chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Feeling abnormal, Grip strength decreased, Headache, Hypoaesthesia
Clinical narrative: he had some facial drooping then resolving and his hand released an object he was holding, limbs going numb and he felt like he was having a stroke.    This occurred about an hour after his vaccine.  in the next few days he experienced severe headaches.  All adverse experiences have resolved as of 1/6
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immediate post-injection reaction, Injection site pain, Uterine contractions during pregnancy
Clinical narrative: I experienced arm soreness at the injection site immediately after.  Fatigued two days afterwards. Also experienced Hixton Braxton contractions after the injection.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: chills fever felt off body aches hives over stomach pounding headache lethargic
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: chills fever felt off body aches hives over stomach pounding headache lethargic
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock, Dyspnoea, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: PATIENT SPOUSE REPORTS THAT PATIENT RECEIVED VACCINE ON 1/4/2021 AND ON 1/5/2021 PATIENT'S ARM BEGAN TO TURN RED AND SWELL AT THE INJECTION SITE. THE SWELLING AND REDNESS BEGAN TO GO DOWN HIS ARM AND HE BROKE OUT INTO A RASH. PATIENT THEN BECAME SHORT OF BREATH. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL, WHERE HE WAS TREATED FOR ANAPHYLACTIC SHOCK TO THE COVID MODERNA VACCINE.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: PATIENT SPOUSE REPORTS THAT PATIENT RECEIVED VACCINE ON 1/4/2021 AND ON 1/5/2021 PATIENT'S ARM BEGAN TO TURN RED AND SWELL AT THE INJECTION SITE. THE SWELLING AND REDNESS BEGAN TO GO DOWN HIS ARM AND HE BROKE OUT INTO A RASH. PATIENT THEN BECAME SHORT OF BREATH. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL, WHERE HE WAS TREATED FOR ANAPHYLACTIC SHOCK TO THE COVID MODERNA VACCINE.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Headache, nausea/vomiting, chills, fatigue
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lethargy, Malaise, Muscular weakness, Pain
Clinical narrative: Fever of 100.4, chills, aches, malaise, lethargy, muscle weakness
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever of 100.4, chills, aches, malaise, lethargy, muscle weakness
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: dizziness, chills, nausea and vomiting, headache,  weakness and pain in the arm/injection site.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: dizziness, chills, nausea and vomiting, headache,  weakness and pain in the arm/injection site.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Peripheral swelling
Clinical narrative: WITHIN THE SAME DAY STARTED WITH RIGHT ARM SWELLING, REDNESS, WARMTH, AND ITCHING AT INJECTION SITE. TAKING IBUPROFEN AND ICED AREA. GOT BETTER AFTER A FEW DAYS AND STARTED BACK UP AGAIN, WORSE THAN BEFORE.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal discomfort, Periorbital swelling, Pruritus
Clinical narrative: Itchy mainly in head ears slight swelling around my eyes.  My throat ticked  I had a headache and felt tired    It feels like it is starting to get better today so far
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysphagia, Hypoaesthesia oral, Rash, Tachycardia
Clinical narrative: Rash, chest pain, tachycardia, numb tongue, hard to swallow
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: right axillary lymphadenopathy
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Queasy and cold chills
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness, Elevated
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Oedema
Clinical narrative: Extreme erythema and edema across entire Left shoulder, approx. 5 inches from shoulder joint, 3 1/2 x 2 1/2, with extreme itching.  It was reported that small amount of redness at injection site  was noted 2 days after the injection, that later resolved, and noted itching at the site on 01/03/2021, and noted the extreme redness, with increased itching on early morning of 01/06/2021 at 4:40am. MD appointment is pending.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Photophobia, Pyrexia
Clinical narrative: extreme headache with sensitivity to light, low grade fever (99.8), large muscle body ache, fatigue lasted from around 2am 1/6 until 5pm 1/6.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Day/night 1, no problem.  Day 2 - soreness in arm around injection site.  Only felt soreness when touched.  Night 2 - had long-sleeve t-shirt on all day, so didn't notice the large red area until nighttime.  Also same area had swelling/hardness that was sore.  Day 3 - morning - redness/swelling still evident.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymph node pain
