chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Tongue began to swell; Back of throat started to swell; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration, administered in left arm on 22Mar2021 (at the age of 63-years-old) as first dose, single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included cetirizine hydrochloride (CETIRIZINE HYDROCHLORIDE) 10 mg once daily taking zyrtec 10 years ago when it first came out. Patient reported other allergies as hay fever, pets, that kind of thing and allergies since patient was born. Reported that patient never had a reaction to a vaccine, flu shot, or any other medicine in the past. It was reported that, on monday, 22Mar2021, patient had the first injection of the Pfizer COVID-19 vaccine. At the vaccination facility wait 15 minutes after the injection and experienced no side effects at that point. The swelling in patient tongue started to subside before the swelling in the back of throat. While patient was driving home about half an hour afterwards, patient tongue and the back of throat started to swell. Patient was able to breathe the whole time during the period when tongue and throat were swollen, so patient did not seek medical attention. Patient took Benadryl when got home on 22Mar2021 and took 2 more Benadryl later that day. (Benadryl: 25 mg capsules; Store brand; Bottle size: 100 capsules; Lot number: P110123; Expiry date: Apr2021). Patient did not visit to emergency room or physician office. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered on 23Mar2021.  Patient had a question for an agent, that the CDC recommends from the reaction patient had following the first dose of the Pfizer COVID-19 vaccine that patient should not get the second vaccine. Patient reported that, doesn't know if that's true or not, that other websites have said that the vaccine mega site will have Benadryl shots and Epi-Pens and she should proceed with getting the second dose of the COVID-19 vaccine. Patient doesn't know what should do as patient was concerned that with the second dose of the COVID-19 vaccine patient may have a stronger reaction that results in throat closing. Description of product complaint: PC is not related to the populated suspect product. Patient reported that she took one store brand Benadryl capsule after she experienced throat and tongue swelling following the first dose of COVID-19 vaccine. Took two capsules later, swelling was gone the next morning. Product strength and count size dispensed: 25 mg capsules; 100 count bottles  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Left forearm between the elbow and wrist swelled and some of hand is swollen; Left forearm between the elbow and wrist swelled and some of hand is swollen; swelling looks bigger when her sister gets up in the morning; received the shot in the upper arm close to the shoulder; This is a spontaneous report from a contactable consumer. A 93-years-old female patient (reporter sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left upper arm on 10Mar2021 as single dose for covid-19 immunisation. The patient medical history included chronic obstructive pulmonary disease from Jun2016 and cardiac disorder from 1998. The reporter stated the patient was (her sister) and was doing good with the heart problems. She was going to the heart doctor and will see the doctor in about 2 weeks. She stated her sister heart was doing good. The patient concomitant medications were not reported. On 10Mar2021, the patient received the shot in the upper arm close to the shoulder. On 17Mar2021 (reported as the next week), the patients left forearm between the elbow and wrist swelled and some of hand was swollen, swelling looks bigger when her sister gets up in the morning. It was been swollen for 11 weeks. The hand was not as big as the arm was. The swelling lightly in the hand. The patient took the vaccine because they thought they were supposed to get it and were told to get it. The reporter stated her sister has been to urgent care and talked to her regular doctor. Urgent care gave the patient a round of Prednisone 5 mg and it did not help. The reporters doctor gave her another round of methylprednisolone (MEDROL) 4mg. It helped some but she was still swollen. The patient has an appointment with (withheld) next week. And she will show him her arm. She was going for a follow-up. The doctor has already seen the swelling before, and they did not think nothing about it. The reporter did not think that patient medical history had anything to do with the adverse events. The package was not available to be returned and was throwed away. The package was sealed and intact. On 31Mar2021, the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613; Expiration Date: 31Jul2021), via an unspecified route of administration, administered unknown anatomical location as 2ND DOSE, SINGLE DOSE for covid-19 immunisation and had no problems with that shot. Patient received the treatment as Prednisone, methylprednisolone. At the time of reporting, the outcome of the events was not recovered. There was product quality complaint (PQC) present.  Follow up attempts needed. Further information is expected.  Follow-up (09Jun2021) Amendment: This follow-up report is being submitted to amend previously reported information (To delete classification).
