chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HEPA, HEPA, HIBV, HPV9, HPV9, RV5, UNK, UNK, UNK, UNK
Symptoms: Product storage error
Clinical narrative: ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005238: US-009507513-2103USA005239: US-009507513-2103USA005240: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; an expired VARlVAX was administered to a patient; This spontaneous report was received from an officer manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 23-MAR-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength was not provided; lot# was s004091 and expiration date was 11-FEB-2021) 0.5 mL once for prophylaxis (expired product administered). The vaccine had not had any prior temperature excursions. No additional adverse event was reported (no adverse event).
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Chills, Decreased appetite, Fatigue, Hyperhidrosis
Clinical narrative: Poor Appetite; Drenched; Got sick; Felt like she was having a fever; Chills; Pain Injection Site; Fatigue/Tired; Anaphylactic shock; A spontaneous report was received from a nurse who was a 49-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue/tired, poor appetite, pain, chills, drenched, felt like she was having a fever, got sick, and anaphylactic shock.  The patient's medical history included psych condition. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A, Exp. date: 22 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced fatigue/tired, poor appetite, pain, chills, drenched, felt like she was having a fever, got sick, and anaphylactic shock. Treatment for the events included one dose of acetaminophen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, fatigue/tired, poor appetite, pain, chills, drenched, felt like she was having a fever, got sick, and anaphylactic shockwas unknown.  The reporter did not provide the causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Injection site pain, Pyrexia
Clinical narrative: Poor Appetite; Drenched; Got sick; Felt like she was having a fever; Chills; Pain Injection Site; Fatigue/Tired; Anaphylactic shock; A spontaneous report was received from a nurse who was a 49-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue/tired, poor appetite, pain, chills, drenched, felt like she was having a fever, got sick, and anaphylactic shock.  The patient's medical history included psych condition. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A, Exp. date: 22 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced fatigue/tired, poor appetite, pain, chills, drenched, felt like she was having a fever, got sick, and anaphylactic shock. Treatment for the events included one dose of acetaminophen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, fatigue/tired, poor appetite, pain, chills, drenched, felt like she was having a fever, got sick, and anaphylactic shockwas unknown.  The reporter did not provide the causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria, Facial paralysis
Clinical narrative: Facial drooping; Slurred speech; A spontaneous report was received from a nurse concerning a 66-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed facial drooping/facial paralysis and slurred speech/dysarthria.   The patient's medical history included pulmonary fibrosis. No relevant concomitant medications were reported.   On 21 Jan 2021, prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) in the arm for prophylaxis of COVID-19 infection.   On 21 Jan 2021, the patient developed facial drooping (medically significant) and slurred speech. The patient did not receive any treatment for the events.     Action taken with mRNA-1273 in response to the event was not reported.     The outcome of the events facial drooping and slurred speech was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Chills, Condition aggravated, Diabetes mellitus, Fatigue
Clinical narrative: blood sugar has been almost at 300; blood sugar has been almost at 300; Aches; fever; Headaches; Chills; Felt tired; A spontaneous report was received from a consumer, concerning a 74 years-old, female patient who received Moderna's COVID-19 vaccine and experienced aches, fever, headaches, chills, felt tired, and blood sugar has been almost at 300.   The patient's medical history included diabetic. Concomitant product use included insulin.  The patient received their first of two planned doses of mRNA-1273 on an unknown date. On 18 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number 031M20A) via intramuscular route for COVID-19 infection prophylaxis.  On 19 Feb 2021, about 25 hours after second dose of vaccine, the patient had a mild reaction which included aches, fever, headaches, chills, and felt tired.  The patient is a diabetic and blood sugar was almost at 300 and not coming down.   The patient received both planned doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The events Aches, Fever, Headache, Chills, felt tired, blood sugar has been almost at 300 was considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (myalgia, pyrexia, headache, chills, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the event (diabetes mellitus and condition aggravated) has been provided at this time. Details regarding the event, medical history, concomitant medications, are required for further evaluation. Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: blood sugar has been almost at 300; blood sugar has been almost at 300; Aches; fever; Headaches; Chills; Felt tired; A spontaneous report was received from a consumer, concerning a 74 years-old, female patient who received Moderna's COVID-19 vaccine and experienced aches, fever, headaches, chills, felt tired, and blood sugar has been almost at 300.   