chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: postive COVID-19 test with no symptoms; postive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). A 62-year old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246), via an unspecified route of administration on 12Jan2021 at 15:30 (at the age of 62-years old) as a single dose in the left arm; and the second dose (Lot number EL9264) via an unknown route of administration on 02Feb2021 at 15:30 (at the age of 62-years old) as a single dose in the left arm both for COVID-19 immunization. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 12Feb2021, the patient tested positive for COVID-19 from a PCR test. The patient did not have any symptoms. The patient did not receive any treatment for the event. The clinical outcome of the event asymptomatic COVID-19 was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Periodontitis
Clinical narrative: teeth periodontitis; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced teeth periodontitis. The patient was scheduled for a "teeth periodontitis" at the time of her second dose. She might have a deep cleaning and might be prescribed antibiotics to take for pain and thus questioned whether she can have the second vaccination on that same day. The clinical outcome of teeth periodontitis was unknown.   Information about lot/batch number has been requested
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Feeling hot, Headache, Pain in extremity
Clinical narrative: Low blood sugar; felt a little warm; Headache; Sore arm; This is a spontaneous report from a contactable consumer (patient).  This 64-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9809), via an unknown route, on 19Feb2021 (at 13:45) at a single dose on the right arm for COVID-19 immunisation, administered at hospital. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318) administered on right arm on 29Jan2021 at 12:30 PM. Relevant medical history includes type II diabetes. No known allergies. Relevant concomitant medications included metformin, insulin detemir (LEVEMIR) and insulin lispro (HUMALOG).The patient did not receive any other vaccines within 4 weeks prior to the COVID 19 vaccine. On 19Feb2021 (in the evening), the patient had a bit of a sore arm and slight headache, she took 2 ibuprofen before bed. She took medications as normal, food intake nothing unusual.  She was woken up at 2:00 am by her continuous monitor which she kept at the side of her bed alarming her of low blood sugar. She never got that. Sugar level was 40. She had a glass of milk and some candy and it reversed. The monitor saved her. On 20Feb2021, she just had a slight headache, felt a little warm and she took Ibuprofen. The event low blood sugar was considered a life-threatening condition. The remaining events were assessed as non-serious.  Post-vaccination COVID test was not performed. The patient was recovering from the events.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a non-contactable physician, the patient. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced fever for 24 hours. The clinical outcome of fever was resolved on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Body temperature, Illness, Oxygen saturation
Clinical narrative: On the 20th between the 2 covid shots I got a very bad sickness/her first COVID-19 Vaccine shot on 06Feb2021, and then got very, very sick on 20Feb2021; I had shock from taking the vaccine twice; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (Batch/Lot Number: EN9581) as SINGLE DOSE for covid-19 immunisation. Medical history included autoimmune disorder from 1996, osteoarthritis (She said she was diagnosed with osteoarthritis, between 2006-2008), SARS (Reported she had SARS), Bird flu (Reported she had "chicken flu"), Allergic reaction to bee sting (stated she was allergic to bee stings. She said if she gets stung by a bee, she will be on the floor in 15 minutes. She said that was why she has an Epi-Pen), Anaphylactic reaction and on Mar2020 COVID-19 Virus. There were no concomitant medications. The patient reported "I had shock from taking the vaccine twice on Feb2021 and on the 20th between the 2 Covid shots I got a very bad sickness/her first covid-19 vaccine shot on 06feb2021, and then got very, very sick on 20feb2021." Reporter states "I had shock from taking the vaccine twice. I had epi pen standby but didn't have to use it. I have some medical issues, autoimmune disease and joint issue which causes me to have difficulties with inflammation. My first dose was on 06Feb2021 and 27Feb2021 was my 2nd shot. I am what you call a "long hauler". I had covid in Mar2020 and every month I have the same symptoms 3 days to 15 days in each month. On the 20th between the 2 covid shots I got a very bad sickness and I don't know if it was covid19 again or the regular flu. I had the same symptoms. Can I get covid again and again even after having the 2 shots. Feb of this year there was 3 days of not being sick, same covid symptoms the whole month, sick again after the 7th. I'm currently recovering from that. I had SARS when I lived there in 2005 and 2008. I had chicken flu and I was really sick with both of them. I recovered and I'm fine. and I'm wondering if I had those two previously in the past history, if it's causing me to have more severe symptoms, due to osteoporosis and an auto immune disease. The patient underwent lab tests and procedures which included blood pressure measurement: good on Feb2021, blood test: inconclusive on 2020 (unspecified date), body temperature: good on Feb2021, oxygen saturation: good on Feb2021, sars-cov-2 test: negative on 2020 and weight: 195-198 lbs on an unspecified date. Outcome of the events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Shock, Weight
