chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain, Vertigo, Vision blurred
Clinical narrative: vision problems (blurriness and sensitivity like a bright light is being shined directly into your eyes).; vision problems (blurriness and sensitivity like a bright light is being shined directly into your eyes).; Vertigo; shaking and twitching (I'm not cold); shaking and twitching (I'm not cold); Pain at the injection sight; mild head ache; fatigue; This is a spontaneous report from a contactable other health professional (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 19Jul2021 18:00 (Lot Number: ER8736; at the age of 40-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included allergy to onion and lavender. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 20Jul2021 07:00, the patient experienced vertigo and vision problems (blurriness and sensitivity like a bright light is being shined directly into your eyes); was shaking and twitching (I'm not cold as reported). The other symptoms were normal side effects like pain at the injection sight, mild head ache, and a little fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Blurring of vision was considered medically significant. Therapeutic measures were taken as the result of the events which included treatment with Zofran; blood test (to be scheduled). The patient also had Covid-19  test on 21Jul2021 which came negative. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported blurring of vision cannot be excluded based on temporal relationship. 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Disturbance in attention, Dizziness, Headache, Swelling
Clinical narrative: The vaccine patient has experienced headaches, loss of focus and vertigo/ Most troubling is the vertigo; Now after the vaccine patient has experienced headaches; The vaccine patient has experienced headaches, loss of focus; Most troubling is the vertigo and dizziness/ dizziness all the time; Swelling and pain in left armpit area; severe soreness for 5days (14Jul-19).; Swelling and pain in left armpit area; As of today, 26Jul site of injection is still sore to the touch; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA6780), intramuscular, administered in arm left on 14Jul2021 (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. Medical history included vertigo [Prior to vaccine suffered mild vertigo sometimes (seldom)] and COVID-19 (if_covid_prior_vaccination: yes) from an unknown date. There were no concomitant medications. On 14Jul2021, the patient experienced swelling and pain in left armpit area; severe soreness for 5days (14Jul-19). As of today, 26Jul site of injection is still sore to the touch. Most troubling is the vertigo and dizziness. Prior to vaccine, suffered mild vertigo sometimes (seldom); now after the vaccine patient has experienced headaches, loss of focus and vertigo/dizziness all the time. There was no treatment received for the events. The event 'The vaccine patient has experienced headaches, loss of focus and vertigo/ Most troubling is the vertigo' was assessed as serious and medically significant by the regulatory authority. The outcome of the event Armpit pain was recovered on 19Jul2021, while of the rest was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vertigo
Clinical narrative: The vaccine patient has experienced headaches, loss of focus and vertigo/ Most troubling is the vertigo; Now after the vaccine patient has experienced headaches; The vaccine patient has experienced headaches, loss of focus; Most troubling is the vertigo and dizziness/ dizziness all the time; Swelling and pain in left armpit area; severe soreness for 5days (14Jul-19).; Swelling and pain in left armpit area; As of today, 26Jul site of injection is still sore to the touch; This is a spontaneous report from a non-contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA6780), intramuscular, administered in arm left on 14Jul2021 (at the age of 54-years-old) as dose 1, single for COVID-19 immunisation. Medical history included vertigo [Prior to vaccine suffered mild vertigo sometimes (seldom)] and COVID-19 (if_covid_prior_vaccination: yes) from an unknown date. There were no concomitant medications. On 14Jul2021, the patient experienced swelling and pain in left armpit area; severe soreness for 5days (14Jul-19). As of today, 26Jul site of injection is still sore to the touch. Most troubling is the vertigo and dizziness. Prior to vaccine, suffered mild vertigo sometimes (seldom); now after the vaccine patient has experienced headaches, loss of focus and vertigo/dizziness all the time. There was no treatment received for the events. The event 'The vaccine patient has experienced headaches, loss of focus and vertigo/ Most troubling is the vertigo' was assessed as serious and medically significant by the regulatory authority. The outcome of the event Armpit pain was recovered on 19Jul2021, while of the rest was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Very minor temporary muscle soreness at the upper arm area of the second shot; This is a spontaneous report from a contactable consumer (patient). A 74-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 74-year-old), dose 2 via an unspecified route of administration, administered in Arm on 28Feb2021 as dose 2, single for covid-19 immunisation. Medical history included asthma (I have asthma (well controlled), in overall very good health). The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 07Feb2021 for covid-19 immunization and No reaction on previous exposure to vaccine. The patient reported, very minor temporary muscle soreness at the upper arm area of the second shot (in the opposite arm of the first shot) on an unspecified date in 2021. Wished to participate in Covid-19 booster shot trial if/when it may occur. Outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Vaccine is causing issues with my arthritis; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA6780, Expiration date was unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 Immunization. Patient stated, I just wanted to, I was not sure if I was actually having side effects from the vaccine or if it was just because of my physical issues. I was almost sure that the vaccine was caused issues with my arthritis and I just wanted to let you guys know about it. I did not know if that was something to be concerned about or I should just report any possible side effects. Patient stated, I had got both of them, but I did not have any issues until after the second one. The outcome of event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: cardiac side effects; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A non-contactable consumer reported for a patient (friend of friend). