chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inflammation, Muscular weakness, Myalgia, Paraesthesia
Clinical narrative: inflammation; he experienced numbness and tingling from the groin to the glues after the first dose of the vaccine.; he experienced numbness and tingling from the groin to the glues after the first dose of the vaccine.; muscle weakness, aching; muscle weakness, aching; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA156507), via an unspecified route of administration in the left arm on 01Feb2021 at (at the age of 24-years-old) as a dose 1, single dose for COVID-19 immunisation. Medical history reported as none. The patient's concomitant medications were not reported. On 01Feb2021, the patient experienced the typical vaccine symptoms, muscle weakness and aching. On 02Feb2021, the patient fully recovered from muscle weakness and aching and on same day the patient experienced numbness and tingly-ness around the groin region, expanding to his inner thigh, along his leg, as well as glutes and he went to the doctor, the patient took Ibuprofen to take down the inflammation, and they were tried to pinpoint. The patient noticed tingliness, only on the left side where the vaccine was administered, in that arm. It had been significantly reduced, he still had some, not as intense as it was last week. Still had relative sensation, like a tingling like when foot falls asleep, not a complete loss of sensation, more that sort of tingling feeling. The patient had appointment for second dose on 23Feb2021. The clinical outcome of the events muscle weakness and aching was recovered for inflammation was unknown while recovering for rest events.  Follow-up attempts completed. No further information expected.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Headache, Paranasal sinus discomfort, Vaccination site pain
Clinical narrative: Injection site pain; headache; Left side earache; sinus pressure; This is a spontaneous report from a contactable consumer (reported for his father). A 94-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 (at the age of 94-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced injection site pain, headache, left side earache and sinus pressure. The clinical course was as follows: the reporter stated that the patient experienced a little soreness at the injection site which was normal and a little bit of a headache. Now, his father has a lot a of sinus pressure. reporter started out with an earache of his left side which is the side his injection was given in his arm. However, it has now moved to his right ear. The caller is asking if this is something his father should be concerned about. Have there been any reports of any earaches. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Paranoia
Clinical narrative: diarrhea; He was paranoid about getting the 2nd dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in Jan2021 as a Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reported worked in a daycare setting. One of the mom's was tested positive to COVID. The patient saw her for 5 sec maximum and both had a mask. On 06Feb2021 (Saturday), the patient had diarrhea on night but might have been due to something he ate. He was feeling a 100 percent great, no fatigue nothing like that. He was paranoid about getting the 2nd dose. He doesn't think he had COVID. The patient had the 1st Pfizer shot few weeks ago and was due for his 2nd dose next Monday. He wanted to know if he should he get the 2nd dose of vaccine. The outcome of events was unknown.  Information on the lot/batch number had been requested.  Follow-up attempts are completed. No further information was expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of lymph nodes; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration on 09Feb2021 (at the age of 80-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated that, she had a first shot of Pfizer vaccine this morning which went fine. Stated that, she was told they would receive invitation to line up another shot and she did. Stated that, she had a fact sheet that listed reactions and the last one was swelling of lymph nodes sometimes. Stated that, she has a CT scan on her neck lined up to check lymph nodes and wanted to know whether she needed to cancel. Wanted to know whether she can get some information on this and was it safe for her to get the COVID vaccine. Clarified that, it was for Pfizer COVID vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: headache; chills; diarrhea; Dizzy; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 79-year) on 04Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Feb2021 the patient experienced headache, chills, diarrhea, dizzy. It was reported that "caller received the Pfizer-BioNTech COVID-19 Vaccine first dose last Thursday and was wondering if it would be possible to experience headache, chills, and diarrhea after taking the vaccine & asking if this would also occur in the second dose. Stated that she got the shot on Thursday. Stated that on Saturday night that she got a headache, chills, dizzy and diarrhea." The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Anxiety
