chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased
Clinical narrative: Increased TSH; This is a spontaneous report from a non-contactable other hcp (patient) reported for herself. A 77-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 23Jan2021 (at the age of 78-years-old) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via intramuscular, administered at an unspecified anatomical location on 13Feb2021 (at the age of 78-years-old) as dose 2, single both for COVID-19 immunization. Patient received co suspect levothyroxine, oral from 1980 to an unspecified date, at unspecified dose for an unspecified indication. Medical history included autoimmune thyroiditis from 2020 to 2020. The patient's concomitant medications were not reported. On an unspecified date in 2021 the patient experienced increased tsh. In 2020, the patient experienced hashimoto's hypothyroidism. In 2021, the patient experienced Elevated TSH levels after both covid vaccines. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone which showed 14.69 result on 01Mar2021, blood thyroid stimulating hormone which showed 14.16 result on 11Mar2021 and blood thyroid stimulating hormone which showed 6.6 on 04May2021. The action taken of levothyroxine was unknown. The outcome of the event was recovering. The reporter's causality for the event(s) of Elevated TSH Levels After Both COVID Vaccines was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Computerised tomogram, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph nodes, found lumps near left and right breasts in the upper inner arms; pain in the upper inner arms, but more pain on the left side; Clusters of nodules on left arm near breast/lumps near left and right breasts; This is a spontaneous report from a contactable consumer (Patient) via COVID-19 Adverse Event Self-Reporting Solution . A 44-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, Formulation : Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 24Mar2021 (at the age of 44- year-old )  at 14:00  PM as DOSE 1, SINGLE for COVID-19 immunization at pharmacy or drug Store.  The patient medical history reported as none. Known allergies include patient became sensitive to alleve. The patient previously took alleve and experienced drug hypersensitivity.  The patient concomitant medications therapy were reported as none. The patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19.  On 01Jun2021, the patient experienced swollen lymph nodes, found lumps near left and right breasts pain in the upper inner arms, but more pain on the left side and clusters of nodules on left arm near breast/lumps near left and right breasts.  The patient underwent lab tests and procedures which included Mammogram and Ultrasound. Second follow up session scheduled to see the size growth. computerised tomogram: clusters of nodules. On Jul CT, found clusters of nodules on left arm near breast. Outcome of the events was not recovered for all.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Memory loss; This is a spontaneous report from a contactable consumer. This 26-year old female consumer (patient) reported  for herself. A 26-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number reported as "28416") as DOSE 1, SINGLE for covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced memory loss (amnesia) (non-serious) on an unspecified date with outcome of unknown. No lab test were done in the last 2 weeks. No treatment information was reported.    The lot number for the vaccine BNT162B2 was not provided and was not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report from a contactable consumer or other non-hcp. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on 06Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included divalproex sodium, cilnidipine, valproate semisodium (DEPAKOTE), blood thinner (unspecified medication) and psychotropic medication (unspecified medication). On an unspecified date the patient experienced sore throat. It was reported that patient was taking Divalproex Sodium and Aspirin where it was not clarified. Outcome of the event sore throat was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: High Blood pressure; This is a spontaneous report from a contactable other HCP. A 92-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included seronegative arthritis from an unknown date and unknown if ongoing Sero-negative Rheumatoid arthritis, hypothyroidism from an unknown date and unknown if ongoing Patient has hypothyroidism  One of my grandmother's sisters also had hypothyroid , gene mutation from an unknown date and unknown if ongoing genetic mutation (FOXC2), lymphoedema from an unknown date and unknown if ongoing Familial Lymphedema  her parents have to have passed on the mutation,  syndrome from an unknown date and unknown if ongoing this mutation is highly related to Ehlers Danlos and immune system abnormalities, immune system disorder from an unknown date and unknown if ongoing this mutation is highly related to Ehlers Danlos and immune system abnormalities, hypotension from an unknown date and unknown if ongoing , rheumatoid arthritis from an unknown date and unknown if ongoing One of my grandmother's sisters also had RA, hypothyroid, and familial lymphedema. Concomitant medication included hydroxychloroquine taken for rheumatoid arthritis, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; torsemide taken for lymphoedema, start and stop date were not reported. The patient previously took miralax and experienced drug hypersensitivity. She had the Pfizer vaccine and tolerated it very well, except three weeks post vaccine she had a few days of exceptionally high blood pressure when her blood pressure (BP) is normally very low. The patient underwent lab tests and procedures which included blood pressure measurement: increased. The outcome of high blood pressure was recovered.  