Clinical narrative: Erythema, swelling, warmth to the site (5in x 2.5in) sore lymph nodes (axillary, cervical, tonsil)
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Injection site pain, Pain
Clinical narrative: Moderna COVID-19 Vaccine EUA. Rather moderate joint soreness, Chills, body aches, slight fever.It all started the night of the vaccine with the soreness at the injection site (1/5/21). Then the next morning I was riding in my car (1/6/21 around 9:45am) and a weird virtigo feeling settled in. After that was when the chills started with the body aches. I checked my temperature before I went in to the shower and it was running 99.7. Then when I was showering I had that uncomfortable feeling when the water hits you right before you get sick. Kind of a werid feeling to describe if you've never experienced it before. I have just been monitoring my symptoms and staying home, and hydrating.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Moderna COVID-19 Vaccine EUA. Rather moderate joint soreness, Chills, body aches, slight fever.It all started the night of the vaccine with the soreness at the injection site (1/5/21). Then the next morning I was riding in my car (1/6/21 around 9:45am) and a weird virtigo feeling settled in. After that was when the chills started with the body aches. I checked my temperature before I went in to the shower and it was running 99.7. Then when I was showering I had that uncomfortable feeling when the water hits you right before you get sick. Kind of a werid feeling to describe if you've never experienced it before. I have just been monitoring my symptoms and staying home, and hydrating.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Limb discomfort, Pyrexia
Clinical narrative: Low grade fever between 99 and 100 lasting 24 hours the day following vaccination, injection site reaction (moderate arm soreness starting 4 hours after injection
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Nodule, Pain
Clinical narrative: First 2 days had redness and swelling at injection site.  5 days later left arm pit was in pain. It was extremely painful to move my arm or touch.  I didnt think it was related to the vaccine.  I just thought it was a muscle strain but now i have  lump under my arm pit.  I believe this is lymphadenopathy.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Feeling abnormal, Feeling cold, Headache
Clinical narrative: moderna COVID-19 Vaccine EUA. Tachycardia sudden onset 4 minutes after injection (6:09am). Arms and legs cold and weak. Generalized weakness. BP 167/78, o2 sats 100%. Tachycardia lasted about 10-15minutes and resolved to HR 88 and BP 138/78.  Still left with overall weakness, malaise, cold feeling. No other symptoms.  Released from the facility at 6:48am.  Drove 2 blocks to my husband's workplace (hospital). Had diarrhea x 2, dull diffuse headache, odd feeling and malaise that persisted. Sudden onset of terrible feeling, the need to get to the ER at 8:36am. Had a bathroom visit to urinate. By the time we got to the ER the intense malaise improved. I sat in the ER lobby not wanting to be admitted to the ER (didn't want to be having a vaccine reaction). I stayed in the ER lobby. Symptoms completely resolved at 9:45am. I stayed there for 30 more minutes to be sure and then drove home with no other symptoms but Left arm soreness. Tachycardia never returned after the first episode. No rash, no itching, no swelling, no dyspnea. Just felt toxic. Then it resolved completely at hour 4.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness, Pain in extremity, Peripheral coldness, Tachycardia
Clinical narrative: moderna COVID-19 Vaccine EUA. Tachycardia sudden onset 4 minutes after injection (6:09am). Arms and legs cold and weak. Generalized weakness. BP 167/78, o2 sats 100%. Tachycardia lasted about 10-15minutes and resolved to HR 88 and BP 138/78.  Still left with overall weakness, malaise, cold feeling. No other symptoms.  Released from the facility at 6:48am.  Drove 2 blocks to my husband's workplace (hospital). Had diarrhea x 2, dull diffuse headache, odd feeling and malaise that persisted. Sudden onset of terrible feeling, the need to get to the ER at 8:36am. Had a bathroom visit to urinate. By the time we got to the ER the intense malaise improved. I sat in the ER lobby not wanting to be admitted to the ER (didn't want to be having a vaccine reaction). I stayed in the ER lobby. Symptoms completely resolved at 9:45am. I stayed there for 30 more minutes to be sure and then drove home with no other symptoms but Left arm soreness. Tachycardia never returned after the first episode. No rash, no itching, no swelling, no dyspnea. Just felt toxic. Then it resolved completely at hour 4.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pruritus, SARS-CoV-2 test negative
Clinical narrative: COVID toes and fingers, with itchy and painful nodules on fingers, feet
