chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Hiccups, Laziness
Clinical narrative: Headache; can't walk/he needs a walker; tired; lazy; hiccups; This is a spontaneous report from a contactable consumer (Reporter's dad). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included diabetes mellitus reported as Diabetes; he has Diabetes, hypertension; High Blood Pressure and he had Brain Stroke (Medical History) 3 years ago, cerebrovascular accident (Brain Stroke) all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other Prior vaccinations (within 4 weeks). On an unspecified date, the patient experienced headache, can't walk/he need a walker, tired, lazy and hiccups. Reporter stated, I am reporting about my family member. He is my dad (patient) and he took (received) the (first dose) shot 10 day ago but I think he is having side effects from the shot and I don't know if that's normal. Reporter said, he (patient) had a headache, he can't walk, he can stand but he can't walk, so he needs a walker, hiccups and headache don't go away. He was tired, lazy. They didn't ask for any conditions and he either didn't say that he has Diabetes, High Blood Pressure and he had Brain Stroke (Medical History) 3 years ago. None of that was asked when he went to get the shot, so I am worried about him. Event start date was reported as, it was day after he took the shot like it was "10" (not clarified) days ago. Reporter stated anatomical site of vaccination as it was in his arm (Further not clarified). Reporter stated, I am not sure about that second shot. Reporter stated, "He only takes medications for Diabetes and High Blood Pressure, he only takes his "injection" (further not clarified) for his diabetes." Treatment received for the event reported as, no, he didn't take any medicine. Outcome of the headache was not recovered whereas, rest of the events were unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus in both ears is much worse; had a hard time hearing over it; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration in arm left on an unspecified date in 2021 as a dose 2, single for COVID-19 immunization. The patient's medical history included tinnitus, before I received the vaccine, I had slight tinnitus. Known allergies were reported as none. The patient's concomitant medications received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID), taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN5318, Expiration date was not reported), via an unspecified route of administration in arm left on 31Jan2021 as a dose 1, single for COVID-19 immunization. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. Covid test type post vaccination included was nasal swab, Covid test name post vaccination was reported as SARS-CoV-2 NAT, NP Swab, Symptomatic. On an unspecified date in Mar2021, the patient experienced tinnitus in both ears was much worse since the second dose of the vaccine. Before the patient received the vaccine, had slight tinnitus but since the second dose it has gotten so loud, she had a hard time hearing over it. Stated that, she was concerned if she got a booster shot, she will not be able to hear over the tinnitus. Stated that, she hadn't experienced any loud noises that would have caused it to worsen. The reporter considered the seriousness criteria of the events as non-serious. Treatment was not received for the events. On 13Aug2021, the patient underwent lab tests and procedures which included SARS-CoV-2 NAT,  Swab, Symptomatic (SARS-CoV-2 test), resulted as negative, SARS-CoV-2 NAT, Nasal Swab. The device date was on 17Aug2021. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Feeling abnormal, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: My heart feels like it is floating in fluid or slightly swollen; My heart feels like it is floating in fluid or slightly swollen; Energy levels are much lower than normal; 1st dose, 17May2021; 2nd dose, 12Aug2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old male patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm right on 12Aug2021 at 11:30 (at the age of 37-years-old) as dose 2, single for covid-19 immunisation. The medical history of the patient included COVID-19 from an unknown date and unknown if ongoing. The patient was allergic to penicillin and Amoxicillin. The concomitant medications of the patient were not reported. The patient previously took first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm right on 17May2021 at 16:00 (at the age of 37-years-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 14Aug2021 at 10:00, the patient experienced my heart feels like it is floating in fluid or slightly swollen, energy levels are much lower than normal. The reporter reported this report as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test: covid on an unspecified date. It was unknown if the patient received the treatment. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysphemia, Feeling abnormal, Headache, Illness
Clinical narrative: 20 minutes later started to feel very ill/feeling sick; stuffiness; Retching; very unusual; weakness; muscle pain; Headache; This is a spontaneous report received from contactable physician (patient father) via Pfizer sponsored program.  A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date in Aug2021 as Dose 1, single for COVID-19 immunization. The patient was strong, good healthy and non-smoker. The patient medical history and concomitant medications were not reported. After 20 minutes of vaccination, the patient started to feel very ill/feeling sick, muscle pain, weakness, stuffiness in nose, headache, retching and very unusual on Aug2021. The patient does not have a fever and no adenopathy. The outcome of the events was unknown.  No follow-up attempts were possible; information about batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Retching
