chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: the joint pain she experienced is something caused by the Pfizer BioNTech Covid-19 Vaccine/her ankle and hip joints pain started to worsen; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reported). A 84-years-old female patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported and expiration date was not reported), via an unspecified route of administration on 24May2021 as second dose, single for COVID-19 immunization. Medical history included arthritis and fibromyalgia from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported and expiration date was not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization and experienced part of her hips started to hurt. On May2021 the patient experienced caller wanted to know if the joint pain she experienced was something caused by the biontech COVID-19 vaccine with, her ankle and hip joints pain started to worsen. She experienced the worsened joint pain a few days after getting her 2nd shot of the BioNTech Covid-19 Vaccine last 24May2021 and the pain persists until now and her ankle and hip joints pain started to worsen after the second shot of the vaccine last 14May2021. During the first shot, a part of her hips started to hurt and went away, on the following day another part of the hip started to hurt and went away again. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gastrointestinal disorder, Headache, Musculoskeletal chest pain, Musculoskeletal stiffness
Clinical narrative: Pain at injection site; pain in rib cage and thoracic spine; pain in rib cage and thoracic spine; stiffness; chills; rash on my face and injection site; rash on my face and injection site; blurred vision/cloudy; digestive issues; headache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0171), via an unspecified route of administration, on 23May2021 at 12:30 (at the age of 42-years) as single dose in left arm, for covid-19 immunization. Medical history included: allergies, meningitis, low back pain, SI joint disfunction, IBS and known allergies: Sulfa drugs, soaps, detergents, and other household products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included: ibuprofen, multivitamin, antioxidants, leaky gut r. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 23May2021 at 22:30, the patient experienced pain at injection site, pain in rib cage and thoracic spine, stiffness, chills, rash on my face and injection site, blurred vision, cloudy, digestive issues and headache. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Spinal pain, Vaccination site pain, Vaccination site rash, Vision blurred
Clinical narrative: Pain at injection site; pain in rib cage and thoracic spine; pain in rib cage and thoracic spine; stiffness; chills; rash on my face and injection site; rash on my face and injection site; blurred vision/cloudy; digestive issues; headache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0171), via an unspecified route of administration, on 23May2021 at 12:30 (at the age of 42-years) as single dose in left arm, for covid-19 immunization. Medical history included: allergies, meningitis, low back pain, SI joint disfunction, IBS and known allergies: Sulfa drugs, soaps, detergents, and other household products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included: ibuprofen, multivitamin, antioxidants, leaky gut r. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 23May2021 at 22:30, the patient experienced pain at injection site, pain in rib cage and thoracic spine, stiffness, chills, rash on my face and injection site, blurred vision, cloudy, digestive issues and headache. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: I had burning feet at night- so hot; This is a spontaneous report from a contactable consumer (patient). A 36-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 am on 20Apr2021 at 01:00 PM as 2nd dose, single for COVID-19 immunization. It was reported that patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left am on 20Apr2021 at 01:00 PM as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered was school or student health clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04May2021 at 06:00 PM, patient had burning feet at night- so hot that patient had to pit ice packs around them for two nights in a row after the 2nd dose. No fever. Patient was not pregnant at time of vaccination. Patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received. The outcome of the event was recovered.  Information on the lot/batch number has been requested
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Joint range of motion decreased, Myalgia, Off label use
Clinical narrative: Wife received her first doe of the Pfizer COVID-19 vaccine on 5Apr2021 and received second dose on 22Apr2021; Wife received her first doe of the Pfizer COVID-19 vaccine on 05Apr2021 and received second dose on 22Apr2021; Right Arm Pain especially at elbow joint; Right Arm Pain especially at elbow joint; Having too much pain in muscle; cannot move joint, having difficulty moving right hand; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: Unknown and expiry date was not provided), via an unspecified route of administration, in the right arm, on 22Apr2021 at 16:00 (at the age of 54-years-old) as a single dose for covid-19 immunisation. Patient's medical history included anxiety and depression. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient had a flu vaccine 3-4 months before and did fine. No adverse events following prior vaccinations. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: Unknown and expiry date was not provided), via an unspecified route of administration in right arm on 05Apr2021 as a single dose for covid-19 immunisation. The patient did not have any other products. On 26Apr2021 (after 4 days of vaccination), patient experienced right arm pain especially at elbow joint, having too much pain in muscle and cannot move joint, having difficulty moving right hand. Treatment received was wrapping arms using (paracetamol) TYLENOL, pain killer rubbing gel, hot water, rubbing with soft cloth, ice, massage and was not getting relief. Reporter seriousness for right arm pain especially at elbow joint and difficulty moving her right hand was unspecified. The events do not result in emergency room/ physician office. Outcome for event right arm pain especially at elbow joint and cannot move joint, having difficulty moving right hand was not resolved and for having too much pain in muscle was unknown.  Follow up attempts are needed. Further information is requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Wife received her first doe of the Pfizer COVID-19 vaccine on 5Apr2021 and received second dose on 22Apr2021; Wife received her first doe of the Pfizer COVID-19 vaccine on 05Apr2021 and received second dose on 22Apr2021; Right Arm Pain especially at elbow joint; Right Arm Pain especially at elbow joint; Having too much pain in muscle; cannot move joint, having difficulty moving right hand; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: Unknown and expiry date was not provided), via an unspecified route of administration, in the right arm, on 22Apr2021 at 16:00 (at the age of 54-years-old) as a single dose for covid-19 immunisation. Patient's medical history included anxiety and depression. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient had a flu vaccine 3-4 months before and did fine. No adverse events following prior vaccinations. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: Unknown and expiry date was not provided), via an unspecified route of administration in right arm on 05Apr2021 as a single dose for covid-19 immunisation. The patient did not have any other products. On 26Apr2021 (after 4 days of vaccination), patient experienced right arm pain especially at elbow joint, having too much pain in muscle and cannot move joint, having difficulty moving right hand. Treatment received was wrapping arms using (paracetamol) TYLENOL, pain killer rubbing gel, hot water, rubbing with soft cloth, ice, massage and was not getting relief. Reporter seriousness for right arm pain especially at elbow joint and difficulty moving her right hand was unspecified. The events do not result in emergency room/ physician office. Outcome for event right arm pain especially at elbow joint and cannot move joint, having difficulty moving right hand was not resolved and for having too much pain in muscle was unknown.  Follow up attempts are needed. Further information is requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Decreased appetite, Fatigue, Headache, Hyperhidrosis
Clinical narrative: sweating; tiredness; no appetite; headache; body aches; a rash on both arms; just laying in the bed pretty much; This is a spontaneous report received from a contactable consumer (patient). A 71-yearsold male patient received second dose of (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided), via an unspecified route of administration on 12Apr2021 (at age of 71-years-old) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. Patient had previously received first dose of vaccine on 15Mar2021 and did not have any side effects. It was reported that patient did not start having any side effects until Wednesday of last week, 19May2021, and he is concerned because of the length of time that has passed since he received his second dose and the onset of side effects. On unspecified date, patient experienced sweating, tiredness, no appetite, headache and body aches, was just laying in the bed pretty much and a rash on both arms. The rash was a little bit worse in the arm which he received his vaccine. He also states that his symptoms were improving and he does feel better. Patient wanted to know if it was normal to have side effects 3 weeks after getting the second shot and reported that he goes to the hospital for all of his medical needs. Reporter seriousness for unspecified side effects three weeks after getting second injection was unspecified. The outcome for all events was resolving.  Information on Lot/Batch number has been obtained. Additional Information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: sweating; tiredness; no appetite; headache; body aches; a rash on both arms; just laying in the bed pretty much; This is a spontaneous report received from a contactable consumer (patient). A 71-yearsold male patient received second dose of (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided), via an unspecified route of administration on 12Apr2021 (at age of 71-years-old) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. Patient had previously received first dose of vaccine on 15Mar2021 and did not have any side effects. It was reported that patient did not start having any side effects until Wednesday of last week, 19May2021, and he is concerned because of the length of time that has passed since he received his second dose and the onset of side effects. On unspecified date, patient experienced sweating, tiredness, no appetite, headache and body aches, was just laying in the bed pretty much and a rash on both arms. The rash was a little bit worse in the arm which he received his vaccine. He also states that his symptoms were improving and he does feel better. Patient wanted to know if it was normal to have side effects 3 weeks after getting the second shot and reported that he goes to the hospital for all of his medical needs. Reporter seriousness for unspecified side effects three weeks after getting second injection was unspecified. The outcome for all events was resolving.  