chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Flushing, Hypersensitivity, Muscle spasms
Clinical narrative: experienced a severe lower back spasm; allergic reaction; chills; couldn't breathe, difficulty in breathing; became extremely flushed; feel very itchy; vomiting; ache; Initial information received on 04-Feb-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional.  This case involves a 69 years old female patient who had a severe lower back spasm (muscle spasms), allergic reaction (hypersensitivity), chills, couldn't breathe, had difficulty in breathing (dyspnoea), became extremely flushed (flushing), feel very itchy (pruritus), vomiting, ache (pain), after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included with standard dose of INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication(s), and family history were not provided.  At the time of the event, the patient had ongoing hypersensitivity to some medicines and nuts.  On an unknown date in October 2019, the patient received dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number: UJ235AB and expiry date not reported] via intramuscular route in an unknown administration site for prophylactic vaccination.  On an unknown date in October 2019, the patient developed a non-serious severe lower back spasm (muscle spasms), allergic reaction (hypersensitivity), chills, couldn't breathe, difficulty in breathing (dyspnoea), extremely flushed (flushing) (on the same day), feel very itchy (pruritus), vomiting, ache (pain) (Unknown latency), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No laboratory data reported.  The patient was treated by an emergency medical technician (EMT) for hypersensitivity, dyspnoea, flushing, muscle spasms and DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL TOTAL) for pruritus.  The patient recovered from hypersensitivity, dyspnoea, flushing, muscle spasms,as it is reported that patient started feeling better and her vital signs for reactions were fine, while the outcome is unknown for chills, pruritus, pain.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Vomiting
Clinical narrative: experienced a severe lower back spasm; allergic reaction; chills; couldn't breathe, difficulty in breathing; became extremely flushed; feel very itchy; vomiting; ache; Initial information received on 04-Feb-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional.  This case involves a 69 years old female patient who had a severe lower back spasm (muscle spasms), allergic reaction (hypersensitivity), chills, couldn't breathe, had difficulty in breathing (dyspnoea), became extremely flushed (flushing), feel very itchy (pruritus), vomiting, ache (pain), after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination(s) included with standard dose of INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication(s), and family history were not provided.  At the time of the event, the patient had ongoing hypersensitivity to some medicines and nuts.  On an unknown date in October 2019, the patient received dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number: UJ235AB and expiry date not reported] via intramuscular route in an unknown administration site for prophylactic vaccination.  On an unknown date in October 2019, the patient developed a non-serious severe lower back spasm (muscle spasms), allergic reaction (hypersensitivity), chills, couldn't breathe, difficulty in breathing (dyspnoea), extremely flushed (flushing) (on the same day), feel very itchy (pruritus), vomiting, ache (pain) (Unknown latency), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No laboratory data reported.  The patient was treated by an emergency medical technician (EMT) for hypersensitivity, dyspnoea, flushing, muscle spasms and DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL TOTAL) for pruritus.  The patient recovered from hypersensitivity, dyspnoea, flushing, muscle spasms,as it is reported that patient started feeling better and her vital signs for reactions were fine, while the outcome is unknown for chills, pruritus, pain.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient had received an Adacel dose just with 6 month interval/ No AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional.  This case involves a 57-year-old female patient who had received 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] just with 6 months interval [lot C5757AA and expiry date: 21-Jul-2022] via an intramuscular route in the left deltoid for prophylactic vaccination On 05-Feb-2021 [Inappropriate schedule of product administration].   The patient past vaccination included ADACELfor prophylactic vaccination. Medical history, medical treatment and family history were not provided. Patient received no concomitant vaccines.  At the time of the event, the patient had ongoing laceration.  This was a case of actual medication error due to drug dose administration interval too short [Latency: on the same day].  It was reported that, reporter asked there were any contraindications that should be of concern. The product was used first time and not used still.  At the time of report, no adverse event 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 available on the batch number for this case.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Gait inability, Hypoaesthesia oral, Injection site induration