Follow-up (11Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives; Itching appeared on her upper body, neck, chest and lower feet; Rash appeared on her upper body/neck/chest/lower feet; This is a spontaneous report from a contactable consumer (parent, patients mother). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0168, expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Aug2021 (at the age of 17-years-old) as dose 1, single for covid-19 immunization. The patient also received meningococcal vaccine (Batch/lot number was not reported, expiration date was not reported) via an unspecified route of administration, administered in left arm on 19Jul2021 as dose number unknown, single for an unspecified indication. The patient medical history and concomitant medications were not reported. It was reported that, reporter is calling on behalf of her 17-year-old daughter who received the first dose of Pfizer covid vaccine. She reports on 09Aug2021 3 hours after her daughter received the Pfizer covid vaccine hives (itching and rash) appeared on her upper body, neck, chest and lower feet. This has now lasted for 3 weeks to this day. She is wondering if she should get the second dose. She declined zip code. Her doctor said he does not have much information and said it is hard to tell. He just gave topical ointment. Her doctor advised antihistamine. When her daughter was a year old she received a vaccine and then after a month she received a call that the vaccine she was given was expired. She has been contacting the healthcare provider and they don't have any information other than topical treatment. The reporter assessed the seriousness as non-serious. The adverse events resulted in physician office visit. Antihistamine was received as treatment for the adverse events. The action taken in response to the events for meningococcal vaccine was unknown. The outcome of the events was not reported.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood cholesterol, Blood test, Chest pain, Dyspnoea
Clinical narrative: Felt like he was running a slight fever.; There were bumps and lumps in his neck; He has fatigue today.; His glands are swollen; Very weak; Swelling on his neck on the left side; He had a hard time breathing/ short of breath; Chest pain; This is a spontaneous report from a contactable consumer (patient).   A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FE3184), via an unspecified route of administration, administered in Arm Left on 29Aug2021 16:00 as (at the age of 43 years old) dose 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any vaccine prior Vaccinations within 4 weeks. The patient's Medical History was not reported. Patient denied having diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient had blood work done a couple weeks ago, on an unspecified date in 2021 (prior to vaccination) which revealed cholesterol was high vitamin d extremely low. The patient received his vaccine on Sunday 29Aug2021. On 30Aug2021 around 1-2 pm, the patient had chest pain. It was a severe sharp pain. He had a hard time breathing. It lasted about 20 minutes. The patient was still short of breath (at the time of report) and just feels drained. On 31Aug21, the patient woke up and felt like he was running a slight fever and noticed the swelling in his neck this morning. The patient got to work and started to feel weaker and weaker. The patient was very weak and had swelling on his neck on the left side. It was reported that the patient drives a truck. He put his arm up on the window and felt pain in his neck. So, he rubbed the left side of his neck, and it hurt. There were bumps and lumps in his neck. His neck is swollen. His glands are swollen. He has fatigue today (31Aug2021). The patient called the pharmacist, and the pharmacist looked up the side effects. The pharmacist said his neck is probably like that because he probably had the Delta variant and didn't know it. The stuff said his neck would swell up because of that. The events did not result in Emergency Room visit nor Physician Office visit. Outcome of event chest pain was recovered on 30Aug2021, after 20 minutes of onset. Outcome of events asthenia, swelling, dyspnoea, neck mass, fatigue, Glands swollen was not recovered at the time of report. Outcome of event pyrexia was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Neck mass, Pyrexia, Swelling