Information on Lot/Batch number has been obtained. Additional Information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed a shingles outbreak that has been getting better; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male consumer patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot number: Not reported and Expiry date: 31Aug2021), via an unspecified route of administration on 03May2021 (at age of 73-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 04May2021 (1 day after vaccination), patient had developed a shingles outbreak that had been getting better. Treatment received was 7 days of tablets. Patients wanted to know if it was okay for him to receive the 2nd dose since his shingles have not healed completely. Patient mentioned that on the day reporting event (at 6:00), he had an appointment for the second dose. The outcome of event was resolving.  Information on lot/batch number was available. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Mass, Mobility decreased, Pain
Clinical narrative: right now what is swollen more and more is at the base of his neck, that lump, on his low throat. Caller states its hurting; right now what is swollen more and more is at the base of his neck, that lump, on his low throat. Caller states its hurting; little lump on the base of his neck where his chest starts; arm was swollen/feels like a swollen tendon; unable to raise his arm because of the pain; pain on the injection site on the arm; dizziness; mild diarrhea; This is a spontaneous report received from contactable consumer (patient). A 38-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported), via unspecified route on left arm on 22May2021 at 11:00 as for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 22May2021, two to three hours after receiving the covid vaccine, the patient had some of the side effects marked on product information such as dizziness mild diarrhea. On 23May2021, the patient had pain on the injection site on the arm, arm was swollen/ felt like a swollen tendon and was unable to raise his arm because of the pain. It was stated it just hurts a little in the area where they put the vaccine, but not like yesterday. On 24May2021, when he woke up, the patient had little lump on the base of his neck where his chest started. It was stated right now what was swollen more and more was at the base of his neck, that lump, on his low throat and stated it was hurting, it was not going away, it just started today. It was also stated that the lump was just persisting, it just hurted when he bended down or presses it, it just hurted. Now he reported that he had a lump in his left bone that goes down from his shoulder to his throat and that felt like a swollen tendon, he also mentioned that he can't lift his arm due to discomfort, he had an appointment with his chiropractor today. The outcome of the events arm was swollen, unable to raise his arm because of the pain, little lump on the base of his neck where his chest starts, pain on the injection site, unable to raise his arm because of the pain on the arm, right now what is swollen more and more is at the base of his neck, that lump, on his low throat and it was hurting was not resolved. The outcome of the events mild diarrhea and dizziness was resolved on 22May2021.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pharyngeal swelling, Vaccination site pain
Clinical narrative: right now what is swollen more and more is at the base of his neck, that lump, on his low throat. Caller states its hurting; right now what is swollen more and more is at the base of his neck, that lump, on his low throat. Caller states its hurting; little lump on the base of his neck where his chest starts; arm was swollen/feels like a swollen tendon; unable to raise his arm because of the pain; pain on the injection site on the arm; dizziness; mild diarrhea; This is a spontaneous report received from contactable consumer (patient). A 38-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported), via unspecified route on left arm on 22May2021 at 11:00 as for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 22May2021, two to three hours after receiving the covid vaccine, the patient had some of the side effects marked on product information such as dizziness mild diarrhea. On 23May2021, the patient had pain on the injection site on the arm, arm was swollen/ felt like a swollen tendon and was unable to raise his arm because of the pain. It was stated it just hurts a little in the area where they put the vaccine, but not like yesterday. On 24May2021, when he woke up, the patient had little lump on the base of his neck where his chest started. It was stated right now what was swollen more and more was at the base of his neck, that lump, on his low throat and stated it was hurting, it was not going away, it just started today. It was also stated that the lump was just persisting, it just hurted when he bended down or presses it, it just hurted. Now he reported that he had a lump in his left bone that goes down from his shoulder to his throat and that felt like a swollen tendon, he also mentioned that he can't lift his arm due to discomfort, he had an appointment with his chiropractor today. The outcome of the events arm was swollen, unable to raise his arm because of the pain, little lump on the base of his neck where his chest starts, pain on the injection site, unable to raise his arm because of the pain on the arm, right now what is swollen more and more is at the base of his neck, that lump, on his low throat and it was hurting was not resolved. The outcome of the events mild diarrhea and dizziness was resolved on 22May2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: low grade fever; vertigo; This is a follow-up spontaneous from a contactable Physician. This Physician reported for a 93-year-old female consumer (patient). A 93-year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 1 via an unspecified route of administration, on 05May2021, as single for COVID-19 immunization. The patient history included COVID-19 in Jan2021. The concomitant medications were not reported. On an unknown date in May2021, the patient had low grade fever and vertigo. She was feeling back into normal in about 48 hours. The patient was reluctant to take second dose of vaccine. The reporter would like to know if his mom should get second dose and what the efficacy of only one dose. The outcome of the events were recovered on an unknown date in May2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: fatigue; nausea; This is a spontaneous report from a contactable consumer reported for herself. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19May2021, in the night as single dose for covid-19 immunization. The patient's medical history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as single dose for COVID-19 immunization. The patient's concomitant medication history was not reported. The patient was okay until the night of 22May2021 after receiving the vaccine. On 22may2021, in the night, the patient experienced fatigue and nausea. The outcome of events was unknown.  No follow-up attempts are possible. Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Near death experience, Neurological symptom
Clinical narrative: near death; serious neurological problems; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location, on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced near death and serious neurological problems on an unspecified date. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypokinesia, Pain in extremity, Varicose vein, Vascular pain
Clinical narrative: she started having pain in her leg and veins; She started having pain in her leg and veins; she can barely walk.; Vein in her leg that popped up; Barely able to move; This is a spontaneous report from a contactable consumer (patient's daughter). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0161), via an unspecified route of administration on 20May2021 at 14:00 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that, yesterday, 4 days after her vaccination, she started having pain in her leg and veins in her thigh popped up. Today, she can barely walk. She mentioned that her mother had no health problems and had no complications before she got the vaccine. She also mentioned that she knew people that had common side effects like body aches after receiving the vaccine but her mother was different due to the vein issue. She was due for her 2nd dose on 10Jun2021 and would like to know if this has been reported with the vaccine. Reporter stated, Okay so my mom got the first shot of Pfizer vaccine. This be like you know because of vaccine because she did not have any problem before just right up she got the shot, she have that. Do you think this thing, is common for most of the people that got Pfizer. Reporter was informed about Pfizer and was provided with the number. Reporter stated, I report these to other representative couple minutes ago but right now I just need to know what we can do in this case. In this case you know for my mom. Should we go to the hospital. When informed about Pfizer . Reporter was informed to select option 3, after dialing the number and the timings as 8 AM to 8 PM from Monday to Friday and 9am to 3 pm from Saturday and Sunday as per EST. When requested for permission for further probing, reporter stated, I mean I did answer all of the questions, medical history for my mom, the age, the information of the vaccination card, I did give that all just right now, 2 minutes ago but I thought this was the medical option. Reporter was informed the timings again. Further information could not be probed as consumer was unwilling to complete the report. Hence, limited information available. Thus, product details (LOT, NDC, UPC and Expiration date) and pharmacy details could not be probed over the call. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: reports a strong metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0182; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in left arm bicep area on 17May2021 as 2nd dose, single dose for COVID-19 immunisation. The patient received the first dose BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0170; Expiration Date: unknown) via an unspecified route of administration on 26Apr2021 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On May2021, the patient experienced reports a strong metallic taste in his mouth. Patient inquired Pfizer heard about this and how long it will last. Caller stated that it was reported on the internet and saying it could last for several days. patient inquired several days was how long and if it is permanent. Its been a week or a week and a half now and nothing seemed to help. It was not changed and was pretty much the same. He did not take any medications. He had no HCP at this time. Patient wondered what Pfizer had heard and how long can they anticipate. Patient stated that it started on 17May2021 or 18May2021. Stated that it comes in waves that it comes and then subsides. Patient received treatment for the reported adverse event and stated that chewing gum was the only thing that helps, tried drinking extra water or fluids but that it did not help. The clinical outcome of the events was not resolved.   Follow up#1(PRD 25May2021): This is a Follow up spontaneous report from a contactable consumer. Batch number for both the doses was added.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Pfizer Covid-19 Vaccine caused sore arm; This is a social media report based on the information received by Pfizer from  A contactable consumer (Patient) reported. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via intramuscular route on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization and took adalimumab (Humira) via subcutaneous route from an unspecified date (Batch/Lot number was not reported) for rheumatoid arthritis and ankylosing spondylitis. The patient past medical history and concomitant medication was not reported. On an unknown date, the patient experienced Pfizer Covid-19 Vaccine caused sore arm. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Event outcome is recovered on unspecified date. The reporter's causality for the event(s) of PFIZER COVID-19 Vaccine caused sore arm was not provided.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal pain
