chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Palpitations, Pharyngeal oedema, Pruritus, Swelling face
Clinical narrative: swollen throat; Difficulty breathing; Dizzy; scratching  from head to toe; swollen face; heart rate was faster than normal; more palpitations than normal; light head headache; Shivering; thought she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on 28Mar2021 at 11:00 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen throat, difficulty breathing, dizzy, scratching  from head to toe, swollen face, heart rate was faster than normal, more palpitations than normal, light head headache, shivering and she thought she was getting the flu on an unknown date, reported as a late reaction after the vaccine (received the vaccine a week ago). The clinical outcome of the events swollen throat, difficulty breathing, dizzy, scratching  from head to toe, swollen face, heart rate was faster, more palpitations, headache, shivering and flu was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable consumer (patient's wife). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in Mar2021 (Lot Number: EP7534) on left arm at single dose for COVID-19 immunization. Ongoing medical history included patient was diagnosed with congestive heart failure probably 10 years ago, was diagnosed with diabetes probably 20 years ago, had been undergoing dialysis for 3.5 years. Concomitant mediation included a blood thinner. The patient experienced fatigue after the first dose of the Covid-19 vaccine in 2021. It was hard to determine the cause of the fatigue because the patient was on dialysis, but that the patient had been more fatigued since he received the first dose of the Covid-19 vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Sinus disorder
Clinical narrative: tested positive for Covid19/ear, neck, and throat feeling yucky; Caller explains her daughter has been experiencing sinus issues; This is a spontaneous report from a contactable consumer (Parent) via medical information team.  A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 27Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has been experiencing sinus issues, ear, neck, and throat feeling yucky on an unknown date in 2021. Her doctor told her to get tested and she was positive. On 05Apr2021, the patient was tested positive for COVID-19. Reporter informs that the patient is due to receive second dose and enquires whether patient should receive or not. Reporter read a new study that said to wait 21 days after your dose and others say to go ahead with your scheduled next dose. Reporter would like clarification. The outcome of the event COVID-19 was not recovered and other event was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Vaccination site swelling
Clinical narrative: swelling at the injection site; Had covid in February; Had covid in February; This is a spontaneous report from a contactable other HCP (Patient). A 78-years-old female patient received BNT162B2 (BNT162B2), formulation: Solution for injection, Lot Number: EL9269), dose 1st via an unspecified route of administration, administered in Left arm on 08Feb2021 as single dose for COVID-19 immunisation. The patient medical history included infectious thyroiditis from 2014 to an unknown date thyroid removed in 2014 or 2017, lymph node abscess from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing, immune system disorder from an unknown date and unknown if ongoing, respiration abnormal from an unknown date and unknown if ongoing, cytogenetic abnormality from an unknown date and unknown if ongoing, endocrine disorder from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing obesity from an unknown date and unknown if ongoing, covid-19 from Feb2020 to an unknown date. Concomitant medication(s) included azithromycin (AZITHROMYCIN) taken for an unspecified indication, start and stop date were not reported; thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced had covid in february (drug ineffective) (medically significant) on an unspecified date with outcome of unknown, had covid in february (covid-19) (medically significant) on Feb2020 with outcome of unknown, swelling at the injection site (vaccination site swelling) (non-serious) on an unspecified date with outcome of unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reassessed should the additional information be available. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first and second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced ringing in ears on an unspecified date. States that 2 other friends have gotten ringing in the ears as well after the vaccine and she is not sure if Pfizer has had reports of that. States that she wanted to report this. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective
Clinical narrative: Ended up testing positive for COVID-19/showing no symptoms; Ended up testing positive for COVID-19/showing no symptoms; This is a spontaneous report received from a contactable male consumer. A patient of an unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), at an unspecified dosage via unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date, the reporter stated that he was around someone who ended up testing positive for COVID-19 on saturday. He mentions that this person had their shots already but because his wife had it, he wanted to get tested as well, despite showing no symptoms. The caller also reports that he himself has gotten tested but has not gotten his results yet. The caller would like to know if he is still okay to receive his second dose following this exposure to COVID-19. The outcome of event was unknown. Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after both vaccines; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose, dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. he patient medical history and concomitant medications were not reported. Patient mentions that she had a sore arm after both doses of the COVID 19 vaccine. Outcome of the event was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Sleepy; arm sore; This is a spontaneous report from Pfizer-sponsored support program via a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry 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 unspecified date in 2021, only problem the patient had was that his arm was sore, and he was sleepy the next day. He took the first dose of the COVID Pfizer vaccine but that the second one he forgot about. and due date was the 19Mar2021. He was given a card, but he was half sleep when he went over there and wants to know if it was ok to take the second vaccine this late. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Vertigo
Clinical narrative: hearing loss in her right ear; Vertigo; Lightheadedness; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm  on 22Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  On 22Mar2021, the patient experienced hearing loss in her right ear, vertigo, lightheadedness. The clinical course was as follows: Patient says she received her first dose of the Pfizer COVID-19 vaccine the 22Mar2021 and she has some questions. She says she had hearing loss in her right ear after the first shot which she got in her right arm. She says she also had vertigo, is that a side effect? She says she is still feeling lightheaded, and she has been taking Tylenol, and she doesn't know why her hearing went away. She says she also used some sweet oil that she sometimes used years ago like her mom used to use, to see if it would clear up. She asks is this a side effect and should she get the second dose? The outcome of the events was not reported.  Information on the lot/Batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica, SARS-CoV-2 test
Clinical narrative: polymyalgia rheumatica after second vaccination/unable to move without pain/first sign was arm pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE , solution for injection, Batch/Lot Number: EL32247), via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 69-years-old) as single dose for COVID-19 immunisation. The vaccine was administered to the patient at a workplace clinic. The patient had no other vaccine in four weeks. Medical history included type 2 diabetes and high blood pressure. The patient's concomitant medications were not reported.  The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3247) administered in the left arm on 14Jan2021 at 01:00 pm (at the age of 68-years-old) for COVID-19 immunisation. The patient previously took lisinopril and experienced allergies.  The patient reported he was unable to move without pain. He had polymyalgia rheumatica after second vaccination on 09Feb2021 which resulted in doctor or other healthcare professional office/clinic visit. Patient was given naproxen (ALEVE) as treatment. It was reported that the first sign was arm pain on 09Feb2021. The patient denied COVID prior to vaccination. The patient undergone COVID testing: nasal swab post vaccination on 26Feb2021 and yielded negative result. Outcome of the event was not recovered.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test
Clinical narrative: Caller also had double pneumonia.; both contracted covid, caller tested positive; This is a spontaneous report received from a contactable consumer. A 59-year-old male patient received, first dose  of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown and expiry date was not provided), via an unspecified route of administration on 18Mar2021, as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not provided. The patient reported that he contracted with covid on 25Mar2021 and had double pneumonia. On 25Mar2021, the patient underwent lab test and found positive with Covid-19. The patient wanted to know if he can take the second dose.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Caller also had double pneumonia.; both contracted covid, caller tested positive; This is a spontaneous report received from a contactable consumer. A 59-year-old male patient received, first dose  of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown and expiry date was not provided), via an unspecified route of administration on 18Mar2021, as single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not provided. The patient reported that he contracted with covid on 25Mar2021 and had double pneumonia. On 25Mar2021, the patient underwent lab test and found positive with Covid-19. The patient wanted to know if he can take the second dose.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: on 20Mar2021  (day 25) they contacted covid; on 20Mar2021  (day 25) they contacted covid; This is a spontaneous report received from a contactable consumer, the patient. This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose  1, single dose via an unspecified route of administration on 24Feb2021 for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported. On 20Mar2021, the patient contracted COVID. The event was reported as non-serious. Quarantine was completed and the patient returned to work. The patient wanted to know when she could have the second dose and her doctor told her to wait for 90 days. The clinical outcome of contracted COVID was recovered on an unknown date.    No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021388404 Same reporter/drug/AE, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Decreased appetite, Dizziness, Inappropriate schedule of product administration, Insomnia