Clinical narrative: On the 20th between the 2 covid shots I got a very bad sickness/her first COVID-19 Vaccine shot on 06Feb2021, and then got very, very sick on 20Feb2021; I had shock from taking the vaccine twice; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 (Batch/Lot Number: EN9581) as SINGLE DOSE for covid-19 immunisation. Medical history included autoimmune disorder from 1996, osteoarthritis (She said she was diagnosed with osteoarthritis, between 2006-2008), SARS (Reported she had SARS), Bird flu (Reported she had "chicken flu"), Allergic reaction to bee sting (stated she was allergic to bee stings. She said if she gets stung by a bee, she will be on the floor in 15 minutes. She said that was why she has an Epi-Pen), Anaphylactic reaction and on Mar2020 COVID-19 Virus. There were no concomitant medications. The patient reported "I had shock from taking the vaccine twice on Feb2021 and on the 20th between the 2 Covid shots I got a very bad sickness/her first covid-19 vaccine shot on 06feb2021, and then got very, very sick on 20feb2021." Reporter states "I had shock from taking the vaccine twice. I had epi pen standby but didn't have to use it. I have some medical issues, autoimmune disease and joint issue which causes me to have difficulties with inflammation. My first dose was on 06Feb2021 and 27Feb2021 was my 2nd shot. I am what you call a "long hauler". I had covid in Mar2020 and every month I have the same symptoms 3 days to 15 days in each month. On the 20th between the 2 covid shots I got a very bad sickness and I don't know if it was covid19 again or the regular flu. I had the same symptoms. Can I get covid again and again even after having the 2 shots. Feb of this year there was 3 days of not being sick, same covid symptoms the whole month, sick again after the 7th. I'm currently recovering from that. I had SARS when I lived there in 2005 and 2008. I had chicken flu and I was really sick with both of them. I recovered and I'm fine. and I'm wondering if I had those two previously in the past history, if it's causing me to have more severe symptoms, due to osteoporosis and an auto immune disease. The patient underwent lab tests and procedures which included blood pressure measurement: good on Feb2021, blood test: inconclusive on 2020 (unspecified date), body temperature: good on Feb2021, oxygen saturation: good on Feb2021, sars-cov-2 test: negative on 2020 and weight: 195-198 lbs on an unspecified date. Outcome of the events was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: This case involves a patient of unknown age and gender who experienced sick (illness), while he/she received INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Suspension for injection) produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/events. Medication details and reason for taking the medicine: unknown. Reporter also stated "what you want America you will have no Freedom pretty soon people are dumbasses". It was unknown if there were lab data/results available. It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown. Result of assessment was not reported. There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: feel bad; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer via media.  This case involves patient (unknown demographics) who experienced feel bad (feeling abnormal) after he/she received INFLUENZA VACCINE.  The patient didn't report of any medical history, concomitant disease or risk factor.  Medical treatment, vaccination and family history were not provided.  Concomitant medication included OSELTAMIVIR PHOSPHATE (FLUCLE).  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious feel bad (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that this case was received via media. It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results reported..  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.   There will be no information on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Vaccine was cold, and customer put away vaccine as normal not knowing too long in transit which was given to a patient, with no AE; Vaccine was cold, and customer put away vaccine as normal not knowing too long in transit which was given to a patient, with no AE; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a patient of an unknown age and gender who received INFLUENZA VACCINE which was cold, and customer put away vaccine as normal not knowing it would take too long in transit (batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (product storage error and product distribution issue).  The patient had no medical history, concomitant disease or risk factor.  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to incorrect product storage and product shipment delay (latency: same day).  Reported Adverse Event Information: Vaccine belonged to the Saturday shipment and arrived on Tuesday. Reporter referred the consumer to contact medical affairs a second time. The first time she did not receive a very warm welcome or much of a response to help navigate the issue. It is unknown if patient's physician provided consent to be contacted. It is unknown if the patient experienced any additional symptoms/ events. There were no lab data/results available.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR4