Clinical narrative: 20 minutes later started to feel very ill/feeling sick; stuffiness; Retching; very unusual; weakness; muscle pain; Headache; This is a spontaneous report received from contactable physician (patient father) via Pfizer sponsored program.  A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date in Aug2021 as Dose 1, single for COVID-19 immunization. The patient was strong, good healthy and non-smoker. The patient medical history and concomitant medications were not reported. After 20 minutes of vaccination, the patient started to feel very ill/feeling sick, muscle pain, weakness, stuffiness in nose, headache, retching and very unusual on Aug2021. The patient does not have a fever and no adenopathy. The outcome of the events was unknown.  No follow-up attempts were possible; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dyspnoea, Oropharyngeal pain
Clinical narrative: Unable to breathe through nose; Loss of voice; Throat hurt; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Father) reported for a 19-year-old female consumer patient (daughter) that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on an unknown date as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on an unknown date as DOSE 1, SINGLE for COVID-19 immunization. Agent stated that the Caller reported that his daughter had side effects, this morning which include, unable to breathe through nose, lost her voice, and throat hurt. Agent also stated the Caller contacted an emergency advice line, and he was advised to call Pfizer, but if his daughter had breathing problems to go to the hospital. The outcome of the event was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported, expiry Date: Not Provided) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported, expiry date: not provided) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, it was reported that the patient had the second shot and had chills and a fever and the next day, nothing. Outcome of event was recovered in 2021.  The lot number for the vaccine, [BNT162B2], was not provided. Follow up attempts are completed. No further information was expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Facial pain, Headache, Hypoaesthesia
Clinical narrative: Left neck glands swelled after 3 days; Left leg lower swolled 5 days; Sick for 3 days; 100 degree temp; Numb hands; Legs pin pricks time to time; Weakness; Severe headaches; Sinus pain pressure; Sinus pain pressure; Insomnia; Facial pain; This is a spontaneous report received from a contactable consumer (patient). A 49-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 30Jul2021 at 09:30 (at the age of 49-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included GI issues, ulcer, seasonal allergy, lactose intolerance and known allergies to amoxicillin, penicillin. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, it was unknown the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021 at 12:00, the patient experienced left neck glands swelled after 3 days, left leg lower swelled 5 days, sick for 3 days, 100 degree temp, numb hands and legs pin pricks time to time, weakness, severe headaches and sinus pain pressure, insomnia, facial pain. Patient visited to doctor or other healthcare professional office/clinic visit. Patient received treatment for Head and sinus issues. 2 urgent care visits 1 ER. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Insomnia, Lymphadenopathy, Paraesthesia, Paranasal sinus discomfort
Clinical narrative: Left neck glands swelled after 3 days; Left leg lower swolled 5 days; Sick for 3 days; 100 degree temp; Numb hands; Legs pin pricks time to time; Weakness; Severe headaches; Sinus pain pressure; Sinus pain pressure; Insomnia; Facial pain; This is a spontaneous report received from a contactable consumer (patient). A 49-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 30Jul2021 at 09:30 (at the age of 49-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included GI issues, ulcer, seasonal allergy, lactose intolerance and known allergies to amoxicillin, penicillin. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, it was unknown the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021 at 12:00, the patient experienced left neck glands swelled after 3 days, left leg lower swelled 5 days, sick for 3 days, 100 degree temp, numb hands and legs pin pricks time to time, weakness, severe headaches and sinus pain pressure, insomnia, facial pain. Patient visited to doctor or other healthcare professional office/clinic visit. Patient received treatment for Head and sinus issues. 2 urgent care visits 1 ER. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, SARS-CoV-2 test, Sinus pain
Clinical narrative: Left neck glands swelled after 3 days; Left leg lower swolled 5 days; Sick for 3 days; 100 degree temp; Numb hands; Legs pin pricks time to time; Weakness; Severe headaches; Sinus pain pressure; Sinus pain pressure; Insomnia; Facial pain; This is a spontaneous report received from a contactable consumer (patient). A 49-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 30Jul2021 at 09:30 (at the age of 49-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included GI issues, ulcer, seasonal allergy, lactose intolerance and known allergies to amoxicillin, penicillin. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, it was unknown the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021 at 12:00, the patient experienced left neck glands swelled after 3 days, left leg lower swelled 5 days, sick for 3 days, 100 degree temp, numb hands and legs pin pricks time to time, weakness, severe headaches and sinus pain pressure, insomnia, facial pain. Patient visited to doctor or other healthcare professional office/clinic visit. Patient received treatment for Head and sinus issues. 2 urgent care visits 1 ER. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy
Clinical narrative: Soft ball size lymph node in arm pit. Same side as injection/lymph node is still enlarged; Soft ball size lymph node in arm pit. Same side as injection. Very painful; vaccine received within 4 weeks PRIOR: Pfizer - Right arm/25Jul2021; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 40-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 25Jul2021 (at the age of 40-year-old) as dose 1, single; dose 2 via an unspecified route of administration, administered in arm right on 08Aug2021 at 12:00 PM (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was reported as none. Patient had no known allergies. The patient concomitant medication included omeprazole (received medication in two weeks) taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 08Aug2021 at 12:00 PM, the patient experienced vaccine received within 4 weeks prior: Pfizer - right arm/25Jul2021. On 08Aug2021 at 16:00 (04:00 PM), the patient experienced soft ball size lymph node in arm pit, same side as injection/lymph node is still enlarged; soft ball size lymph node in arm pit, same side as injection, very painful. Adverse event: Soft ball size lymph node in arm pit. Same side as injection. Very painful for about a week starting the night I received the vaccine. I'm currently on day 13 and the lymph node is still enlarged, but only to the size of a golf ball. The patient did not receive treatment for the events. Outcome of the events lymph nodes enlarged, lymph node pain was not recovered and outcome of remaining event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Parosmia
Clinical narrative: Experiencing sick, chemical smells bleach and all that; chemical smells bleach; This is a spontaneous report from a contactable consumer. This consumer reported for 25-year-old female patient (reporter's daughter) that:  A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, in left arm on 13Aug2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. On an unspecified date of Aug2021 the patient experienced sick, chemical smells bleach and all that. The reporter stated that the patient started experiencing sick a couple of days after reporters other daughter got the shot. Experiencing sick, chemical smells bleach and all that, patient told to reporter about that Thursday. Reporter thought it was something going on with patient sinuses. Reporter queried if that virus was introduced in patient body could get them sick. Reporter called the emergency room, and they could not tell reporter. Reporter queried if emergency room are sure, it cannot be shed. The response reporter had that Individuals who have received a COVID-19 vaccine cannot shed or release any of the vaccine components. In addition, none of the vaccines authorized for use contain a live virus so it was not possible to shed it. Reporter stated that for almost 2 years, they have been ok. When they go out, they wear masks, use hand sanitizers and sprays, and had never gotten sick. Reporter stated that she called the hospital the other day when her daughter got her shot and everyone else in the house got sick. Reporter was trying to figure out, even though they are not giving them the Corona virus, it was the same type of molecule or a fake virus. Reporter was clarified that her daughter, who took the COVID vaccine had not experienced anything. Reporters whole thing she read was that if it was COVID in the house, even if she got in the house, would they still experience the same type of symptoms. The outcome of the reported events was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at the injection site after her first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm at the injection site after her first dose. Verbatim and Event Description: Talked to (name) had both doses of the Pfizer Covid-19 vaccine in (withheld) (withheld), her 8 years old granddaughter attended a party and developed some symptoms like vomiting and she did a test on her that they found out that she's positive to Covid-19. Precautions how we should handle this to avoid the spread of the virus. (name) experienced Sore arm at the injection site after her first dose, can I visit my granddaughter if I am completely vaccinated. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: I had huge lump in my armpit pit swell up/It is just like a swollen ball probably a lymph node; Pain; This is a spontaneous report from a contactable consumer reported for self. A patient of unspecified age and gender received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: unknown), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced huge lump in armpit pit swell up. It is just like a swollen ball probably a lymph node patient was assuming anyways it was really sore. Patient was wondering how long this thing is going to last. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: headache; a little bit of fever; tired; arm was sore; This is a spontaneous report from a contactable consumer (parent). A contactable consumer reported similar events for two patients. This is the second of two reports. A male patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN; Lot number was not provided), via an unspecified route of administration on an unspecified date of 2021 as dose 1, single and on an unspecified date of 2021 as dose 2, single both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of 2021, the patient experienced headache, a little bit of fever, tired and arm was sore. It was further reported that the patient got his COVID-19 vaccine about 3 months ago, he had both doses and had a headache, a little bit of fever, was tired so he slept and his arm was sore but overall he flew through both doses (meaning he was not worried about it all). The outcome of the events was unknown.  The lot number for the BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101127262 same reporter and drug, similar events but different patient