Clinical narrative: Felt like he was running a slight fever.; There were bumps and lumps in his neck; He has fatigue today.; His glands are swollen; Very weak; Swelling on his neck on the left side; He had a hard time breathing/ short of breath; Chest pain; This is a spontaneous report from a contactable consumer (patient).   A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FE3184), via an unspecified route of administration, administered in Arm Left on 29Aug2021 16:00 as (at the age of 43 years old) dose 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any vaccine prior Vaccinations within 4 weeks. The patient's Medical History was not reported. Patient denied having diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient had blood work done a couple weeks ago, on an unspecified date in 2021 (prior to vaccination) which revealed cholesterol was high vitamin d extremely low. The patient received his vaccine on Sunday 29Aug2021. On 30Aug2021 around 1-2 pm, the patient had chest pain. It was a severe sharp pain. He had a hard time breathing. It lasted about 20 minutes. The patient was still short of breath (at the time of report) and just feels drained. On 31Aug21, the patient woke up and felt like he was running a slight fever and noticed the swelling in his neck this morning. The patient got to work and started to feel weaker and weaker. The patient was very weak and had swelling on his neck on the left side. It was reported that the patient drives a truck. He put his arm up on the window and felt pain in his neck. So, he rubbed the left side of his neck, and it hurt. There were bumps and lumps in his neck. His neck is swollen. His glands are swollen. He has fatigue today (31Aug2021). The patient called the pharmacist, and the pharmacist looked up the side effects. The pharmacist said his neck is probably like that because he probably had the Delta variant and didn't know it. The stuff said his neck would swell up because of that. The events did not result in Emergency Room visit nor Physician Office visit. Outcome of event chest pain was recovered on 30Aug2021, after 20 minutes of onset. Outcome of events asthenia, swelling, dyspnoea, neck mass, fatigue, Glands swollen was not recovered at the time of report. Outcome of event pyrexia was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vitamin D decreased
Clinical narrative: Felt like he was running a slight fever.; There were bumps and lumps in his neck; He has fatigue today.; His glands are swollen; Very weak; Swelling on his neck on the left side; He had a hard time breathing/ short of breath; Chest pain; This is a spontaneous report from a contactable consumer (patient).   A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FE3184), via an unspecified route of administration, administered in Arm Left on 29Aug2021 16:00 as (at the age of 43 years old) dose 1, single for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any vaccine prior Vaccinations within 4 weeks. The patient's Medical History was not reported. Patient denied having diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient had blood work done a couple weeks ago, on an unspecified date in 2021 (prior to vaccination) which revealed cholesterol was high vitamin d extremely low. The patient received his vaccine on Sunday 29Aug2021. On 30Aug2021 around 1-2 pm, the patient had chest pain. It was a severe sharp pain. He had a hard time breathing. It lasted about 20 minutes. The patient was still short of breath (at the time of report) and just feels drained. On 31Aug21, the patient woke up and felt like he was running a slight fever and noticed the swelling in his neck this morning. The patient got to work and started to feel weaker and weaker. The patient was very weak and had swelling on his neck on the left side. It was reported that the patient drives a truck. He put his arm up on the window and felt pain in his neck. So, he rubbed the left side of his neck, and it hurt. There were bumps and lumps in his neck. His neck is swollen. His glands are swollen. He has fatigue today (31Aug2021). The patient called the pharmacist, and the pharmacist looked up the side effects. The pharmacist said his neck is probably like that because he probably had the Delta variant and didn't know it. The stuff said his neck would swell up because of that. The events did not result in Emergency Room visit nor Physician Office visit. Outcome of event chest pain was recovered on 30Aug2021, after 20 minutes of onset. Outcome of events asthenia, swelling, dyspnoea, neck mass, fatigue, Glands swollen was not recovered at the time of report. Outcome of event pyrexia was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Illness
Clinical narrative: so sick; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program. A 56-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization; desvenlafaxine succinate monohydrate (PRISTIQ), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unknown date, the patient was so sick right now from this being messed up, had to go cold turkey off the med, patient was so sick from going cold turkey, and got sick from the Pfizer vaccine and patient health was just crashing. The outcome of the event was unknown.