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced cardiac side effects. The reporter stated I have several medication allergies and trying to determine if those anaphylactic reaction to those medication; predispose me to have a reaction with the Pfizer covid vaccine. My pharmacist told me to call you and give you medications I'm allergic to and to check on any cross reaction. What if I have an anaphylactic reaction after the first does. I know someone who had a bad reaction after the first dose. Immediately after the Pfizer covid vaccine the person had cardiac side effects (it was a friend of a friend). I had a side effect after the first dose of the vaccine. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The clinical outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951798 same reporter/ drug, different AE/ patient
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nervous system disorder
Clinical narrative: Neurological side effects.; So debilitated; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program. A young female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer covid vaccine in Feb2021 and she was so debilitated after the vaccine. Six months later she had neurological side effects. The events were reported as non-serious. The outcome of both the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951798 same reporter/ drug, different AE/ patient
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Nausea
Clinical narrative: Abdominal Pain; Nausea; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 02Jul2021 at 16:30 (at the age of 20-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 23Jul2021 at 16:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and migraine. The patient was allergic to cephalosporin. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), and paracetamol (TYLENOL) for migraine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Jul2021 at 08:00, the patient experienced abdominal pain, nausea, headache and fatigue. The clinical outcome of the events abdominal pain, nausea, headache and fatigue was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea
Clinical narrative: Having abdominal symptom; Mid abdomen, he is having this discomfort almost like a short pain usually on activities, so if he like stand up and does that he is getting abdominal pain; If he tries to be active and move around he gets some short pain in his abdomen and he feels very nauseated; This is a spontaneous report from a contactable consumer (Patient's parent). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA7485, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration Date: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient was having abdominal symptom; mid abdomen, he was having this discomfort almost like a short pain usually on activities, so if the patient like stood up and does that the patient was getting abdominal pain. So, if the patient just sat and doesn't move, it got a little bit better if the patient tried to be active and moved around the patient gets some short pain in the abdomen and the patient feels very nauseated. When probed if the consumer wanted some medical assistance regarding the same, reporter stated, the reporter was just trying to, was not sure, the reporter tried to call doctor's office but they were very busy on that day, so the reporter had not received a call back yet. The outcome of the events was unknown.  The lot number for the bnt162b2 vaccine was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Pain in extremity, Poor quality sleep
Clinical narrative: Both arms and legs are stiff, sore, and cramping; Both arms and legs are stiff, sore, and cramping; Both arms and legs are stiff, sore, and cramping; wakes me up at night with pain/soreness; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 21Jul2021 at 14:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. Concomitant medications included unspecified medicine from an unknown date for blood pressure abnormal and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jul2021 at 00:00, the patient experienced both arms and legs were stiff, sore, and cramping which wakes him up at night with pain/soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with pain reliever every 4-6 hours every day. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events both arms and legs were stiff, sore, and cramping was not recovered at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure timing unspecified, Pain
Clinical narrative: She is pregnant and is fully vaccinated; She did go see her family doctor for the pain she was having; This is a spontaneous report received from Pfizer Sponsored Program. A contactable pregnant female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date it was mentioned that patient was pregnant and was fully vaccinated (Maternal drug exposure). She wanted to know if the side effects for normal people was the same for pregnant women. She did go see her family doctor for the pain she was having. After she got her information someone in the back told her to disconnect. The outcome of maternal drug exposure was unknown and pain was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Post herpetic neuralgia
Clinical narrative: Exacerbation of postheretic neuralgia; This is a spontaneous report from a contactable Physician. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN9581), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. It was reported that he did not received any other vaccine within 4 weeks. He was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On an unspecified date, the patient experienced exacerbation of postherpetic neuralgia. It was stated that, patient had received the treatment for the event Gabapentin. Patient had visited physician office. The seriousness of the event was considered as non-serious. The outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision in the right eye; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received single dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 21Jul2021 (Batch/Lot Number: EW0198) as, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blurred vision in the right eye on an unspecified date. The outcome of the event was unknown.