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching, Paraesthesia, Vertigo
Clinical narrative: Vertigo for 1 week; Right eye twitch for 1 month; Diffuse numbness/ tingling still present; Diffuse numbness/ tingling still present; This is a spontaneous report from a contactable Other HCP. This 58-year-old female Other HCP (patient) reported that.  A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8734), dose 2 via an unspecified route of administration, administered in Arm Right on 01May2021 09:00 as (At the age of 58-years) dose 2, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, taken for an unspecified indication, start and stop date were not reported; estrogens conjugated (PREMARIN) taken for an unspecified indication, start and stop date were not reported and Multivitamin. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No covid tested post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FP7534), dose 1 via an unspecified route of administration, administered in Arm Right on 05Apr2021 03:00 PM as (At the age of 58-years) dose 1, single for covid-19 immunisation. The patient experienced vertigo for 1-week, right eye twitch for 1-month, diffuse numbness/ tingling still present on 03May2021 05:00. Patient did not receive any treatment for events. The outcome of events was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: severe body aches (myalgias); severe body aches (myalgias); joint pain throughout back/spine; joint pain throughout back/spine; joint pain throughout back/spine; after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements).; after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements).; This is a spontaneous report from a contactable physician (patient) reported for herself. A 36-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: FC3184), via intramuscular route o administration in left arm on 01Sep2021 (at the age of 36-years-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient's medical history included known allergy to PCN (Penicillin) and seasonal allergy, otherwise healthy. Concomitant medication was not reported. No other vaccine in four weeks. Other medications in two weeks were reported as none. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EU0168), via intramuscular route of administration in left arm on an unknown date in Aug2021 (at the age of 36-years-old) as historical vaccine dose 1, single for COVID-19 immunisation and experienced COVID test name post vaccination=Binax Now Antigen Card/Covid test result=Positive. On 01Sep2021, after the second dose, est 10 hrs later, severe body aches (myalgias), joint pain throughout back/spine, after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements). Yes, COVID tested prior vaccination and post vaccination. In Aug2021, COVID test post vaccination (BinaxNow Antigen Card) was resulted positive by nasal swab. On 28Aug2021, COVID test post vaccination (BinaxNow Antigen Card) was resulted negative by nasal swab. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Spinal pain
Clinical narrative: severe body aches (myalgias); severe body aches (myalgias); joint pain throughout back/spine; joint pain throughout back/spine; joint pain throughout back/spine; after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements).; after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements).; This is a spontaneous report from a contactable physician (patient) reported for herself. A 36-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: FC3184), via intramuscular route o administration in left arm on 01Sep2021 (at the age of 36-years-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient's medical history included known allergy to PCN (Penicillin) and seasonal allergy, otherwise healthy. Concomitant medication was not reported. No other vaccine in four weeks. Other medications in two weeks were reported as none. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EU0168), via intramuscular route of administration in left arm on an unknown date in Aug2021 (at the age of 36-years-old) as historical vaccine dose 1, single for COVID-19 immunisation and experienced COVID test name post vaccination=Binax Now Antigen Card/Covid test result=Positive. On 01Sep2021, after the second dose, est 10 hrs later, severe body aches (myalgias), joint pain throughout back/spine, after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements). Yes, COVID tested prior vaccination and post vaccination. In Aug2021, COVID test post vaccination (BinaxNow Antigen Card) was resulted positive by nasal swab. On 28Aug2021, COVID test post vaccination (BinaxNow Antigen Card) was resulted negative by nasal swab. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arms feel like bomb; It is some deformation; I have a ache in my arm  where I got the vaccination; This is a spontaneous report from a contactable consumer or other non hcp.   A 78-years-old female patient received bnt162b2 (BNT162B2 Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 (Batch/Lot Number: EW0153) as dose 2, single for covid-19 immunisation. Medical history included diabetes mellitus. Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus. Patient did not receive any vaccine with in four weeks. The patient experienced my arms feel like bomb; some deformation, have a ache in my arm where got the vaccination on Apr2021 with outcome of unknown.   Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Extra dose administered, Fatigue, Nausea, Off label use
