chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Feeling cold, Headache, Oropharyngeal pain
Clinical narrative: dry throat; coughing; headache; chilly; sore throat; her body is itching; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on 25Mar2021, as dose 1, single for COVID-19 immunisation. Medical history included seasonal allergy. Patient was taking unspecified concomitant medication for seasonal allergies. The patient experienced dry throat, coughing, headache, chilly, sore throat, and her body is itching on an unspecified date in Mar2021. Patient stated she was coughing too much. Patient took paracetamol (TYLENOL), Dextromethorphan (DELSYM), Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine (ALKA-SETZER COLD & FLU), and benzocaine, menthol (CEPACOL) for sore throat and as a result of events. Patient stated it was not working and wants to know what she can do to feel better. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: dry throat; coughing; headache; chilly; sore throat; her body is itching; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on 25Mar2021, as dose 1, single for COVID-19 immunisation. Medical history included seasonal allergy. Patient was taking unspecified concomitant medication for seasonal allergies. The patient experienced dry throat, coughing, headache, chilly, sore throat, and her body is itching on an unspecified date in Mar2021. Patient stated she was coughing too much. Patient took paracetamol (TYLENOL), Dextromethorphan (DELSYM), Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine (ALKA-SETZER COLD & FLU), and benzocaine, menthol (CEPACOL) for sore throat and as a result of events. Patient stated it was not working and wants to know what she can do to feel better. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Heart rate increased, Pruritus
Clinical narrative: Itching hands; Welt on her jaw and bottom of left foot, this was all on the left side; Rash only on her upper chest between neck and breast and on her back; Headache; Chills; Heart was beating faster than normal; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 18Mar2021, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose on 18Mar2021. The next day (19Mar2021), the patient woke up to itching hands. The patient also noticed a welt on her jaw and bottom of left foot, this was all on the left side (19Mar2021). The patient also had a rash only on her upper chest between neck and breast and on her back (19Mar2021). On 19Mar2021, the patient had headache and chills. All this happened within 30 hours of getting the vaccine. The patient took diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), and it helped. By Monday (22Mar2021), the patient was fine. One week later (Mar2021), the patient woke up from her sleep and her heart was beating faster than normal. The patient went back to sleep and when she woke up, she was okay. The patient was wondering if this has been reported. The patient recovered from "Heart was beating faster than normal" in Mar2021; and from the remaining events on 22Mar2021.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Itching hands; Welt on her jaw and bottom of left foot, this was all on the left side; Rash only on her upper chest between neck and breast and on her back; Headache; Chills; Heart was beating faster than normal; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 18Mar2021, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose on 18Mar2021. The next day (19Mar2021), the patient woke up to itching hands. The patient also noticed a welt on her jaw and bottom of left foot, this was all on the left side (19Mar2021). The patient also had a rash only on her upper chest between neck and breast and on her back (19Mar2021). On 19Mar2021, the patient had headache and chills. All this happened within 30 hours of getting the vaccine. The patient took diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), and it helped. By Monday (22Mar2021), the patient was fine. One week later (Mar2021), the patient woke up from her sleep and her heart was beating faster than normal. The patient went back to sleep and when she woke up, she was okay. The patient was wondering if this has been reported. The patient recovered from "Heart was beating faster than normal" in Mar2021; and from the remaining events on 22Mar2021.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Swelling
Clinical narrative: lump in armpit; it got a little swollen but in the opposite side of the body where the vaccine was administered; a pain started right below her armpit; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN8730), via an unspecified route of administration on 23Mar2021 at the age of 32-year-old as dose number unknown, single for covid-19 immunisation. Medical history included Prediabetes (probably around 5 to 6 years ago) and anxiety from an unknown date and unknown if ongoing. Concomitant medications included metformin taken 500 mg once a day  for Prediabetes, start and stop date were not reported and sertraline hcl taken for anxiety, start and stop date were not reported.  On 30Mar2021 the patient experienced a pain started right below her armpit and it got a little swollen, also noticed that have a lump in armpit but in the opposite side of the body where the vaccine was administered. She is worried whether she has to consult her physician about this (swollen in the opposite side of the body) or not.  Patient was concerned if its because of the vaccine or do I get it checked. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Chest discomfort, Chest pain, Disease recurrence, Nasopharyngitis