Symptoms: Pain
Clinical narrative: This case involved a female patient of unknown age who got body aches post vaccination (pain), while patient received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient body aches post vaccination (pain), (latency: unknown) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown, at the time of reporting. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 28-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that Last time patient had the flu was the last time patient got a flu shot. Been over 10 years, no shot, no flu Imagine.  It was unknown if there were lab data/results available.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on batch number for this case.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: The medical assistant forgot to mix the liquid with the powdered ACT-HIB, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician. This case involves a four-month-old female patient who received only the liquid portion of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension for injection, lot UJ394AA and expiry date not reported) via an intramuscular route in an unknown administration site for prophylactic vaccination on an unknown date (product preparation issue). The medical assistant forgot to mix the liquid with the powdered ACT-HIB.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  This was a case of actual medication error case due to inappropriate reconstitution technique (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue, Wrong technique in product usage process
Clinical narrative: nurse failed to mix the powder substance with the liquid before injecting the patient with Pentacel vaccine and HIB portion was not received, with no adverse event; nurse failed to mix the powder substance with the liquid before injecting the patient with Pentacel vaccine, with no adverse event; Initial and additional information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a two years old female patient who's nurse failed to mix the powder substance with the liquid before injecting the patient with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] dose: 0.5 ml (batch number and expiry date not reported) via an unknown route in unknown administration site on an unknown date in Dec-2020 for prophylactic vaccination and HIB portion of the vaccine was not received by the patient (product preparation issue and wrong technique in product usage process)  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was an actual medication error due to inappropriate reconstitution technique and wrong injection technique (latency: same day).  Potential Product Technique Complain: No. Description: The caller would like to know how to proceed in caring for the patient. The caller would like to know the effects this will have on his daughter and how to proceed to ensure that she has the complete vaccine. Reporter relationship: Caregiver. Product used. Caller is consumer father and he is calling back to update information for potential Adverse event (AE) 00495357. Caller providing additional information for previously reported AE (00495357) to provide nurse practitioner.  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Breath sounds abnormal, Dyspnoea
Clinical narrative: had difficulty breathing; making choking sounds; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case from other health professional (Medical Assistant (MA)) via Media Information (MI- under reference- 00495848).  This case involves a 3 months old female patient who experienced had difficulty breathing (dyspnea) and was making choking sounds (breath sounds abnormal), after receiving HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) via unknown route in the left thigh on 28-Jan-2021.  On 28-Jan-2021, the patient received 0.5 ml first  dose of suspect HIB (PRP/T) VACCINE (solution for injection, lot UJ316AA and expiration date: 08-Jun-2021) via intramuscular route in the right thigh for prophylactic vaccination.  On 28-Jan-2021, the patient developed a non-serious had difficulty breathing (dyspnoea) and was making choking sounds (breath sounds abnormal), 1 day following the administration of HIB (PRP/T) VACCINE.  Also reported that the patient and her father came in yesterday, that is on 25-Feb-2021, and reported this events. The parents never called the office or went to the emergency department. It lasted a few hours. MA (medical assistant) states they were not going to give ACTHIB or prevnar 13 to the patient. Also to be noted, inadvertently submitted a PTC (product technical complaint) and to be considered this case AE (adverse event) only.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting,  the outcome was not reported for the reported events.  The caller stated the doctor was away for a month so if additional information needed, safety can email her and she will forward it to the doctor covering for him.