Sex: F
Vaccine: UNK
Symptoms: Heavy menstrual bleeding
Clinical narrative: after getting her 2nd dose of the Covid vaccine she has been bleeding a lot; wanting to know if there is an interaction between Depo Provera and the Covid vaccine.; 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 second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 2, single for covid-19 immunisation; medroxyprogesterone acetate (DEPO-PROVERA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. On an unspecified date the patient experienced after getting her 2nd dose of the covid vaccine she has been bleeding a lot, wanting to know if there is an interaction between depo provera and the covid vaccine. Reporter is on Depo Provera and noticed that after getting her 2nd dose of the Covid vaccine she has been bleeding a lot. She is wanting to know if there is an interaction between Depo Provera and the Covid vaccine. Action taken for medroxyprogesterone acetate (DEPO-PROVERA) was unknown. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Lymph node pain, Pain
Clinical narrative: burning pain under her arms and pointed out lymph nodes; burning pain under her arms and pointed out lymph nodes; burning pain under her arms and pointed out lymph nodes; This is a spontaneous report from a contactable consumer (patient caregiver) and Pfizer-sponsored program  Support (NCSP Id: 159558).  A 30-years-old female patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: Unknown) (age at the time of vaccination was 30-years-old) administered via unspecified route of administration, as Dose 1 Single, on 24Jun2021 for Covid-19 immunisation.The patient's medical history and concomitant medications were not reported.The patient experienced burning pain under her arms and pointed out lymph nodes on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Tenderness, Vaccination site pain
Clinical narrative: sharp pain under her arm/a very sharp piercing pain in her armpit, under the same arm that she received the injection in; soreness in the injection site; it was so swollen that she couldn't feel the pea size lymph node; The caller's armpit on the side where she had her injection it was throbbing; tenderness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 26Jun2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, she got her first dose of the Pfizer Covid 19 vaccine last 26Jun2021. Day after her first dose she woke up with a sharp pain under her arm. She said that when she researched it, she thinks that it swollen lymph node. There was pain and tenderness. She took Advil. Each day it got better and it was almost gone after 2 weeks. By the day that she was scheduled to get her second dose the lymph node went to her other arm. She stated that her arm was super sore arm when touching. It got better each day and now it's okay. The caller also had a very sharp piercing pain in her armpit, under the same arm that she received the injection in. The caller researched it and it may have been a swollen lymph node but everything she read said it may be tender and you may feel it. But for the caller, it was so swollen that she couldn't feel the pea size lymph node. At about 2 weeks the caller's armpit was tender when she touched it. 3 weeks after the first dose, the caller had a pain on the other side under her arm. The caller was nervous to get the second dose because of this. The soreness under her opposite arm wasn't as bad and subsided each day. The caller's armpit on the side where she had her injection it was throbbing. A few days before the caller was scheduled for the second dose her opposite armpit was very tender but not as sharp and piercing and she could feel the pea. Outcome of events was recovering.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Decreased appetite, Dysphagia, Gastric disorder, Headache
Clinical narrative: she was hurting everywhere whole body, muscles arms legs; swollen neck left side down to shoulder; nauseous; can't eat, hard to swallow; feeling sick; every organ feels like it is inflamed; her stomach is doing numbers/stomach issues; Headache; she has no appetite; swelling has gone down in neck, the  swelling in my gut, underneath my boobs; This is a spontaneous report form a contactable consumer (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0165) via unknown route of administration on 22Jul2021 18:00 as dose 2 single in left arm for COVID-19 immunization. Medical history included Bouts of Colitis (Scared that she has her Colitis Inflammed), Osteopenia, Nonalcoholic fatty liver disease all ongoing. Prior Vaccinations (within 4 weeks) were none. Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) on 01Jul2021 in left arm for COVID-19 immunization. It was reported that patient received her 2nd dose of the Pfizer covid-19 vaccine on Thursday, 22Jul2021, Friday evening she was hurting everywhere whole body, muscles arms legs, swollen neck left side down to shoulder, so nauseous and can't eat, hard to swallow feel like every organ was inflamed and her stomach was doing numbers, now Tuesday still feeling sick are these normal reactions or side effects and how long they should last? Should she go to the hospital? patient stated, that regarding her throat she was so nauseous she can't swallow and she has no appetite, not related to a restriction in her throat, just when she gets real nauseous. The swelling has gone down in neck, the swelling in my gut, underneath my boobs, I feel like everything was inflamed." patient stated it was persisting, especially the inflammation, headache, and stomach issues. Treatment received included Celebrex 200mg for inflammation, Zofran 8mg for nausea, 81mg Aspirin every night. The outcome of events was not recovered.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Malaise, Nausea, Pain, Swelling
