome "unknown", described as "she couldn''t get out of bed; she is like completely bed within."; DIZZINESS (non-serious) with onset 01Jan2022, outcome "unknown", described as "She was dizzy."; NASOPHARYNGITIS (non-serious) with onset 01Jan2022, outcome "unknown", described as "She have a cold"; FEELING ABNORMAL (non-serious) with onset 01Jan2022, outcome "unknown", described as "brain Fogg"; DISORIENTATION (non-serious) with onset 01Jan2022, outcome "unknown", described as "she was completely disoriented, she couldn't function"; SUSPECTED COVID-19 (non-serious), outcome "recovered", described as "I don't know, she tested negative for COVID with almost like she had symptoms of one whole COVID, and its lasted for about three days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, headache, fatigue, movement disorder, dizziness, nasopharyngitis, feeling abnormal, disorientation, suspected covid-19.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Movement disorder, Nasopharyngitis, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I don't know, she tested negative for COVID with almost like she had symptoms of one whole COVID, and its lasted for about three days; Headache; tired/fatigue; she couldn''t get out of bed; she is like completely bed within.; She was dizzy.; She have a cold; brain Fogg; she was completely disoriented, she couldn't function; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Lot number: TJ1620) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic cough" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: she had breast cancer like several years ago like probably 15-20 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "extreme fatigue", "brain Fogg"; Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "extreme fatigue", "brain Fogg". The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 01Jan2022, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 01Jan2022, outcome "unknown", described as "tired/fatigue"; MOVEMENT DISORDER (non-serious) with onset 01Jan2022, outcome "unknown", described as "she couldn''t get out of bed; she is like completely bed within."; DIZZINESS (non-serious) with onset 01Jan2022, outcome "unknown", described as "She was dizzy."; NASOPHARYNGITIS (non-serious) with onset 01Jan2022, outcome "unknown", described as "She have a cold"; FEELING ABNORMAL (non-serious) with onset 01Jan2022, outcome "unknown", described as "brain Fogg"; DISORIENTATION (non-serious) with onset 01Jan2022, outcome "unknown", described as "she was completely disoriented, she couldn't function"; SUSPECTED COVID-19 (non-serious), outcome "recovered", described as "I don't know, she tested negative for COVID with almost like she had symptoms of one whole COVID, and its lasted for about three days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, headache, fatigue, movement disorder, dizziness, nasopharyngitis, feeling abnormal, disorientation, suspected covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance, Pain, Type 1 diabetes mellitus
Clinical narrative: diabetic (type 1); not able to walk more than 5-10 min; started having debilitating pain; joint inflammation in the hip and knees; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient was in good health prior to the vaccine. It was reported that the patient's sister was diabetic (Type 1). The following information was reported: TYPE 1 DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetic (type 1)"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "not able to walk more than 5-10 min"; PAIN (non-serious), outcome "unknown", described as "started having debilitating pain"; ARTHRITIS (non-serious), outcome "unknown", described as " joint inflammation in the hip and knees".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: blind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (Batch/Lot number: unknown) 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: BLINDNESS (medically significant), outcome "unknown", described as "blind".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Fever of over 102, uncontrollably sweating that turned into uncontrollably shaking from being cold.  Swollen throat, hardly can swallow. Headache, extreme body aches, light headed.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngeal swelling, Pyrexia, Tremor
Clinical narrative: Fever of over 102, uncontrollably sweating that turned into uncontrollably shaking from being cold.  Swollen throat, hardly can swallow. Headache, extreme body aches, light headed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: Chronic urticaria all over the body at random times and duration x 5 weeks
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Muscular weakness
Clinical narrative: Unexplained intermittent chest pain, intermittent shortness of breath, feeling of weakness in hands.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Confusional state, Encephalopathy, Mental status changes
