chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: The day after the vaccination, started out with tiredness; 3rd day I felt pressure on my chest; day 5 start having difficulty of breathing, day 7-10 difficulty off breathing with cough and phylum; day 5 start having difficulty of breathing, day 7-10 difficulty off breathing with cough and phylum; Day 10 my temperature is increased from 97.2 F to 99.5 F. Because of the difficulty of breathing, I feel lightheaded; Day 10 my temperature is increased from 97.2 F to 99.5 F. Because of the difficulty of breathing, I feel lightheaded; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Ep7533), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:00 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), amoxicillin and allergy pills taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). The patient was not pregnant at the time of vaccination. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient reported that, the day after the vaccination, started out with tiredness (07Apr2021 14:00) and the 3rd day she felt pressure on her chest (Apr2021), day 5 started had difficulty of breathing (Apr2021), day 7-10 difficulty off breathing with cough and phylum (Apr2021). Day 10 her temperature was increased from 97.2 F to 99.5F (Apr2021). Because of the difficulty of breathing, she felt lightheaded when she moves around (Apr2021). Taken Mucinex and inhaler to manage her symptoms. There was no treatment for the events tiredness, body temperature increased and lightheadedness. The patient underwent lab tests and procedures which included temperature: 97.2 to 99.5 fahrenheit (increased from 97.2 F to 99.5F) on Apr2021. Therapeutic measures (mucinex and inhaler) were taken as a result of events chest pressure, breathing difficult and productive cough. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Productive cough
Clinical narrative: The day after the vaccination, started out with tiredness; 3rd day I felt pressure on my chest; day 5 start having difficulty of breathing, day 7-10 difficulty off breathing with cough and phylum; day 5 start having difficulty of breathing, day 7-10 difficulty off breathing with cough and phylum; Day 10 my temperature is increased from 97.2 F to 99.5 F. Because of the difficulty of breathing, I feel lightheaded; Day 10 my temperature is increased from 97.2 F to 99.5 F. Because of the difficulty of breathing, I feel lightheaded; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Ep7533), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:00 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), amoxicillin and allergy pills taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). The patient was not pregnant at the time of vaccination. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient reported that, the day after the vaccination, started out with tiredness (07Apr2021 14:00) and the 3rd day she felt pressure on her chest (Apr2021), day 5 started had difficulty of breathing (Apr2021), day 7-10 difficulty off breathing with cough and phylum (Apr2021). Day 10 her temperature was increased from 97.2 F to 99.5F (Apr2021). Because of the difficulty of breathing, she felt lightheaded when she moves around (Apr2021). Taken Mucinex and inhaler to manage her symptoms. There was no treatment for the events tiredness, body temperature increased and lightheadedness. The patient underwent lab tests and procedures which included temperature: 97.2 to 99.5 fahrenheit (increased from 97.2 F to 99.5F) on Apr2021. Therapeutic measures (mucinex and inhaler) were taken as a result of events chest pressure, breathing difficult and productive cough. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: random sharp pain in left temple only lasting 30-60 seconds; Ice pick migraines; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 14Apr2021 at 12:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation.The patient did not have any relevant medical history, never had migraines before either. The patient had no allergies to medications, food or other products. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 19:00, the patient felt random sharp pain in his left temple which only lasted for 30-60 seconds. The patient never had migraines before and he believed it was commonly referred as ice pick migraines. They have been reoccurring regularly since the day the patient was vaccinated. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event random sharp pain in left temple and ice pick migraines was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 34-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0169), via an unspecified route of administration, left arm, on Apr 15, 2021, at 13:15, single dose, for COVID-19 immunisation. The patient did not report any other health issue. The patient has no allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8733), via an unspecified route of administration, left arm, on Mar 25, 2021, at 16:45, single dose, for COVID-19 immunisation. On Apr 16, 2021, patient experienced fever, chills, body aches and headache. 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, patient has not tested for COVID-19. The outcome of fever, chills, body aches and headache resolved on an unspecified date in Apr 2021. No follow-up attempts possible. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and painful lymph; Very swollen and painful lymph in the armpit; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 15Apr2021 at 15:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included Meniere's disease and seasonal allergy.  The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (ADVIL) from an unknown date and unknown if ongoing for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 15:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 16:00, the patient reported that she had very swollen and painful lymph in the armpit on the same arm as the second injection. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events very swollen and painful lymph in the armpit was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Malaise, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 33-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0162), at the age of 33, via an unspecified route of administration, left arm, on Apr 15, 2021, at 14:30, single dose, for COVID-19 immunisation. Medical history included COVID-19 on an unknown date in 2020 (four months prior to vaccination). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, patient has not tested for COVID-19. Concomitant medications included Wellbutrin 150mg (bupropion hydrochloride) for an unknown indication, from an unknown date and unknown if ongoing. On Apr 16, 2021, at 10:00, patient experienced swollen lymph node under left armpit, chills, feeling unwell (10-36 hours after injection) and sore arm. The outcome of the swollen lymph node under left armpit, chills, feeling unwell and sore arm: recovering (at the time of this report). No follow-up attempts needed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Feeling hot, SARS-CoV-2 test, Tinnitus