Clinical narrative: she was hurting everywhere whole body, muscles arms legs; swollen neck left side down to shoulder; nauseous; can't eat, hard to swallow; feeling sick; every organ feels like it is inflamed; her stomach is doing numbers/stomach issues; Headache; she has no appetite; swelling has gone down in neck, the  swelling in my gut, underneath my boobs; This is a spontaneous report form a contactable consumer (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0165) via unknown route of administration on 22Jul2021 18:00 as dose 2 single in left arm for COVID-19 immunization. Medical history included Bouts of Colitis (Scared that she has her Colitis Inflammed), Osteopenia, Nonalcoholic fatty liver disease all ongoing. Prior Vaccinations (within 4 weeks) were none. Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8733) on 01Jul2021 in left arm for COVID-19 immunization. It was reported that patient received her 2nd dose of the Pfizer covid-19 vaccine on Thursday, 22Jul2021, Friday evening she was hurting everywhere whole body, muscles arms legs, swollen neck left side down to shoulder, so nauseous and can't eat, hard to swallow feel like every organ was inflamed and her stomach was doing numbers, now Tuesday still feeling sick are these normal reactions or side effects and how long they should last? Should she go to the hospital? patient stated, that regarding her throat she was so nauseous she can't swallow and she has no appetite, not related to a restriction in her throat, just when she gets real nauseous. The swelling has gone down in neck, the swelling in my gut, underneath my boobs, I feel like everything was inflamed." patient stated it was persisting, especially the inflammation, headache, and stomach issues. Treatment received included Celebrex 200mg for inflammation, Zofran 8mg for nausea, 81mg Aspirin every night. The outcome of events was not recovered.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Eye swelling, Ocular hyperaemia, Periorbital swelling
Clinical narrative: Red, sore, swollen, itchy puffy eyes; Red, sore, swollen, itchy puffy eyes; Red, sore, swollen, itchy puffy eyes; Itchy puffy eyes; Puffy eyes; Puffy face; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 26Jul2021 at 10:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included leg and knee pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medications in two weeks of vaccination. The patient previously took levofloxacin (LEVAQUIN) on unknown date for an unspecified indication and experienced drug allergy. On 26Jul2021 at 23:00, the patient experienced red, sore, swollen, itchy puffy eye and puffy face. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red, sore, swollen, itchy puffy eye and puffy face were not resolved at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Red, sore, swollen, itchy puffy eyes; Red, sore, swollen, itchy puffy eyes; Red, sore, swollen, itchy puffy eyes; Itchy puffy eyes; Puffy eyes; Puffy face; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 26Jul2021 at 10:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included leg and knee pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medications in two weeks of vaccination. The patient previously took levofloxacin (LEVAQUIN) on unknown date for an unspecified indication and experienced drug allergy. On 26Jul2021 at 23:00, the patient experienced red, sore, swollen, itchy puffy eye and puffy face. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red, sore, swollen, itchy puffy eye and puffy face were not resolved at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Endoscopy upper gastrointestinal tract, Impaired gastric emptying, Inappropriate schedule of product administration
Clinical narrative: Gastroparesis; abdominal pain; administration date: 09May2021/dose number: 1/vaccine date: 09May2021/dose number: 2; This is a spontaneous report from a non-contactable consumer. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09May2021 15:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included allergy. There were no concomitant medications.  The patient experienced gastroparesis on 18Jun2021 21:00 with outcome of not recovered, administration date: 09May2021/dose number: 1/vaccine date: 09May2021/dose number: 2 on 09May2021, abdominal pain 3 weeks after second shot on 18Jun2021 21:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included computerised tomogram: unknown results, endoscopy upper gastrointestinal tract: unknown results, ultrasound scan: unknown results.  Therapeutic measures were taken as a result of gastroparesis and abdominal pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Gastroparesis; abdominal pain; administration date: 09May2021/dose number: 1/vaccine date: 09May2021/dose number: 2; This is a spontaneous report from a non-contactable consumer. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09May2021 15:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 09May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included allergy. There were no concomitant medications.  The patient experienced gastroparesis on 18Jun2021 21:00 with outcome of not recovered, administration date: 09May2021/dose number: 1/vaccine date: 09May2021/dose number: 2 on 09May2021, abdominal pain 3 weeks after second shot on 18Jun2021 21:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included computerised tomogram: unknown results, endoscopy upper gastrointestinal tract: unknown results, ultrasound scan: unknown results.  Therapeutic measures were taken as a result of gastroparesis and abdominal pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myocarditis