Clinical narrative: Patient is fully vaccinated.  Tested COVID + on 12/4/2021. Admitted on 12/3/2021 for 5 days.  Admitting dx altered mental status and COVID 19.  Encepalopathy, debility, UTI with possible sepsis.  51-year-old white male, who apparently was brought to the emergency room because of change of mentation.  The patient is debilitated with advanced multiple sclerosis.  The patient is immobile with contractures.  The patient has indwelling catheter as well.  The patient was found to have severe UTI with possibility of sepsis, empirically was covered with IV antibiotics.  I was unable to get history of the patient due to his confusion.  The patient was getting very restless.  He was having legs cramps on screaming, I had to give him Ativan IV in the ER.  When I saw him, the patient looks in a very poor condition. The patient is being discharged home with home care today to the care of his family in a stable clinical condition
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Restlessness, SARS-CoV-2 test positive, Screaming, Urinary tract infection
Clinical narrative: Patient is fully vaccinated.  Tested COVID + on 12/4/2021. Admitted on 12/3/2021 for 5 days.  Admitting dx altered mental status and COVID 19.  Encepalopathy, debility, UTI with possible sepsis.  51-year-old white male, who apparently was brought to the emergency room because of change of mentation.  The patient is debilitated with advanced multiple sclerosis.  The patient is immobile with contractures.  The patient has indwelling catheter as well.  The patient was found to have severe UTI with possibility of sepsis, empirically was covered with IV antibiotics.  I was unable to get history of the patient due to his confusion.  The patient was getting very restless.  He was having legs cramps on screaming, I had to give him Ativan IV in the ER.  When I saw him, the patient looks in a very poor condition. The patient is being discharged home with home care today to the care of his family in a stable clinical condition
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Computerised tomogram head abnormal, Confusional state, Delirium, Dysarthria
Clinical narrative: Dec 18th severe headache, no medication administered due to patient's dislike of taking pills. SEVERE headache with right side eye pain, vomitting and fever continued until 12/21 .. when I took him to the ER ..  no confusion or change in mental ability presented in days prior. In ER slurred speech along with mental state changed drastically. Confusion, delirium, physical stability to walk or sustain own weight wasn't possible. Sedation was given to calm patients aggravation.  CT confirmed Intracranial hemorrhage on the right side between occipital and temporal lobe. Patient was intubated and air lifted to larger hospital.  In transit had a seizure.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Endotracheal intubation, Eye pain, Gait inability, Haemorrhage intracranial, Headache
Clinical narrative: Dec 18th severe headache, no medication administered due to patient's dislike of taking pills. SEVERE headache with right side eye pain, vomitting and fever continued until 12/21 .. when I took him to the ER ..  no confusion or change in mental ability presented in days prior. In ER slurred speech along with mental state changed drastically. Confusion, delirium, physical stability to walk or sustain own weight wasn't possible. Sedation was given to calm patients aggravation.  CT confirmed Intracranial hemorrhage on the right side between occipital and temporal lobe. Patient was intubated and air lifted to larger hospital.  In transit had a seizure.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Pyrexia, Sedation, Seizure, Vomiting
Clinical narrative: Dec 18th severe headache, no medication administered due to patient's dislike of taking pills. SEVERE headache with right side eye pain, vomitting and fever continued until 12/21 .. when I took him to the ER ..  no confusion or change in mental ability presented in days prior. In ER slurred speech along with mental state changed drastically. Confusion, delirium, physical stability to walk or sustain own weight wasn't possible. Sedation was given to calm patients aggravation.  CT confirmed Intracranial hemorrhage on the right side between occipital and temporal lobe. Patient was intubated and air lifted to larger hospital.  In transit had a seizure.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a elderly female patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix (received 1st dose on 13th December 2018) and shingrix (received 2nd dose on an unknown date). On an unknown date, the patient received the 3rd dose of shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was unknown. The reporter stated that, she returned to the pharmacy and received her second dose, but the pharmacy told her to consider it as first dose. The reporter did not know why she was told this information. The reporter also had a third dose of shingrix as directed by the pharmacy, which led to extra dose administered. The reporter had no information regarding the dates of 2nd and 3rd dose of shingrix. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 YEARS); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age (17 years), and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient of inappropriate age (17 years) and off label use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dyspnoea, Gait disturbance, Peripheral swelling, Thrombosis