Clinical narrative: tightness of chest which feels like bronchitis, achiness; tightness of chest which feels like bronchitis, achiness; tightness of chest which feels like bronchitis, achiness; feeling feverish; Disease recurrence; cold symptoms; This is a spontaneous report from a contactable consumer (patient) received via medical information team and a Pfizer Sponsored Program. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 30Mar2021 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma and bronchitis. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced tightness of chest which feels like bronchitis, achiness, feeling feverish and cold symptoms on 30Mar2021. It was reported that patient knows that these are some of the side effects of the vaccine. It was asked can she take asthma medicine, or will it cause adverse reaction with the vaccine and can the doctor test her for COVID 19 even though she have had the vaccine already. Patient also asked that having a cold affects the effectiveness of the vaccine because she feels like she has symptoms of a cold and how dangerous is this for her since she has history of asthma. Outcome of events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: tightness of chest which feels like bronchitis, achiness; tightness of chest which feels like bronchitis, achiness; tightness of chest which feels like bronchitis, achiness; feeling feverish; Disease recurrence; cold symptoms; This is a spontaneous report from a contactable consumer (patient) received via medical information team and a Pfizer Sponsored Program. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 30Mar2021 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma and bronchitis. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced tightness of chest which feels like bronchitis, achiness, feeling feverish and cold symptoms on 30Mar2021. It was reported that patient knows that these are some of the side effects of the vaccine. It was asked can she take asthma medicine, or will it cause adverse reaction with the vaccine and can the doctor test her for COVID 19 even though she have had the vaccine already. Patient also asked that having a cold affects the effectiveness of the vaccine because she feels like she has symptoms of a cold and how dangerous is this for her since she has history of asthma. Outcome of events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: developed rashes in his leg/It is a little red rash on the legs; Itchy; This is a spontaneous report from a contactable consumer (wife of patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 27Mar2021 at 13:00 (at the age of 82-year-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included Memory Problems. The patient has had memory problems for about a year or so. The patient's concomitant medications included medication for his memory (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 06Mar2021 (at the age of 82-year-old) as DOSE 1, SINGLE for covid-19 immunization. On 30Mar201, the patient felt itchy. Then it was still itching in morning and on 31Mar2021, the patient experienced a rash on his legs. It was a little red rash on the legs. The patient never had it before. The patient wanted to know, if that would decrease the efficacy of the vaccine. The outcome of the event Erythematous rash was unknown an Itchy was Not recovered at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Head discomfort
Clinical narrative: feeling stoned/ fuzzy; flushed/face is a little flushed; pressure in the lower forehead and topd of the nose/pressure above her nose; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 31Mar2021 08:00 at the age of 52-year-old as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Mar2021, a couple of hours ago patient started feeling stoned, fuzzy , flushed and pressure in the lower forehead and top of the nose. Patient states it is not a headache, just pressure and her face is a little flushed she does not have a fever and did not feel bad but different. Patient wanted to know if she can take over the counter pain medications. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: rash occurred, and she noticed a rash on the inside of her elbow/ her body, thighs, calves, hip/rashes on her body/rash all over her body; rash was now raised, itchy and sore, like patches; rash was now raised, itchy and sore, like patches; This is a spontaneous report from a Pfizer sponsored program   A contactable female consumer (patient) reported for herself. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EN6208, expiry date: 30Jun2021) via unknown route of administration on 13Mar2021 (at the age of 61-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 29Mar2021 after vaccination, rash occurred, and she noticed a rash on the inside of her elbow/ her body, thighs, calves, hip/rashes on her body/rash all over her body; and rash was raised, itchy and sore, like patches. It was reported at first, she did not think it was because of the vaccine. She was not sure if it was a side effect or if it was because of the body wash that she used. She called the other day to see if anyone else had reported a rash. Now the rash was all over her body. The rash was on her whole arms, thighs, legs, hips, and stomach. The rash had been spreading since Monday. The rash was raised, itchy and sore, like patches. She was due to have her second dose of the covid vaccine on 03Apr2021, Saturday. She did look at the CDC's website and saw listed a COVID 19 arm rash. It indicated that was no problem and she should get the second dose. She asked for advice on whether or not she should get the second dose of the covid vaccine. She stated she believes she filed a report previously, but she did not mean to. At the time of this report the outcome of the events were unknown.  