Sex: M
Vaccine: HEP, TDAP
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: one month old patient was administered Adacel in error today instead of the intended hepatitis with no adverse event, no AE; one month old patient was administered Adacel in error today instead of the intended hepatitis with no adverse event, no AE; Initial information received on 02-Mar-2021 regarding an unsolicited valid non-serious case from a physician. This case involves a 1 months old male patient who was given DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6817BA ad expiration date 18-sep-2022) in error instead of the intended HEPATITIS B VACCINE (lot number and expiration date not reported),via unknown route in the right vastus lateralis for prophylactic vaccination on 02-Mar-2021 (wrong product administered) (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication(s) were given to the patient.   It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (same day latency).  It was also reported that registered nurse was calling about accidental administration of ADACEL. What information was available? How does Adacel compare to DTaP (diphtheria, pertussis, and tetanus)? also with a question that any information do the agency have about DTaP given to a child under the minimum age?   It was not reported that the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 100.0
Sex: F
Vaccine: FLU4
Symptoms: Bedridden, Condition aggravated, Dementia, Feeding disorder, Gait inability
Clinical narrative: 20 lb weight loss; she cannott walk, becoming bed bound; gastrointestinal issues; not eating; worsened dementia; Guillain-Barre Syndrome; Initial information received on 04-Mar-2021 regarding an unsolicited valid serious case from pharmacist on behalf of a consumer.  This case involves a 100 year elderly female patient who had worsened dementia (dementia), Guillain Barre syndrome (Guillain-Barre syndrome), 20 lb. (pound) weight loss (weight decreased), was unable to walk, had become bed bound (gait inability), had gastrointestinal issues (gastrointestinal disorder) and was not able to eat (feeding disorder), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included SODIUM (NA).  On an unknown date in January 2021, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number: UJ500AB and expiry date: 30-Jun-2021] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in January, 2021, the patient developed possible Guillain-Barre Syndrome (Guillain-Barre syndrome) (as reported it began the day after getting the vaccine in Jan, 2021), worsening of dementia (dementia), (serious events) and had gastrointestinal issues (gastrointestinal disorder) resulting in not eating (feeding disorder), had 20 lb. weight loss (weight decreased), unable to walk, became bed bound (gait inability) (non-serious), (exact latency unknown), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Guillain-Barre syndrome and dementia were assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient did not recover from the reported events.; Sender's Comments: This case concerns a 100 years elderly female patient who presented with worsened dementia, Guillain-Barre syndrome, gastrointestinal disorder, weight decrease, gait inability and feeding disorder after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. Concomitant medication included Sodium for unknown indication. There is, moreover, no information regarding patient's condition at time of vaccination, past history and laboratory test. Based upon the reported information and advanced age of the patient, the role of the  suspect vaccine cannot be assessed.
Age: 100.0
Sex: F
Vaccine: FLU4
Symptoms: Gastrointestinal disorder, Guillain-Barre syndrome, Weight decreased
Clinical narrative: 20 lb weight loss; she cannott walk, becoming bed bound; gastrointestinal issues; not eating; worsened dementia; Guillain-Barre Syndrome; Initial information received on 04-Mar-2021 regarding an unsolicited valid serious case from pharmacist on behalf of a consumer.  This case involves a 100 year elderly female patient who had worsened dementia (dementia), Guillain Barre syndrome (Guillain-Barre syndrome), 20 lb. (pound) weight loss (weight decreased), was unable to walk, had become bed bound (gait inability), had gastrointestinal issues (gastrointestinal disorder) and was not able to eat (feeding disorder), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included SODIUM (NA).  On an unknown date in January 2021, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number: UJ500AB and expiry date: 30-Jun-2021] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date in January, 2021, the patient developed possible Guillain-Barre Syndrome (Guillain-Barre syndrome) (as reported it began the day after getting the vaccine in Jan, 2021), worsening of dementia (dementia), (serious events) and had gastrointestinal issues (gastrointestinal disorder) resulting in not eating (feeding disorder), had 20 lb. weight loss (weight decreased), unable to walk, became bed bound (gait inability) (non-serious), (exact latency unknown), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Guillain-Barre syndrome and dementia were assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient did not recover from the reported events.; Sender's Comments: This case concerns a 100 years elderly female patient who presented with worsened dementia, Guillain-Barre syndrome, gastrointestinal disorder, weight decrease, gait inability and feeding disorder after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. Concomitant medication included Sodium for unknown indication. There is, moreover, no information regarding patient's condition at time of vaccination, past history and laboratory test. Based upon the reported information and advanced age of the patient, the role of the  suspect vaccine cannot be assessed.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Nausea, Pain in extremity