Clinical narrative: increased anxiety; Increased agitation; This is a spontaneous report from a contactable consumer or other non hcp (Patient) via medical information team. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9561, Expiry date: unknown) via an unspecified route of administration, administered in right arm on 04Feb2021 12:10 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included ongoing anxiety from a child, ongoing agitation; and also included hashimoto's disease and thalassaemia both from 20 years ago however thalassemia minor. The patient concomitant medications were not reported. There was no prior vaccinations within 4 weeks. Patient does not require a visit to physician or ER for any adverse event. Vaccine administered at military facility was no. On 04Feb2021, the patient experienced increased anxiety and increased agitation. Patient stated that she already had anxiety and agitation but it was worse now and she inquired that if anyone reported a reaction like that and can it be a side effect and whether it is permanent or temporary. Patient reported that she didn't have this feeling right after and it started suddenly around 6-7 hours after the vaccine and she was not the same as before but maybe it's a little better. Patient checked with her doctor regarding information on mental and psychological changes and he suggested as it may possible, but he did not know what are the possible side effects; most likely not; it can be temporary. Patient stated she was very nervous. Patient reported as she was scheduled for the second dose on 25Feb2021. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; fever; headache; This is a spontaneous report from a contactable consumer(patient) reported that. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), dose 2 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as DOSE 2 SINGLE for covid-19 immunization. The patient medical history was and concomitant medications were not reported. On an unspecified date the patient experienced chills, fever, and headache. Asking if can pass Sars-COV-2 to immunosuppressed roommate. The event outcome was Unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Illness, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: bad cold; chills; sore throat; Hot; Very sick like she was coming down with a cold; to bed and woke up about 3 hours later and felt fine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 03Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 09Feb2021 morning, 6 days after first dose of vaccine, the patient experienced bad cold; really bad chills; sore throat; hot; very sick like she was coming down with a cold; and went to bed and woke up about 3 hours later and she felt fine. Patient was feeling ok but was very careful at her work. Second dose was scheduled for 24Feb2021. The clinical outcome of all the events was resolved on unspecified dates in Feb2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: bad cold; chills; sore throat; Hot; Very sick like she was coming down with a cold; to bed and woke up about 3 hours later and felt fine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 03Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 09Feb2021 morning, 6 days after first dose of vaccine, the patient experienced bad cold; really bad chills; sore throat; hot; very sick like she was coming down with a cold; and went to bed and woke up about 3 hours later and she felt fine. Patient was feeling ok but was very careful at her work. Second dose was scheduled for 24Feb2021. The clinical outcome of all the events was resolved on unspecified dates in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Rash
Clinical narrative: Rash developed within 48 hrs of second dose; The rash is slightly itchy; Fever; Chills; Body aches; Headache; Pain in the arm the injection; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 07Feb2021 09:15 (at the age of 42-years-old) as single for COVID-19 immunization and was administered at Hospital. The patient's Other medical history was reported as no. The patient's concomitant medications included Ibuprofen taken for unspecified indication start date and stop date was not provided. (other medications in two weeks). The patient previously took amoxicillin, biaxin, cefzil flagyl [metronidazole benzoate] and Flourescene Dye and experienced drug allergy. No oher vaccine was given in four weeks. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL0142), via an unspecified route of administration, administered in Arm Left on 17Jan2021 10:45 (at the age of 42-years-old) as single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 09Feb2021 at 06:00 (48 hrs of second dose), the patient developed rash as she woken up with the rash. Rash stated on arms then spread to chest, legs and face. The rash was slightly itchy. Prior to development, other symptoms included: fever, chills, body aches, headache and pain in the arm the injection was received. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was unknown.    Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site pain