Clinical narrative: My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so bad I cannot drive; Eyes are blurry; Nausea; Couldn't keep food down; Dizzy; can't get balance; Couldn't sleep for five days; Sore throat; runny nose; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (Lot Number: SJCFR EN 6199) on 24Mar2021 09:00 as single dose, and dose 2 (Lot Number: En6199) on 24Mar2021 (to be confirmed) as single dose, both via an unspecified route of administration, administered in left arm for covid-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID prior vaccination. She has not been tested for COVID after vaccination. On 31Mar2021, the patient reported that her ears were ringing constantly, her eyesight changed, and she couldn't see out of her glasses. Her eyes were blurry, and vision was so bad she cannot drive. She had nausea for a week straight. She also couldn't keep food down. She was dizzy and couldn't get balance. She also couldn't sleep for five days. She also had sore throat, and runny nose for a week. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and has caused disability or permanent damages. Treatment for the events included prednisone and anti-nausea medicine. The outcome of the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Oropharyngeal pain, Rhinorrhoea, Tinnitus
Clinical narrative: My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so bad I cannot drive; Eyes are blurry; Nausea; Couldn't keep food down; Dizzy; can't get balance; Couldn't sleep for five days; Sore throat; runny nose; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (Lot Number: SJCFR EN 6199) on 24Mar2021 09:00 as single dose, and dose 2 (Lot Number: En6199) on 24Mar2021 (to be confirmed) as single dose, both via an unspecified route of administration, administered in left arm for covid-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID prior vaccination. She has not been tested for COVID after vaccination. On 31Mar2021, the patient reported that her ears were ringing constantly, her eyesight changed, and she couldn't see out of her glasses. Her eyes were blurry, and vision was so bad she cannot drive. She had nausea for a week straight. She also couldn't keep food down. She was dizzy and couldn't get balance. She also couldn't sleep for five days. She also had sore throat, and runny nose for a week. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and has caused disability or permanent damages. Treatment for the events included prednisone and anti-nausea medicine. The outcome of the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: My ears are ringing constantly; My eyesight changed and I can't see out of my glasses./vision is so bad I cannot drive; Eyes are blurry; Nausea; Couldn't keep food down; Dizzy; can't get balance; Couldn't sleep for five days; Sore throat; runny nose; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; 1st dose: 24Mar2021, 2nd dose: 24Mar2021; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (Lot Number: SJCFR EN 6199) on 24Mar2021 09:00 as single dose, and dose 2 (Lot Number: En6199) on 24Mar2021 (to be confirmed) as single dose, both via an unspecified route of administration, administered in left arm for covid-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID prior vaccination. She has not been tested for COVID after vaccination. On 31Mar2021, the patient reported that her ears were ringing constantly, her eyesight changed, and she couldn't see out of her glasses. Her eyes were blurry, and vision was so bad she cannot drive. She had nausea for a week straight. She also couldn't keep food down. She was dizzy and couldn't get balance. She also couldn't sleep for five days. She also had sore throat, and runny nose for a week. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and has caused disability or permanent damages. Treatment for the events included prednisone and anti-nausea medicine. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient mentioned that she had COVID-19 a few weeks ago; patient mentioned that she had COVID-19 a few weeks ago; This is a spontaneous report from a contactable consumer (patient, self-reported).   A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unknown date, the patient mentioned that she had COVID-19 a few weeks ago. Outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Nerve injury, SARS-CoV-1 test, Vertigo
Clinical narrative: Cannot drive, not feeling safe taking care of my child, have a hard time reading and working due to the dizziness; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; This is a spontaneous report from a contactable consumer (patient). This 38- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 01Apr2021 at 02:00 pm (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a Public Health Clinic facility and anatomically located on the left arm.  Allergies to medications: CIPRO. The medical history and concomitant medications were not reported. 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 vaccination. On 01APR2021 01:00, she experienced severe vertigo that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage. Cannot drive, not feeling safe taking care of my child, have a hard time reading and working due to the dizziness. Treatment received for the adverse event: IV, Benadryl and other medication. The clinical outcome of the events was not recovered. On 05Apr2021, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Cannot drive, not feeling safe taking care of my child, have a hard time reading and working due to the dizziness; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; This is a spontaneous report from a contactable consumer (patient). This 38- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 01Apr2021 at 02:00 pm (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a Public Health Clinic facility and anatomically located on the left arm.  