Clinical narrative: esophagus and trachea closed; experienced some heavy breathing; some pins and needles sensation around her outer thigh, hip bone, liver, and abdomen; arm felt like someone took a brick and kept pounding it; arm had hardness; the area was hot, hard, and heated; couldn't swallow saliva; Couldn't raise arm over shoulder; tongue felt like it was numb; Couldn't walk or stand up straight; A spontaneous report was received from a healthcare professional (HCP) concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced esophagus and trachea closing/tracheal inflammation, heavy breathing/dyspnea, pins and needle sensation around her outer thigh, hip bone, liver and abdomen/paraesthesia, arm felt like someone took a brick and kept pounding it/limb discomfort, arm had hardness/injection site induration, area was hot and heated/injection site warmth, couldn't swallow saliva/dysphagia, couldn't raise arm over shoulder/injection site movement impairment, tongue felt like it was numb/hypoaesthesia oral, and couldn't walk or stand up straight/gait inability.  The patient's medical history was not provided.  Concomitant medication history was not provided.  On 03 FEB 2021, one day prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot number: 043L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 04 FEB 2021, the patient experienced her esophagus and trachea closing.  She had some heavy breathing along with pins and needle sensation around her outer thigh, hip bone, liver and abdomen.  She stated that her arm felt like someone took a brick and kept pounding it.  Her arm had hardness and she couldn't raise it over her shoulder.  The area of her arm was hot, hard and heated.  The patient couldn't swallow her saliva, couldn't walk or stand up straight and her tongue felt like it was numb and stretched out.  An ambulance was called, and she was taken to the hospital.  She stated that she had never had such a reaction to a vaccine before.  She stated that since the event, her memory has been affected.  Treatments of these events included saline solution, a medication for relaxing and pain, and oxygen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, esophagus and trachea closing/tracheal inflammation, heavy breathing/dyspnea, pins and needles sensation around her outer thigh, hip bone, liver and abdomen/paraesthesia, arm felt like someone took a brick and kept pounding it/limb discomfort, arm had hardness/injection site induration, area was hot, and heated/injection site warmth, couldn't swallow saliva/dysphagia, couldn't raise arm over shoulder/injection site movement impairment, tongue felt like it was numb/hypoaesthesia oral, and couldn't walk or stand up straight/gait inability were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Brain hypoxia, Coma, Death, Loss of consciousness
Clinical narrative: Passed away; Found unconscious; Coma; Lack of oxygen to the brain; A spontaneous report was received from a consumer, concerning his mother, a 71-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away, prior to death, patient experienced lack of oxygen to the brain and was found unconscious and went to coma.  The patient's medical history reported included seizures. Concomitant medications included phenobarbital, lamotrigine and levetiracetam.   On 27 Jan 2021, approximately six days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 01 Feb 2021 at 4 am, the patient was found to be unconscious on the couch, hence she was rushed to the hospital with lack of oxygen to the brain. Later, she went into a coma, hence she was in hospital for 30 hours and then was transferred to a different hospital for a second opinion on 06-Feb-2021, where she was passed away at 02:20 PM. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of events, lack of oxygen to the brain, found unconscious and coma were considered unknown.  The outcome of event passed away was fatal as she died on 06 Feb 2021 at 2:20 pm.  The cause of death was not provided.  Plans for an autopsy were unknown.; Reporter's Comments: This is a case of 71-year-old female subject with a history of seizures who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Passed away
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Haemoglobin, Haemoglobin decreased, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Shortness of breath; Hemoglobin went from 8.8 to 8.2; oxygen level was at 82 whenever she is standing or walking; Sore arm; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, sore arm, oxygen level at 82 when walking, and hemoglobin went from 8.8 to 8.2.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Lot number:039K20A) for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced soreness in arm immediately after receiving the shot. The soreness resolved few days later.  On 29 Jan 2021, Lab work done due to her being anemic and on perpetual oxygen therapy. Her hemoglobin level went down from 8.8 to 8.2 and her oxygen level was 82 on exertion.   On 31 Jan 2021, the patient started experiencing shortness of breath. Patient stated that her saturation level was at 82 percent whenever she is standing up or walking and she runs out of breath. When she sits down, the level of the oxygen will go up. She said she is not sure if her medical condition is getting worse or if this is vaccine related  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, shortness of breath, sore arm, oxygen level at 82 percent when walking, and hemoglobin went from 8.8 to 8.2 were unknown.; Reporter's Comments: Based on the information from the source document that the patient is an anemic patient on perpetual oxygen, the events of oxygen saturation decreased, hemoglobin decreased and dyspnea on exertion is assessed as unlikely related to mRNA-1273. The event of pain in extremity is possibly related. Further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Shortness of breath; Hemoglobin went from 8.8 to 8.2; oxygen level was at 82 whenever she is standing or walking; Sore arm; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, sore arm, oxygen level at 82 when walking, and hemoglobin went from 8.8 to 8.2.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Lot number:039K20A) for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced soreness in arm immediately after receiving the shot. The soreness resolved few days later.  On 29 Jan 2021, Lab work done due to her being anemic and on perpetual oxygen therapy. Her hemoglobin level went down from 8.8 to 8.2 and her oxygen level was 82 on exertion.   On 31 Jan 2021, the patient started experiencing shortness of breath. Patient stated that her saturation level was at 82 percent whenever she is standing up or walking and she runs out of breath. When she sits down, the level of the oxygen will go up. She said she is not sure if her medical condition is getting worse or if this is vaccine related  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the events, shortness of breath, sore arm, oxygen level at 82 percent when walking, and hemoglobin went from 8.8 to 8.2 were unknown.; Reporter's Comments: Based on the information from the source document that the patient is an anemic patient on perpetual oxygen, the events of oxygen saturation decreased, hemoglobin decreased and dyspnea on exertion is assessed as unlikely related to mRNA-1273. The event of pain in extremity is possibly related. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Product dispensing issue