Clinical narrative: Covid vaccine kicked his butt; This is a spontaneous report from a contactable consumer, the patient.  A 33-year-old male patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that the covid vaccine kicked his butt. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Rash, Vision blurred
Clinical narrative: I keep getting these headaches; Neck is stiff; Rash on my neck; Eyes were blurry; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot no: EW0179, Expiration date is unknown) via an un-specified route of administration on 21May2021 at my left arm as a single dose for covid-19 immunisation. The patient's medical history includes Epilepsy, asthma. Concomitant medications includes Lamotrigine, Proair, Symbicort, Alebe (220mg), to treat the Headache. Patient previously took first dose of vaccine BNT162B2 (Lot number: EWO172) on 29Apr2021 on right arm. On 22 may 2021 the patient experienced keep getting these headaches, Neck is stiff, Rash on my neck, Eyes were blurry, Patient stated that yes, I took my 2nd Pfizer shot on 21st and I have been getting headache so I was taking a pain pill and couple hours later it will comes back but it has been a whole week. Okay, my neck is stiff, I keep getting these headaches. I have a rash on my neck that I have been cleaning with alcohol and I put cream on it. It will go away and then instantly come back and yesterday, my eyes were blurry. When paraphrased, consumer stated, "I want both, I want guidance for it because it won't go away. patient was informed about the Pfizer Medical Information for the concern and was provided with the number as option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and 9am to 3 pm from Saturday and Sunday as per EST. When probed for Healthcare professional, Reporter Stated, "A doctor, No, No, I am cook, I am chef". Consumer added, "I keep having the headache, do I go to the ER. Consumer was again informed to contact for the concern. Patient received treatment included Aleve, 220mg, for headache. Outcome of the events was unknown.   Information about Lot/Batch number is obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I had a headache for almost a week that went away now; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program.  An 84-year-old female patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: was not reported), via an unspecified route of administration on an unspecified date respectively, as single for covid-19 immunization. The patient's medical history included hysterectomy and patient's Aunt and Mother had the same kind of hysterectomy. The patient's concomitant medications were not reported. The patient was seeking assistance with Premarin. She stated that she wished that she was in her 50's so she would not have this issue with this female problem at age of 84. She stated that her mom had bleeding like this too and so did her aunt and they had the same kind of hysterectomy and they left her ovaries in. She thought what was leaking and she did not know if people do have the breakthrough bleeding at her age. She said that there was vein or something, a blood thing going through her ovaries. She said it was going to be taken out, but her blood pressure went too high, and the woman would not put her under, so she went home. That was 7 to 8 years ago might be and she was having the same problem now, again. If she did not have it, she would go enough for two days, then she would start flaring again. The only thing she did not like about the cream was the applicator. She meant that she needed to put that cream on the applicator and supposed to plunge that thing which seemed that some of the cream stuck really on the applicator. She really had to clean that off to get that off and she thought it would just come off inside instead of on the applicator but that was how it was invented, she guessed. On an unspecified date, she got both shots of COVID vaccine and experienced headache for almost a week that went away at the time of this report. Further she said that she heard some young men are getting pericarditis from the vaccine and when she was using that cream, she kind of get like stomach cramps. The outcome of the event headache was resolved on an unspecified date.  Information on the Lot/Batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chest X-ray, Chills, Dizziness
