chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; chills; bodyaches; This is a spontaneous report from a contactable consumer. An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration on 30Mar2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. Patient received other unspecified medications within 2 weeks of vaccination. It was not known whether the patient was pregnant at time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination it was not known if patient has been tested for COVID-19.  The patient experienced fever, chills and body aches on an unspecified date for 48hours. The events were considered non serious. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymph node pain, Pain
Clinical narrative: Chills; Soreness; Sore lymph nodes; Tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in left arm on 12Apr2021 (at the age of 38-years-old) at 12:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior and was not pregnant. The patient experienced chills, soreness, sore lymph nodes and tiredness on 12Apr2021 at 16:00. The patient had not been tested for COVID-19 since vaccination. No treatment was received for the events. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got her first dose of the vaccine last March 29, 2021. She got tested for Covid-19 last Thursday and results came positive for Covid-19 on Friday.; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 29Mar2021 as a single dose for COVID-19 vaccination. The medical history and concomitant medications were not reported. The patient received first dose of the vaccine last 29Mar2021. She got tested for Covid-19 last Thursday and results came positive for Covid-19 on Friday. She is due to have her second dose on 19Apr2021. The clinical outcome of the event positive for Covid-19 was unknown.   Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore arm around injection site; tired; This is a spontaneous report from a contactable pharmacist. A 26-years-old female patient received second dose of (BNT162B2) (COVID-19 Pfizer vaccine), via intramuscular route, administered in right arm on 10Apr2021 16:00 (Lot Number: EP6955) as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medication included Loratadine, Birth control pill and Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had previously received the first dose of (BNT162B2) (COVID-19 Pfizer vaccine), via intramuscular route, administered in right arm on 20Mar2021 16:00 (Lot Number: EP6955) as single dose for COVID-19 immunization. On 10Apr2021 at 22:00, the patient experienced sore arm around injection site and tired. As a therapeutic measures included Tylenol, apply ice to site, and nap were taken. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovering for both the events at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Muscle tightness
Clinical narrative: muscle tension on his shoulder area up to his neck; pressure on his chest; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 10Apr2021 at a single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient received his 1st dose yesterday (10Apr2021) and experienced muscle tension on his shoulder area up to his neck and pressure on his chest in Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Impaired gastric emptying
Clinical narrative: gastroparesis symptoms were heightened; gastroparesis symptoms were heightened; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history includes ongoing gastroparesis. Concomitant medications were not reported. On an unspecified date, after the first vaccination, the patient's gastroparesis symptoms were heightened. The clinical outcome of gastroparesis symptoms were heightened was not resolved.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Chronic kidney disease
Clinical narrative: suffers from stage 4 chronic kidney disease; chills and shivering on her whole body; This is a spontaneous report from a contactable consumer (reporting for his wife) from a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via an unspecified route of administration on 09Apr2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 19Mar2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient was experiencing chills and shivering on her whole body for 3 and half hours now (Apr2021). She also suffered from stage 4 chronic kidney disease. The outcome of the events was not recovered.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; COVID-19; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), first dose on an unspecified date and second dose on 09Apr2021, both via an unspecified route of administration at single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she tested positive for COVID-19 on 12Apr2021 despite receiving second dose of the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412463 same patient/drug, different doses/events
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache presenting behind the ear and going down her neck; This is a spontaneous report via a contactable consumer (Patient herself). A 55-year-old female received first dose of BNT162b2 (BNT162B2 Formulation: Solution for injection, Lot/Batch number: Unknown, Expiration date: Unknown) an unspecified route of administration on 12Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache presenting behind her ears and going down her neck on an unspecified date. The reporter assessed the events as non-serious. She has since been experiencing a headache presenting behind her ears and going down her neck, that she has been treating with Advil. She wants to know how long this may last. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal discomfort, Pyrexia, Vaccination site discomfort, Vaccination site joint swelling