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: Left forearm between the elbow and wrist swelled and some of hand is swollen; Left forearm between the elbow and wrist swelled and some of hand is swollen; swelling looks bigger when her sister gets up in the morning; received the shot in the upper arm close to the shoulder; This is a spontaneous report from a contactable consumer. A 93-years-old female patient (reporter sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 Expiration Date: 30Jun2021), via an unspecified route of administration, administered in left upper arm on 10Mar2021 as single dose for covid-19 immunisation. The patient medical history included chronic obstructive pulmonary disease from Jun2016 and cardiac disorder from 1998. The reporter stated the patient was (her sister) and was doing good with the heart problems. She was going to the heart doctor and will see the doctor in about 2 weeks. She stated her sister heart was doing good. The patient concomitant medications were not reported. On 10Mar2021, the patient received the shot in the upper arm close to the shoulder. On 17Mar2021 (reported as the next week), the patients left forearm between the elbow and wrist swelled and some of hand was swollen, swelling looks bigger when her sister gets up in the morning. It was been swollen for 11 weeks. The hand was not as big as the arm was. The swelling lightly in the hand. The patient took the vaccine because they thought they were supposed to get it and were told to get it. The reporter stated her sister has been to urgent care and talked to her regular doctor. Urgent care gave the patient a round of Prednisone 5 mg and it did not help. The reporters doctor gave her another round of methylprednisolone (MEDROL) 4mg. It helped some but she was still swollen. The patient has an appointment with (withheld) next week. And she will show him her arm. She was going for a follow-up. The doctor has already seen the swelling before, and they did not think nothing about it. The reporter did not think that patient medical history had anything to do with the adverse events. The package was not available to be returned and was throwed away. The package was sealed and intact. On 31Mar2021, the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613; Expiration Date: 31Jul2021), via an unspecified route of administration, administered unknown anatomical location as 2ND DOSE, SINGLE DOSE for covid-19 immunisation and had no problems with that shot. Patient received the treatment as Prednisone, methylprednisolone. At the time of reporting, the outcome of the events was not recovered. There was product quality complaint (PQC) present.  Follow up attempts needed. Further information is expected.  Follow-up (09Jun2021) Amendment: This follow-up report is being submitted to amend previously reported information (To delete classification).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Herpes virus infection
Clinical narrative: herpes, in her vagina and it burns when she uses bathroom; it burns when she uses bathroom; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number: and expiry date was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 Immunisation. Medical history included as child had chicken pox then when older had shingles. After 2nd dose of Covid vaccine, on an unspecified date patient experienced with woke up of herpes in her vagina and it burns when she uses bathroom. It was reported that HCP's have never heard of this side effect from a vaccine. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Genital herpes
Clinical narrative: herpes, in her vagina and it burns when she uses bathroom; it burns when she uses bathroom; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, (Lot Number: and expiry date was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 Immunisation. Medical history included as child had chicken pox then when older had shingles. After 2nd dose of Covid vaccine, on an unspecified date patient experienced with woke up of herpes in her vagina and it burns when she uses bathroom. It was reported that HCP's have never heard of this side effect from a vaccine. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: On 04/01/21 patient presented to Emergency Department with altered mental status and fever.  Husband stated that at baseline patient has no dementia and speaks and interacts normally.  He stated they had their Covid vaccine on 03/31/21 in the morning (location of vaccine administration was not specified).   He said beginning 04/01 in the morning she was not acting like normal self.  She was not speaking as much as she normally does.  He stated she did fall on 03/31, but does not believe she struck her head.  He said her behavior was normal yesterday.  She does not walk since a seizure 3 months ago.  No shortness of breath or cough was reported.  He stated her chest seemed red earlier but that has resolved.  The patient was unable to give history and not responding to questions.   Patient was admitted to hospital to monitor closely. On 04/02 patient was back to baseline and was discharged from the hospital.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF culture negative, Cognitive disorder, Computerised tomogram head normal, Erythema, Fall