Clinical narrative: Rash developed within 48 hrs of second dose; The rash is slightly itchy; Fever; Chills; Body aches; Headache; Pain in the arm the injection; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 07Feb2021 09:15 (at the age of 42-years-old) as single for COVID-19 immunization and was administered at Hospital. The patient's Other medical history was reported as no. The patient's concomitant medications included Ibuprofen taken for unspecified indication start date and stop date was not provided. (other medications in two weeks). The patient previously took amoxicillin, biaxin, cefzil flagyl [metronidazole benzoate] and Flourescene Dye and experienced drug allergy. No oher vaccine was given in four weeks. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL0142), via an unspecified route of administration, administered in Arm Left on 17Jan2021 10:45 (at the age of 42-years-old) as single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 09Feb2021 at 06:00 (48 hrs of second dose), the patient developed rash as she woken up with the rash. Rash stated on arms then spread to chest, legs and face. The rash was slightly itchy. Prior to development, other symptoms included: fever, chills, body aches, headache and pain in the arm the injection was received. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was unknown.    Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity
Clinical narrative: Sore arm that she could had trouble lifting for about 24 hours; Diarrhea; Headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Feb2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing She takes Aimovig monthly to prevent migraines and she was due for her monthly injection the previous day. Concomitant medication(s) included erenumab aooe (AIMOVIG) taken for migraine, start and stop date were not reported.  The patient experienced sore arm that she could had trouble lifting for about 24 hours on Feb2021 with outcome of recovered , diarrhoea and headache on Feb2021 with outcome of unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Little chill; Sore arm; This is a spontaneous report from a contactable consumer (patient), from a Pfizer-sponsored program.  A female patient of an unspecified age (Age: 71 Units: Unknown, as reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history included allergy to penicillin. Concomitant medications were not reported. It was reported that, patient reports a little chill and sore arm, she fell asleep and woke up the next day feeling fine. Also, reports an allergy to penicillin. Patient would like to know whether antibiotics would diminish the effects of the dose of the covid vaccine, whether participants in the clinical trial for the covid vaccine were allowed to take antibiotics, whether people with an allergy to penicillin are able to take the covid vaccine. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Body temperature increased, Diarrhoea, Pain in extremity
Clinical narrative: A little soreness in our arms.; Had complained of his lower back hurting; Fever was 102.9; Husband woke up with diarrhea; Running a temperature.; Low grade fever/low temperature 100 or so; This is a spontaneous report received from a contactable consumer or patients wife. A 80-years-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as Dose 1,single for an unspecified indication .Medical history included road traffic accident from an unknown date and unknown if ongoing ,When patient was young he was injured in an automobile accident; and had to remove his spleen.The patient's concomitant medications were not reported.The patient experienced a little soreness in his arms on an unspecified date, husband woke up with diarrhea, running a temperature, low grade fever/low temperature 100 or so on Feb2021, had complained of his lower back hurting on an unspecified date, fever was 102.9 on Feb2021.The patient underwent lab tests and procedures which included body temperature: low temperature 100 or so on Feb2021,body temperature: fever was 102.9 on Feb2021 ,body temperature: 102.4 on Feb2021 last night that it was 102.9 and this morning it was 102.4. Therapeutic measures were taken as a result of running a temperature,low grade fever/low temperature 100 or so and fever was 102.9.The outcome of the events was unknown.The batch or lot number was not available because the Caller was unwilling to complete the report.The caller Wanted to know if one can get side effects after two weeks. Clarified that it was the right arm and it is for Pfizer Covid vaccine.The caller also reported that her husband was on blood thinner,So will it effect him.  Follow-up (09Feb2021): This is a follow-up spontaneous report received from a contactable consumer (patient's wife). This consumer (patient's wife) reported for a 80-year-old patient that her husband reported of his back hurting and dates for adverse events like right arm was a little sore,for Low grade fever,Diarrhea was unspecified.Ndc,expiry date and lot number was not provided by the caller.Reporter details: Email address was captured as provided.  