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Headache, Hypertension, Myalgia, Oral candidiasis
Clinical narrative: Headache, Myalgia, Anaphylaxis, Fever, HYPERtension, oral thrush Narrative:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, Myalgia, Anaphylaxis, Fever, HYPERtension, oral thrush Narrative:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Product storage error; This spontaneous report was received from a physician regarding to a patient of unknown age and gender.    Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 08-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) lot # T021302, expiration date 19-DEC-2021, 0.5 milliliter for prophylaxis (route of administration was not provided).  The improperly stored suspect vaccine experienced a temperature of -5 degree Celsius (°C) for 20 hours with no previous temperature excursion.   The call was made due to a digital data logger.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pruritus, Stress
Clinical narrative: Suspected vaccination failure / have gotten the Shingrix shot / Since having / Shingrix series / continues to have shingles outbreaks; have shingles for over 20 yrs have gotten outbreak now / has the shingles outbreaks at least twice a year; she does get blisters; blisters / they do itch; blisters/ are painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (for over 20 yrs). Previously administered products included Zostavax.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, pruritus and pain. On an unknown date, the outcome of the vaccination failure, blister, pruritus and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pruritus and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was repored by patient herself. The patient had the Shingrix 2-dose series in 2018. Since having the Shingrix series, she continued to have shingles outbreaks. She had the shingles outbreaks at least twice a year. She stated they were not as severe as they were prior to being vaccinated with Shingrix but she did get blisters and they do itch and were painful. They were treated with (unspecified) antiviral prescription medications. She usually goes to urgent care when she had an outbreak. She tried to go to urgent care as soon as the symptoms begin but with her last outbreak she was hesitant to go to the urgent care due to the Covid-19 epidemic and so she waited over a week to go and due to that her outbreak lasted 3 weeks.  The patient was calling to see if she could receive a third dose of Shingrix. She states that her shingles outbreaks were triggered by stress such as the stress of wearing a mask while at the gym.  The patient was currently on an anti-viral drug being have gotten outbreak now. Also yearly, the patient get the shingles minimum of 2 times a year and need to take the anti-viral drug. This case was considered as suspected vaccination failure since the details regarding laboratory test were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure / have gotten the Shingrix shot / Since having / Shingrix series / continues to have shingles outbreaks; have shingles for over 20 yrs have gotten outbreak now / has the shingles outbreaks at least twice a year; she does get blisters; blisters / they do itch; blisters/ are painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (for over 20 yrs). Previously administered products included Zostavax.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister, pruritus and pain. On an unknown date, the outcome of the vaccination failure, blister, pruritus and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, pruritus and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was repored by patient herself. The patient had the Shingrix 2-dose series in 2018. Since having the Shingrix series, she continued to have shingles outbreaks. She had the shingles outbreaks at least twice a year. She stated they were not as severe as they were prior to being vaccinated with Shingrix but she did get blisters and they do itch and were painful. They were treated with (unspecified) antiviral prescription medications. She usually goes to urgent care when she had an outbreak. She tried to go to urgent care as soon as the symptoms begin but with her last outbreak she was hesitant to go to the urgent care due to the Covid-19 epidemic and so she waited over a week to go and due to that her outbreak lasted 3 weeks.  The patient was calling to see if she could receive a third dose of Shingrix. She states that her shingles outbreaks were triggered by stress such as the stress of wearing a mask while at the gym.  The patient was currently on an anti-viral drug being have gotten outbreak now. Also yearly, the patient get the shingles minimum of 2 times a year and need to take the anti-viral drug. This case was considered as suspected vaccination failure since the details regarding laboratory test were unknown at the time of reporting.