Clinical narrative: Vial was shaken before administration; A spontaneous report was received from a consumer concerning a 75-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the vial being shaken before administration/product dispensing issue.  The patient's medical history was not provided.  Concomitant medications were not provided.  On an unknown date, the patient received her dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  The patient's daughter called stating that the vial was shaken before being administrated.  Treatment for this event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, the vial being shaken before administration/product dispensing issue was recovered.; Reporter's Comments: This reports refers to a case of Product dispensing issue for mRNA-1273 (lot number unknown) with no associated AEs. Causality for the event is not applicable
Sex: M
Vaccine: COVID19
Symptoms: Nephrolithiasis, Urinary tract infection, Vaccination site discolouration, Vaccination site pain
Clinical narrative: urinary tract infection; Soreness in the shoulder; Kidney stone; Shoulder was black and blue; A spontaneous report  was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection, soreness in the shoulder, shoulder was black and blue and kidney stone.   The patient's medical history was not reported.  Concomitant medication was not reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown dose, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient stated that he had a urinary tract infection after having the Moderna COVID-19 vaccine. The patient was given keflex but did not know if it would affect the vaccine. Patient had kidney stones two to three days before the second dose of the vaccine. Patient also reports a little soreness in the shoulder and that it was black and blue. He had the shot in his left arm and took Tylenol to help treat his symptoms.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome for the events urinary tract infection, soreness in the shoulder, shoulder was black and blue and kidney stone was unknown.; Reporter's Comments: Urinary tract infection is assessed as unlikely related to mRNA-1273  in the setting of newly diagnosed kidney stone. Based on the current available information and temporal association between the use of the product and the onset date of soreness in the shoulder and shoulder was black and blue, a causal relationship cannot be excluded.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache, Hypoaesthesia
Clinical narrative: Possible Stroke; Increase pressure and numbness in fingers; Headache; A spontaneous report was received from a pharmacist concerning an 81-year old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible stroke, face numbness, startled speech, increase pressure and numbness in fingers and headache.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included alprazolam and hydroxyzine.  On 02 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of Covid-19 infection.   On unknown date, days after the vaccine was administered, the patient reported that he started having a headache, increased pressure and numbness in fingers. Patient had been having intermittent symptoms for 9 days. Patient was admitted to hospital on 10 Feb 2021 due to possible stroke. On 11 Feb 2021, the patient began to have startled speech and face numbness. Patient was evaluated by Neurology and an MRI was done. No further information was provided. Treatment for headache included Excedrin Migraine, ibuprofen and acetaminophen.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome for the events possible stroke, face numbness, startled speech, headache, increase pressure and numbness in fingers, were considered as unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia
Clinical narrative: pneumonia; got Covid-19 after vaccinated; A spontaneous report was received from a consumer concerning a female patient of 69 year old, who was administered moderna's COVID-19 vaccine and tested positive for covid-19 and Experienced pneumonia.  The patients medical history was not provided. No relevant concomitant medications were reported.  On 06-JAN-2021, prior to the onset of events, the Patient received their first of two planned dose of Mrna-1273(Lot number: 012L20A) intramuscularly. On 11-JAN-2021,five days after receiving vaccine, the patient tested positive for covid-19 and had pneumonia. Patient  was admitted in the hospital for five days of a ten day intravenous therapy and recently got home. Patient has one treatment left. Doctor said wait 90 days to get the second shot . Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events was not reported.; Reporter's Comments: This case concerns a 69-year-old female hospitalized with serious unexpected events of COVID-19 and COVID-19 pneumonia. Event onset 6 days after the first dose of mRNA-1273. Treated with 10 days of IV therapy. Very limited information regarding the events has been provided at this time.  Further information has been requested. Based on the current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy returned after recieving the Moderna COVID 19 vaccine; This spontaneous report  was received from a Physician who phoned the call center regarding a 66-year-old female patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced a return of Bell's Palsy.  The patient's medical history was reported as, "having Bell's Palsy this past summer and it resolved". Concomitant medications were not reported.   