Information about batch/lot number has been requested. Follow-up (07MAY2021): Follow-up attempts completed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: A little soreness in our arms.; Had complained of his lower back hurting; Fever was 102.9; Husband woke up with diarrhea; Running a temperature.; Low grade fever/low temperature 100 or so; This is a spontaneous report received from a contactable consumer or patients wife. A 80-years-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as Dose 1,single for an unspecified indication .Medical history included road traffic accident from an unknown date and unknown if ongoing ,When patient was young he was injured in an automobile accident; and had to remove his spleen.The patient's concomitant medications were not reported.The patient experienced a little soreness in his arms on an unspecified date, husband woke up with diarrhea, running a temperature, low grade fever/low temperature 100 or so on Feb2021, had complained of his lower back hurting on an unspecified date, fever was 102.9 on Feb2021.The patient underwent lab tests and procedures which included body temperature: low temperature 100 or so on Feb2021,body temperature: fever was 102.9 on Feb2021 ,body temperature: 102.4 on Feb2021 last night that it was 102.9 and this morning it was 102.4. Therapeutic measures were taken as a result of running a temperature,low grade fever/low temperature 100 or so and fever was 102.9.The outcome of the events was unknown.The batch or lot number was not available because the Caller was unwilling to complete the report.The caller Wanted to know if one can get side effects after two weeks. Clarified that it was the right arm and it is for Pfizer Covid vaccine.The caller also reported that her husband was on blood thinner,So will it effect him.  Follow-up (09Feb2021): This is a follow-up spontaneous report received from a contactable consumer (patient's wife). This consumer (patient's wife) reported for a 80-year-old patient that her husband reported of his back hurting and dates for adverse events like right arm was a little sore,for Low grade fever,Diarrhea was unspecified.Ndc,expiry date and lot number was not provided by the caller.Reporter details: Email address was captured as provided.  Information about batch/lot number has been requested. Follow-up (07MAY2021): Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: Extremely tired; Body and joint pain; Body and joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (Age: 58; Unit: Unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9265) via an unspecified route of administration on 04Feb2021 at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 07Feb2021 the patient experienced extremely tired, body and joint pain. Reporter stated she received first dose of the covid vaccine on 04Feb and experienced some side effects started on Sunday. she said she is experiencing body and joint pain, extremely tired and wanted to know if they are common. Reporter received the Covid-19 vaccine on 04Feb2021. She started having side effects on Sunday. She is still having side effects today. Outcome of the events was not resolved.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haematoma, Wrong technique in product usage process
Clinical narrative: but the medical assistant "hit a spot lower and hit a blood vessel". There were "a couple of drops of blood when the needle was pulled out, and a large marble-sized hematoma formed"; but the medical assistant "hit a spot lower and hit a blood vessel". There were "a couple of drops of blood when the needle was pulled out, and a large marble-sized hematoma formed"; This is a spontaneous report from a contactable hospital pharmacist via Medical Information Team. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The pharmacist mentioned that a patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine but the medical assistant "hit a spot lower and hit a blood vessel". There were "a couple of drops of blood when the needle was pulled out, and a large marble-sized hematoma formed". Pharmacist was asking if this would affect the efficacy or the mechanism of the vaccine and if the patient need to be revaccinated. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Pain in extremity
Clinical narrative: sore arm after administration; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of Feb2021 caller received the second dose of the Covid vaccine yesterday and stated that he did not have a reaction with either dose of the vaccine. Caller rates a 1 out of 10 for a sore arm after administration. Caller asked what it means when he does not have a reaction or side effect to either dose. Caller asked what the point is in receiving the vaccine if you don't know the duration of protection, if it will protect everyone, and you still must follow CDC guidelines of a wearing a mask and social distancing. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Oropharyngeal pain, Stomatitis