Sex: U
Vaccine: TDAP
Symptoms: Apnoea, Asthma, Cough, Dyspnoea, Illness
Clinical narrative: suspected vaccination failure; whooping cough; lose my breath; asthma; did not feel well; cough.; sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), apnea (serious criteria GSK medically significant), asthma, sickness, malaise and cough. The patient was treated with anti-asthmatic (nos) (Asthma Medicines (Nos)). On an unknown date, the outcome of the vaccination failure, whooping cough, apnea and asthma were unknown and the outcome of the sickness and malaise were recovered/resolved and the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, whooping cough, apnea, asthma, sickness, malaise and cough to be related to Tdap Vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received TDAP vaccine in 2016. The patient experinced whooping cough two years ago from the day of reporting The patient had developed asthma after over whooping cough The patient had coughed every day for over two years The patient lose breath when talk a lot (which patient normally do not do). The patient waas sick for 5 months and I did not feel well until months after that. At the time of reporting felt better. The patient's pulmonologist upped the asthma medicine and still patient had cough.
Sex: U
Vaccine: TDAP
Symptoms: Malaise, Pertussis, Vaccination failure
Clinical narrative: suspected vaccination failure; whooping cough; lose my breath; asthma; did not feel well; cough.; sick; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), apnea (serious criteria GSK medically significant), asthma, sickness, malaise and cough. The patient was treated with anti-asthmatic (nos) (Asthma Medicines (Nos)). On an unknown date, the outcome of the vaccination failure, whooping cough, apnea and asthma were unknown and the outcome of the sickness and malaise were recovered/resolved and the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, whooping cough, apnea, asthma, sickness, malaise and cough to be related to Tdap Vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received TDAP vaccine in 2016. The patient experinced whooping cough two years ago from the day of reporting The patient had developed asthma after over whooping cough The patient had coughed every day for over two years The patient lose breath when talk a lot (which patient normally do not do). The patient waas sick for 5 months and I did not feel well until months after that. At the time of reporting felt better. The patient's pulmonologist upped the asthma medicine and still patient had cough.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid; covid; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The physician inquired whether a person with previous history of COVID would experience more significant reaction to the COVID vaccine than a person without a previous diagnosis due to having already produced antibodies. Reporter's colleague (physician) had the vaccine 2 weeks ago, had a severe reaction (unspecified) wherein he got a shot of epi. Patient recovered and was okay. At the time of reporting, patient now had Covid or maybe he had Covid before, reporter was not sure. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 vaccine cannot be completely excluded for event "Covid".
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid two days after getting vaccine; tested positive for Covid two days after getting vaccine/nasal swab/ NP PCR and result was positive; This is a spontaneous report from a contactable physician.  A 39-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), intramuscular on the left arm on 24Dec2020 at 08:30 at a single dose for Covid-19 immunization. There were no medical history and no concomitant medications. The patient has no known allergies to medications, food, or other products. On 25Dec2020 at 09:00 am, also reported as 26Dec2020, the patient was tested positive for Covid two days after getting vaccine. He was wondering if he should get the booster dose in 3 weeks or not since he will have natural immunity. The patient did not receive any treatment for the events. The patient had a nasal swab/ NP PCR and result was positive on 26Dec2020. The outcome of the events was not recovering. The events were assessed as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the COVID-19 PCR test positive represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Cough, Fatigue, Headache, Pain
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable unspecified HCP reporting for herself. This 61-year-old female patient received on 22Dec2020 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 24Dec2020, the patient had a bad reaction, coughing, headache, no taste, tiredness and body aches. The patient thought originally, she was having a reaction to the vaccine, and took some ibuprofen (ADVIL). The patient was still congested and was sent for testing. She was tested positive on 28Dec2020. The test was a nasal swab. Outcome was unknown. The patient was wondering if this was part of the side of effect of the vaccine.  