Clinical narrative: BLOOD CLOTS; BURNING IN THE LEGS; SWELLING IN THE LEGS; TROUBLE WALKING; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, smoker (3 cigarettes/day), hypertension, hypothyroidism, and the patient had no known drug allergies. The patient experienced drug abuse when treated with cannabis sativa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180270, and expiry: UNKNOWN) dose was not reported, 1 total administered on 09-MAR-2021 for prophylactic vaccination.  Concomitant medications included amlodipine for hypertension, and levothyroxine for hypothyroidism.  On 11-MAR-2021, the patient experienced shortness of breath. On 12-MAR-2021, the patient experienced blood clots. On 12-MAR-2021, the patient experienced burning in the legs. On 12-MAR-2021, the patient experienced swelling in the legs. On 12-MAR-2021, the patient experienced trouble walking. On 13-JAN-2022, the primary care physician (PCP) prescribed ipratropium bromide/salbutamol sulfate (Combivent Respimat) for shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, shortness of breath, burning in the legs, swelling in the legs, and trouble walking. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220126392.; Sender's Comments: V0-20220126621- Covid-19 vaccine ad26.CoV-2.s - Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Thrombosis
Clinical narrative: BLOOD CLOTS; BURNING IN THE LEGS; SWELLING IN THE LEGS; TROUBLE WALKING; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, smoker (3 cigarettes/day), hypertension, hypothyroidism, and the patient had no known drug allergies. The patient experienced drug abuse when treated with cannabis sativa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180270, and expiry: UNKNOWN) dose was not reported, 1 total administered on 09-MAR-2021 for prophylactic vaccination.  Concomitant medications included amlodipine for hypertension, and levothyroxine for hypothyroidism.  On 11-MAR-2021, the patient experienced shortness of breath. On 12-MAR-2021, the patient experienced blood clots. On 12-MAR-2021, the patient experienced burning in the legs. On 12-MAR-2021, the patient experienced swelling in the legs. On 12-MAR-2021, the patient experienced trouble walking. On 13-JAN-2022, the primary care physician (PCP) prescribed ipratropium bromide/salbutamol sulfate (Combivent Respimat) for shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots, shortness of breath, burning in the legs, swelling in the legs, and trouble walking. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220126392.; Sender's Comments: V0-20220126621- Covid-19 vaccine ad26.CoV-2.s - Blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO 17 YEAR OLD; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 17-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 17-JAN-2022, the patient experienced vaccine administered to 17 year old, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to 17 year old and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I can not stand my arm it hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I can not stand my arm it hurts a lot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I can not stand my arm it hurts a lot). At the time of the report, PAIN IN EXTREMITY (I can not stand my arm it hurts a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2022: Follow-up received on 13-Jan-2022 and included no new information. On 13-Jan-2022: Translation document received on 14-Jan-2022 included no new information. On 14-Jan-2022: Follow-up information received on 14/Jan/2022: Upon follow up the case became valid. New event (pain in arm) replaced with the previous event. Corresponding fields and narrative updated accordingly.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: She is itching like crazy; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (She is itching like crazy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (She is itching like crazy). At the time of the report, PRURITUS (She is itching like crazy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: entire arm including hand hurt; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (entire arm including hand hurt) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (entire arm including hand hurt). At the time of the report, PAIN IN EXTREMITY (entire arm including hand hurt) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Illness
Clinical narrative: Received full dose instead of 0.25 mL; She has been very ill last night; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (She has been very ill last night) and ACCIDENTAL OVERDOSE (Received full dose instead of 0.25 mL) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Received full dose instead of 0.25 mL). In January 2022, the patient experienced ILLNESS (She has been very ill last night). On 14-Jan-2022, ACCIDENTAL OVERDOSE (Received full dose instead of 0.25 mL) had resolved. At the time of the report, ILLNESS (She has been very ill last night) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity, Peripheral swelling