No follow-up attempts were needed. No further information was expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Swollen lymph node in neck; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 22Mar2021 at 15:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos disease and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), metformin hydrochloride (METFORMIN XR) and magnesium (MANUFACTURER UNKNOWN) supplement; all for unknown indications from unknown dates and unknown if ongoing. On 31Mar2021 at 07:00, the patient experienced swollen lymph node in neck and sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node in neck and sore throat was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: "I" began experiencing pain in my left armpit; although it does list lymphadenopathy in the possible effects; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 30Mar2021 at 11:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and metformin hydrochloride (MANUFACTURER UNKNOWN); all from unknown date and for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Mar2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 31Mar2021 at 13:00, the patient experienced pain in the left armpit, and although it does list lymphadenopathy in the possible effects, it felt, that the patient needed to report it as it is happening as a result of receiving the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, pain in left armpit, and although it does list lymphadenopathy in the possible effects  was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Somnolence
Clinical narrative: fatigue; cough; sleeping around the clock; Headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (Lot number was not reported) dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know the timing of dose two. The patient will go for a Sars-COV-2 Test. The patient was experiencing fatigue and cough on an unknown date. The patient stated that it seems like a horrible thing to go through to get a vaccine (as reported). The patient was having a hard time, was sleeping around the clock and has a headache on an unknown date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain, Wrong technique in product usage process
Clinical narrative: It appeared to be too quick. They squeezed my arm/the shot appeared that they did it much too quickly and they pushed the plunger in very fast. It felt like it was in there only a second; shoulder pain a little bit/Sore shoulder; I had a sore arm; little soreness where the needle went in; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9262, expiration date was not reported) via an unspecified route of administration, in left arm, on 28Jan2021 08:00 (at the age of 72-years-old), at dose 1, single for covid-19 immunization from school/student health clinic. The patient had no medical history. There were no concomitant medications. Historical vaccine included flu shots (INFLUENZA VACCINE), shingles vaccines (VARICELLA ZOSTER VACCINE), Pneumonia shot (PNEUMOCOCCAL VACCINE) and never had any events. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. No additional vaccines administered on the same date of vaccination. On 28Jan2021, the patient experienced shoulder pain a little bit/sore shoulder, had a sore arm, little soreness where the needle went in and the patient concern is that when he got the first vaccine the individual who injected the shot appeared that they did it much too quickly and they pushed the plunger in very fast; felt like it was in there only a second/ felt like it was not administered correctly. No treatment was received for the events. The patient underwent lab tests and procedures which included: tested 6 times for covid and always negative on 3 days prior to first vaccine (25Jan2021) and 3 days prior to second shot (15Feb2021) and took it again on an unspecified date. The patient received the second dose of vaccine (Lot number EN6200) in the left upper arm on 28Jan2021 and had a sore arm and shoulder pain a little bit. The outcome of the events shoulder pain and sore arm was recovered on 28Jan2021 and outcome of other events other events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366630 same reporter/drug & different patient/events
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 31Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced metallic mouth. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event metallic mouth was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 24Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included implantable defibrillator pacemaker replaced (15Mar2021). Concomitant medications were not reported. It was reported that the patient received the first dose of Pfizer vaccine on 24Feb2021, had her defibrillator pacemaker replaced on 15Mar2021 and developed post-surgical rash three days later (18Mar2021). The patient was supposed to receive the second dose on 24Mar2021. The reporter stated that the event was not related to the vaccine. The outcome of the event was not recovered with treatment received.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event of Rash is assessed as unrelated to vaccine, As the rash was seen after surgery and the narrative clearly explains to having post surgical rash.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Myalgia, Nausea