Clinical narrative: sores inside her mouth and tongue; sores inside her mouth and tongue; sore throat; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included autoimmune disease. The patient's concomitant medications were not reported. The patient previously took two shots of cortisone last Wednesday. On an unspecified date, patient stated that she has sores inside her mouth and tongue and a sore throat. Patient further wanted to know that cortisone could reduce the effectiveness of the vaccine? The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: diarrhea; fever; sneezing; headache; coughing; felt weak; exhausted; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via Pfizer Sponsored Program.  A male patient (age 53 units unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose number unknown, single for covid-19 immunisation. Patients relevant medical history and concomitant medications were not reported. On 06Feb2021, the patient experienced coughing and felt weak. On 07Feb2021, the patient experienced sneezing and headache. On 08Feb2021, the patient experienced diarrhea and fever. On an unspecified date in Feb2021 the patient was exhausted. It was reported that the patient received Pfizer vaccine on Friday and wanted to know if his symptoms were communicable. He was experiencing sneezing, headache, coughing, diarrhea and fever. He enquired if he got tested, would he get a false positive. It was reported that patient received the Covid-19 Vaccine on Friday and reported that he is sneezing, headache, coughing, diarrhea, and fever. The patient clarified that on Saturday (06Feb2021) he felt weak and stayed in bed. On Sunday (07Feb2021) he started having a headache and some sneezing. He said that Monday (08Feb2021) he had diarrhea and was feverish. He said that he was basically exhausted. The patient said that the diarrhea only lasted a day to a day and a half. He said that he ate peanut butter and it seemed to resolve. Patient said that he wants to make certain that he was not putting his fellow workers at risk since he has these symptoms. He said that it feels like a flu or stomach flu, mild case. He said that it could possible be a adverse reaction, but he does not know.  He said he does not want to get anyone sick. Patient asked does this mean he temporarily has a communicable disease. The outcome of the events sneezing, fever, felt weak, headache and coughing was not recovered. The outcome of the event diarrhea was recovered on an unspecified date in Feb2021. The outcome of the event exhausted was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sneezing
Clinical narrative: diarrhea; fever; sneezing; headache; coughing; felt weak; exhausted; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient) via Pfizer Sponsored Program.  A male patient (age 53 units unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 as dose number unknown, single for covid-19 immunisation. Patients relevant medical history and concomitant medications were not reported. On 06Feb2021, the patient experienced coughing and felt weak. On 07Feb2021, the patient experienced sneezing and headache. On 08Feb2021, the patient experienced diarrhea and fever. On an unspecified date in Feb2021 the patient was exhausted. It was reported that the patient received Pfizer vaccine on Friday and wanted to know if his symptoms were communicable. He was experiencing sneezing, headache, coughing, diarrhea and fever. He enquired if he got tested, would he get a false positive. It was reported that patient received the Covid-19 Vaccine on Friday and reported that he is sneezing, headache, coughing, diarrhea, and fever. The patient clarified that on Saturday (06Feb2021) he felt weak and stayed in bed. On Sunday (07Feb2021) he started having a headache and some sneezing. He said that Monday (08Feb2021) he had diarrhea and was feverish. He said that he was basically exhausted. The patient said that the diarrhea only lasted a day to a day and a half. He said that he ate peanut butter and it seemed to resolve. Patient said that he wants to make certain that he was not putting his fellow workers at risk since he has these symptoms. He said that it feels like a flu or stomach flu, mild case. He said that it could possible be a adverse reaction, but he does not know.  He said he does not want to get anyone sick. Patient asked does this mean he temporarily has a communicable disease. The outcome of the events sneezing, fever, felt weak, headache and coughing was not recovered. The outcome of the event diarrhea was recovered on an unspecified date in Feb2021. The outcome of the event exhausted was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over the body; This is a spontaneous report from a contactable pharmacist. A 55-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that, reporter had a patient about to get her second vaccine, Covid vaccine (not confirmed that it was the Pfizer BioNTech Covid-19 vaccine). Patient developed rash all over the body after the 1st dose of vaccine (not confirmed that it was the Pfizer BioNTech Covid-19 vaccine). She still has the rash from her last dose 3 weeks ago. Patient informed the pharmacist stating, it (rash) came a couple of hours after she got the shot and then by 24 hours she had a full body rash. The patient was ready to get 2nd dose of vaccine. The reporter inquired if this patient is able to get 2nd dose. Reporter queried stating, if the patient does get shot, can she pre-medicate or post medicate with Benadryl. The event was non-serious. The clinical outcome for the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: She experienced lethargy; vomiting; low grade fever; This is a spontaneous report from a contactable other health care professional. This nurse reported for a female patient (grandmother). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Feb2021, the patient experienced she experienced lethargy and low grade fever. Caller would like to know if it is safe to receive the 2nd dose of the covid vaccine with symptoms of lethargy, vomiting and low-grade fever. Caller does not wish to report at this time. Caller was reporting on behalf of her grandmother who is due to receive the 2nd dose of the covid vaccine tomorrow. She experienced lethargy, vomiting on Saturday and a low grade fever. Caller does not believe this is due to the vaccine however since the 1st dose was closer to 3 weeks ago. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Rhinorrhoea, Sneezing
Clinical narrative: diarrhea; runny nose; sneezing; arm soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Right (right arm/right shoulder) on 08Feb2021 at 14:50 pm (at the age of 84-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included bad/sore back from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that after receiving the first dose of vaccine the patient experienced diarrhea, runny nose, sneezing and arm soreness on 09Feb2021. The patient stated that received his first dose of vaccine and stated that he got up in the next morning feeling very good. His arm was sore. Then, he started sneezing a little bit and he got diarrhea. He didn't see that was a side effect on the sheets he received. He was wondering if the sneezing and diarrhea are part of the COVID-19 vaccine and wanted to ask if these are the side effects. He further mentioned that He didn't feel the shot and didn't feel any soreness last night after receiving the vaccine. He confirmed that the arm soreness started in the next morning. He can move his arm, and it was not hurting. However, after touching right on the spot he was injected, it was still sore. Overall, he confirmed that the soreness has improved. He had breakfast and he clarified that he had some cereal this morning and the sneezing started after that. The sneezing was not continuous. In fact, all afternoon, he hasn't sneezed. He did have a runny nose though. He declined to include healthcare professional for this report. He stated that he doesn't see a Lot number on his vaccine record card. The card has his name, date of birth, and a date. The patient was recovered from the events of sneezing and arm soreness on an unspecified date in 2021 and was not recovered from the events of diarrhea and runny nose.   Information about Batch/Lot number has been requested.   Follow-up attempts completed. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Gait disturbance, Limb discomfort, Pain
Clinical narrative: her back ached; she started feeling achy all over and had a lot of pain; She can barely lift her right arm when the shot was administered in the left arm.; Her hips and joints all over her body are aching./having really bad joint pain; it was bad she could hardly walk she was having a difficult time walking on her walker; This is a spontaneous report from a non-contactable consumer or other non hcp. A 92-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration, administered in Arm Left on 04Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included hip surgery from an unknown start and stop dates. The patient's concomitant medications were not reported. The patient experienced she started feeling achy all over and had a lot of pain, she can barely lift her right arm when the shot was administered in the left arm, her hips and joints all over her body are aching/having really bad joint pain on 09Feb2021, her back ached on an unspecified date and it was bad she could hardly walk she was having a difficult time walking on her walker on Feb2021. Patient had really bad joint pain. Patient got the shot in her left arm but it was her right arm she was having the joint pain in. Patient couldnt lift up it was so sore in the joint she could not use but one way and otherwise she couldn't use it at all. Her shoulder was really bad and she kind of ached all over in her joints and her back ached. The outcome of the events were reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: burning pain on her left breast, side, arm pit, back and arm/ a little bit of the pain comes and goes; swelling; This is a spontaneous report from a contactable consumer. A 92-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 26Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included lung cancer and breast cancer surgery on the left side many years ago and she also has a tumor from an unknown date and unknown if ongoing. The concomitant medications includes a lot pain medication for other reasons from an unknown date and unknown if ongoing. On an unspecified date of 2021 caller states her injection was given in her right arm. Caller states she has a burning pain on her left breast, side, arm pit, back and arm. Caller states there is a little bit of swelling and the pain comes and goes. Caller states she also takes a lot pain medication for other reasons. Caller would like to know if her symptoms are normal for people who have had cancer and lymph nodes removed. Caller may also be postponing second dose of vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Somnolence, Vaccination site pain