The patient's medical history included diabetic. Concomitant product use included insulin.  The patient received their first of two planned doses of mRNA-1273 on an unknown date. On 18 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number 031M20A) via intramuscular route for COVID-19 infection prophylaxis.  On 19 Feb 2021, about 25 hours after second dose of vaccine, the patient had a mild reaction which included aches, fever, headaches, chills, and felt tired.  The patient is a diabetic and blood sugar was almost at 300 and not coming down.   The patient received both planned doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The events Aches, Fever, Headache, Chills, felt tired, blood sugar has been almost at 300 was considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (myalgia, pyrexia, headache, chills, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the event (diabetes mellitus and condition aggravated) has been provided at this time. Details regarding the event, medical history, concomitant medications, are required for further evaluation. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: Was scheduled for his 2nd vaccine and did not receive it; Tested positive for Covid-19; A spontaneous report, was received from a consumer (patient's wife), concerning husband, a male patient of an unspecified age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and tested positive for COVID-19 (COVID-19 virus test positive) and was scheduled for his 2nd vaccine and did not receive it (Product dose omission).  The patient's medical history was not provided. No concomitant product use was reported.  On 20 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient was tested positive for COVID-19. The patient was scheduled for his second dose of vaccine on 17 Feb 2021 and did not receive it. The patient wanted to know when he could receive the second dose of vaccine. Treatment information was unknown.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of events tested positive for COVID-19 and was scheduled for his 2nd vaccine and did not receive it were not reported.; Reporter's Comments: This report refers to a case of Product dose omission for mRNA-1273, with the event of COVID-19 virus test positive.
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Fatigue, Headache, Myalgia, Pain
Clinical narrative: fingers hurt; legs hurt; vaccine arm  aches; headache; barely able to make it to bed; delirious; soreness; whole body hurt/achy; soreness, tender in her arm; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site soreness/tenderness, body aches, delirium, asthenia/fatigue, vaccine arm pain, headache, whole body, arms and fingers hurt.    The patient's medical history was not provided but the mother is the caregiver. No relevant concomitant medications were reported.   On 24-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) for prophylaxis of COVID-19 infection.  On 24-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch unknown) for prophylaxis of COVID-19 infection.  On 24-FEB-2021, 3 hours later, the patient experienced soreness, tender in her arm. By 10 pm same day, she was achy, delirious, barely able to make it to bed after brushing her teeth. Next morning, she was still achy, vaccine arm aches and had headache. Her whole body, legs, arms and fingers hurt.   No laboratory data was provided. Treatment information was not provided. Delirium is a medically significant event, hence this is a serious case.  Action taken with mRNA-1273 in response to the events  was unknown.  The outcome of the events, vaccination site soreness/tenderness, body aches, delirium, asthenia/fatigue, vaccine arm pain, headache, whole body, arms and fingers hurt, was considered as not resolved at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-028353:Same Reporter, Different Patient MOD-2021-028539:Same Reporter, Different Patient MOD-2021-028543:Same Reporter, Different Patient MOD-2021-028562:Same Reporter, Different Patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: fingers hurt; legs hurt; vaccine arm  aches; headache; barely able to make it to bed; delirious; soreness; whole body hurt/achy; soreness, tender in her arm; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site soreness/tenderness, body aches, delirium, asthenia/fatigue, vaccine arm pain, headache, whole body, arms and fingers hurt.    The patient's medical history was not provided but the mother is the caregiver. No relevant concomitant medications were reported.   On 24-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) for prophylaxis of COVID-19 infection.  On 24-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch unknown) for prophylaxis of COVID-19 infection.  On 24-FEB-2021, 3 hours later, the patient experienced soreness, tender in her arm. By 10 pm same day, she was achy, delirious, barely able to make it to bed after brushing her teeth. Next morning, she was still achy, vaccine arm aches and had headache. Her whole body, legs, arms and fingers hurt.   No laboratory data was provided. Treatment information was not provided. Delirium is a medically significant event, hence this is a serious case.  Action taken with mRNA-1273 in response to the events  was unknown.  The outcome of the events, vaccination site soreness/tenderness, body aches, delirium, asthenia/fatigue, vaccine arm pain, headache, whole body, arms and fingers hurt, was considered as not resolved at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-028353:Same Reporter, Different Patient MOD-2021-028539:Same Reporter, Different Patient MOD-2021-028543:Same Reporter, Different Patient MOD-2021-028562:Same Reporter, Different Patient