Clinical narrative: fever at 2am in the morning; ache and sore all over her back, neck; ache and sore all over her back, neck; ache and sore all over her back, neck and arm where the point of; lymph node is swelling as well her armpit on the same arm where she got injected.; swelling as well her armpit on the same arm where she got injected; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 08Apr2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient mentioned that she got her 2nd dose of the vaccine last Thursday, 08Apr2021 and then she experienced side effect such as fever at 2am in the morning yesterday on 09Apr2021 which is Friday and around 5am she took Tylenol. Patient also mentioned that she experienced ache and sore all over her back, neck and arm where the point of injection was located. She stated that this morning she realized that her lymph node is swelling as well her armpit on the same arm where she got injected. She asked if these are normal side effects of the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: fever at 2am in the morning; ache and sore all over her back, neck; ache and sore all over her back, neck; ache and sore all over her back, neck and arm where the point of; lymph node is swelling as well her armpit on the same arm where she got injected.; swelling as well her armpit on the same arm where she got injected; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 08Apr2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient mentioned that she got her 2nd dose of the vaccine last Thursday, 08Apr2021 and then she experienced side effect such as fever at 2am in the morning yesterday on 09Apr2021 which is Friday and around 5am she took Tylenol. Patient also mentioned that she experienced ache and sore all over her back, neck and arm where the point of injection was located. She stated that this morning she realized that her lymph node is swelling as well her armpit on the same arm where she got injected. She asked if these are normal side effects of the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was so sore, it is hurting; This is a spontaneous report from a contactable consumer (Patient herself). A 64-year-old female patient received second dose of BNT162b2 (BNT162B2) via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162b2 (BNT162B2) via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. she did not feel anything nor had side effects after first dose. The patient experienced her arm was so sore, it is hurting on 13Apr2021. She did experience that "her arm was so sore, it is hurting, she took Tylenol, and she wanted to know if it would hurt having a heating pad on her arm for the pain. Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness; This is a spontaneous report received from two contactable consumers. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration in left arm on 09Apr2021 at single dose for COVID-19 immunization. Patient medical history included seizures and heartburn bot are ongoing. Concomitant medications included levetiracetam and phenobarbital both for seizures and dexlansoprazole (DEXILANT) for heartburn. It was reported as patient received her first dose of the Pfizer vaccine Friday. She is experiencing itchiness post vaccination on 12Apr2021. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lupus myositis, Nausea, Sinusitis
Clinical narrative: had malaise and then she started going through one of her cycles of lupus where she had headaches and dystonia in her shoulders and neck; a sinus infection; Gets nausea; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 48-year-old female patient (consumer) received bnt162b2 (COMIRNATY, solution for injection, (Batch/Lot Number: Unknown) dose 1 via intramuscular route of administration on unspecified date as SINGLE DOSE for covid-19 immunization. The medical history included of lupus, cluster migraines, ADHD. Concomitant medication was not reported. Patient took medication for cluster migraines, Tylenol and naproxen. Patient got her first Pfizer covid vaccine and for 5 days after, had malaise and then she started going through one of her cycles of lupus where she had headaches and dystonia in her shoulders and neck and these symptoms will last for 15 days. The headache then turned into a sinus infection and as a result of all this, she missed her second dose.  Patient wanted to know if it's ok to take these medications because her headaches affect her ability to function daily. Patient had to delay her second dose of the vaccine because she was feeling unwell. Her doctor told her to schedule two weeks away which would be today but she was about to start a new medication for her ADHD and to do that she had to come off of her other one which is a stimulant. She did not want to start a new medication right now with the problems that might come up along with getting the second shot and any side effects that she might have. She was frozen, just not sure what to do. Patient heard if you only get one dose, it was 80% effective. Patient was concerned if she only gets one dose, she'll be prevented from flying or doing other things because having the vaccine might be required but she had missed the window for getting the second shot so she doesn't know what to do. Rescheduled 2nd dose due to not feeling well. Has mild case of Lupus. Gets headaches and nausea. Would like to take Tylenol or Advil before getting 2nd dose but was worried it might interfere with vaccine. The outcome of the events were unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Medication error