Clinical narrative: On 04/01/21 patient presented to Emergency Department with altered mental status and fever.  Husband stated that at baseline patient has no dementia and speaks and interacts normally.  He stated they had their Covid vaccine on 03/31/21 in the morning (location of vaccine administration was not specified).   He said beginning 04/01 in the morning she was not acting like normal self.  She was not speaking as much as she normally does.  He stated she did fall on 03/31, but does not believe she struck her head.  He said her behavior was normal yesterday.  She does not walk since a seizure 3 months ago.  No shortness of breath or cough was reported.  He stated her chest seemed red earlier but that has resolved.  The patient was unable to give history and not responding to questions.   Patient was admitted to hospital to monitor closely. On 04/02 patient was back to baseline and was discharged from the hospital.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Mental status changes, Pyrexia
Clinical narrative: On 04/01/21 patient presented to Emergency Department with altered mental status and fever.  Husband stated that at baseline patient has no dementia and speaks and interacts normally.  He stated they had their Covid vaccine on 03/31/21 in the morning (location of vaccine administration was not specified).   He said beginning 04/01 in the morning she was not acting like normal self.  She was not speaking as much as she normally does.  He stated she did fall on 03/31, but does not believe she struck her head.  He said her behavior was normal yesterday.  She does not walk since a seizure 3 months ago.  No shortness of breath or cough was reported.  He stated her chest seemed red earlier but that has resolved.  The patient was unable to give history and not responding to questions.   Patient was admitted to hospital to monitor closely. On 04/02 patient was back to baseline and was discharged from the hospital.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid one week after getting first vaccination; sinus issues; got what he thought was allergies; This is a spontaneous report from a contactable consumer. This male patient of an unspecified age reported for himself that he received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient tested positive for covid one week after getting first vaccination and sinus issues on an unspecified date. He got what he thought was allergies on Saturday, 20Mar2021. On Tuesday, his nose cleared up and he added that he did not really feel bad, but he wanted to be checked just to be sure. He added that he tested positive for Covid, approximately a week after he got his first vaccine. He was asking what to do about the second vaccination and whether he should receive the second vaccination. He stated that he was not severe so he was wondering if the first shot did do something or he was immune.  He wonders if the shot helped with his covid symptoms. He offered information regarding medical institute, and that they can not provide medical advice. He added that he does not mind getting the second vaccine and that he thinks it was interesting that he got Covid. He gave information to contact physician if for medical advice, and stated that he will do that. The patient also stated that can you riddle me this then, Saturday at noon he saw a guy who had the same symptoms with his sinuses also. He said see you later to the guy, and then two hours later had an allergy attack when he was out in the woods, so he figured it was just allergies, but his sinuses continued to have issues. He wanted to know if he could have contracted or have gotten the attack within two hours, like could he have contracted COVID from that other guy, within just two hours.  He clarifies that he means could he have developed covid in those two hours. He offered information for medical institute and transfer, but states that his phone was blowing up so he will have to call later. He declined to complete a report or additional information regarding the guy that he saw on Saturday, and state he will tell that guy to call directly.  Caller did not provide details whether the man he saw on Saturday had Covid or had received the vaccine. He added that he would like to go through the safety report for himself, but then stated that he had to go. He asked what the incubation time for Covid. He asked how many questions the report was, stated that he will contact his physician to follow up. He added he will go to the websites given for information and to report any events. He said he has to get running and will go online. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Sinus disorder
Clinical narrative: tested positive for Covid one week after getting first vaccination; sinus issues; got what he thought was allergies; This is a spontaneous report from a contactable consumer. This male patient of an unspecified age reported for himself that he received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient tested positive for covid one week after getting first vaccination and sinus issues on an unspecified date. He got what he thought was allergies on Saturday, 20Mar2021. On Tuesday, his nose cleared up and he added that he did not really feel bad, but he wanted to be checked just to be sure. He added that he tested positive for Covid, approximately a week after he got his first vaccine. He was asking what to do about the second vaccination and whether he should receive the second vaccination. He stated that he was not severe so he was wondering if the first shot did do something or he was immune.  