Clinical narrative: Ear ringing; Right ear pain; Ear fullness; Warmth; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the 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 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 16Mar2021, the patient underwent SARS-COV-2 test through nasal swab and the result was negative. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 00:00, one week after first dose of vaccination, the patient experienced ear ringing which began in right ear followed by pain, fullness and warmth which was ongoing at the time of report. The patient had to consulted with primary care doctor. The patient's ear was clean but pain and ringing seemed to be worsening as days went by. Therapeutic measures were taken as a result of the events which included treatment with unknown ear drops. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events ear ringing, right ear pain, ear fullness and warmth were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Sharp pain in the hip/joint area.; Walk with a limp; This is a spontaneous report from a contactable consumer, the patient. A 55-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 left arm on 16Apr2021 (at the age of 55-year-old) as a single dose for COVID-19immunisation. The patient had no relevant medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021 (at the age of 54-year-old) as a single dose for COVID-19immunisation. On 17Apr2021 the patient experienced sharp pain in the hip/joint area and was not able to put pressure on the left leg due to pain. On the same day, the patient was walking with a limp and was trying to give it 24/48 hours before seeing a doctor. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sharp pain in the hip/joint area and walk with a limp was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: smelling mild cigarette smoke smell; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of an unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the left arm on 01Mar2021 at 12:15 as a single dose for COVID-19 immunisation. Medical history included GERD and sulfonamide allergy (Sulfa drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received other medications within two weeks of vaccination, names were unspecified.  On 12Apr2021, the patient experienced smelling mild cigarette smoke smell. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event smelling mild cigarette smoke smell was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swollen under armpit; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Apr2021 at 17:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medication, food or other products. The patient did not receive any medication within two weeks of vaccination. 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. On 04Apr2021 at 17:00, the patient experienced swollen under armpit. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen under armpit was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Twitching started in upper arm and move to legs and finally settled in the feet. Twitching continued for 4 weeks; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergies to penicillin, erythromycin, levofloxacin, bactrim and milk. Concomitant medications included calcium (MANUFACTURER UNKNOWN) and loratadine, pseudoephedrine sulfate (CLARITIN-D) for unknown indication, from unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. On 18Mar2021, the patient reported that she had twitching, started in upper arm and move to legs and finally settled in the feet, twitching continued for 4 weeks. Almost gone before 2nd vaccine. On an unknown date within 4 hours of second dose of vaccination twitching started, this time only below the knee and in the feet. Constant twitching even when feet was elevated. The feet was not numb. No therapeutic measures were taken as a result of reported events. The event resulted in doctor or other healthcare professional office or clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event twitching started in upper arm and move to legs and finally settled in the feet, twitching continued for 4 weeks, Second vaccine was given and twitching started within 4 hours of vaccine was not recovered at the time of this report.  No follow-up attempts are needed; information about lot or batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Had headache and fever, into the second day post vaccine.; Some arm soreness, dissipated after less than 48 hours; Headache a few hours after receiving first dose; Headache a few hours after receiving first dose, alongwith lethargy.; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 15Apr2021 at 15:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine (ADZENYS XR ODT), biotin (MANUFACTURER UNKNOWN) and citalopram (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and sulfamethoxazole; trimethoprim (BACTRIM DS)  for unknown indications on an unknown date and experienced drug 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 vaccination. On 15Apr2021 at 18:30, the patient experienced some arm soreness, dissipated after less than 48 hours. The patient had headache a few hours after receiving the first dose, along with lethargy. The patient felt fine until around 4 p.m. The day after into the second day post vaccine on 16Apr2021, the patient had headache and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 event arm soreness, headache a few hours after receiving the first dose, along with lethargy and fever was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Sudden chills and fatigue; Sudden chills and fatigue; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0158) via an unspecified route of administration on 10Apr2021 at 09:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination. The patient's concomitant medications included tetanus vaccine(MANUFACTURER UNKNOWN), levothyroxine sodium (UNITHROID), bupropion hydrochloride (WELLBUTRIN) and duloxetine hydrochloride (CYMBALTA), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7543) via an unspecified route of administration on 20Mar2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. On 11Apr2021, the patient experienced sudden chills and fatigue which were not constant, the patient would get chills and be tired. The patient was concerned because the events was continued past 1 week mark. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department/urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sudden chills and fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site swelling