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Had some heat to it; Itches; Red knot on arm at the injection site that was hard; Red knot on arm at the injection site; Inappropriate age at vaccine administration; A spontaneous report  was received from a consumer concerning a 6-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) at inappropriate age at vaccine administration  and experienced red knot on arm at injection site/ vaccination site erythema, that was hard/ vaccination site induration, had some heat to it/ vaccination site warmth, itches/ vaccination site pruritus.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 042L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the events inappropriate age at vaccine administration, red knot on arm at injection site, that was hard, had some heat to it, itches.  Treatment details included Took Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   On 26 Jan 2021, the outcome of event inappropriate age at vaccine administration was considered resolved. The outcome of events, red knot on arm at injection site, that was hard, had some heat to it, itches was unknown.; Reporter's Comments: This report refers to a case of inappropriate age (6 y/o) for mRNA-1273, lot # 042L20A) with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: Bleeding side effects; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 (mRNA-1273) vaccine and developed bleeding side effects/haemorrhage.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On a unknown date, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Within 24 hours of receiving the second Moderna vaccine, the patient experienced bleeding side effects.  The reporter stated that their physician did not know about the bleeding side effects. Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the events, bleeding side effects, was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cellulitis, Hypersensitivity
Clinical narrative: Looked like a cellulitis; Hypersensitivity; A spontaneous report was received from physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis and hypersensitivity.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date, prior to the onset of the event, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced side effects that almost looked like a cellulitis, a medically significant event and would like to know if hypersensitivity occur to this patient or if they develop it.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, cellulitis and hypersensitivity was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erectile dysfunction, Myalgia
Clinical narrative: Impotent; Muscle pain; Chills; This spontaneous report was received from a consumer concerning a 56-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, muscle pain/ myalgia and was impotent/ erectile dysfunction.  The patient's medical history was not provided. Concomitant medications included metformin, glimepiride, atorvastatin, losartan, pantoprazole and doxazosin.  On 26 Feb 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the got chills, muscle pain and the patient was impotent a medically significant event. Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, chills, muscle pain and was impotent was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pulmonary congestion
Clinical narrative: Heavy congestion in chest; light headedness; a little shortness of breath; A spontaneous report was received from a health care professional concerning an 85-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed shortness of  breath and a little light headedness and heavy congestion in the chest.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, were not provided.  On 11 Feb  2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (Lot 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021, prior to the onset of the event, the patient received the second of two planned doses of mRNA-1273 (Lot 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient developed shortness of  breath and a little light headedness and heavy congestion in the chest. Treatment for the event, was not reported.  Action taken with mRNA-1273 in response to the event was not reported.   On an unknown date, the events, shortness of  breath and a little light headedness were considered resolved.  The outcome of the event heavy congestion in chest was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: ITT low grade; A spontaneous report  was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Immune Thrombocytopenic Purpura (ITP) low grade wherein her platelet count was 81.  The patient's medical history was not provided. concomitant product use was not provided by the reporter.  On 16 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for the prophylaxis of COVID-19 infection.  Over a month later the patient reported to have ITT low grade (Immune thrombocytopenic) where in her platelet count was 81. No treatment medication was reported. This event considered medically significant.  Action taken with the mRNA-1273 in response to the event was not applicable.  The outcome of the event was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Herpes zoster, Rash, Syncope, Vomiting