He wonders if the shot helped with his covid symptoms. He offered information regarding medical institute, and that they can not provide medical advice. He added that he does not mind getting the second vaccine and that he thinks it was interesting that he got Covid. He gave information to contact physician if for medical advice, and stated that he will do that. The patient also stated that can you riddle me this then, Saturday at noon he saw a guy who had the same symptoms with his sinuses also. He said see you later to the guy, and then two hours later had an allergy attack when he was out in the woods, so he figured it was just allergies, but his sinuses continued to have issues. He wanted to know if he could have contracted or have gotten the attack within two hours, like could he have contracted COVID from that other guy, within just two hours.  He clarifies that he means could he have developed covid in those two hours. He offered information for medical institute and transfer, but states that his phone was blowing up so he will have to call later. He declined to complete a report or additional information regarding the guy that he saw on Saturday, and state he will tell that guy to call directly.  Caller did not provide details whether the man he saw on Saturday had Covid or had received the vaccine. He added that he would like to go through the safety report for himself, but then stated that he had to go. He asked what the incubation time for Covid. He asked how many questions the report was, stated that he will contact his physician to follow up. He added he will go to the websites given for information and to report any events. He said he has to get running and will go online. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm started aching, and it continued down my left side and down into both legs. Tylenol and  cold packs helped a little for about two months before clearing.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: Left arm started aching, and it continued down my left side and down into both legs. Tylenol and  cold packs helped a little for about two months before clearing.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 20Mar2021, 1 week later first shot, the patient experienced symptoms of COVID-19 and tested positive. 2 days later he got an antibody infusion. His doctor suggested to get the second shot 2 weeks after he feel 100 percent or close and stated that as per the CDC guidelines if he got the shot and the antibodies, he should wait 90 Days. The outcome of the event was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear discomfort, Feeling abnormal, Head discomfort, Migraine
Clinical narrative: Extreme Headache; Tinnitus; Vertigo; Dizziness morning after and worse the 3rd day after Vaccine; Vestibular Neuritis; Trigeminal Neuritis; extreme head pressure; nausea; vomiting; dysautonomia; Very scared; Feeling like total Neurologic Decline; Neuro Inflammation; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 at 12:00 (Batch/Lot Number: EN6208) as 1st dose, single for COVID-19 immunization. Medical history included Lumbar Sacral Disc disease, arachnoid cyst, non-ventricular shunt placement and asthmas. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lorazepam (received within 2 weeks of vaccination). On 17Mar2021 at 4:00 AM, the patient experienced extreme headache, tinnitus, vertigo, dizziness morning after and worse the 3rd day after vaccine,  severe headaches persisted, nonstop turning into vestibular neuritis, trigeminal neuritis, extreme head pressure, nausea, vomiting, dysautonomia, still having extreme symptoms 2.5 months out and counting, very scared, felt like total neurologic decline, neuro inflammation. Patient never experienced these symptoms in his life. The adverse event resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received steroids as treatment for anti-inflammatory. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (nasal swab test with negative result on 14Apr2021). Allergies were unknown. The outcome of events was not recovered.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ocular discomfort, Paraesthesia, Paranasal sinus discomfort, Tinnitus, Vertigo
Clinical narrative: Extreme Headache; Tinnitus; Vertigo; Dizziness morning after and worse the 3rd day after Vaccine; Vestibular Neuritis; Trigeminal Neuritis; extreme head pressure; nausea; vomiting; dysautonomia; Very scared; Feeling like total Neurologic Decline; Neuro Inflammation; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 at 12:00 (Batch/Lot Number: EN6208) as 1st dose, single for COVID-19 immunization. Medical history included Lumbar Sacral Disc disease, arachnoid cyst, non-ventricular shunt placement and asthmas. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lorazepam (received within 2 weeks of vaccination). On 17Mar2021 at 4:00 AM, the patient experienced extreme headache, tinnitus, vertigo, dizziness morning after and worse the 3rd day after vaccine,  severe headaches persisted, nonstop turning into vestibular neuritis, trigeminal neuritis, extreme head pressure, nausea, vomiting, dysautonomia, still having extreme symptoms 2.5 months out and counting, very scared, felt like total neurologic decline, neuro inflammation. Patient never experienced these symptoms in his life. The adverse event resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received steroids as treatment for anti-inflammatory. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (nasal swab test with negative result on 14Apr2021). Allergies were unknown. The outcome of events was not recovered.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autonomic nervous system imbalance, Dizziness, Head discomfort, Headache, Inflammation