On 25JAN2021, prior to the onset of the symptoms, the patient received her first of two planned doses of Moderna COVID-19 (mRNA-1273) Vaccine intramuscularly (Lot number: not provided).   On 25JAN2021, the Physician reported, "I have a patient who had Bells Palsy this past summer and it resolved. The patient had her first Moderna COVID 19 vaccine today and the Bells Palsy returned. Physician is not sure which arm the patient received the Moderna Covid-19 Vaccine in. Physician provides consent to Safety to contact regarding Adverse Event follow up".  The action taken for Moderna COVID-19 Vaccine was not reported.  The outcome of the events, "Bells Palsy returned after receiving the Moderna COVID 19 Vaccine" 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 event, a causal relationship cannot be excluded.  The patient's medical history of having Bells Palsy this past summer (but it resolved) is a contributing factor. Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fungal infection, Pain in extremity, Vaccination site discolouration, Vaccination site mass
Clinical narrative: arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; arm was very black and blue where the shot was administered and way around it/severe black and blue mark and bump like a golf ball on the arm where she got vaccinated; yeast infection from it; incredible arm pain/arm was really hurting bad; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), via an unspecified route of administration on 23Jan2021 at 12:00 at a single dose on the arm for COVID-19 immunization. The patient's medical history included high blood pressure. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she was fine but on 23Jan2021 at 16:00, she experienced an incredible arm pain and fatigue. Her arm was really hurting bad. On 25Jan2021, the patient stated that her arm was very black and blue where the shot was administered and way around it. There was a severe black and blue mark and bump like a golf ball on the arm where she got vaccinated and had yeast infection from it. She never had this before since she never had a vaccine when she was a little kid. She wanted to know if they have heard about this before. She wanted to know if this was normal and if she needs go to the doctor. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient can't get appointment for second shot. The patient was not pregnant at the time of vaccination. The outcome of the events incredible arm pain and fatigue was recovering while the other events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: burning sensation in her right arm (not where she received the shot); This is a spontaneous report from a contactable consumer reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3247/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 10:15 (at the age of 45 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included birth control pills.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jan2021 at 23:30, the patient experienced burning sensation in her right arm (not where she received the shot) late at night, lasting for about 20minutes. The patient did not receive any treatment for these events. The event did not require hospitalization. The outcome of the event burning sensation in her right arm (not where she received the shot) was recovered on an unspecified date in Jan2021. Since the vaccination, the patient had not been tested for COVID-19.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Hives; itching; shortness of breath; This is a spontaneous report from a contactable Other Health Professional, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El1284), via an unspecified route of administration on 19Jan2021 at 16:00 (at the age of 74-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient had unspecified concomitant medications that were received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jan2021, the patient experienced hives, itching, all over and eventually some shortness of breath. The events resulted in visit to doctor or other healthcare professional office/clinic visit. The patient was treated for the events with prednisone and a variety of (unspecified) antihistamines.  The patient was due to get the second dose of vaccination on Tuesday and the patient has been told she can get the second dose if she does it in the hospital under observation, and was requesting assistance in scheduling second vaccine. The clinical outcomes of the hives, itching, and shortness of breath were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever; chills; headache; fatigue; This is a spontaneous report from Pfizer via a contactable consumer (mother). A 92-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (at the age of 92-years-old), via an unspecified route of administration on 21Jan2021 as a single dose for covid-19 immunization.  The patient has no medical history and Is not taking any concomitant medications. On 26Jan2021, she experienced fever, chills, headache, and fatigue. The clinical outcome of the events fever, chills, headache, fatigue was not recovered.  Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: "pins and needles" sensation that happens "on-and-off" and soreness in the arm where she received the vaccination; "pins and needles" sensation that happens "on-and-off" and soreness in the arm where she received the vaccination; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program Support. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 25Jan2021 at a single dose on the arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "pins and needles" sensation that happens "on-and-off" and soreness in the arm where she received the vaccination. She wanted to know if this is commonly reported and how long the soreness usually lasts. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pyrexia, Vomiting