Clinical narrative: had malaise and then she started going through one of her cycles of lupus where she had headaches and dystonia in her shoulders and neck; a sinus infection; Gets nausea; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 48-year-old female patient (consumer) received bnt162b2 (COMIRNATY, solution for injection, (Batch/Lot Number: Unknown) dose 1 via intramuscular route of administration on unspecified date as SINGLE DOSE for covid-19 immunization. The medical history included of lupus, cluster migraines, ADHD. Concomitant medication was not reported. Patient took medication for cluster migraines, Tylenol and naproxen. Patient got her first Pfizer covid vaccine and for 5 days after, had malaise and then she started going through one of her cycles of lupus where she had headaches and dystonia in her shoulders and neck and these symptoms will last for 15 days. The headache then turned into a sinus infection and as a result of all this, she missed her second dose.  Patient wanted to know if it's ok to take these medications because her headaches affect her ability to function daily. Patient had to delay her second dose of the vaccine because she was feeling unwell. Her doctor told her to schedule two weeks away which would be today but she was about to start a new medication for her ADHD and to do that she had to come off of her other one which is a stimulant. She did not want to start a new medication right now with the problems that might come up along with getting the second shot and any side effects that she might have. She was frozen, just not sure what to do. Patient heard if you only get one dose, it was 80% effective. Patient was concerned if she only gets one dose, she'll be prevented from flying or doing other things because having the vaccine might be required but she had missed the window for getting the second shot so she doesn't know what to do. Rescheduled 2nd dose due to not feeling well. Has mild case of Lupus. Gets headaches and nausea. Would like to take Tylenol or Advil before getting 2nd dose but was worried it might interfere with vaccine. The outcome of the events were unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: she developed left knee pain and swelling.; she developed left knee pain and swelling.; This is a spontaneous report from a contactable consumer (patient).  A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 11Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Apr2021 the patient developed left knee pain and swelling. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: got covid /sars-cov-2 test positive; got covid; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable male consumer (patient) reported that, a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date, the patient received the first dose and after receiving the first dose patient experienced COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient tested positive for COVID with mild cough.; patient tested positive for COVID with mild cough.; This is a spontaneous report from a contactable consumer.   A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient received Covid vaccination in Feb2021. On Apr2021 after travel, patient tested positive for COVID with mild cough. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait inability, Laboratory test, Motor dysfunction, Speech disorder
Clinical narrative: Not been able to walk; Motor skills diminished; Speech has also been deterred; She is in bed right now, can't move; She is not responding; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on 30Mar2021 on right arm at a single dose for COVID-19 immunisation. Medical history included Blood pressure high, heart condition, diverticulitis, ongoing constipation and ongoing pain. Concomitant medications included clonidine (tablet, 0.1 mg) at 0.1 mg, once a day, duloxetine (capsule, 20 mg), orally at 20 mg, two times a day (one in morning and one in evening), simvastatin (tablet, 10 mg), at 10 mg, once a day (at bed time once a day), doxazosin (tablet, 4 mg) at 4 mg, two times a day, carvedilol (tablet) at 3.125 mg, twice a day (takes half a tablet twice a day one in the morning one in the evening half, they cut in half), lisinopril (tablet, 5 mg) at 5 mg, once a day, paracetamol (TYLENOL, tablet, 500 mg) at 500 mg, as needed (takes one in the morning and one in the evening or as needed if she is in pain) for pain, acetylsalicylic acid (ASPIRIN, tablet, 81 mg) at 81 mg, once a day, iron (tablet, 65 mg) at 65 mg, two times a day, bisacodyl (tablet, 5 mg) as needed for the constipation and geri-Kot 8.6 mg, tablet as needed for the constipation. Reporter stated, "he just wanted to call on behalf of his mom. She took the vaccination on the 30Mar2021 and her side effects has been, she has not been able to walk and so right after the shot we brought her home and immediately after that her motor skills diminished. So, She was in bed and can't move on an unspecified date in 2021. He had called the doctor and let them know what her prognosis is. Her speech has also been deterred on an unspecified date in 2021. She was due for the second shot, he was scared for her to get the second shot