Clinical narrative: body aches; fever of 102; severe sinus pressure; a little nausea; joint pain; muscle pain; headaches; wheezing; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 51-year-old), as dose 2, single for COVID-19 immunisation. Medical history included ongoing asthma and ongoing lung disease. Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for lung disease (reported as Advair Discus 250). On an unspecified date, 14 hrs. after administration of vaccine, the patient experienced body aches, fever of 102, severe sinus pressure, and little nausea. It was reported that the patient was hurting and at one point of time he was wheezing so he had to take his rescue inhaler. The patient also experienced few aches and pains, joint pain, muscle pain and headaches. It was reported that, the patient knows that it was okay to take Tylenol after receiving the vaccine, but he would like to know if it was okay to take Motrin, Prednisone, Advair and nasal antihistamine that was prescribed by his allergist. The patient asked how soon after the shot he can take Advair. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on an unspecified date. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paranasal sinus discomfort, Pyrexia, Wheezing
Clinical narrative: body aches; fever of 102; severe sinus pressure; a little nausea; joint pain; muscle pain; headaches; wheezing; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 51-year-old), as dose 2, single for COVID-19 immunisation. Medical history included ongoing asthma and ongoing lung disease. Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for lung disease (reported as Advair Discus 250). On an unspecified date, 14 hrs. after administration of vaccine, the patient experienced body aches, fever of 102, severe sinus pressure, and little nausea. It was reported that the patient was hurting and at one point of time he was wheezing so he had to take his rescue inhaler. The patient also experienced few aches and pains, joint pain, muscle pain and headaches. It was reported that, the patient knows that it was okay to take Tylenol after receiving the vaccine, but he would like to know if it was okay to take Motrin, Prednisone, Advair and nasal antihistamine that was prescribed by his allergist. The patient asked how soon after the shot he can take Advair. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on an unspecified date. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abnormal faeces, Haematochezia, Hot flush, Hyperhidrosis
Clinical narrative: several passing of what appear to be blood and tissue; several passing of what appear to be blood and tissue; Extreme abdominal pain and cramping; hot flashes; sweating; nausea; ear ringing; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3302) via an unspecified route of administration in the right arm on 30Mar2021 at 12:15 (at 42-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa from an unknown date. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram hydrobromide (CELEXA), bupropion hydrochloride (WELLBUTRIN), alprazolam (XANAX), and zolpidem tartrate (AMBIEN), all from unknown dates for unknown indications. The patient experienced extreme abdominal pain and cramping about 2 hours after vaccination, followed by several passing of what appeared to be blood and tissue on 30Mar2021 at 14:30. The cramps were also accompanied by hot flashes, sweating, nausea, and ear ringing. The patient reported symptoms lasted 12 hours. No treatment was received for the events. The clinical outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: several passing of what appear to be blood and tissue; several passing of what appear to be blood and tissue; Extreme abdominal pain and cramping; hot flashes; sweating; nausea; ear ringing; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3302) via an unspecified route of administration in the right arm on 30Mar2021 at 12:15 (at 42-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa from an unknown date. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram hydrobromide (CELEXA), bupropion hydrochloride (WELLBUTRIN), alprazolam (XANAX), and zolpidem tartrate (AMBIEN), all from unknown dates for unknown indications. The patient experienced extreme abdominal pain and cramping about 2 hours after vaccination, followed by several passing of what appeared to be blood and tissue on 30Mar2021 at 14:30. The cramps were also accompanied by hot flashes, sweating, nausea, and ear ringing. The patient reported symptoms lasted 12 hours. No treatment was received for the events. The clinical outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Urticaria
Clinical narrative: hives; shingles; This is a spontaneous report from a contactable consumer (parent). A 28 (unit not reported) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE, solution for injection), via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives and shingles on an unspecified date in Jan2021. The course of the events was as follows: The patient took the vaccine in January. She has had hives every since. They had put her on steroids and that did not help. They told her she had shingles, but the reporter did not believe it was shingles. She has had hives since she got the first shot and then they gave her the second shot and that was when they thought it was shingles. The doctors did not know how to help her. They kept passing her off. No one was helping her. Her body was shutting down. She was not anaphylactic but can it turn anaphylactic. The patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE) on an unspecified date for COVID-19 immunisation. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over her body/ itchiness on her legs, feet and arms/ extreme itching on my feet and then it way up to my leg and little bit on her face; This is a spontaneous report from a contactable consumer (patient) from a Pfizer- sponsored program COVAX US Support. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left deltoid (shoulder) on 30Mar2021 (Lot Number: ER8733) (at the age of 57-years-old) as dose 1, single for covid-19 immunisation. Medical history included environmental and animal allergies, asthma and gastroesophageal reflux disease (GERD) from probably 2 and half years ago. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D) taken for an unspecified indication, start and stop date were not reported; salbutamol (PROVENTIL) taken for asthma, start and stop date were not reported. The patient stated that she got the first dose of the covid 19 vaccine a day before reporting on 30Mar2021 and that on 30Mar2021 two hours after the vaccine she experienced itching all over her body, extreme itchiness on her legs, feet and arms (also reported as extreme itching on feet and then it way up to leg). She said it stopped for a while, but it started again. The itching started again on the morning of reporting day, not last probably 2 hours or so and on morning it started on her arm and then also left for 2 hours. Patient stated it was not just an itch, where you can scratch and then goes away, its deep prickly kind of itch that just travels it's kind of weird and then about 2 hours probably from 8-10 and then around 6 this evening she started experiencing it again but now on all her limbs. This not just her leg it was her leg and her arm and little bit on her face. Patient wanted to know if she can take Benadryl or some kind of allergy medication that might help that itching. No lab tests were done. Patient stated that she made sure not to take anything before the vaccine. Patient asked could she expect the same reaction from the second dose. The second dose was scheduled on 20Apr2021. She knows that one cannot complete the series with moderna and that one takes the vaccine at your own risk, she wanted to know who was advised not to take the vaccine. The patient was experiencing the adverse events till the time of reporting, it was not as extreme as yesterday, but she still had it. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eye pain, Fatigue, Feeling abnormal
Clinical narrative: has a cold; She's never slept this much in her life; She just feels off; fever; lightheaded/dizzy; achy; chills; headache; tired and fatigued; eyes hurt; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Right on 27Mar2021 11:15 (at the age of 38-years-old) at dose 1, single for covid-19 immunization. Medical history was none. There were no concomitant medications. The last vaccine she had was the flu vaccine and she only received the flu vaccine because she was pregnant, that was years ago. The patient experienced chills, headache, tired and fatigued, lightheaded/dizzy, achy and eyes hurt on 27Mar2021. She had gone for running Saturday(27Mar2021). She thought maybe she was tired and achy from running. On Sunday morning, 28Mar2021 she felt a little better, so she went running and ran some errands. She had fever on 28Mar2021, had a cold on an unspecified date. She works in public schools and they look at her like she has the plague. She wanted to know if these side effects were rare. She still feels really tired at the time of report. She still has a headache, her eyes hurt. She went to bed at 7:00PM at night on 28Mar2021 and woke up for work next morning around 5:00AM on 29Mar2021. She still felt bad, so she called out of work, she went back to bed after calling out of work and slept until 8:00AM. She said that she has never slept this much in her life. She was reluctant about getting the Covid-19 vaccine to begin with and now she regrets getting it. She just feels off. The vaccine was not administered at Facility. The events not resulted in emergency room or Physician Office. Patient had no relevant tests. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events lightheaded/dizzy and fever was recovering, outcome of the events (She's never slept this much in her life, feels off) was unknown, outcome of rest of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Pain, Pyrexia, Sleep disorder
Clinical narrative: has a cold; She's never slept this much in her life; She just feels off; fever; lightheaded/dizzy; achy; chills; headache; tired and fatigued; eyes hurt; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Right on 27Mar2021 11:15 (at the age of 38-years-old) at dose 1, single for covid-19 immunization. Medical history was none. There were no concomitant medications. The last vaccine she had was the flu vaccine and she only received the flu vaccine because she was pregnant, that was years ago. The patient experienced chills, headache, tired and fatigued, lightheaded/dizzy, achy and eyes hurt on 27Mar2021. She had gone for running Saturday(27Mar2021). She thought maybe she was tired and achy from running. On Sunday morning, 28Mar2021 she felt a little better, so she went running and ran some errands. She had fever on 28Mar2021, had a cold on an unspecified date. She works in public schools and they look at her like she has the plague. She wanted to know if these side effects were rare. She still feels really tired at the time of report. She still has a headache, her eyes hurt. She went to bed at 7:00PM at night on 28Mar2021 and woke up for work next morning around 5:00AM on 29Mar2021. She still felt bad, so she called out of work, she went back to bed after calling out of work and slept until 8:00AM. She said that she has never slept this much in her life. She was reluctant about getting the Covid-19 vaccine to begin with and now she regrets getting it. She just feels off. The vaccine was not administered at Facility. The events not resulted in emergency room or Physician Office. Patient had no relevant tests. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events lightheaded/dizzy and fever was recovering, outcome of the events (She's never slept this much in her life, feels off) was unknown, outcome of rest of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Limb discomfort