Clinical narrative: Extreme Headache; Tinnitus; Vertigo; Dizziness morning after and worse the 3rd day after Vaccine; Vestibular Neuritis; Trigeminal Neuritis; extreme head pressure; nausea; vomiting; dysautonomia; Very scared; Feeling like total Neurologic Decline; Neuro Inflammation; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 at 12:00 (Batch/Lot Number: EN6208) as 1st dose, single for COVID-19 immunization. Medical history included Lumbar Sacral Disc disease, arachnoid cyst, non-ventricular shunt placement and asthmas. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lorazepam (received within 2 weeks of vaccination). On 17Mar2021 at 4:00 AM, the patient experienced extreme headache, tinnitus, vertigo, dizziness morning after and worse the 3rd day after vaccine,  severe headaches persisted, nonstop turning into vestibular neuritis, trigeminal neuritis, extreme head pressure, nausea, vomiting, dysautonomia, still having extreme symptoms 2.5 months out and counting, very scared, felt like total neurologic decline, neuro inflammation. Patient never experienced these symptoms in his life. The adverse event resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received steroids as treatment for anti-inflammatory. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (nasal swab test with negative result on 14Apr2021). Allergies were unknown. The outcome of events was not recovered.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Nervousness, Neuropathy peripheral, SARS-CoV-2 test, Tinnitus
Clinical narrative: Extreme Headache; Tinnitus; Vertigo; Dizziness morning after and worse the 3rd day after Vaccine; Vestibular Neuritis; Trigeminal Neuritis; extreme head pressure; nausea; vomiting; dysautonomia; Very scared; Feeling like total Neurologic Decline; Neuro Inflammation; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 at 12:00 (Batch/Lot Number: EN6208) as 1st dose, single for COVID-19 immunization. Medical history included Lumbar Sacral Disc disease, arachnoid cyst, non-ventricular shunt placement and asthmas. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lorazepam (received within 2 weeks of vaccination). On 17Mar2021 at 4:00 AM, the patient experienced extreme headache, tinnitus, vertigo, dizziness morning after and worse the 3rd day after vaccine,  severe headaches persisted, nonstop turning into vestibular neuritis, trigeminal neuritis, extreme head pressure, nausea, vomiting, dysautonomia, still having extreme symptoms 2.5 months out and counting, very scared, felt like total neurologic decline, neuro inflammation. Patient never experienced these symptoms in his life. The adverse event resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received steroids as treatment for anti-inflammatory. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (nasal swab test with negative result on 14Apr2021). Allergies were unknown. The outcome of events was not recovered.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Trigeminal neuritis, Vertigo, Vestibular neuronitis, Vomiting
Clinical narrative: Extreme Headache; Tinnitus; Vertigo; Dizziness morning after and worse the 3rd day after Vaccine; Vestibular Neuritis; Trigeminal Neuritis; extreme head pressure; nausea; vomiting; dysautonomia; Very scared; Feeling like total Neurologic Decline; Neuro Inflammation; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Mar2021 at 12:00 (Batch/Lot Number: EN6208) as 1st dose, single for COVID-19 immunization. Medical history included Lumbar Sacral Disc disease, arachnoid cyst, non-ventricular shunt placement and asthmas. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lorazepam (received within 2 weeks of vaccination). On 17Mar2021 at 4:00 AM, the patient experienced extreme headache, tinnitus, vertigo, dizziness morning after and worse the 3rd day after vaccine,  severe headaches persisted, nonstop turning into vestibular neuritis, trigeminal neuritis, extreme head pressure, nausea, vomiting, dysautonomia, still having extreme symptoms 2.5 months out and counting, very scared, felt like total neurologic decline, neuro inflammation. Patient never experienced these symptoms in his life. The adverse event resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received steroids as treatment for anti-inflammatory. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 (nasal swab test with negative result on 14Apr2021). Allergies were unknown. The outcome of events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: After a tick bite, had an allergic reaction consisting of eczema and psoriasis (biopsy).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Myalgia, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: After a tick bite, had an allergic reaction consisting of eczema and psoriasis (biopsy).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: After a tick bite, had an allergic reaction consisting of eczema and psoriasis (biopsy).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropod bite, Biopsy, Dermatitis allergic
Clinical narrative: After a tick bite, had an allergic reaction consisting of eczema and psoriasis (biopsy).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip disorder, Sensitive skin, Skin exfoliation, Stomatitis, Tongue disorder