Clinical narrative: Developed a rash; Swelling of left arm around the vaccine injection site; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 09:45 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. The 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. The patient did not receive any concomitant medications. On 16Apr2021 at 22:00, 11 days after the vaccination, the patient developed a rash on COVID vaccine arm and swelling of left arm around the vaccine injection site. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with diphenhydramine (BENADRYL PLUS) oral and local steroid (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events developed rash and swelling of left arm around the vaccine injection site were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Vaccination site rash
Clinical narrative: A large itchy rash below the injection site. There is some pain associated with it.; A large itchy rash below the injection site. There is some pain associated with it.; A large itchy rash below the injection site. There is some pain associated with it.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 15Apr2021 at 15:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. The patient had taken other medications (unspecified) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 12:00, the patient experienced a large itchy rash below the injection site. There was some pain associated with it. Therapeutic measures were not taken as a result of the events. The events did not result  in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event a large itchy rash below the injection site; there was some pain associated with it was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Headache, Herpes zoster, Sensitive skin
Clinical narrative: Blisters; Developed shingles around the L1/L2 dermatome on the left side.; extra sensitive skin in the area; strong headache.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the  right arm on 05Apr2021 at 08:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes and celiac disease. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 15Mar2021 at 08:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included insulin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 07:30, the patient experienced shingles (herpes zoster) developed around the L1/L2 dermatome on the left side, prodromal phase started 5 days after vaccine with extra sensitive skin in the area and a strong headache. On 15Apr2021, after 10 days of shot, the patient experienced blisters. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with antiviral - valacyclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of developed shingles around the the L1/L2 dermatome on the left side, extra sensitive skin in the area, strong headache and blisters was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Cough, Nausea, Pain in extremity
Clinical narrative: Stomach cramps; Hurts to cough; Arm feels like it got a tetanus shot; Nauseous (threw up); Fever; Chills; This is a spontaneous report from a contactable other healthcare professional, the patient. A 26-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 left arm on 16Apr2021 at 08:15 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known  allergies to medications, food or other products. Concomitant medications included biotin (MANUFACTURER UNKNOWN), delta8 th (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date 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 right arm on 26Mar2021 at 17:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the first vaccination, the patient had been tested for COVID-19.On 11Apr2021, the patient underwent Rite Aide test (nasal swab) and the result was negative. On 17Apr2021 at 01:30, the patient experienced nauseous (threw up), fever, chills, stomach cramps, hurts to cough and arm feels like it got a tetanus shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cough, hurts to cough, stomach cramps, arm feels like it got a tetanus shot, event nauseous (threw up), fever and chills were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Stomach cramps; Hurts to cough; Arm feels like it got a tetanus shot; Nauseous (threw up); Fever; Chills; This is a spontaneous report from a contactable other healthcare professional, the patient. A 26-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 left arm on 16Apr2021 at 08:15 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known  allergies to medications, food or other products. Concomitant medications included biotin (MANUFACTURER UNKNOWN), delta8 th (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date 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 right arm on 26Mar2021 at 17:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the first vaccination, the patient had been tested for COVID-19.On 11Apr2021, the patient underwent Rite Aide test (nasal swab) and the result was negative. On 17Apr2021 at 01:30, the patient experienced nauseous (threw up), fever, chills, stomach cramps, hurts to cough and arm feels like it got a tetanus shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events cough, hurts to cough, stomach cramps, arm feels like it got a tetanus shot, event nauseous (threw up), fever and chills were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Fever 101.4; Tired; Headache; This is a spontaneous report from a contactable consumer, the patient. A 59-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 right arm on 16Apr2021 at 02:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and cholesterol high. Patient had no known allergies. 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-19 vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 17Apr2021 at 09:00, the patient experienced fever 101.4, tired, headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 17Apr2021, the patient underwent Body temperature and the result was 101.4 (UNSPECIFIED UNITS). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 101.4, tired, headache was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Arm pain at injection site about 2 1/2 to 3 hrs after receiving vaccine; Slight body aches; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 11:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included lupus, DVT (deep vein thrombosis), antiphospholipid syndrome and migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included warfarin (MANUFACTURER UNKNOWN) and levothyroxine sodium (SYNTHROID); both for unspecified indications from unknown dates and unknown if ongoing. The patient previously took sulfur and povidone-iodine (BETADINE) and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 17Apr2021 at 15:00, the patient experienced arm pain at injection site about two and half hours to three hours after she received the vaccine; the patient also experienced slight body aches. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and 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 arm pain at injection site and slight body aches was resolving 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.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Rash