Clinical narrative: For the first 24 hours I had no symptoms other than arm pain. For the next 6 days experienced debilitating headaches, which led to nausea (because they were so severe). Elevated blood pressure also coupled with headaches.  I initially took Ibuprofen (which helped somewhat), whereas Tylenol did nothing. I also have a flexible ice pack that I placed over my head. That also helped a little. I went to the doctor on March 17th, but he was dismissive of the headaches being related to the vaccine. I have since been referred to  a neurologist (April 1st appointment).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke he stated the next day
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full arm rash on left arm. Rash on both hands also.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: On period for 3 weeks
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Heart rate increased, Painful respiration
Clinical narrative: Fast resting heart  rate (>100 bpm), chills, difficulty/pain taking deep breath, dizziness
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Injection site bruising, Injection site pain
Clinical narrative: Elevated Fever (102) Night of Injection Exhaustion Evening of Injection for a 36 hour period Soreness and bruising at Injection site
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: about 10 days after 2nd dose of pfizer covid vaccine developed a headache and sore scratchy throat that persists advised evaluation .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: first shot i woke up 7 days later to rash and itchy at site and very Hard...this SECOND shot i got i woke up next day with swollen arm and pain..took benedryl and icepack..will watch it and tell my family doctor.  thank you...i did NOT get sick..
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm and also hand that he received that shot in has swollen fingers.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Heart rate increased, Muscle spasms, Myalgia
Clinical narrative: Joint Pain, Muscle cramping, Headache, and increase in resting heart rate
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness postural, Headache, Peripheral coldness
Clinical narrative: About 9:30 PM on March 17, 2021 (the day that the vaccine was administered), patient began experiencing chills with shivering. Went to bed shortly thereafter. Woke two or three times in the night. Began feeling somewhat warm instead of chilled (except for extremities, which remained cold to the touch). Felt weak and temporarily dizzy each time of getting out of bed. Awoke at one point with a headache, so took one Excedrin migraine tablet. Took a second Excedrin migraine tablet later in the morning of March 18, 2021, since headache persisted. Other than that, took no other prescriptions or supplements until the evening of March 18, 2021. Throughout March 18, 2021, patient felt occasional periods of weakness and took bedrest for it. Probably slept an additional 3 to 4 hours during the day. By evening of March 18, 2021, patient was feeling more normal. On March 19, 2021, patient experienced no adverse effects.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Condition aggravated, Nodal arrhythmia, Troponin increased
Clinical narrative: Patient went in to atypical rhythm junctions rhythm and atrial flutter and fib which was difficult to control. Our cardiologist says she?s been seeing a number of these post vaccine
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test normal, Chest X-ray normal, Chest discomfort, Discomfort
Clinical narrative: pt states about 5 minutes after taking the covid vax she started swelling on the left inside of her throat and then she noticed the swelling was moving up towards her face around her eyes and ears then back down towards her mouth.  Vax administrator checked her vitals.  Her BP 133/78 which is high for her. Her O2 level was good.  About 20 minutes later she started feeling light headed and noticed some swelling in the right side of her throat and also experienced some discomfort on the right side of her body and had some chest tightening.  She started having SOB and could feel her tongue swelling.  Her blood pressure started going up.  She was given 50cc Benadryl.  Pt was transported by wheelchair to ER.  Her BP 160/88, pulse was 79 and respiration was 18.  Temp was 97.1.  She had a normal EKG, normal Chest X-ray normal blood work.  She was administered a steroid shot and given an IV.  She was monitored and released to FU w/ PCP and advised not to take 2nd dose.  Pt is waiting for her doctor to receive ER records to schedule FU appt.  Pt still has some sensation on the left side of her face.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Ear swelling, Electrocardiogram normal, Eye swelling