Clinical narrative: SENSITIVE MOUTH; DIMINISHED TASTE; FOOD TASTED FUNNY HAD WEIRD TEXTURE; SKIN ON MOUTH FELT BURNT OR DEAD; PEELING OF SKIN ON MOUTH; SORE ARM; COVID TONGUE OR WHITE SPOTS ON TONGUE AND BACK OF TONGUE WAS ALSO WHITE; TOP OF TISSUE WAS DEAD OF MOUTH; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 205 kilograms, and height was 63 inches. The patient's past medical history included thyroid cancer, and thyroidectomy, and concurrent conditions included type 2 diabetic, and environmental allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced covid tongue or white spots on tongue and back of tongue was also white. On APR-2021, the subject experienced top of tissue was dead of mouth. On 10-APR-2021, the subject experienced peeling of skin on mouth. On 10-APR-2021, the subject experienced food tasted funny had weird texture. On 10-APR-2021, the subject experienced skin on mouth felt burnt or dead. On 10-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced sensitive mouth. On 11-APR-2021, the subject experienced diminished taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from peeling of skin on mouth on 06-MAY-2021, and sore arm on 11-APR-2021, had not recovered from sensitive mouth, diminished taste, and food tasted funny had weird texture, and the outcome of skin on mouth felt burnt or dead, covid tongue or white spots on tongue and back of tongue was also white and top of tissue was dead of mouth was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypogeusia, Oral discomfort, Oral mucosal exfoliation, Oral pain, Pain in extremity
Clinical narrative: SENSITIVE MOUTH; DIMINISHED TASTE; FOOD TASTED FUNNY HAD WEIRD TEXTURE; SKIN ON MOUTH FELT BURNT OR DEAD; PEELING OF SKIN ON MOUTH; SORE ARM; COVID TONGUE OR WHITE SPOTS ON TONGUE AND BACK OF TONGUE WAS ALSO WHITE; TOP OF TISSUE WAS DEAD OF MOUTH; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 205 kilograms, and height was 63 inches. The patient's past medical history included thyroid cancer, and thyroidectomy, and concurrent conditions included type 2 diabetic, and environmental allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced covid tongue or white spots on tongue and back of tongue was also white. On APR-2021, the subject experienced top of tissue was dead of mouth. On 10-APR-2021, the subject experienced peeling of skin on mouth. On 10-APR-2021, the subject experienced food tasted funny had weird texture. On 10-APR-2021, the subject experienced skin on mouth felt burnt or dead. On 10-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced sensitive mouth. On 11-APR-2021, the subject experienced diminished taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from peeling of skin on mouth on 06-MAY-2021, and sore arm on 11-APR-2021, had not recovered from sensitive mouth, diminished taste, and food tasted funny had weird texture, and the outcome of skin on mouth felt burnt or dead, covid tongue or white spots on tongue and back of tongue was also white and top of tissue was dead of mouth was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder, Tissue injury, Tongue disorder
Clinical narrative: SENSITIVE MOUTH; DIMINISHED TASTE; FOOD TASTED FUNNY HAD WEIRD TEXTURE; SKIN ON MOUTH FELT BURNT OR DEAD; PEELING OF SKIN ON MOUTH; SORE ARM; COVID TONGUE OR WHITE SPOTS ON TONGUE AND BACK OF TONGUE WAS ALSO WHITE; TOP OF TISSUE WAS DEAD OF MOUTH; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 205 kilograms, and height was 63 inches. The patient's past medical history included thyroid cancer, and thyroidectomy, and concurrent conditions included type 2 diabetic, and environmental allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced covid tongue or white spots on tongue and back of tongue was also white. On APR-2021, the subject experienced top of tissue was dead of mouth. On 10-APR-2021, the subject experienced peeling of skin on mouth. On 10-APR-2021, the subject experienced food tasted funny had weird texture. On 10-APR-2021, the subject experienced skin on mouth felt burnt or dead. On 10-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced sensitive mouth. On 11-APR-2021, the subject experienced diminished taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from peeling of skin on mouth on 06-MAY-2021, and sore arm on 11-APR-2021, had not recovered from sensitive mouth, diminished taste, and food tasted funny had weird texture, and the outcome of skin on mouth felt burnt or dead, covid tongue or white spots on tongue and back of tongue was also white and top of tissue was dead of mouth was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Hypersensitivity, Suffocation feeling
Clinical narrative: First shot - hives; This is a spontaneous report from a contactable Pharmacist (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 13:15 (Batch/Lot number was not reported) (at age of 53-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included COVID-19 prior to vaccination. known allergies: Prior to the vaccine: aspirin, ibuprofen, MIT/CIT/BIT. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took methylisothiazolinone. The patient experienced  hives on 02May2021 14:30 . The event result in Doctor or other healthcare professional office/clinic visit and  Emergency room/department or urgent care. Therapeutic measures were taken as a result of hives included: at hospital anti-histaminic and anti-inflammatory.The outcome was not resolved. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021645254 same reporter/patient/product, different dose/event.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Food allergy, Postmenopausal haemorrhage