because he doesn't know if she is going to recuperate from the first shot, she is due 27Apr2021. Needed to report this information on what her prognosis is, was very scared and patient was not responding on an unspecified date in 2021 and reported that don't know what to do. It reported that, her primary doctor gives her lab and her kidney doctor takes lab. The patient had not recovered from the events not been able to walk and she is in bed right now, can't move and the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Not been able to walk; Motor skills diminished; Speech has also been deterred; She is in bed right now, can't move; She is not responding; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on 30Mar2021 on right arm at a single dose for COVID-19 immunisation. Medical history included Blood pressure high, heart condition, diverticulitis, ongoing constipation and ongoing pain. Concomitant medications included clonidine (tablet, 0.1 mg) at 0.1 mg, once a day, duloxetine (capsule, 20 mg), orally at 20 mg, two times a day (one in morning and one in evening), simvastatin (tablet, 10 mg), at 10 mg, once a day (at bed time once a day), doxazosin (tablet, 4 mg) at 4 mg, two times a day, carvedilol (tablet) at 3.125 mg, twice a day (takes half a tablet twice a day one in the morning one in the evening half, they cut in half), lisinopril (tablet, 5 mg) at 5 mg, once a day, paracetamol (TYLENOL, tablet, 500 mg) at 500 mg, as needed (takes one in the morning and one in the evening or as needed if she is in pain) for pain, acetylsalicylic acid (ASPIRIN, tablet, 81 mg) at 81 mg, once a day, iron (tablet, 65 mg) at 65 mg, two times a day, bisacodyl (tablet, 5 mg) as needed for the constipation and geri-Kot 8.6 mg, tablet as needed for the constipation. Reporter stated, "he just wanted to call on behalf of his mom. She took the vaccination on the 30Mar2021 and her side effects has been, she has not been able to walk and so right after the shot we brought her home and immediately after that her motor skills diminished. So, She was in bed and can't move on an unspecified date in 2021. He had called the doctor and let them know what her prognosis is. Her speech has also been deterred on an unspecified date in 2021. She was due for the second shot, he was scared for her to get the second shot because he doesn't know if she is going to recuperate from the first shot, she is due 27Apr2021. Needed to report this information on what her prognosis is, was very scared and patient was not responding on an unspecified date in 2021 and reported that don't know what to do. It reported that, her primary doctor gives her lab and her kidney doctor takes lab. The patient had not recovered from the events not been able to walk and she is in bed right now, can't move and the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Feeding disorder, Neck mass
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said that after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she developed a lump in her neck in Apr2021. She said she is scared and has not been able to eat since then in Apr2021. She wants to know if this is a common reaction to the vaccine. Consumer is also seeking advice on how to treat the symptom. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Heart rate, Heart rate increased, Hypersensitivity, Vaccination site pain
Clinical narrative: my heart rate became elevated to a range of 120-165; severe allergic reaction; I started feeling jittery; I also had injection site pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 13Apr2021 at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient got her first Pfizer Biontech Covid vaccine yesterday, 13Apr2021, and approximately 7-8 hours after the dose, patient started feeling jittery and heart rate became elevated to a range of 120-165 throughout last night and into the morning in Apr2021. It was currently ongoing at the time of report. Patient also had injection site pain in Apr2021. Overall safety summary reported it as a common side effect but reference to "a fast heartbeat" as a possible sign of severe allergic reaction in Apr2021 along with other symptoms. The outcome of event heart rate increased was not recovered, while for others was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: runny nose; sore throat; sneezing; This is a spontaneous report received from a contactable consumer (parent) via medical information team. A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 09Apr2021 at single dose for COVID-19 immunization. Medical history included exposed to someone who was possibly Covid positive on 05Apr2021. Concomitant medications were not reported. It was reported that patient received her first Pfizer Covid vaccine dose on 09Apr2021. Before she received the dose patient had been exposed to someone who was possibly Covid positive, on 05Apr2021. Her runny nose, sore throat, and sneezing in Apr2021 and have continued. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: I am having a lot of problems with vertigo; This is a spontaneous report from a contactable consumer. A 82-year-old male patient received first dose of BNT162B2 (Solution for injection, Batch/lot number was unknown), via an unspecified route of administration on 2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had experienced a lot of problems with vertigo on an unspecified date of 2021. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Eye swelling, Laboratory test