Clinical narrative: Got the booster shot; Got the booster shot; Nausea; Abdominal discomfort; Fatigue; This is a spontaneous report from a contactable other hcp. A 68-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0182, Expiry date: 31Aug2021) via an unspecified route of administration on 20Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history include hypersensitivity from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Prior to the vaccine, she was on no medication just an Epipen for allergies. She had no health problems no nothing. The patient previously took bnt162b2 (dose 1, Lot number: EL3248) on 21Jan2021 experienced Shingles and Raynaud's, the shingles went away, but the Raynaud's have not and dose 2 (Lot number: EL9266) on 11Feb2021 for COVID-19 immunization.On an unspecified date patient experienced nausea, abdominal discomfort, fatigue. It was reported that patient got the booster shot. The outcome of the event was unknown.  Follow-up (14Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Cyanosis, Herpes zoster
Clinical narrative: Got the booster shot; Got the booster shot; Nausea; Abdominal discomfort; Fatigue; This is a spontaneous report from a contactable other hcp. A 68-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EW0182, Expiry date: 31Aug2021) via an unspecified route of administration on 20Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history include hypersensitivity from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Prior to the vaccine, she was on no medication just an Epipen for allergies. She had no health problems no nothing. The patient previously took bnt162b2 (dose 1, Lot number: EL3248) on 21Jan2021 experienced Shingles and Raynaud's, the shingles went away, but the Raynaud's have not and dose 2 (Lot number: EL9266) on 11Feb2021 for COVID-19 immunization.On an unspecified date patient experienced nausea, abdominal discomfort, fatigue. It was reported that patient got the booster shot. The outcome of the event was unknown.  Follow-up (14Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: struggling to keep his blood sugar in check/blood sugars have been continually high; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number FC3184), via an unspecified route of administration, administered in arm left on 07Sep2021 08:30 as dose 1, single for covid-19 immunisation. Medical history included type 1 diabetes. Concomitant medication included insulin taken for type 1 diabetes, start and stop date were not reported. The patient did not receive other vaccines in four weeks. It was unknown if the patient had covid-19 prior to the vaccination. The patient informed that he was a type 1 diabetic and; he has been struggling to keep his blood sugar in check on 07Sep2021 since receiving the vaccine. His blood sugars have been continually high for no apparent reason since 07Sep2021, and his insulin dosage has increased immensely to compensate the high glucose levels (also reported as no treatment received). The patient had not recovered from the adverse event at the time of the report. The patient had not been tested for covid-19 post vaccination.   Follow-up (17Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID19 VACCINE), dose 1 at vaccination age of 55-year-old via an unspecified route of administration in the left arm (reported as upper, bicep of left arm) on 13Sep2021 at  09:20 (Lot Number: FA7485) as dose 1, single for covid-19 immunisation. Medical history included Graves' disease diagnosed in 2010 and had surgery in 2012. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect or other vaccines administered on same date of the Pfizer Suspect were none. The patient received the vaccine in a pharmacy. On 13Sep2021 at 10:20, the patient experienced tongue swelling started about an hour later. She feels like it has worsened since it feels like her tongue is wanting to go over her teeth. She added that she can feel it when she is talking. She inquired if this is a normal side effect of the vaccine. The patient was advised to consult with healthcare professional which the patient stated that she already called her doctor and is waiting on a call back. As for the treatment, it was mentioned that the patient declines any and she waiting to hear from her doctor. As of the time of this initial report, the adverse event did not result in emergency room visit or physician's office visit. The outcome of the event was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Loss of consciousness, Muscle twitching, Muscular weakness