Clinical narrative: pt states about 5 minutes after taking the covid vax she started swelling on the left inside of her throat and then she noticed the swelling was moving up towards her face around her eyes and ears then back down towards her mouth.  Vax administrator checked her vitals.  Her BP 133/78 which is high for her. Her O2 level was good.  About 20 minutes later she started feeling light headed and noticed some swelling in the right side of her throat and also experienced some discomfort on the right side of her body and had some chest tightening.  She started having SOB and could feel her tongue swelling.  Her blood pressure started going up.  She was given 50cc Benadryl.  Pt was transported by wheelchair to ER.  Her BP 160/88, pulse was 79 and respiration was 18.  Temp was 97.1.  She had a normal EKG, normal Chest X-ray normal blood work.  She was administered a steroid shot and given an IV.  She was monitored and released to FU w/ PCP and advised not to take 2nd dose.  Pt is waiting for her doctor to receive ER records to schedule FU appt.  Pt still has some sensation on the left side of her face.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: pt states about 5 minutes after taking the covid vax she started swelling on the left inside of her throat and then she noticed the swelling was moving up towards her face around her eyes and ears then back down towards her mouth.  Vax administrator checked her vitals.  Her BP 133/78 which is high for her. Her O2 level was good.  About 20 minutes later she started feeling light headed and noticed some swelling in the right side of her throat and also experienced some discomfort on the right side of her body and had some chest tightening.  She started having SOB and could feel her tongue swelling.  Her blood pressure started going up.  She was given 50cc Benadryl.  Pt was transported by wheelchair to ER.  Her BP 160/88, pulse was 79 and respiration was 18.  Temp was 97.1.  She had a normal EKG, normal Chest X-ray normal blood work.  She was administered a steroid shot and given an IV.  She was monitored and released to FU w/ PCP and advised not to take 2nd dose.  Pt is waiting for her doctor to receive ER records to schedule FU appt.  Pt still has some sensation on the left side of her face.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Pharyngeal swelling
Clinical narrative: pt states about 5 minutes after taking the covid vax she started swelling on the left inside of her throat and then she noticed the swelling was moving up towards her face around her eyes and ears then back down towards her mouth.  Vax administrator checked her vitals.  Her BP 133/78 which is high for her. Her O2 level was good.  About 20 minutes later she started feeling light headed and noticed some swelling in the right side of her throat and also experienced some discomfort on the right side of her body and had some chest tightening.  She started having SOB and could feel her tongue swelling.  Her blood pressure started going up.  She was given 50cc Benadryl.  Pt was transported by wheelchair to ER.  Her BP 160/88, pulse was 79 and respiration was 18.  Temp was 97.1.  She had a normal EKG, normal Chest X-ray normal blood work.  She was administered a steroid shot and given an IV.  She was monitored and released to FU w/ PCP and advised not to take 2nd dose.  Pt is waiting for her doctor to receive ER records to schedule FU appt.  Pt still has some sensation on the left side of her face.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Flushing, Pallor
Clinical narrative: After receiving vaccine, patient sat down for the 15 minute observation. He reports about 1-2 minutes after sitting down feeling flushed, lightheaded. Patient's color pale. EMS on site and took over triage of patient. BP 83/50, P 58-60. Patient reported eating a bar before coming. His blood sugar 111. Patient was given water to drink. BP increased to 100/62, color returning, still pale. He reports feeling better. He stood and sat in a w/c to take to the stretcher for additional observation. Patient ate a pack of peanut butter crackers, drank 1 16.9 oz bottle water, color pink, BP 121/76. Patient says he drove from DIFFRENT STATE to receive his vaccine and is alone. Patient reports feeling better. He was instructed to walk around, he did so without any complications, color remained pink. He says he feels better. After additional 15 minute observation, he was checked out. I instructed if the symptoms come back to pull over and call 911, he verbalized understanding.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: I had initial soreness in arm for 2 days after shot on 3/11. Then, I had a delayed reaction on 3/19. I woke up on 3/19 with a knot/hardness in my arm at injection site as well as redness. I called health department where I received shot and they told me to submit this form and monitor arm, and contact my physician if it gets worse.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: Patient received vaccine 03/18/21 at approximately 1200. At 1205 the patient reported a tightness in her throat and a tingling in her arm. At 1209 Epinephrine 0.5 mg (0.5 mL) was administered IM. EMS called. At 1213 O2 saturation was 98 At 1215 BP was 169/87 HR was 73 At 1218 O2 saturation was 97 BP 167/83 HR 68 At 1220 O2 saturation was 98 BP 169/83 HR 76 At 1221 EMS arrived and took patient to the ED via ambulance. Update (03/19/21) Called patient to follow up and she stated she was evaluated at Medical Center ED and monitored for approximately an hour before being discharged home on 03/18/21. She stated she has had no further s/sx.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain, Pyrexia, Sleep disorder