Clinical narrative: she woke up and threw up; had diarrhea all day long; fever; tired; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 23Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she had the first dose of the vaccine on Saturday (23Jan2021) at her school she works at; she did not feel any side effects that day. On 24Jan2021 she felt tired; and on 25Jan2021 she woke up and threw up, had diarrhea all day long and had a fever. She referred to her doctor who gave her "something to stop the throwing up." The patient was told by her doctor that only 1% experience her side effects and to contact Pfizer; the patient wanted to know if that was true and how long did the side effects typically occur. The clinical outcomes of tired, she woke up and threw up, had diarrhea all day long and fever were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Fatigue
Clinical narrative: Tiredness; chills; leg weakness; confusion; This is a spontaneous report from a contactable consumer (patient). This 96-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 23Jan2021 at 12:15 PM (at the age of 96-years-old) as a single dose for COVID-19 immunization.  The patient's medical history was not reported. The patient's concomitant medications included atorvastatin from an unknown date for an unknown indication; atenolol from an unknown date for an unknown indication; losartan from an unknown date for an unknown indication; buspirone from an unknown date for an unknown indication; and "levot" from an unknown date for an unknown indication. The patient had not received any other vaccines in the four weeks prior to vaccination and did not have COVID prior to vaccination. On 25Jan2021 at 11:00 PM the patient experienced tiredness, chills, leg weakness, and confusion. The clinical outcomes of tiredness, chills, leg weakness and confusion were recovered in Jan2021. It was also reported the patient had not received a COVID test post-vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This is a spontaneous report from a contactable consumer. A 68-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via unknown route of administration in her left arm on 26Jan2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient did not have COVID. On 26Jan2021 the patient experienced soreness at injection site. The clinical outcome of soreness at injection site was recovered on an unspecified date. It was also reported the patient was not tested for COVID after vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: developed a rash 5 days after the vaccine; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated their wife developed a non-itching rash five days after the vaccine. The patient was prescribed prednisone and "now" (as of 26Jan2021) the rash was significantly less. The reporter inquired if the patient should get the second dose. The reporter also inquired about clinical trials; how many "does" was it before they reported side effects, and if the people in the clinical trials that reported rash as a side effect got the second dose. The clinical outcome of rash was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: Feeling fatigued/unwell; Feeling fatigued/unwell; This is a spontaneous report from a contactable consumer (patient). This 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3248; dose 1) via an unspecified route of administration on 20Jan2021 at 15:00 (at the age of 79-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had an allergy to morphine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient experienced feeling fatigued and unwell on 21Jan2021. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive treatment for the event. The outcome of feeling fatigued and unwell was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Vaccination site erythema, Vaccination site rash
Clinical narrative: Noticed red blotchy rash around injection site 3cm in diameter; Noticed red blotchy rash around injection site 3cm in diameter; Her throat was feeling a little swollen without difficulty swallowing or breathing; This is a spontaneous report received from a contactable pharmacist (reporting for a patient). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular in the left arm on 25Jan2021 13:15 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history was unknown. The patient had no known allergies. It was unknown if the patient had COVID prior to vaccination. It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medication was unknown. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in the left arm on 04Jan2021 12:45 (at the age of 31-years-old) as a single dose for COVID-19 immunization; the patient had no reaction to the first dose. On 25Jan2021, the patient noticed a red blotchy rash around injection site 3 cm in diameter at 13:15. She was treated with diphenhydramine hcl (BENADRYL) 25 mg orally one dose. Her throat was feeling a little swollen without difficulty swallowing or breathing (also at 13:15 on 25Jan2021). She reported similar reactions to bee stings. At 13:25, the rash was almost gone, her throat was feeling better, and she ambulated independently to her vehicle. The clinical outcome of the events was recovered on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Hyperhidrosis, Presyncope, Xanthopsia
Clinical narrative: broke out in a sweat/very diaphoretic; the room turned a yellow color and she knew she was getting ready to pass out; the room turned a yellow color and she knew she was getting ready to pass out; blood pressure was lower than normal; This is a spontaneous report from a contactable nurse (parent reporting for her daughter). A 40-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for Covid-19 immunization. Medical history included allergic to bee stings and carries an EpiPen. The patient's concomitant medications were not reported. On an unspecified date, within the first 15 minutes of vaccination the patient broke out in a sweat and she had to lay down. They got her a coke and she felt a little better. The patient works in a dental office and 2.5 hours later, she was working on a patient in her dental office and she broke out in a sweat again, very diaphoretic, and the patient reported that the room turned a yellow color and she knew she was getting ready to pass out, but they took her in a room and put her in a reclining chair and let her stay there for 1 hour. They kept a wet towel on the patient's forehead. The caller said that they checked her daughter's blood pressure and it was lower than normal when checked. The patient was going to be receiving her second dose in an hour. The clinical outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; numbness at times in her right foot; This is a spontaneous report from a contactable nurse reporting for herself. A 33-years-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EK9231, via an unspecified route of administration on 28Dec2020 16:45 (33 years old) as a SINGLE DOSE for COVID-19 immunization.  