Clinical narrative: First shot - hives; This is a spontaneous report from a contactable Pharmacist (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 13:15 (Batch/Lot number was not reported) (at age of 53-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included COVID-19 prior to vaccination. known allergies: Prior to the vaccine: aspirin, ibuprofen, MIT/CIT/BIT. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took methylisothiazolinone. The patient experienced  hives on 02May2021 14:30 . The event result in Doctor or other healthcare professional office/clinic visit and  Emergency room/department or urgent care. Therapeutic measures were taken as a result of hives included: at hospital anti-histaminic and anti-inflammatory.The outcome was not resolved. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021645254 same reporter/patient/product, different dose/event.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: First shot - hives; This is a spontaneous report from a contactable Pharmacist (patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02May2021 13:15 (Batch/Lot number was not reported) (at age of 53-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included COVID-19 prior to vaccination. known allergies: Prior to the vaccine: aspirin, ibuprofen, MIT/CIT/BIT. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took methylisothiazolinone. The patient experienced  hives on 02May2021 14:30 . The event result in Doctor or other healthcare professional office/clinic visit and  Emergency room/department or urgent care. Therapeutic measures were taken as a result of hives included: at hospital anti-histaminic and anti-inflammatory.The outcome was not resolved. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021645254 same reporter/patient/product, different dose/event.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Coma, Electrocardiogram
Clinical narrative: Heart stopped on 2/15, rushed to the emergency room. Hospitalized 42 days
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Catheterisation cardiac normal, Computerised tomogram normal, Electroencephalogram normal, Magnetic resonance imaging normal
Clinical narrative: Heart stopped on 2/15, rushed to the emergency room. Hospitalized 42 days
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Madarosis
Clinical narrative: Eyebrows fell out
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Madarosis
Clinical narrative: Eyebrows fell out
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypopnoea, Limb discomfort, Musculoskeletal stiffness, Paraesthesia, Unresponsive to stimuli
Clinical narrative: shortness of breath, lightheadedness, tongue swelling ,rash, convulsions, lost of conscience
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Rash, Seizure
Clinical narrative: shortness of breath, lightheadedness, tongue swelling ,rash, convulsions, lost of conscience
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: shortness of breath, lightheadedness, tongue swelling ,rash, convulsions, lost of conscience
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Fatigue, Nausea, Product administered to patient of inappropriate age, Swelling face
Clinical narrative: First of all My Daughter was given the COVID19(Moderna) Vaccination, I was not aware that this vaccine is for 18yrs and older. Secondly My Daughter developed a massive ball under her left armpit. This is the same arm used for the vaccine.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary mass, Product administered to patient of inappropriate age
Clinical narrative: First of all My Daughter was given the COVID19(Moderna) Vaccination, I was not aware that this vaccine is for 18yrs and older. Secondly My Daughter developed a massive ball under her left armpit. This is the same arm used for the vaccine.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Herpes zoster, Oral herpes, Physical examination
Clinical narrative: developed a small patch of painful blisters on my right hand, inner area of ring finger, went to the walk-in clinic and was diagnosed with shingles and given a prescription for generic Valtrex; i developed a cold sore on my lower lip on the left side; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration, administered in left arm on 23Apr2021 at 10:00 (at the age of 63-year-old) at a single dose for covid-19 immunization. The patient medical history included hypothyroidism and penicillin Allergy. The patient did not receive any other vaccine within 4 weeks prior to vaccination. Concomitant medication included levothyroxine, Estradiol, cefalexin (CEPHALEXINE) and ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Nine days after the vaccination on 02May2021, at 09:00 the patient developed a cold sore on her lower lip on the left side and fourteen days post vaccination on 07May2021 at 09:00 the patient experienced a small patch of painful blisters on her right hand, inner area of ring finger. On 09May2021, she went to the walk-in clinic/doctor or other healthcare professional office and was diagnosed with shingles and given a prescription for generic Valtrex. It was reported patient experienced adverse event on 23Apr2021 at 11:15 (pending for clarification). Patient COVID-19 booster is scheduled on 14May2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.