Information on the batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable unspecified HCP reporting for herself. This 61-year-old female patient received on 22Dec2020 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 24Dec2020, the patient had a bad reaction, coughing, headache, no taste, tiredness and body aches. The patient thought originally, she was having a reaction to the vaccine, and took some ibuprofen (ADVIL). The patient was still congested and was sent for testing. She was tested positive on 28Dec2020. The test was a nasal swab. Outcome was unknown. The patient was wondering if this was part of the side of effect of the vaccine.  Information on the batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site tenderness/it is a little tender; swollen at injection site/It is swollen at the injection site; itchiness at injection site; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (upper left arm) on 21Dec2020 (between 9:00AM and 9:30AM) at single dose for Covid-19 immunization. Medical history included allergic to dust mites and grass, summertime allergies (haven't been diagnosed but she has sneezing and watery eyes during the summer), obese at 190, and flu vaccine in Oct2020, and smoker. Her mother passed from COPD and stated that more than likely she has that because she is a smoker. Her father had congestive heart failure. Concomitant medications were not reported. The patient previously took flu vaccine vii and experienced migraine; also, previously took Novocaine (probably 10 to 15 years ago) out of the blue she had a reaction. "Eons ago" when she was probably 25 she had a reaction to the very first flu shot that she got. The reaction was a migraine and she could not get out of bed. The patient wanted to know if it was normal to have side effects a week later after receiving Covid vaccine. She received vaccine on 21Dec2020 and today (29Dec2020 5AM) she was experiencing injection site tenderness, appearing swollen at injection site, and itchiness at injection site. It was further reported that she woke up this morning and her arm is itchy. It is swollen at the injection site. It is about the size of a fifty-cent piece. It is itchy and it is a little tender. The patient added, "It is a little tender": it was a little sore the first day like a flu shot. It is annoying like a bug bite itch. The swelling has been the same throughout the day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: got the COVID-19 vaccine last week and six days later tested positive for COVID-19; got the COVID-19 vaccine last week and six days later tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unspecified date in Dec2020 at single dose, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the covid-19 vaccine last week and six days later (Dec2020) tested positive for Covid-19. The outcome of event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations, Tremor
Clinical narrative: breathlessness; racing heart rate; shaking disease; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 27Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Dec2020, the patient had an immediate reaction which included breathlessness, racing heart rate, and "shaking disease." She said that the reactions happened a minute after getting the vaccine. She was observed for an hour and said she still had the breathlessness, but was improving. She wanted to know if she should still take the second dose of the vaccine. Outcome of the event breathlessness was recovering, while for the other events was unknown.  Information about the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Depressed level of consciousness
Clinical narrative: anaphylaxis; ALOC/decreased level of consciousness; This is a spontaneous report from a contactable Pharmacist (patient). a 40-year-old female patient (no pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140) via intramuscular at Left arm on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history included known allergies to egg, seafood, azithromycin, orange and seasonal allergies. The concomitant was reported as cetirizine hydrochloride (ALLERTEC) and PRN 1371. The patient with no known past medical history brought in by CODE Team to RUH ED with concern for ALOC after getting the COVID vaccination 30-40 minutes PTA. Patient was a nurse and experienced decreased level of consciousness following her COVID vaccination. Patient reports h/o anaphylaxis. She was given epinephrine PTA. Denies SOB, oral swelling, CP. Blood glucose (BGL) within normal limits. Patient denies any other complaints or symptoms at this time. Adverse event start date: 23Dec2020. Treatment was unknown for decreased level of consciousness. The outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis /decreased level of consciousness cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: She has been feeling rotten for a few days; This is a spontaneous report from a Pfizer-sponsored program via a contactable physician reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing COVID positive since 22Dec2020. She was COVID positive before she got the vaccine. She got tested for COVID Corona Virus, because they do it weekly. She does weekly self-testing as part of a study she is in. There was an outbreak at her office and that is why she had to get a whole other test. On 22Dec2020 she did a nasal swab. She didn't get the results from the nasal swab until the day of report. The patient's concomitant medications were not reported. It was reported she was having an immune reaction to the vaccine and she was expecting it and said it was ok. On the 23rd she had symptoms. On the 