Clinical narrative: and a bit swollen; My arm was sore; now it's sore around my armpit area; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (and a bit swollen), PAIN IN EXTREMITY (My arm was sore) and AXILLARY PAIN (now it's sore around my armpit area) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PERIPHERAL SWELLING (and a bit swollen), PAIN IN EXTREMITY (My arm was sore) and AXILLARY PAIN (now it's sore around my armpit area). At the time of the report, PERIPHERAL SWELLING (and a bit swollen), PAIN IN EXTREMITY (My arm was sore) and AXILLARY PAIN (now it's sore around my armpit area) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 patients had recieved expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Immunisation, SARS-CoV-2 test
Clinical narrative: COVID-19; got her booster dose and then got COVID; got her booster dose; sick for about a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: COVID-19 (medically significant), outcome "recovered", described as "COVID-19"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "got her booster dose and then got COVID"; IMMUNISATION (medically significant), outcome "unknown", described as "got her booster dose"; ILLNESS (non-serious), outcome "recovered", described as "sick for about a week". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Caller reported that, her sister got her booster dose and then got COVID. Was sick for about a week, was fine. After the COVID-19 Vaccine patient tested positive for COVID.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 9 year old female tested positive for covid-19 approximately one month after 2nd dose of the Pfizer. Pediatric (5-11) vaccine.; 9 year old female tested positive for covid-19 approximately one month after 2nd dose of the Pfizer. Pediatric (5-11) vaccine.; Mild cold like symptoms; low grade fever; This is a spontaneous report received from a contactable reporter (Consumer).  A 9 year-old female patient received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "9 year old female tested positive for covid-19 approximately one month after 2nd dose of the Pfizer. Pediatric (5-11) vaccine."; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Mild cold like symptoms"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: Caught COVID; Caught COVID; Sore arm; With son-in-law's COVID symptoms, he had a fever with his head cold; With son-in-law's COVID symptoms, he had a fever with his head cold; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caught COVID"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PYREXIA (non-serious), NASOPHARYNGITIS (non-serious), outcome "unknown" and all described as "With son-in-law's COVID symptoms, he had a fever with his head cold". Clinical course: Patient had two doses of Pfizer Comirnaty, had a sore arm. Then two months later, patient caught COVID. Had to stay in isolation for ten days. This was around the time of the Delta variant. With patient's COVID symptoms, he had a fever with his head cold.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; took a mandatory test and it came back positive; took a mandatory test and it came back positive; 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. The report was forwarded as an Adverse Event.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown, Manufacturer 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: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "took a mandatory test and it came back positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The reporter stated he/she just received his/her booster and started experiencing side effects 12 hours post shot and they have not gone away since. He/she just took a mandatory test for work and it came back positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: 2 shots of Moderna + Pfizer booster; 2 shots of Moderna + Pfizer booster; have gotten Covid; have gotten Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (dose 1), for COVID-19 immunization; Moderna vaccine (dose 2), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "2 shots of Moderna + Pfizer booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have gotten Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: The patient mentioned that it got him, despite 2 shots of Moderna and Pfizer booster-last Wednesday he tested positive for Covid. Symptoms minimal-mostly scratchy throat that disappeared in hours-never any fever or loss of taste. He was isolating and wears mask.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: 2 shots of Moderna + Pfizer booster; 2 shots of Moderna + Pfizer booster; have gotten Covid; have gotten Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (dose 1), for COVID-19 immunization; Moderna vaccine (dose 2), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "2 shots of Moderna + Pfizer booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have gotten Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: The patient mentioned that it got him, despite 2 shots of Moderna and Pfizer booster-last Wednesday he tested positive for Covid. Symptoms minimal-mostly scratchy throat that disappeared in hours-never any fever or loss of taste. He was isolating and wears mask.