Clinical narrative: developed like neck pain; muscle pain, my shoulders and my back; I developed like neck pain; muscle pain, my shoulders and my back; I developed like neck pain; muscle pain, my shoulders and my back; I developed like neck pain; muscle pain, my shoulders and my back; I developed like neck pain; muscle pain, my shoulders and my back; chills on and off not always but they come and go; Mild headache; some sort of discomfort behind my knee cap in both of my legs; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6199), via an unspecified route of administration on 07Mar2021 (at the age of 65-year-old), dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism, osteo arthritis knees, gastrooesophageal reflux disease (GERD), and osteoporosis. Concomitant medications included levothyroxine; famotidine; zolpidem; pantoprazole; colecalciferol (VITAMIN D3); magnesium. On an unspecified date in Mar2021 (Saturday), the patient developed like neck pain and muscle pain, her shoulders and her back and sometimes in her left leg which had not gone away. The patient felt like sometimes she was having this like pain on her shoulders, neck and down her neck, and back part of her back. The patient stated that this time it was better but in morning it was worse. The patient stated sometimes it was worse and sometimes it was better. The patient further stated she had chills on and off not always, but they come and go. The patient also had mild headache too. The patient had some sort of discomfort behind her knee cap in both of her legs. The patient had not taken any treatment for neck pain and all. The patient stated the events were persistent and they were not going away. The patient asked whether should wait or was it safe for her to have second shot of COVID-19 vaccine.  No follow-up attempts are possible; No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain in extremity
Clinical narrative: developed like neck pain; muscle pain, my shoulders and my back; I developed like neck pain; muscle pain, my shoulders and my back; I developed like neck pain; muscle pain, my shoulders and my back; I developed like neck pain; muscle pain, my shoulders and my back; I developed like neck pain; muscle pain, my shoulders and my back; chills on and off not always but they come and go; Mild headache; some sort of discomfort behind my knee cap in both of my legs; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6199), via an unspecified route of administration on 07Mar2021 (at the age of 65-year-old), dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism, osteo arthritis knees, gastrooesophageal reflux disease (GERD), and osteoporosis. Concomitant medications included levothyroxine; famotidine; zolpidem; pantoprazole; colecalciferol (VITAMIN D3); magnesium. On an unspecified date in Mar2021 (Saturday), the patient developed like neck pain and muscle pain, her shoulders and her back and sometimes in her left leg which had not gone away. The patient felt like sometimes she was having this like pain on her shoulders, neck and down her neck, and back part of her back. The patient stated that this time it was better but in morning it was worse. The patient stated sometimes it was worse and sometimes it was better. The patient further stated she had chills on and off not always, but they come and go. The patient also had mild headache too. The patient had some sort of discomfort behind her knee cap in both of her legs. The patient had not taken any treatment for neck pain and all. The patient stated the events were persistent and they were not going away. The patient asked whether should wait or was it safe for her to have second shot of COVID-19 vaccine.  No follow-up attempts are possible; No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pruritus
Clinical narrative: Nose bleed; nose was bloody after itching it; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER8733; Expiration Date: Jul2021), via an unspecified route of administration, in Left Arm, on 28Mar2021 at 14:15 (at the age of 33-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included diabetes mellitus from 1989 and ongoing. Concomitant medication included insulin lispro (HUMALOG) taken for diabetes mellitus from 2005 and ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  On 29Mar2021 at 11:30, The patient experienced nosebleed, nose was bloody after itching it. It was not dripping blood, but it was inside her nostril. The nosebleed was not treated.   The outcome of the events was recovered in 29Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on my right breast; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, in the right arm on 26Mar2021 at 13:00 (at the age of 63-years-old) as dose 1, single for covid-19 immunisation. Medical history included she had radiation for cancer (neoplasm malignant) a year ago in the right breast. Lymp nodes removed. Prior to vaccination patient was not diagnosed with covid-19. since the vaccination the patient had not been tested for COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 28Mar2021 at 04:00, the patient experienced rash on my right breast. The patient did not receive any treatment for the event. Outcome of the event was recovering.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.