Medical history included High blood pressure from an unknown date and unknown if ongoing.  Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included sertraline, melatonin, colecalciferol (VITAMIN D), folic acid, iron (PRENATAL).  The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021, the patient experienced have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine. Patient also had some numbness at times in her right foot on 07Jan2021. She has not been able to see her primary care provider but has an appointment in Feb to be evaluated.  The events were non-serious. No treatment was received for the events. Outcome of the events was not recovered. The patient received the second dose on 19Jan2021 in the Left arm lot EL3302.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: My cheeks were red and hot.; My cheeks were red and hot.; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9263/expiration date: not provided), via an unspecified route of administration, on 23Jan2021 at 14:30 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included allergic reaction to almonds and brewers yeast in Sep2019, being pre-diabetic, and osteoporosis. The patient had allergies to codeine (all forms), almonds, brewers yeast, mold and dust. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin, alendronate sodium (FOSAMAX), and multivitamin, other supplement. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 at 15:15, the patient experienced that her cheeks were red and hot. The clinical course was as follows: because of a prior significant allergic reaction (Sep2019 determined to be primarily almonds and to a lesser extent brewers yeast), she waited 30 min. and she didn't notice anything until she left the property and removed her mask. Her cheeks were red and hot. She had a diphenhydramine (BENADRYL) tablet (OTC) which within 30+ min reversed it. The outcome of the events cheeks were red and hot was recovered on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Nausea, Vision blurred
Clinical narrative: dizzy; foggy; diaphoretic; blurred vision; nausea; had one episode of vomiting; This is a spontaneous report from a contactable pharmacist. A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN5318/expiration date: not provided), via intramuscular route of administration, on 23Jan2021 12:00 (at the age of 32 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient did not have any known allergies. On 23Jan2021 at 12:00 immediately after the injection, the patient felt dizzy, foggy, diaphoretic, had blurred vision, nausea and had one episode of vomiting. The patient did not receive any treatment for these events. After the patient had emesis episode, the patient immediately returned to baseline and felt better. The patient stated that he normally had some type of reactions after injections. The patient was observed for a full 30 minutes and given water. 1225 patient check on and a this time had made a complete return to baseline. Patient discharge home after his full 30minute observation period ended at 1230. The outcome of the events dizzy, foggy, diaphoretic, had blurred vision, nausea and had one episode of vomiting was recovered 23Jan2021 at 12:30.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dizzy; foggy; diaphoretic; blurred vision; nausea; had one episode of vomiting; This is a spontaneous report from a contactable pharmacist. A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN5318/expiration date: not provided), via intramuscular route of administration, on 23Jan2021 12:00 (at the age of 32 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient did not have any known allergies. On 23Jan2021 at 12:00 immediately after the injection, the patient felt dizzy, foggy, diaphoretic, had blurred vision, nausea and had one episode of vomiting. The patient did not receive any treatment for these events. After the patient had emesis episode, the patient immediately returned to baseline and felt better. The patient stated that he normally had some type of reactions after injections. The patient was observed for a full 30 minutes and given water. 1225 patient check on and a this time had made a complete return to baseline. Patient discharge home after his full 30minute observation period ended at 1230. The outcome of the events dizzy, foggy, diaphoretic, had blurred vision, nausea and had one episode of vomiting was recovered 23Jan2021 at 12:30.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Eye oedema
Clinical narrative: Severe puffiness of eyes.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number E69263), via an unspecified route of administration in the right arm on 25Jan2021 at 09:15 (at the age of 37-years) as a single dose for Covid-19 immunization. Historical vaccine included the first dose of BNT162B2 (Lot Number E61284) on 04Jan2021 at 09:00 (at the age of 37-years) in the right arm for Covid-19 immunization. The patient's medical history and concomitant medications was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 11:45, the patient experienced severe puffiness of eyes. The patient was seen in emergency department or urgent care. The patient was treated for the severe puffiness of eyes with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the event severe puffiness of eyes was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.