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: 2 shots of Moderna +Pfizer booster; 2 shots of Moderna +Pfizer booster; 2 shots of Moderna +Pfizer booster; gotten Covid; gotten Covid; This is a spontaneous report from a contactable consumer. A patient (no qualifiers provided) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA) as dose 2, single and 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: off label use (medically significant), interchange of vaccine products (medically significant), immunisation (medically significant), outcome "unknown" and all described as "2 shots of Moderna +Pfizer booster"; drug ineffective (medically significant), suspected covid-19 (medically significant), outcome "unknown" and all described as "gotten Covid". Despite 2 shots of Moderna +Pfizer booster-last Wednesday patient tested positive for Covid. Symptoms minimal mostly scratchy throat that disappeared in hours-never any fever or loss of taste. Patient was isolating and mask wearing thankfully neither wife nor daughter was positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 RT-PCR test: positive.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: 2 shots of Moderna +Pfizer booster; 2 shots of Moderna +Pfizer booster; 2 shots of Moderna +Pfizer booster; gotten Covid; gotten Covid; This is a spontaneous report from a contactable consumer. A patient (no qualifiers provided) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA) as dose 2, single and 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: off label use (medically significant), interchange of vaccine products (medically significant), immunisation (medically significant), outcome "unknown" and all described as "2 shots of Moderna +Pfizer booster"; drug ineffective (medically significant), suspected covid-19 (medically significant), outcome "unknown" and all described as "gotten Covid". Despite 2 shots of Moderna +Pfizer booster-last Wednesday patient tested positive for Covid. Symptoms minimal mostly scratchy throat that disappeared in hours-never any fever or loss of taste. Patient was isolating and mask wearing thankfully neither wife nor daughter was positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 RT-PCR test: positive.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Dyspnoea, Maternal exposure timing unspecified
Clinical narrative: Fully vaccinated with the Covid Vaccine but I tested Covid positive; Fully vaccinated with the Covid Vaccine but I tested Covid positive; pregnant; can't breath; soreness; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Fully vaccinated with the Covid Vaccine but I tested Covid positive"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "pregnant"; DYSPNOEA (non-serious), outcome "unknown", described as "can't breath"; PAIN (non-serious), outcome "unknown", described as "soreness"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever". The patient underwent the following laboratory tests and procedures: body temperature: low grade fever; sars-cov-2 test: positive. Additional Information:  When probed for the concern, consumer stated, "So I have tested (Covid) positive I fully vaccinated with the Covid (Covid-19 Vaccine) but I tested positive, and I was asked to you guys for the adverse reaction occurred, I am having symptoms because I am pregnant (conservatively captured as event) I guess and my symptoms are like I can't breathe, soreness and a low grade fever, so I guess the Nurses wanted me to kind of give you guys."   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fully vaccinated with the Covid Vaccine but I tested Covid positive; Fully vaccinated with the Covid Vaccine but I tested Covid positive; pregnant; can't breath; soreness; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Fully vaccinated with the Covid Vaccine but I tested Covid positive"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "pregnant"; DYSPNOEA (non-serious), outcome "unknown", described as "can't breath"; PAIN (non-serious), outcome "unknown", described as "soreness"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever". The patient underwent the following laboratory tests and procedures: body temperature: low grade fever; sars-cov-2 test: positive. Additional Information:  When probed for the concern, consumer stated, "So I have tested (Covid) positive I fully vaccinated with the Covid (Covid-19 Vaccine) but I tested positive, and I was asked to you guys for the adverse reaction occurred, I am having symptoms because I am pregnant (conservatively captured as event) I guess and my symptoms are like I can't breathe, soreness and a low grade fever, so I guess the Nurses wanted me to kind of give you guys."   The lot number for bnt162b2 was not provided and will be requested during follow up.