Allergies to medications: CIPRO. The medical history and concomitant medications were not reported. 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 vaccination. On 01APR2021 01:00, she experienced severe vertigo that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage. Cannot drive, not feeling safe taking care of my child, have a hard time reading and working due to the dizziness. Treatment received for the adverse event: IV, Benadryl and other medication. The clinical outcome of the events was not recovered. On 05Apr2021, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: left arm pain at the injection site; could not move her arm at all; it has spread up to her shoulder.; This is spontaneous report received from a contactable consumer (patient) reported for herself that a 64-years-old female patient received BNT162B2, dose 2, via an unspecified route of administration, administered in left arm on 02Apr2021 10:45 AM (Lot Number: ER8734) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot # EN6207) in the left arm on 14Mar2021, before noon, for COVID-19 immunisation. Caller had a hard time reading this Lot number on the card that was provided to her. She stated the first Lot number was covered up a little by the second Lot number. She verified that this was the Lot number. She gets magnifying glass to read card. The patient received the second dose of the Pfizer-BioNtech Covid-19 vaccine on Friday, she had left arm pain at the injection site and it had spread up to her shoulder. She had her second shot this past Friday and her left arm hurt so bad where the shot was, she can feel it up to her shoulders. It was not swollen, she just felt it. She asked if she should keep taking Acetaminophen. She stated yesterday and this morning she was fine but then after she moves, it hurts again. She stated she can feel it and it was hard to move at night, she keeps her arm on a pillow. She stated she does have very small arms. Caller did not specify her start date of adverse event onset but that her symptoms were still ongoing and that her treatment medications helped. Treatment included: Caller stated she has used ice packs and has taken Acetaminophen Extra Strength (Lot # SEA041, Expiry Mar2024) and Ibuprofen, (Lot # OCE3209A, Expiry Jan2022), and Acetaminophen PM (Lot # PPA014, Expiry Sep2021) for treatment. Caller stated that the Ibuprofen was every 6 hours, the Acetaminophen Extra Strength was in between 5-6 hours, and the Acetaminophen PM she took a couple of nights ago and last night. Caller stated her treatment medications help. Caller's arm hurting was ongoing. Caller stated the Acetaminophen PM helped her sleep, not all night but some sleep. She was having a really hard time moving at night, she could not move her arm at all and would keep it on a pillow and then yesterday she felt fine. This morning trying to do a few things she felt good and then once she got going, she said forget it, and had to take two Acetaminophen right now. She had really small arms. She didn't know how long it should last. The outcome of the event "left arm pain at the injection site" was not recovered, of the event "could not move her arm at all" was recovered. The outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: had a positive covid test; This is a spontaneous report from a contactable consumer.   A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 28Mar2021, the patient had a positive covid test and on 05Apr2021, the patient was out of quarantine. 07Apr2021, second dose is scheduled. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Within 6 hours of getting my shot, I went into A-Fib; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration at 63-years, at single dose in right arm on 17Mar2021 at 09:30 (Lot Number: ER2613) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that, within 6 hours of getting his shot, he went into A-Fib (on 17Mar2021). He was in it for 18 hours before going back into the clinic. They took him to ER where he was electro-cardioverted. The adverse event resulted in "Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care". And the patient received treatment of electro-cardioverted for the event. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Event outcome was recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleeds after 2nd dose of the shots for about a week; This is a spontaneous report from a Pfizer-sponsored programs, COVAX US Support. This is a report from a contactable consumer (registered dietician reporting on herself). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), was received on 31Dec2020, lot number EL0140 for COVID-19 immunization.  Medical history included immunodeficiency from an unknown date and unknown if ongoing (she was informed she may not be able to build antibodies) and splenectomy (her spleen was removed 30-35 years ago). The patient's concomitant medications were not reported.  The patient experienced nose bleeds after 2nd dose of the shots for about a week in Jan2021 with outcome of recovered in 2021.  States the nosebleeds started a couple of days after the vaccine and she had the nose bleeds for a week.  No treatment was received.