Clinical narrative: Rash covering left abdomen from belt line to chest; Minor nausea; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 16Apr2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic fatigue, chronic pain, clinical depression, memory loss. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously took sumatriptan (IMITREX) from an unknown date for an unspecified indication and experienced drug allergy. On 17Apr2021, the patient experienced rash covering left abdomen from belt line to chest, minor nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events rash covering left abdomen from belt line to chest, minor nausea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm right on 15Apr2021 at 09:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) 25mg and potassium (MANUFACTURER UNKNOWN) 30 mg from an unknown date and for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the arm right on 25Mar2021 at 10:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021 at 05:00, the patient experienced swollen lymph nodes in arm pit. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in arm pit was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: Lymph nodes were swollen; This is a spontaneous report from a contactable consumer, the patient. A 60-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 left arm on 08Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included Sjogren's disease. The patient had a known allergy to sulfa (sulfonamide). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates 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 on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Apr2021, the patient reported that she went for a diagnostic mammogram and ultrasound screening 5 days following the second shot and was informed that her lymph nodes were swollen, likely due to the vaccine. The events did not result in doctor or other health care professional office/clinic visit, and 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 event lymph nodes swollen was unknown 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dehydration, Feeling abnormal, Feeling of body temperature change
Clinical narrative: chills; hot/cold; sweating; stomach cramping; vomiting; dehydrated; tachycardic; hypotensive; felt like passing out; This is a spontaneous report from a contactable other hcp. A 38-years-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0164), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:30 AM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Depression, in remission from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride (ZOLOFT), cetirizine (CETIRIZINE), buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) all SID taken for an unspecified indication, start and stop date were not reported. The patient previously took abilify and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 07:00 AM patient began having acute chills, hot/cold, sweating but what was unbearable was the stomach cramping and vomiting. I became so dehydrated because I couldn't hold any water down. Was tachycardic and hypotensive and felt like passing out. The patient received treatment with IV fluid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Tachycardia, Vomiting
Clinical narrative: chills; hot/cold; sweating; stomach cramping; vomiting; dehydrated; tachycardic; hypotensive; felt like passing out; This is a spontaneous report from a contactable other hcp. A 38-years-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0164), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:30 AM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Depression, in remission from an unknown date and unknown if ongoing. Concomitant medications included sertraline hydrochloride (ZOLOFT), cetirizine (CETIRIZINE), buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) all SID taken for an unspecified indication, start and stop date were not reported. The patient previously took abilify and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 07:00 AM patient began having acute chills, hot/cold, sweating but what was unbearable was the stomach cramping and vomiting. I became so dehydrated because I couldn't hold any water down. Was tachycardic and hypotensive and felt like passing out. The patient received treatment with IV fluid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles (never had it before).; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER 8727) via an unspecified route of administration in the left arm on 22Mar2021 at 15:15 (at the age of 49-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC) started from an unknown date for unspecified indication and unknown if ongoing. The patient previously took amoxicillin, clavulanic acid (AUGMENTIN) for unknown indication on unknown date and experienced drug allergy. On 10Apr2021, the patient experienced shingles which he never had before. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of shingles and included treatment with VALTREX. The clinical outcome of the event shingles was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: 100.0 Fever; sore throat; tired; achy; This is a spontaneous report from a contactable consumer, the parent. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0619412121) via an unspecified route of administration in the right arm on 16Apr2021 at 13:15 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, the patient experienced 100.0 fever, sore throat, tired and achy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 100.0 fever, sore throat, tired and achy was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.