Clinical narrative: Extreme dizziness/Light headedness; Muscle weakness/ can't walk on her own and is extremely weak; Muscle weakness/ can't walk on her own and is extremely weak; Muscle weakness/ can't walk on her own and is extremely weak; shakiness; Face completely swollen; Nausea; lump under arm pit, swollen lymph node; Low grade Fever; Chills; Night sweats; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0182, expiration date: 31Aug2021), via an unspecified route of administration in the left arm on 18May2021 at 14:15 (at the age of 35-year-old), at a 0.3 ml single dose for COVID-19 immunisation in hospital. The patient had no medical history and concomitant medications were not reported. The patient did not receive any vaccination within 4 weeks. Patient had no family history, but her husband got the vaccine and has not had any reactions. Everyone was fine. On 23May2021, the patient experienced lump under arm pit, swollen lymph nodes. She went to her general practitioner's office to check the lump and said it was normal from the vaccine and was swollen lymph nodes. On the same day overnight, she had fever/ low grade fever, chills, night sweats. On 24May2021, when she woke up, her face was completely swollen. She doesn't know if it was from the low grade fever. On the same day, she experienced nausea. On 25May2021, she experienced light headedness/extreme dizziness, muscle weakness/ can't walk on her own, was extremely weak and was shakiness. The patient was admitted to the emergency room for the events, and she was treated with Tylenol and anti-nausea medicines. They did a bunch of bloodwork and everything was in normal range and chest X-ray which was clear, then the patient was discharged, and patient was not admitted to the hospital (reported that probably best for her to rest at home and told her to come back if it got worse). She was also seen by the hospital neurologist and musculoskeletal neurologist. They initially thought she had Guillain-Barre syndrome but were able to rule that out. She was home today and was still experiencing light headedness and dizziness. She can't really walk on her own and need to hold on to something to walk as her legs are weak. She has a follow up with a neurologist on 10Jun2021. The outcome of the events lump under arm pit, swollen lymph node, muscle weakness/ can't walk on her own and is extremely weak was not recovered, shakiness was recovered and the rest of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Lymphadenopathy, Muscular weakness, Nausea, Night sweats
Clinical narrative: Extreme dizziness/Light headedness; Muscle weakness/ can't walk on her own and is extremely weak; Muscle weakness/ can't walk on her own and is extremely weak; Muscle weakness/ can't walk on her own and is extremely weak; shakiness; Face completely swollen; Nausea; lump under arm pit, swollen lymph node; Low grade Fever; Chills; Night sweats; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0182, expiration date: 31Aug2021), via an unspecified route of administration in the left arm on 18May2021 at 14:15 (at the age of 35-year-old), at a 0.3 ml single dose for COVID-19 immunisation in hospital. The patient had no medical history and concomitant medications were not reported. The patient did not receive any vaccination within 4 weeks. Patient had no family history, but her husband got the vaccine and has not had any reactions. Everyone was fine. On 23May2021, the patient experienced lump under arm pit, swollen lymph nodes. She went to her general practitioner's office to check the lump and said it was normal from the vaccine and was swollen lymph nodes. On the same day overnight, she had fever/ low grade fever, chills, night sweats. On 24May2021, when she woke up, her face was completely swollen. She doesn't know if it was from the low grade fever. On the same day, she experienced nausea. On 25May2021, she experienced light headedness/extreme dizziness, muscle weakness/ can't walk on her own, was extremely weak and was shakiness. The patient was admitted to the emergency room for the events, and she was treated with Tylenol and anti-nausea medicines. They did a bunch of bloodwork and everything was in normal range and chest X-ray which was clear, then the patient was discharged, and patient was not admitted to the hospital (reported that probably best for her to rest at home and told her to come back if it got worse). She was also seen by the hospital neurologist and musculoskeletal neurologist. They initially thought she had Guillain-Barre syndrome but were able to rule that out. She was home today and was still experiencing light headedness and dizziness. She can't really walk on her own and need to hold on to something to walk as her legs are weak. She has a follow up with a neurologist on 10Jun2021. The outcome of the events lump under arm pit, swollen lymph node, muscle weakness/ can't walk on her own and is extremely weak was not recovered, shakiness was recovered and the rest of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Tremor
Clinical narrative: Extreme dizziness/Light headedness; Muscle weakness/ can't walk on her own and is extremely weak; Muscle weakness/ can't walk on her own and is extremely weak; Muscle weakness/ can't walk on her own and is extremely weak; shakiness; Face completely swollen; Nausea; lump under arm pit, swollen lymph node; Low grade Fever; Chills; Night sweats; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0182, expiration date: 31Aug2021), via an unspecified route of administration in the left arm on 18May2021 at 14:15 (at the age of 35-year-old), at a 0.3 ml single dose for COVID-19 immunisation in hospital. The patient had no medical history and concomitant medications were not reported. The patient did not receive any vaccination within 4 weeks. Patient had no family history, but her husband got the vaccine and has not had any reactions. Everyone was fine. On 23May2021, the patient experienced lump under arm pit, swollen lymph nodes. She went to her general practitioner's office to check the lump and said it was normal from the vaccine and was swollen lymph nodes. On the same day overnight, she had fever/ low grade fever, chills, night sweats. On 24May2021, when she woke up, her face was completely swollen. She doesn't know if it was from the low grade fever. On the same day, she experienced nausea. On 25May2021, she experienced light