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chills, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller never got the fever from the COVID, she did get the chills, but it was like she had a cold; tested positive for COVID-19/ Caller was diagnosed with COVID on 04Apr2021; tested positive for COVID-19/ Caller was diagnosed with COVID on 04Apr2021; This is a spontaneous report from a Pfizer-sponsored program, reported by contactable consumer (patient, self-reported). A 79-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6207 and expiry date was unknown), via an unspecified route of administration, in left arm, on 16Mar2021 at 11:15 AM, as a single dose for COVID-19 immunization. After vaccination, patient did not have any problems and not even hurt. Patient did not receive any previous immunization with the Pfizer vaccine considered as suspect. Patient did not receive any other vaccines on the same day as the suspect product. aPatient's ongoing medical history included lupus and type 2 diabetes. Patient's husband died of COVID in December. Her husband was in a nursing home and she could not be there with him. Concomitant Medications were not provided. Patient had blood work done a few weeks ago (results were not provided) and it was before she had any COVID symptoms. It was reported that on 04Apr2021, patient diagnosed with COVID-19 and was under 10-days quarantine. She had both a rapid test, and the three-day test and they both came positive for COVID-19. She did not have fever from the COVID. She had chills, but it was like she had a cold, or she thought it was allergies. Patient's next dose was scheduled on 13Apr2021and her quarantine time will be over the day before she was scheduled for her second dose of the vaccine. She wanted to know how to proceed with the second dose of vaccine with her condition. She caught with COVID from her daughter as her daughter's daughter has it. Her daughter visited her child in (Withheld), and they had COVID, so her daughter got it by visiting them. Her daughter was pretty sick, and she was having the worst of it, but the patient was not too bad. Seriousness of the events drug ineffective and COVID-19 were reported as medically significant. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot and batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, SARS-CoV-2 test, Swelling face, Urticaria
Clinical narrative: Shortness of breath; itching; hives; face swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on the left arm on 26Mar2021 09:45 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included thyroid disease, HBP (high blood pressure), mild depression, ADD (attention deficit hyperactivity disorder), and migraines. Patient was not pregnant. There no other vaccine in four weeks. Other medication were taken in two weeks. The patient previously took sumatriptan (IMITREX) and zolmitriptan (ZOMIG) and experienced allergy. The patient experienced shortness of breath, itching/hives, face swollen on 27Mar2021 14:00 that resulted in clinic/ emergency room visit. Patient was given IV steroid, Benadry, Prilosec at hospital. Patient was not diagnosed with covid prior to vaccination and had been tested (nasal swab) post vaccination on 28Mar2021 with negative result. Outcome of the events was recovered with sequel.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: occasional headaches since corona vaccine 2 weeks ago; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program. A 81-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diarrhoea from Nov2020, alopecia from Nov2020. Concomitant medication included palbociclib (IBRANCE), oral from 2020 to an unspecified date, at 75 mg, cyclic (21 days on/ 7 days off) for breast cancer, letrozole taken for an unspecified indication, start and stop date were not reported. The patient reports before and after start of therapy diarrhea off and on. hair thinning. occasional headaches since corona vaccine 2 weeks ago on an unknown date. md thinks ibrance is working. advised to inform md. The action taken in response to the event for bnt162b2 was not applicable and palbociclib was unknown. The outcome of the event was unknown.  No Follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Burning sensation, Contusion, Dizziness
Clinical narrative: faintness in the morning; Skin itching; can't sleep at night tossing and turning all night; stomach upset; low grade fever; bruises on leg form scratching; hands burning; This is a spontaneous report from a contactable consumer (patient).  An adult female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Mar2021 13:00 (Batch/Lot Number: ER8727) as SINGLE DOSE for covid-19 immunization.  Medical history included hypertension and glaucoma. Concomitant medications included losartan, amlodipine, and latanoprost, netarsudil mesilate (ROCKLATAN). On 26Mar2021 06:00, the patient experienced skin itching, faintness in the morning, can't sleep at night tossing and turning all night, stomach upset, low grade fever, bruises on leg form scratching, hands burning. Still experiencing some of the adverse events. The outcome of events was reported as recovering. Patient received shot of Benadryl and was prescribed prednisone as treatment.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Pyrexia