Clinical narrative: stated that he was diagnosed with myocarditis; stated that he is weak; This is a spontaneous report from a contactable consumer. The report from a 25-year-old male patient received bnt162b2 (Pfizer Covid 19 vaccine), single dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. The patient experienced stated that he was diagnosed with myocarditis (hospitalization) on an unspecified date with outcome of unknown, stated that he is weak on an unspecified date with outcome of unknown. Dates when patient was in hospital for stated that he was diagnosed with myocarditis was Unspecified. Caller stated that they wanted information. Stated that patient was hospitalized after the second administration of Pfizer vaccine. Stated that he was diagnosed with myocarditis. Wanted to know if there was any support for men diagnosed with that. Stated that it was quite expensive and confusing. Is for the Pfizer Covid 19 vaccine. Stated that he was weak. Stated that he was just released yesterday.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Lung disorder, Pulmonary oedema, Pulmonary pain
Clinical narrative: pain at the right side of his lungs and he doesn't know if it was piling up with fluids and this had been bothering him; pain at the right side of his lungs and he doesn't know if it was piling up with fluids and this had been bothering him; when he stretches, he feels like " his right lung is scratching up against something and that it was temperature sensitive; when he stretches, he feels like " his right lung is scratching up against something and that it was temperature sensitive; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Jul2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received pneumococcal shot (over 65 flu type) on unspecified date in 2021 and experienced he had a little pain, then after 3-4 weeks took Pfizer COVID-19 vaccine. The patient had the first dose of the Pfizer BioNTech COVID-19 vaccine last 03Jul2021, stated that he was given a "Pulmonary Flu Shot" a month and a half before. He mentioned that on Jul2021 he had experienced pain at the right side of his lungs and he doesn't know if it was piling up with fluids and this had been bothering him. He also mentioned that when he stretches, he feels like "his right lung is scratching up against something and that it was temperature sensitive". It was said that if it's hot, he could take his shirt off and then the pain would seize. Patient wanted to know if these had been reported as side effect with the Pfizer BioNTech COVID-19 vaccine. Patient called about symptomatic stuff to ask what happens if you have certain actions. He said "you know a little before the 19 started", he was breathing normally then something took his right lung, he doesn't know what or how. He said for 6-8 months at night when he turned over it would wake him up. He said one of the things he did before anything else was he took the pneumococcal thing, the over 65 flu type, he took that, then after 3-4 weeks from there, he took the Pfizer flu shot and he was wondering if he should wait a bit longer than three months or three weeks for the second. He said after the pneumococcal shot he had a little pain, he thought before that he must have been exposed to that flu, he didn't know if he has it now, it has subsided. He said he was supposed to go get the second shot, he wanted to know if he was supposed to have any other interference with it. Patient said on the back page it said it was a low situation. Patient clarified that he had his Pfizer first shot, "GT19 or the 19 ". Patient clarified he meant the Pfizer COVID-19 vaccine. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pruritus, Urticaria
Clinical narrative: Itchy scalp; Hives; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm at the age of 68-years-old on 24Mar2021 (Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included stomach acid reflux and cholesterol. Concomitant medications included omeprazole taken for stomach acid reflux; atorvastatin taken for cholesterol; salmon oil.  The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on left side on unknown date (Lot Number: EN6205) as single dose for covid-19 immunisation. Caller stated they took all his information and told him to call this number and select option 3. Caller stated he received his second dose on 24Mar2021 and then a month later(in Apr2021) started having hives and an itchy scalp(scalp started getting itchy). Caller stated he had had it for three months and its getting better but he cannot rid of it 100%. Caller stated he had been to the doctor and was prescribed something to put on it but it had not gone away completely. Caller would like to know if his side effect had been reported by anyone else and if its related to the vaccine? He said that he felt good now but he still has hives and itchy scalp. Caller stated so that's why he was calling to see if this side effect could be related to the vaccine. Caller wanted to know if the side effect was normal, how long does it last and what can he do to get rid of it? Caller stated he didn't know what else it could be coming from and his doctor doesn't know either. Consumer stated  he had a blood test but everything was fine.(The blood test was probably about two week ago, in 2021).  The doctor said it was good.  The outcome of the events was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Back pain, Chest pain, Cough, Dyspnoea