Clinical narrative: severe mouth dryness that pushed to be drinking water; Injection site pain; somnolence; feeling tired; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of unspecified age received bnt162b2 (BNT162B2, Batch/Lot Number: EM9809) via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1,SINGLE for an unspecified indication at Health Clinic . The patient medical history was not reported. Concomitant medication(s) included metformin (1000), lisinopril (20mg) and atorvastatin (40) taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination.The patient had not covid tested post vaccination. On 09Feb2021 at 04:45,The patient experienced severe mouth dryness that pushed to be drinking water, injection site pain, somnolence and feeling tired. Treatment reported as no. The outcome of the events was recovering on an unspecified date.    Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Gait disturbance, Pain, X-ray
Clinical narrative: Her knee is throbbing; really bad left knee flare up; severe pain; couldn't walk; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 90-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 29Jan2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history included arthritic knee from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that after receiving the first dose of vaccine on an unspecified date in 2021 the patient experienced her knee is throbbing, really bad left knee flare up, severe pain and couldn't walk. The reporter stated that "the patient got the first dose of the vaccine on 29Jan2021 and next vaccine was scheduled for 19Feb2021. She ended up having a really bad left knee flare up. The pain was exorbitant. She did not know for a fact the vaccine triggered it. She went to the orthopaedic and they x-rayed the knee; nothing to be causing such severe pain. doesn't look as inflamed as her right knee which was very arthritic, which can see physically. It was an overnight thing. She couldn't walk and it's been like that since then, maybe 2-3 days later. At first, reporter thought it was the weather change. They have an idea wondering if it was a reaction to the vaccine. The reporter was giving Tylenol given but the orthopaedic said to avoid it, but patient was in a lot of pain and don't know what to do. She can't walk. They don't know what to do. Her PCP was not helpful. They x-rayed it and it doesn't show up why she can't walk. Reporter wanted to ask what about the second dose what if it gets her even more pain, then she will be a paraplegic. The orthopaedic gave a prescription for therapy, the pain was excruciating. She cannot walk. What if it was an allergic reaction. How do they not know it's not the vaccine that triggered this? She has pain even at moments when she was not standing on it. Her knee was throbbing. She might just take her to the ER. The orthopaedic said he could have given her a cortisone shot if it was reaction or not but they couldn't get a cortisone shot. Why was there no way to test if the vaccine is causing this severe reaction?". The patient underwent lab tests and procedures which included X-ray the knee: unknown results (nothing to be causing such severe pain). Therapeutic measures were taken in response to event. The outcome of the event was unknown.   Information about lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Caller reports that she is now experiencing some numbness at front of her tongue and lips.; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Feb2021 as DOSE 1, SINGLE covid-19 immunisation. Medical history included anaphylactics from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient had first dose of vaccine a few hours ago. Patient reports that patient was now experiencing some numbness at front of her tongue and lips on 09Feb2021. Patient states she was just calling to report her symptoms. Patient was not seeking medical advice. Patient states that she will follow up with HCP on if she should get second dose. The outcome of the event was unknown.  Informatio0n about lot/batch has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Malaise
Clinical narrative: elevated blood pressure; dizzy; light-headed and crummy; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for an unspecified indication. Medical history included neoplasm malignant from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination she had been treated for cancer and blood pressure issues. On 27Jan2021 the patient experienced elevated blood pressure, dizzy, light-headed and crummy. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 08Feb2021.The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.