24th, the rapid test was positive. The results from the nasal swab on 22Dec2020 was positive, so she was COVID positive before she got the vaccine. She has been feeling rotten for a few days and couldn't reach out before today. The patient wanted to know if it would be effective for her to receive the second dose of the COVID vaccine after being positive for the COVID virus. Outcome of the event was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: She has been feeling rotten for a few days; This is a spontaneous report from a Pfizer-sponsored program via a contactable physician reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing COVID positive since 22Dec2020. She was COVID positive before she got the vaccine. She got tested for COVID Corona Virus, because they do it weekly. She does weekly self-testing as part of a study she is in. There was an outbreak at her office and that is why she had to get a whole other test. On 22Dec2020 she did a nasal swab. She didn't get the results from the nasal swab until the day of report. The patient's concomitant medications were not reported. It was reported she was having an immune reaction to the vaccine and she was expecting it and said it was ok. On the 23rd she had symptoms. On the 24th, the rapid test was positive. The results from the nasal swab on 22Dec2020 was positive, so she was COVID positive before she got the vaccine. She has been feeling rotten for a few days and couldn't reach out before today. The patient wanted to know if it would be effective for her to receive the second dose of the COVID vaccine after being positive for the COVID virus. Outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased
Clinical narrative: Elevated HR up to 130 for a few hrs after administration and intermittently for several days; Severe fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiry date not reported), intramuscular on the left arm on 16Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. On 16Dec2020 14:00, the patient experienced elevated HR up to 130 for a few hours after administration and intermittently for several days and severe fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered with sequelae on Dec2020.  Follow-up attempts are not possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: had her shot of Covid vaccine last (22Dec2020) 7 days and was tested positive on Dec2020; had her shot of Covid vaccine last (22Dec2020) 7 days and was tested positive on Dec2020; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. It was reported that the patient had her shot of Covid vaccine last (22Dec2020) 7 days and was tested positive on Dec2020. She wanted to know if this was normal to get false positive results after getting the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive for Covid after receiving the vaccine; Positive for Covid after receiving the vaccine; This is a spontaneous report from a Pfizer Sponsored Program. This consumer reported similar event for two patients. This is the 2nd of 2 reports.    A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 22Dec2020 at a single dose for Covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was positive for Covid after receiving the vaccine. It was reported that patient was positive and they were all in the breakroom without a mask. The patient (person that is positive) got the vaccine and got worse, so co-workers are thinking that she (patient) had the virus before getting the vaccine and just didn't have any symptoms. Outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518090 same reporter/drug, similar event, different patient
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive, Viral test positive
Clinical narrative: Asymptotic positive rapid COVID test 12 days post vaccination.  Close contact testing/Nasal Swab positive; Asymptotic positive rapid COVID test 12 days post vaccination.  Close contact testing/Nasal Swab positive; This is a spontaneous report from a contactable Other HCP (patient). A 52-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscular in arm left on 17Dec2020 13:15 at single dose for COVID-19 immunisation. Medical history included seasonal allergies, depression and Allergies: Sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), cefixime (FLEXERIL), fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), omeprazole (PRILOSEC).  The patient previously took pethidine hydrochloride (DEMEROL) and experienced 'allergies: Demerol', codeine and experienced 'allergies: codeine'.  The patient experienced asymptotic positive rapid COVID test 12 days post vaccination. Close contact testing on 29Dec2020.  The patient underwent lab tests and procedures which included [{covid test type post vaccination= Nasal Swab, covid test date=29Dec2020, covid test result= Positive}].  Facility type vaccine was workplace clinic. No treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Erythema, Joint swelling, Limb discomfort