Clinical narrative: Anaphylactic reaction; Eyes swollen; This is a spontaneous report from a contactable Other Health Care Professional (reporting on her-self). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP6955 and Expiry date was not re-ported), via an unspecified route of administration on 06Apr2021 13:35 as single dose for COVID-19 immunization. Medical history included diabetes mellitus, fibromyalgia, intervertebral disc de-generation, post-traumatic stress disorder, back disorder all from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; gabapentin (GABAPENTIN) taken for fibromyalgia, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for fibromyalgia, post-traumatic stress disorder, start and stop date were not reported; naproxen (NAPROXEN) taken for back disorder, start and stop date were not reported. The patient previously 'Incurin' and 'Epitab' and experienced anaphylactic reaction. Historical vaccine includes first dose of bnt162b2 for covid-19 immunisation. It was reported that on 06Apr2021 at 13:35, patient had her second BNT162B2 vaccine. she ended up having an anaphylactic reaction was hospitalized and just got out today. She also want to say she have a history of having anaphylactic reaction from three different medication 'Incurin' and 'Epitab'. Patient stated that she had nothing wrong after the first one. Patient is a Nurse but not working right now. she was disabled (Further not clarified if consumer is physically disabled or financially) but she was a nurse. Patient was hospitalized on 06Apr2021. patient stated, she, was better. Her eyes are still swollen but she breathing when she went to hospital. Consumer stated for laboratory work Well in hospital they got lab, not before the vaccine and in the hospital they did lab when she got admitted in the hospital. Patient stated since she got in the hospital she have to take Prednisone for 5 days and Benadryl (treatment) for 5 days. she just got out of the hospital. The outcome of the event Anaphylactic reaction was recovering and for event eyes swollen was not recovered.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Lymphadenopathy; Under arm swelling and pain; under arm swelling and pain; This is a spontaneous report received from a non-contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a shot in the left arm, on "Monday" experienced lymphadenopathy, under arm swelling and pain 12/10. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: sore arm; headache; fever; the pot holder slipped but she didn't feel getting burned due to the numbness in her hand.; tingling and numbness in her right hand fingers; tingling and numbness in her right hand fingers; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162B2 (Solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot number: unknown) at single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient experienced sore arm, headache and fever which have all resolved. On 11Apr2021 she experienced tingling and numbness in her right hand fingers and it has just been two fingers her thumb and pinky and patient went to get something out the microwave and the pot holder slipped but she didn't feel getting burned due to the numbness in her hand. Outcome of sore arm, headache and fever was recovered on an unspecified date. Outcome of rest of the events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: sore arm; headache; fever; the pot holder slipped but she didn't feel getting burned due to the numbness in her hand.; tingling and numbness in her right hand fingers; tingling and numbness in her right hand fingers; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162B2 (Solution for injection), via an unspecified route of administration on 06Apr2021 (Batch/Lot number: unknown) at single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient experienced sore arm, headache and fever which have all resolved. On 11Apr2021 she experienced tingling and numbness in her right hand fingers and it has just been two fingers her thumb and pinky and patient went to get something out the microwave and the pot holder slipped but she didn't feel getting burned due to the numbness in her hand. Outcome of sore arm, headache and fever was recovered on an unspecified date. Outcome of rest of the events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Rash
Clinical narrative: rash on chest/rash on neck; headache; swollen glands; This is a spontaneous report from a Pfizer- sponsored program.   A contactable consumer (patient) reported that a female consumer of unknown age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history includes- allergic to penicillin and has only ever had the polio vaccine.  Concomitant medications were not reported. It was reported that the patient got second Covid dose Wed and now has a rash on neck and chest, headache, swollen glands. There is no information whether the patient did a test Covid post vaccination or if the patient received any treatment. Outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection) dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced that her top eyelid got swollen, placed hot compress but did not resolved it. She will be getting her second shot on 22Apr2021 and queried what she should do if her swollen eyelid will get worse on the second shot. The outcome of the event was not recovered.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Eyelid ptosis, Migraine