headedness/extreme dizziness, muscle weakness/ can't walk on her own, was extremely weak and was shakiness. The patient was admitted to the emergency room for the events, and she was treated with Tylenol and anti-nausea medicines. They did a bunch of bloodwork and everything was in normal range and chest X-ray which was clear, then the patient was discharged, and patient was not admitted to the hospital (reported that probably best for her to rest at home and told her to come back if it got worse). She was also seen by the hospital neurologist and musculoskeletal neurologist. They initially thought she had Guillain-Barre syndrome but were able to rule that out. She was home today and was still experiencing light headedness and dizziness. She can't really walk on her own and need to hold on to something to walk as her legs are weak. She has a follow up with a neurologist on 10Jun2021. The outcome of the events lump under arm pit, swollen lymph node, muscle weakness/ can't walk on her own and is extremely weak was not recovered, shakiness was recovered and the rest of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Feeding disorder, Headache
Clinical narrative: skin itching/ skin itches; skin break out/ rash that spread in both arms; knot in the arm (hard ball) on the administration site; nauseous/sick to her stomach; upset stomach described as almost killing her; felt very Sleepy/ she is just in a sleepy mode; have to run back in forth popping all the time (diarrhea).; swollen administration site; felt very drain; got headaches like shot pain on the temporal on the right side; she has not been able to eat; Not feeling well/feel sick; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182; Expiration Date: Jul2021), via an unspecified route of administration on 18May2021 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 27Apr2021 (patient provided the numbers 1887 but could not read rest) (at the age of 63-year-old) as a single dose for COVID-19 immunisation. It was reported that patient had skin itching/skin itches and skin break out on 18May2021, knot in the arm (hard ball) on the administration site, swollen administration site, nauseous, upset stomach described as almost killing her, felt very drain, felt very sleepy/she was just in a sleepy mode, have to run back in forth popping all the time (diarrhea) all in 2021. She also additionally mentioned that she got headaches like shot pain on the temporal on the right side and she even have a rash that spread in both arms in 2021. She added that she had used Cortisone but that didn't worked. she mentions her stomach was nauseous, she hasn't been able to eat, and her skin was all broke out from the 2nd vaccine and it itches in 2021. Her arms have been itching as soon as she got the vaccine. Her skin broke out after she had the shot on 18May2021, she states she was still itchy and still broken out. She started putting cortisone on her arms and it did not work. patient clarified that was was a maximum strength cortisone 10 cream with aloe. patient verifies that the itching has not improved and was persisting. While probing the caller for event details she stated that all these questions were making her feel sick and sick to her stomach in 2021. patient states that she really was not feeling well in 2021. The outcome of the events pruritus and rash was reported as not recovered. The outcome of all other events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pruritus, Rash, Somnolence
Clinical narrative: skin itching/ skin itches; skin break out/ rash that spread in both arms; knot in the arm (hard ball) on the administration site; nauseous/sick to her stomach; upset stomach described as almost killing her; felt very Sleepy/ she is just in a sleepy mode; have to run back in forth popping all the time (diarrhea).; swollen administration site; felt very drain; got headaches like shot pain on the temporal on the right side; she has not been able to eat; Not feeling well/feel sick; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0182; Expiration Date: Jul2021), via an unspecified route of administration on 18May2021 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 27Apr2021 (patient provided the numbers 1887 but could not read rest) (at the age of 63-year-old) as a single dose for COVID-19 immunisation. It was reported that patient had skin itching/skin itches and skin break out on 18May2021, knot in the arm (hard ball) on the administration site, swollen administration site, nauseous, upset stomach described as almost killing her, felt very drain, felt very sleepy/she was just in a sleepy mode, have to run back in forth popping all the time (diarrhea) all in 2021. She also additionally mentioned that she got headaches like shot pain on the temporal on the right side and she even have a rash that spread in both arms in 2021. She added that she had used Cortisone but that didn't worked. she mentions her stomach was nauseous, she hasn't been able to eat, and her skin was all broke out from the 2nd vaccine and it itches in 2021. Her arms have been itching as soon as she got the vaccine. Her skin broke out after she had the shot on 18May2021, she states she was still itchy and still broken out. She started putting cortisone on her arms and it did not work. patient clarified that was was a maximum strength cortisone 10 cream with aloe. patient verifies that the itching has not improved and was persisting. While probing the caller for event details she stated that all these questions were making her feel sick and sick to her stomach in 2021. patient states that she really was not feeling well in 2021. The outcome of the events pruritus and rash was reported as not recovered. The outcome of all other events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.