Clinical narrative: top of left hand red; top of left hand pain; uncomfortable to open left hand; left wrist swollen; left hand swollen/the top of his left hand was warm and red; regular shot pain in left shoulder; regular shot pain in left shoulder/ top left wrist pain; This is a spontaneous report from a contactable consumer(patient). A 55-year-old male patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left arm, on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient stated that he got his Pfizer Covid vaccination on Tuesday last week on 22Dec2020. The patient had few days regular shot pain in left shoulder. The patient stated that on Thursday(24Dec2020) that he was okay but got on his wrist on same arm and top of hand swollen was painful to movement. The patient stated that the top of his left hand was warm and red on Saturday(26Dec2020). The patient experienced top of left hand pain and top left wrist pain on 26Dec2020. The patient stated that he got the Covid vaccination in his left arm. The patient stated that on Sunday that he made a clinic appointment and they sent him anti-inflammatories. The patient stated that now he was getting better. The patient was uncomfortable to open left hand 25Dec2020. The patient stated that the pain in his left shoulder resolved Thursday or Friday. The patient stated that he can see his hand muscles more defined now. The patient stated that he can stretch his left hand better than before. The patient stated that he had blood work in doctor in Oct2020. The outcome of the events"regular shot pain in left shoulder" was recovered, of the event"top of left hand red" was not recovered and of the other events was recovering.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Procedural pain
Clinical narrative: top of left hand red; top of left hand pain; uncomfortable to open left hand; left wrist swollen; left hand swollen/the top of his left hand was warm and red; regular shot pain in left shoulder; regular shot pain in left shoulder/ top left wrist pain; This is a spontaneous report from a contactable consumer(patient). A 55-year-old male patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left arm, on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient stated that he got his Pfizer Covid vaccination on Tuesday last week on 22Dec2020. The patient had few days regular shot pain in left shoulder. The patient stated that on Thursday(24Dec2020) that he was okay but got on his wrist on same arm and top of hand swollen was painful to movement. The patient stated that the top of his left hand was warm and red on Saturday(26Dec2020). The patient experienced top of left hand pain and top left wrist pain on 26Dec2020. The patient stated that he got the Covid vaccination in his left arm. The patient stated that on Sunday that he made a clinic appointment and they sent him anti-inflammatories. The patient stated that now he was getting better. The patient was uncomfortable to open left hand 25Dec2020. The patient stated that the pain in his left shoulder resolved Thursday or Friday. The patient stated that he can see his hand muscles more defined now. The patient stated that he can stretch his left hand better than before. The patient stated that he had blood work in doctor in Oct2020. The outcome of the events"regular shot pain in left shoulder" was recovered, of the event"top of left hand red" was not recovered and of the other events was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: the patient experienced tongue swelling 9 hours after injection; This is a spontaneous report from a contactable physician (patient).  A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Arm Left from 28Dec2020 12:45 to 28Dec2020 12:45 as single dose for COVID-19 immunization.  Medical history included allergy to Latex and depression.  Concomitant medication included duloxetine hydrochloride (CYMBALTA).  The patient previously took Percocet and experienced allergies. On 28Dec2020 at 09:45 PM, the patient experienced tongue swelling 9 hours after injection. The patient stated had this similar feeling or reaction after taking Percocet when she had her first child. The patient took Benadryl 25mg as treatment to the event. The outcome of the event was recovered.  Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain in extremity, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0140), intramuscular in the right arm on 21Dec2020 15:00 at a single dose for COVID-19 immunization at the age of 31 years old at the workplace clinic. Medical history included asthma and seasonal allergies. Concomitant medications included fluticasone nasal spray, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler, montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D), salbutamol sulfate (ALBUTEROL), zinc and unspecified multivitamin. On 29Dec2020 16:00, 8 days after the vaccine, the patient had swelling at the injection site on her right arm, it is hot and painful. Also, the patient had pain in right fingers and lymph pain in axillary region. Outcome of the events was unknown. No treatment was given for the events. The events were assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I got the Pfizer vaccine, the first shot; I tested positive for Covid; I got the Pfizer vaccine, the first shot; I tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  Consumer stated, "I had a question, I got the Pfizer vaccine, the first shot on the 18Dec but I tested positive for Covid on the 27Dec, so, my question is this and I asked my healthcare institution and they still haven't got back to me, so I just wanted to call you guys, what do I do about the second dose because I am scheduled to get the second dose net week?" The outcome of event was unknown.