Clinical narrative: faintness in the morning; Skin itching; can't sleep at night tossing and turning all night; stomach upset; low grade fever; bruises on leg form scratching; hands burning; This is a spontaneous report from a contactable consumer (patient).  An adult female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Mar2021 13:00 (Batch/Lot Number: ER8727) as SINGLE DOSE for covid-19 immunization.  Medical history included hypertension and glaucoma. Concomitant medications included losartan, amlodipine, and latanoprost, netarsudil mesilate (ROCKLATAN). On 26Mar2021 06:00, the patient experienced skin itching, faintness in the morning, can't sleep at night tossing and turning all night, stomach upset, low grade fever, bruises on leg form scratching, hands burning. Still experiencing some of the adverse events. The outcome of events was reported as recovering. Patient received shot of Benadryl and was prescribed prednisone as treatment.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Magnetic resonance imaging, Paraplegia
Clinical narrative: lose function of my lower legs/struggling with my mobility; increased back & hip pain; increased back & hip pain; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included Ulcerative Colitis, Inflammatory Arthritis. No known allergies. Concomitant medication included duloxetine hydrochloride (CYMBALTA). No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 on 23Dec2020 01:00 PM intramuscularly administered in left arm for COVID-19 immunization. The patient experienced lose function of her lower legs/struggling with her mobility on 25Jan2021, increased back & hip pain on 25Jan2021. Clinical course: 2 weeks s/p 2nd vaccine, she began to lose function of her lower legs - and increased back & hip pain. 3 months later, she was still struggling with her mobility and pain control. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, disability or permanent damage. Treatment received for the adverse events which included high dose prednisone; biologics; neurology appointments; rheumatology; ED (MRI - brain through hip). No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered.   Information about lot/batch number has been requested.; Sender's Comments: The causal association between the reported events and the vaccine cannot be excluded at this time based on a plausible temporal association. 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caller received her first Pfizer covid vaccine on April 1st and the on April 2nd, was diagnosed with the covid-19 virus.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown) via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received her first Pfizer covid vaccine on 01Apr2021. On 02Apr2021, the patient was diagnosed with the covid-19 virus. Patient received monoclonal antibody therapy to treat the virus. Patient wanted to know when she should get her second vaccination, given these events. Patient stated just read about another lady who received her first covid vaccine (manufacturer unknown) and then the next day tested positive for Covid as well. The outcome of the event unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Immunodeficiency, Wrong product administered
Clinical narrative: immunocompromised; inadvertently given the Prevnar 13 again; This is a spontaneous report from a non-contactable pharmacist.   A 56-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunisation.  The patient's medical history and concomitant medications was not reported. The patient experienced immunocompromised on an unspecified date, received a Prevnar 13 last year and came in today to get her Pneumovax but was inadvertently given the Prevnar 13 again on an unspecified date. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The association between the event "immunocompromised" with PREVENAR 13 use can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Wound infection
Clinical narrative: for relative who is hospitalized and will be released on 08Apr due to an infected wound (POST 1st Pfizer shot); The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 07Apr2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer (patient's relative) via a Pfizer-sponsored program and the other contactable consumer (the patient). A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was looking for information for relative who was hospitalized and would be released on 08Apr2021 due to an infected wound (Post 1st Pfizer shot) and should be getting 2nd Pfizer shot tomorrow, Currently on antibiotics wondering if he can receive the 2nd shot while on antibiotics. The outcome of the event was unknown.  Information on lot/batch number had been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Peripheral swelling
Clinical narrative: his eyes and feet are really swollen; his eyes and feet are really swollen; This is a spontaneous report from a contactable consumer. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 06Apr2021 at 09:05 (Lot Number: EW0150; Expiration Date: 31Jul2021), at the age of 63 years, as a single dose for COVID-19 immunization.  Medical history included cerebrovascular accident, diabetes mellitus since 2008, hypertension since 2008, both ongoing. Concomitant medications taken within two weeks of vaccination included warfarin sodium (COUMADIN), acetylsalicylic acid (ASPIRIN), atorvastatin taken for blood cholesterol since 04Mar2021, carvedilol (CARVEDILOL ABZ) taken for blood pressure since 05Mar2021, and insulin lispro; all ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 10:15, when the patient woke up he experienced his eyes and feet are really swollen. The reporter informed that when the patient woke up today his eyes were really swollen. It looked like he was stung by a bee or something. The reporter was wondering if that is a common side effect of the Pfizer vaccine. The patient had not received any treatment. The clinical outcome of the eye swelling was not recovered, and the clinical outcome of swelling of feet was unknown.  No follow-up attempts are needed. No further information is expected