Clinical narrative: experienced migraine, double vision, and droopy eyelid when he took the 1st dose; experienced migraine, double vision, and droopy eyelid when he took the 1st dose; experienced migraine, double vision, and droopy eyelid when he took the 1st dose; This is a spontaneous report from Pfizer Sponsored Program. A contactable male consumer patient (reporting for herself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported that patient received first dose of Pfizer covid vaccine on 20Mar2021. The 2nd dose should be on 10Apr2021, but the patient rescheduled the 2nd dose because the patient experienced migraine, double vision, and droopy eyelid on unspecified date when patient took the 1st dose. The patient would like to know if what are the side effects of the vaccine before he will take the 2nd dose and would also like to know if he needs to take the 2nd dose or not. Provided the number. The patient refused to be transferred to PMI because he already spoke to them and receive no help. Outcome of the events unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Eyelid disorder, Migraine
Clinical narrative: experienced migraine, double vision, and droopy eyelid when he took the 1st dose; experienced migraine, double vision, and droopy eyelid when he took the 1st dose; experienced migraine, double vision, and droopy eyelid when he took the 1st dose; This is a spontaneous report from Pfizer Sponsored Program. A contactable male consumer patient (reporting for herself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported that patient received first dose of Pfizer covid vaccine on 20Mar2021. The 2nd dose should be on 10Apr2021, but the patient rescheduled the 2nd dose because the patient experienced migraine, double vision, and droopy eyelid on unspecified date when patient took the 1st dose. The patient would like to know if what are the side effects of the vaccine before he will take the 2nd dose and would also like to know if he needs to take the 2nd dose or not. Provided the number. The patient refused to be transferred to PMI because he already spoke to them and receive no help. Outcome of the events unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 17Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on 01Apr2021. The patient was off his quarantine at the time of the report. The outcome of the event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Loss of consciousness, Nausea
Clinical narrative: Passed out on the floor; nausea; every limb hurt; 103 fever chills; 103 fever chills; severe headache; This is a spontaneous report received from a contactable consumer. A female patient in her 40s received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation.  On an unspecified date the patient experienced passed out on the floor, severe headache, nausea, 103 fever chills and every limb hurt. The clinical course was reported as follows: "after the 2nd dose, every limb hurt, severe headache for 48hrs, nausea, 103 fever chills for 2days. She crawled downstairs to get water and passed out on the floor. Woke up and crawled back to bed." The clinical outcomes of the events passed out on the floor, severe headache and 103 fever chills were all recovered/resolved on unspecified dates and the clinical outcomes of the events nausea and every limb hurt were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Passed out on the floor; nausea; every limb hurt; 103 fever chills; 103 fever chills; severe headache; This is a spontaneous report received from a contactable consumer. A female patient in her 40s received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation.  On an unspecified date the patient experienced passed out on the floor, severe headache, nausea, 103 fever chills and every limb hurt. The clinical course was reported as follows: "after the 2nd dose, every limb hurt, severe headache for 48hrs, nausea, 103 fever chills for 2days. She crawled downstairs to get water and passed out on the floor. Woke up and crawled back to bed." The clinical outcomes of the events passed out on the floor, severe headache and 103 fever chills were all recovered/resolved on unspecified dates and the clinical outcomes of the events nausea and every limb hurt were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: She stated that he had the virus and got over it.; This is a spontaneous report from a non-contactable consumer via a medical information team. A male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. She was calling on behalf of her boyfriend. On an unspecified date, she stated that he had the virus and got over it. He got his first dose of the Pfizer vaccine. Can he get tested again for COVID-19 infection? Referred back to her boyfriend's HCP for recommendations on getting tested for COVID-19. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 05Apr2021, the patient was diagnosed with covid (COVID-19). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Apr2021 diagnosed with covid. The patient wants to know if it's ok to get the second dose which has scheduled for this Friday 16Apr2021. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed (tested positive) with Covid19; Diagnosed (tested positive) with Covid19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Apr2021, after the first dose of vaccination, the patient was diagnosed (tested positive) with COVID-19. The outcome of the event was unknown. The patient was scheduled to receive the second dose of vaccination on 13Apr2021, and was told to put it off.  Information about lot/batch number has been requested.