Clinical narrative: Fainting; Vomiting; Shingles R Herpes infection; Rash on the back; A spontaneous report  was received from a consumer concerning a 82- year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Fainting (Syncope), Shingles R Herpes infection (Herpes zoster), Rash on the back (Rash) and Vomiting (Vomiting).  The patient's medical history included shingles but not had since 2006.. She received the old Shingles shot in 2006. Now receiving new Shingles shot a year before and later. The patient's current conditions included diabetes and heart disorders. Concomitant medications included,medications for heart conditions and diabetes.   On 04-Mar-2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number-unknown) via unknown route on right arm for prophylaxis of COVID-19 infection.  On 18-Mar-2021,the patient experienced, about to Pass out, fainting followed by vomiting-3 episodes. On an unknown date in Mar 2021, she had Shingles R Herpes infection which broke out now. On an unknown date in Mar 2021, she also felt rash on the back. The event  about to Pass out and fainting was medically significant events.  On 18 Mar 2021, the laboratory data included, blood pressure was 128/84 and pulse rate was 94/50 .Treatment information included pain relievers and calamine lotion for rash.  Action taken with mRNA-1273 in response to the events  was unknown.  The outcome of the events, Fainting (Syncope), Shingles R Herpes infection (Herpes zoster) and Vomiting (Vomiting) was unknown at the time of the reporting. On an unknown date, the outcome of the event, Rash on the back (Rash) was recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lymph node pain, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: swollen lymph nodes which are painful; swollen lymph nodes which are painful; has difficulty eating and drinking due to the swelling; low grade fever on/off; has swollen lymph nodes and tonsils; experienced sleeplessness; This is a spontaneous report from a contactable consumer reported that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was unknown. The patient's concomitant medications were unknown. second dose (dose 2) of the Pfizer COVID-19 vaccine last Tuesday. On unspecified date She has been, experiencing symptoms ever since she got the second dose in the last 6 days, swollen lymph nodes which are painful and impacting her sleep, has difficulty eating and drinking due to the swelling, low grade fever on/off, has swollen lymph nodes and tonsils, experienced sleeplessness. Therapeutic measures were taken with Tylenol and Ibuprofen for, low grade fever on/off. She took another medication which reduced some of her symptoms. She wants to know if its normal for the adverse event to last this long. Caller heard symptoms only last 24-48 hours post vaccination. Outcome of the events were unknown.  Information on the Lot/Batch Number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tonsillar hypertrophy
Clinical narrative: swollen lymph nodes which are painful; swollen lymph nodes which are painful; has difficulty eating and drinking due to the swelling; low grade fever on/off; has swollen lymph nodes and tonsils; experienced sleeplessness; This is a spontaneous report from a contactable consumer reported that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was unknown. The patient's concomitant medications were unknown. second dose (dose 2) of the Pfizer COVID-19 vaccine last Tuesday. On unspecified date She has been, experiencing symptoms ever since she got the second dose in the last 6 days, swollen lymph nodes which are painful and impacting her sleep, has difficulty eating and drinking due to the swelling, low grade fever on/off, has swollen lymph nodes and tonsils, experienced sleeplessness. Therapeutic measures were taken with Tylenol and Ibuprofen for, low grade fever on/off. She took another medication which reduced some of her symptoms. She wants to know if its normal for the adverse event to last this long. Caller heard symptoms only last 24-48 hours post vaccination. Outcome of the events were unknown.  Information on the Lot/Batch Number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Blood pressure going as high as 206/128.; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 09Feb2021 08:30 as single dose for covid-19 immunisation. Relevant medical history reported as none. Concomitant medications included losartan, loratadine (LORTAB), piroxicam (FELDENE), fluoxetine hydrochloride (PROZAC), simvastatin (ZOCOR), budesonide (ENTOCORT) all are taken for an unspecified indication, start and stop date were not reported. It was reported that blood pressure going as high as 206/128 12Feb2021 23:30pm. Even taking blood pressure medication lotrel it's only going to 138/80 at the lowest. Usually runs 95/60 to 105/75. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective
Clinical narrative: got covid in between the shots; got covid in between the shots/was currently asymptomatic; This is a spontaneous report from a contactable consumer reported for a female patient (mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetic, high blood pressure from an unknown date, both were controlled. The patient's concomitant medications were not reported. The patient got covid in between the shots in 2021, but had since been doing better and was currently asymptomatic. Outcome of event was unknown. Reporter wanted to know when her mother (patient) can receive the second dose of the vaccine.  Information on Lot /Batch Number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Tenderness