Clinical narrative: Received vaccine at 3:40pm. Tiredness started around 7pm. Fever started at 11pm and lasted until morning. Terrible body aches, unable to sleep. Painful. Fever broke around 5am but then returned around 1pm. Finally broke fever around 4pm. Body aches lasted the rest of the day. Overall weakness and tiredness for a week.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Janssen COVID-19 vaccine EUA  Vaccine administered 9:20am 3/18. By 4:30 pm same day onset of chills, followed by fever of 102.6 measured at 7:00pm. Took Tylenol, fever unchanged an hour later. Also experienced joint aches. Symptoms started to subside around 12 midnight that night. Fever completely gone and had no other symptoms by 7am next morning 3/19.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Myalgia, Pyrexia
Clinical narrative: Chills, high fever (102) first and second nights.  Tylenol helped.  Fever broke around 2 am second night.  Starting Mar 18, muscle aches in back.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Cough, Diarrhoea, Dyspnoea, Musculoskeletal chest pain
Clinical narrative: I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird.  The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs.  Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad.   My stomach feels better.  Haven?t eaten anything,  I am more concerned about under my breast hurt so much when I take a deep breathe or cough.    I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird.  The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs.  Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad.   My stomach feels better.  Haven?t eaten anything,  I am more concerned about under my breast hurt so much when I take a deep breathe or cough.    I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia oral, Lip swelling, Pruritus
Clinical narrative: After receiving the vaccine patient began complaining of numbness & swelling on upper lip. Patient immediately asked NP on site to look at lips. Erythema noted above lip. Patient stated that had an epipen. History was reviewed. Patient stated she has unknown allergies. Patient was sent to observation for evaluation and possible treatment. Verbal handoff and assistance to NP in observation. VS 126/90, P-102, 02 stat 97%. NP in observation took over care. Redness around lips and itching resolved. Benadryl was offered but she refused stating she had a history of passing out from IV Benadryl. She had personal Zrytec which she took. Patient stayed an additional 30 minutes & reported feeling 100% better. She was stable and ok to drive home.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: side effect on March 18, 2021: a red and itchy rash  about 5 inches at the site(arm) of covid Moderna vaccine injection after one week of the 1st dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dry throat, Flushing
Clinical narrative: Patient received vaccine and was sitting for her 15 minute observation. She reported after about 10 minutes feeling flushed, throat feeling dry and she started coughing. EMS triaged patient. BP 198/105, P 65. She reported taking all of her medication this morning and reported while the cuff was being pumped up a "twinge of chest pain, nothing bad though." She was able to drink water and reported swallowing with no problems. BP 187/110, then 176/90. Patient reported feeling better. She was instructed she will be observed another 15 minutes, she verbalized understanding. Patient was checked out without any other adverse reactions.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate increased, Nausea, Vomiting
Clinical narrative: Pfizer-BioNTech Covid-19 Vaccine EUA.   Increased heart rate, severe headache, vomiting (due to nausea from headache).  Warm but did not take temperature.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Headache, Pruritus, Rash
Clinical narrative: First night and following day, extreme headache....nothing would take it away. Second Day - Extreme Burning and Itchy hands and wrists. Third Day - Extreme itching and burning all over body - feet, back, head, hands and wrists. Also, very large rash on back side...very itchy and irritated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Delayed soreness, swelling, redness, and itching, about 3 inches in diameter around the injection site.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Lymph node pain, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: Right lymph node under collar bone is swollen, hard, and tender.  Muscles on top of right thigh are painful to touch (feels like a very deep bruise).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Constant headaches
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe itch on arm from shoulder to fingertips.  I tried ice, but it did not help.  After 7 days, I was desperate, so I called Dr. who told me to take a Benedryl and use Hydrocortizone cream.  I did that for 8 days and it stopped.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Palpitations
Clinical narrative: Palpitations, HR 150 for 30 min, sense of impending doom
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: Body aches and lethargy x 10 days