Clinical narrative: Passing out; Could not feel arms and legs- Had numbness immediately along with weakness; Could not feel arms and legs- Had numbness immediately along with weakness; Distorted face; Dizziness; This is a spontaneous report from a contactable nurse. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm on Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (age at vaccination was 59-year-old).  Medical history included a lot of allergies. The patient's concomitant medications were not reported. Historical vaccine included flu shot for immunization and patient experienced allergies to the flu shot. The patient experienced a distorted face, passed out, dizziness and could not feel arms and legs on the day of vaccination. Clinical course was reported as distorted face- started immediately. She was passing out and they had to lay her down, put her feet up, and she told them she was going out. They laid her down and told them her face felt numb then it was noted her face was all distorted. This lasted four hours. Passing out-Occurred same day had the vaccine, immediately after the vaccine. This would have been really life threatening if she went out and hit her head, but she got down and was able to put feet up. Dizziness: this happened immediately after getting the vaccine. It lasted on and off for days. She had to miss a couple of days of work. Could not feel arms and legs- had numbness immediately along with weakness. This lasted 3-4 days. Passing out and could not feel arms and legs- Had numbness immediately along with weakness were reported as life-threatening by reporter. Distorted face and dizziness were reported as disability by reporter. Outcome of passing out was unknown. Outcome of distorted face was resolved in Jan2021. Outcome of other events was resolved in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events loss of consciousness, hypoaesthesia, muscular weakness, muscle twitching and dizziness cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Muscle twitching, Neuralgia, SARS-CoV-2 test
Clinical narrative: nerve pain in my right hand; left arm started to twitch and spasm/twitches all over my body; left arm started to twitch and spasm; fatigue in my legs; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Fa7484, expiry date not reported), via an unspecified route of administration, administered in left arm on 26Jul2021 18:00 (at the age of 35 years old) as dose 1, single for covid-19 immunisation. There were no medical history and concomitant medications.  The patient had no covid prior to vaccination. The patient had no known allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. On 07Aug2021 12:15, after vaccination, the patient experienced nerve pain in right hand (neuralgia), left arm started to twitch and spasm, left arm started to twitch and spasm, twitches all over body and fatigue in legs. This was further reported as 2 1/2 weeks after shot, left arm started to twitch and spasm. Over the next two days that grew to twitches all over the body. Patient was still twitching in left arm consistently. Predominately, twitch in belly, legs, and chest, but had twitch in random places in addition to that. Patient was still experiencing fatigue in legs. The events resulted to doctor or other healthcare professional office/clinic visit, and disability or permanent damage. The patient had tested for Covid post vaccination which included nasal swab negative on an unknown date in 2021. No treatments were received in response to the events reported. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Neuralgia
Clinical narrative: Dizziness; headaches; severe total body aches; nerve pain; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history and there were no concomitant medications. There were no other vaccine in four weeks and no other medication in two weeks. The patient had no Covid prior vaccination and was covid tested post vaccination (Nasal Swab: PCR) on 15Apr2021 with Negative result. It was reported that the patient experienced Dizziness, headaches, severe total body aches, nerve pain, nausea, and fatigue on 09Apr2021. The events resulted in: Doctor or other healthcare professional office/ clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The events were treated (also reported as ER visits, PCP visits, and several specialists). The outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: Dizziness; headaches; severe total body aches; nerve pain; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history and there were no concomitant medications. There were no other vaccine in four weeks and no other medication in two weeks. The patient had no Covid prior vaccination and was covid tested post vaccination (Nasal Swab: PCR) on 15Apr2021 with Negative result. It was reported that the patient experienced Dizziness, headaches, severe total body aches, nerve pain, nausea, and fatigue on 09Apr2021. The events resulted in: Doctor or other healthcare professional office/ clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The events were treated (also reported as ER visits, PCP visits, and several specialists). The outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Headache, Malaise, Ocular hyperaemia
Clinical narrative: Swollen, red, splotchy left eye; Swollen, red, splotchy left eye; Moderate to severe headache every day; malaise; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: 30135BA), via an unspecified route of administration, administered in left arm on 10Sep2021 14:00 (at the age of 37 years old) as dose 1, single for COVID-19 immunisation. The patient has no medical history and no known allergies. The patient has not had COVID prior to vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO). On 10Sep2021, the patient experienced Moderate to severe headache every day since day 1, fatigue and malaise. The patient also experienced Swollen, red, splotchy left eye on day 4, on 14Sep2021. No treatment was given in response to the events. The patient was not COVID tested post vaccination.  The outcome of the events was not recovered.