Clinical narrative: anaphylaxis; mid-back pain; coughing; wheezing; SOB; severe pain in chest; flushing and itching immediately; itching; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 27Apr2021 15:15 (Batch/Lot Number: ER8733) (at age 49-years-old) as dose 1, single for covid-19 immunisation. Medical history included kidney stones, chronic migraines, sinusitis, numerous food/environmental allergies and penicillin allergies. Concomitant medications included ZYRTEC, TOPAMAX, spironolactone, VITAMIN D, and BENADRYL, all taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalasporins, oral Diflucan, clindamycin, PEG, Polysorbate, Propylene glycol, sulfa, Levaquin and experienced allergies. The patient had known allergies to polysorbate, polyethylene glycol, and propylene glycol, but patient was approved for vaccine with pre-meds of Benadryl to take 45 min prior to Pfizer vaccine in hospital setting. Nurse observed her for 1 hour after. ER was next to room. Patient experienced flushing, itching immediately on 27Apr2021, and was given oral Benadryl 5-10 min after shot. She went home, slept for 3-4 hours and woke up with mid-back pain and starting coughing, wheezing, and SOB on 27Apr2021 20:45. She was unable to catch her breath. Patient recognized symptoms of anaphylaxis. She was advised to return to ER if she had any symptoms and she returned to ER immediately. She had to explain to ER staff/docs that she had covid vaccine earlier and this was a reaction, but staff and doctor stated it would have happened immediately. Patient had to re-explain that she was pre-medicated with Benadryl prior to vaccine due to allergies and after meds wore off, she experienced anaphylaxis on 27Apr2021 20:45. Patient had a very hard time with non-stop coughing for over an hour, shortness of breath, wheezing, and severe pain in chest and back. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment included additional medications/ steroid given in ER. Outcome of the events was recovered with sequel. Patient was diagnosed with COVID-10 prior to vaccination and had been tested post-vaccination on 24Mar2021: negative.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, SARS-CoV-2 test, Wheezing
Clinical narrative: anaphylaxis; mid-back pain; coughing; wheezing; SOB; severe pain in chest; flushing and itching immediately; itching; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 27Apr2021 15:15 (Batch/Lot Number: ER8733) (at age 49-years-old) as dose 1, single for covid-19 immunisation. Medical history included kidney stones, chronic migraines, sinusitis, numerous food/environmental allergies and penicillin allergies. Concomitant medications included ZYRTEC, TOPAMAX, spironolactone, VITAMIN D, and BENADRYL, all taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalasporins, oral Diflucan, clindamycin, PEG, Polysorbate, Propylene glycol, sulfa, Levaquin and experienced allergies. The patient had known allergies to polysorbate, polyethylene glycol, and propylene glycol, but patient was approved for vaccine with pre-meds of Benadryl to take 45 min prior to Pfizer vaccine in hospital setting. Nurse observed her for 1 hour after. ER was next to room. Patient experienced flushing, itching immediately on 27Apr2021, and was given oral Benadryl 5-10 min after shot. She went home, slept for 3-4 hours and woke up with mid-back pain and starting coughing, wheezing, and SOB on 27Apr2021 20:45. She was unable to catch her breath. Patient recognized symptoms of anaphylaxis. She was advised to return to ER if she had any symptoms and she returned to ER immediately. She had to explain to ER staff/docs that she had covid vaccine earlier and this was a reaction, but staff and doctor stated it would have happened immediately. Patient had to re-explain that she was pre-medicated with Benadryl prior to vaccine due to allergies and after meds wore off, she experienced anaphylaxis on 27Apr2021 20:45. Patient had a very hard time with non-stop coughing for over an hour, shortness of breath, wheezing, and severe pain in chest and back. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment included additional medications/ steroid given in ER. Outcome of the events was recovered with sequel. Patient was diagnosed with COVID-10 prior to vaccination and had been tested post-vaccination on 24Mar2021: negative.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Arm tenderness; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 26Jul2021 at 10:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included vertigo and COVID-19. Concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jul2021 at 16:00, the patient experienced arm tenderness, headache and fatigue. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events arm tenderness, headache and fatigue was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.