Clinical narrative: A rash developed; Within three hours of receiving the Pfizer vaccine my right thigh became painful; started itching; area of the rash is tender when pressure is applied; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Left arm on 16Feb2021 16:00 as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. If Other vaccine in four weeks: No. Facility type Vaccine: Doctor's office/urgent care. if Covid prior vaccination: No, if covid tested post vaccination: No. known allergies: n/a. The patient experienced a rash developed (non-serious) on 16Feb2021 18:30, within three hours of receiving the pfizer vaccine my right thigh became painful (non-serious) on 16Feb2021 18:30, started itching (non-serious) on 16Feb2021 18:30, area of the rash is tender when pressure is applied (non-serious) on 16Feb2021 18:30. if treatment AE: No. Within three hours of receiving the Pfizer vaccine my right thigh became painful and started itching. A rash developed, about 5" wide and 6" long. The itching lasted about two to three hours. Twenty-four hours after the vaccine, the rash remains and the area of the rash is tender when pressure is applied. For event rash developed, area of the rash is tender when pressure is applied, outcome was not recovered and for started itching, outcome was recovered on unspecified date in 2021, for other remaining, outcome was recovering.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Fatigue, Headache, Influenza like illness
Clinical narrative: mild difficulty breathing; swelling lymph nodes; feels like he got the flu; nausea; pain at injection site; headache; tired; Low Appetite; This is a spontaneous report received from sponsored program , from a contactable consumer (patient's son). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Feb2021, as single dose for COVID-19 immunisation. After receiving the first dose of the BNT162B2, approximately in Feb2021, the patient experienced pain at injection site, headache, swelling lymph nodes, nausea, tired, mild difficulty breathing and low appetite. He also felt like he got the flu. The patient's medical history and concomitant medications were not reported. It was informed to reporter to consult HCP since his father was experiencing mild difficulty breathing which require immediate medical attention. All the other side effects except low appetite have been reported with the BNT162B2. The vaccine might vary person to person the side effects listed are not different from one dose to another. These side effects could occur with either dose. The duration of the symptoms is undetermined and asked him to consult his HCP if symptoms worsen or don't go away. No treatment was received for the events. The outcome of the events was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Vaccination site pain
Clinical narrative: mild difficulty breathing; swelling lymph nodes; feels like he got the flu; nausea; pain at injection site; headache; tired; Low Appetite; This is a spontaneous report received from sponsored program , from a contactable consumer (patient's son). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Feb2021, as single dose for COVID-19 immunisation. After receiving the first dose of the BNT162B2, approximately in Feb2021, the patient experienced pain at injection site, headache, swelling lymph nodes, nausea, tired, mild difficulty breathing and low appetite. He also felt like he got the flu. The patient's medical history and concomitant medications were not reported. It was informed to reporter to consult HCP since his father was experiencing mild difficulty breathing which require immediate medical attention. All the other side effects except low appetite have been reported with the BNT162B2. The vaccine might vary person to person the side effects listed are not different from one dose to another. These side effects could occur with either dose. The duration of the symptoms is undetermined and asked him to consult his HCP if symptoms worsen or don't go away. No treatment was received for the events. The outcome of the events was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: received the first dose of the Pfizer COVID-19 vaccine on 29JAN2021. Yesterday he tested positive for COVID-19; received the first dose of the Pfizer COVID-19 vaccine on 29JAN2021. Yesterday he tested positive for COVID-19; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 29Jan2021 at single dose for Covid-19 immunisation. The patient Medical history and concomitant medications were not reported. It was reported that Patient tested positive for covid-19 after the vaccination On 17Feb2021. The patient underwent lab test and procedures which included sars-cov-2 antibody test: which resulted positive on 17Feb2021. The outcome for the event was unknown.  Information about lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I woke up with violent rush at right thigh; This is a spontaneous report from a contactable consumer (patient). An 85-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Left arm on 17Feb2021 07:30 at single dose for covid-19 immunisation. Medical history includes Emphysema, Penicillin Allery and Covid. Concomitant medications in two weeks were not reported. The patient reported, she woke up with violent rush at right thigh spread to several places in half hour. Red bumpy spots spread to left inner thigh and both arms on 19Feb2021 04:00. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Headache, Vaccination site erythema
Clinical narrative: Tightness in chest; dizziness; chills; headache; warm red injection site; warm red injection site; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old non-pregnant female patent received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm at the age of 79-years (non-pregnant at the time of vaccination), on 17Feb2021 at 01:30 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot number: EL8982), via an unspecified route of administration in left arm at the age of 79-years on 27Jan2021 at 01:30 AM at a single dose for COVID-19 immunisation. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced tightness in chest, dizziness, chills, headache and warm red injection site on 17Feb2021. The seriousness of the events was reported as no. The patient did not receive any treatment for the events. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Tightness in chest; dizziness; chills; headache; warm red injection site; warm red injection site; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old non-pregnant female patent received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm at the age of 79-years (non-pregnant at the time of vaccination), on 17Feb2021 at 01:30 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot number: EL8982), via an unspecified route of administration in left arm at the age of 79-years on 27Jan2021 at 01:30 AM at a single dose for COVID-19 immunisation. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced tightness in chest, dizziness, chills, headache and warm red injection site on 17Feb2021. The seriousness of the events was reported as no. The patient did not receive any treatment for the events. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Low density lipoprotein, Low density lipoprotein increased
Clinical narrative: total cholesterol and LDL were both elevated; The total cholesterol and LDL were both elevated; This is a spontaneous report from a contactable pharmacist reporting for patient. A patient of unspecified age and gender received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and expiration Date were Unknown) via an unspecified route of administration as single dose for COVID-19 immunisation on Jan2021. The patient medical history and concomitant medications were not reported. The patient had a routine lipid panel drawn. The total cholesterol and LDL were both elevated on an unspecified date. The patient is otherwise healthy without any other underlying medical problems. The outcome of the events were unknown. The reporter was wondering if there is a correlation or if you have had any other reports of similar effects.  Information about lot/batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness appeared at injection site; This is a spontaneous report from a contactable 81-year-old non-pregnant female consumer reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 15Jan2021, 11:00 at single dose in left arm for covid-19 immunization. The patient's medical history included GERD, osteoporosis, high blood pressure, urticaria, osteoarthritis, high cholesterol. Known allergies: sulfa, known allergies: NSAIDS, known allergies: Tuna, salmon; known allergies: strawberries, corn, intolerant of seasonings, citrus, chocolate; known allergies: lactose intolerant and known allergies: caffeine. Concomitant medications included levothyroxine sodium (LEOXYL), atorvastatin calcium (LIPITOR), amlodipine besilate (NORVASC), pantoprazole sodium sesquihydrate (PROTONIX) and fexofenadine hydrochloride (ALLEGRA). Past drugs included Cipro with reaction known allergies: cipro; Vantin with reaction known allergies: vantin; Levaquin with reaction known allergies: Levaquin; Percocet with reaction known allergies: Percocet; Bactrim with reaction known allergies: Bactrim; Codeine with reaction known allergies: Codeine; Cleocin with reaction known allergies: Cleocin; Flomax with reaction known allergies: Flomax; Lexapro with reaction known allergies: Lexapro, Imodium with reaction known allergies: Imodium; Kaopectate with reaction known allergies: Kaopectate; and  PeptoBismol with reaction known allergies: PeptoBismol. On 17Jan2021, the patient experienced redness appeared at injection site (vaccinated 15Jan2021) about 3rd-4th day after injection, patch of redness 3 x 5 inches, remained red 2 weeks, began to pale in third week; was still mildly visible 05Feb2021, date of 2nd vaccine dose. The patient was allergic to long list of meds but doctor on 15Jan2021 reviewed her list and said ok to taking the first dose. The patient had not needed Epi-pen to cope with allergic reactions to medications but did carry one with her on each of the vaccination days. The patient had 2nd dose in unaffected arm and experienced no reaction or side effects to 2nd dose on 05Feb2021. The patient took Benadryl for 1-2 days for the event. The outcome of the event was recovered on an unknown date.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: 09Feb2021 and couple days later I got a slight rash on my stomach and back and it was itchy and a little redness; 09Feb2021 and couple days later I got a slight rash on my stomach and back and it was itchy and a little redness; 09Feb2021 and couple days later I got a slight rash on my stomach and back and it was itchy and a little redness; This is a spontaneous report from a contactable consumer or other non hcp. A 76 years female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection, dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.The patient's Medical history included drug hypersensitivity, Hives  The patient's concomitant medications were not reported. Caller stated that her My back was itching before she got the vaccine. So that was nerves, that had nothing to do with the vaccine. But her stomach got that little spots on it, not like little, tiny rash, nothing raised or anything. she got the Pfizer covid vaccine first dose on 09Feb2021 and couple days later she got a slight rash on my stomach and back and it was itching and a little redness. It was a little red, faint which spread on my stomach and it was itchy. I was told to use Eucerin cream. Then went to see my Primary Care Physician to make sure and she called Pfizer and advised me not to get the 2nd vaccination. With this rash, some people have effects with the 2nd one. The consumer enquired about the ingredients, dose and virus of the second dose. She narrated that her son got the Moderna one and he got chills, fever, felt like he got the flu. Therapeutic measures were taken as a result of 09feb2021. The outcome of the events was unknown