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Developed a bump on her right arm where she had the shot/she got her 2nd dose of the Pfizer COVID 19 vaccine on her left arm and had another bump; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not reported, Expiry Date: Not Reported), via an unspecified route of administration, administered in Right Arm on 13Aug2021 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not reported, Expiry Date: Not Reported), via an unspecified route of administration, administered in Left Arm on 03Sep2021 as dose 2, single for covid-19 immunization. The patient received hpv vaccine (HPV VACCINE), via an unspecified route of administration on 18Aug2021 (Batch/Lot number was not reported) to 18Aug2021, as dose number unknown, single for immunization. The patient medical history and concomitant medications were not reported. Patient called to report side effect of the Pfizer COVID 19 vaccine - She received the 1st dose of the vaccine on 13Aug2021 and 2 weeks after she developed a bump on her right arm where she had the shot - On 18Aug2021 she received a HPV vaccine - 03Sep2021 she got her 2nd dose of the Pfizer COVID 19 vaccine on her left arm and had another bump - She was advised to call her provider if she will develop another bump - When she tried to call her provider, she was referred to us - Asking on what to do. The reporter assessed the seriousness of the case as non-serious. The 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blepharospasm, Dizziness, Eyelid disorder, Fatigue
Clinical narrative: This is a spontaneous report from a contactable nurse (patient) reported that: A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178, Expiry Date was not provided), via an unspecified route of administration in left arm, on 16Aug2021 (age at vaccination was 52-Years-old) as DOSE 2, SINGLE for COVID-19 immunization at Hospital. Medical history was not reported. The concomitant medication was not reported. Patient had known allergies of Rocephin and Macrodantin. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731, Expiry Date was not provided), via an unspecified route of administration in left arm, on 20Apr2021 (age at vaccination was 51 Years Old) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines in four weeks. Patient did not receive any other medications in two weeks. Patient did not have COVID prior vaccination. Patient has not been tested post vaccination. On 16Aug2021, patient said that she got the shot in her left deltoid. she had headaches, joint pains and generalized bodily pain. Dizzy and tired the entire time. She then developed intermittent fevers for 4 days along with swollen armpits but more on my left armpit. Then 2 inches below the injection site, she developed a lump which was itchy, swollen and red. And for approximately a week, she couldn't blink her right eyelid normally without 'quivering' or like 'spasmic movements. She just couldn't close her right eyelid right. When she tried to close her eyes to sleep, her right eyelid would try to open by the spasmodic or quivering sensation. It all went away after about a week of misery. AE did not result in anything. Patient received treatment for all the events with Tylenol/Motrin intermittently. The outcome of all events was recovered on 2021.   Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: This is a spontaneous report from a contactable nurse (patient) reported that: A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178, Expiry Date was not provided), via an unspecified route of administration in left arm, on 16Aug2021 (age at vaccination was 52-Years-old) as DOSE 2, SINGLE for COVID-19 immunization at Hospital. Medical history was not reported. The concomitant medication was not reported. Patient had known allergies of Rocephin and Macrodantin. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731, Expiry Date was not provided), via an unspecified route of administration in left arm, on 20Apr2021 (age at vaccination was 51 Years Old) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines in four weeks. Patient did not receive any other medications in two weeks. Patient did not have COVID prior vaccination. Patient has not been tested post vaccination. On 16Aug2021, patient said that she got the shot in her left deltoid. she had headaches, joint pains and generalized bodily pain. Dizzy and tired the entire time. She then developed intermittent fevers for 4 days along with swollen armpits but more on my left armpit. Then 2 inches below the injection site, she developed a lump which was itchy, swollen and red. And for approximately a week, she couldn't blink her right eyelid normally without 'quivering' or like 'spasmic movements. She just couldn't close her right eyelid right. When she tried to close her eyes to sleep, her right eyelid would try to open by the spasmodic or quivering sensation. It all went away after about a week of misery. AE did not result in anything. Patient received treatment for all the events with Tylenol/Motrin intermittently. The outcome of all events was recovered on 2021.   Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse (patient) reported that: A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178, Expiry Date was not provided), via an unspecified route of administration in left arm, on 16Aug2021 (age at vaccination was 52-Years-old) as DOSE 2, SINGLE for COVID-19 immunization at Hospital. Medical history was not reported. The concomitant medication was not reported. Patient had known allergies of Rocephin and Macrodantin. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731, Expiry Date was not provided), via an unspecified route of administration in left arm, on 20Apr2021 (age at vaccination was 51 Years Old) as DOSE 1, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines in four weeks. Patient did not receive any other medications in two weeks. Patient did not have COVID prior vaccination. Patient has not been tested post vaccination. On 16Aug2021, patient said that she got the shot in her left deltoid. she had headaches, joint pains and generalized bodily pain. Dizzy and tired the entire time. She then developed intermittent fevers for 4 days along with swollen armpits but more on my left armpit. Then 2 inches below the injection site, she developed a lump which was itchy, swollen and red. And for approximately a week, she couldn't blink her right eyelid normally without 'quivering' or like 'spasmic movements. She just couldn't close her right eyelid right. When she tried to close her eyes to sleep, her right eyelid would try to open by the spasmodic or quivering sensation. It all went away after about a week of misery. AE did not result in anything. Patient received treatment for all the events with Tylenol/Motrin intermittently. The outcome of all events was recovered on 2021.   Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysaesthesia, Hypoaesthesia, Joint swelling, Pain in extremity
Clinical narrative: right hand and wrist was swollen and painful to touch; right hand and wrist was swollen and painful to touch; right hand and wrist was swollen and painful to touch; right hand and wrist was swollen and painful to touch; fingers were like pins and needles; like his hand falls asleep; numbness at times in fingertips; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 18Oct2021, this case now contains serious adverse reactions. Information processed together.   This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 12Aug2021 at 14:00 (Lot Number: FC3181, unknown expiration) as dose 1, single; and via intramuscular in right arm on 02Sep2021 at 14:00 (Lot Number: FC3184, unknown expiration) as dose 2, single at the age of 46 years old for COVID-19 immunisation.  Medical history and concomitant medications reported as none. No family medical history relevant to events. No prior vaccinations (within 4 weeks). No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No other vaccines administered on same date with the Pfizer vaccine considered as suspect.  On 13Aug2021 at 05:00, after receiving the first dose, the patient reported that his right hand and wrist was swollen and painful to touch. The event further described as fingers were like pins and needles from time to time, like his hand falls asleep, and has numbness at times in fingertips. He thought he was sleeping on his arm awkwardly, but it was not that, it's like a numbness at times in his fingertips. It was ongoing sporadically, not every day, and was persisting. He confirmed that it began on 13Aug2021. Right hand/wrist is still swollen, and this condition has not subsided. Ice has been applied to the hand to reduce swelling. There has been no sign of swelling prior to receiving the first Pfizer injection. No treatment was received for the remaining events. The patient confirmed that he hasn't seen him by HCP since it started. The patient has not yet recovered from the events. The events were assessed as serious (Important medical event).   No follow-up attempts are possible; information about batch number was already obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: right hand and wrist was swollen and painful to touch; right hand and wrist was swollen and painful to touch; right hand and wrist was swollen and painful to touch; right hand and wrist was swollen and painful to touch; fingers were like pins and needles; like his hand falls asleep; numbness at times in fingertips; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 18Oct2021, this case now contains serious adverse reactions. Information processed together.   This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 12Aug2021 at 14:00 (Lot Number: FC3181, unknown expiration) as dose 1, single; and via intramuscular in right arm on 02Sep2021 at 14:00 (Lot Number: FC3184, unknown expiration) as dose 2, single at the age of 46 years old for COVID-19 immunisation.  Medical history and concomitant medications reported as none. No family medical history relevant to events. No prior vaccinations (within 4 weeks). No relevant tests. No history of all previous immunization with the Pfizer vaccine considered as suspect. No other vaccines administered on same date with the Pfizer vaccine considered as suspect.  On 13Aug2021 at 05:00, after receiving the first dose, the patient reported that his right hand and wrist was swollen and painful to touch. The event further described as fingers were like pins and needles from time to time, like his hand falls asleep, and has numbness at times in fingertips. He thought he was sleeping on his arm awkwardly, but it was not that, it's like a numbness at times in his fingertips. It was ongoing sporadically, not every day, and was persisting. He confirmed that it began on 13Aug2021. Right hand/wrist is still swollen, and this condition has not subsided. Ice has been applied to the hand to reduce swelling. There has been no sign of swelling prior to receiving the first Pfizer injection. No treatment was received for the remaining events. The patient confirmed that he hasn't seen him by HCP since it started. The patient has not yet recovered from the events. The events were assessed as serious (Important medical event).   No follow-up attempts are possible; information about batch number was already obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Malaise
Clinical narrative: second Covid shot on 01Apr2021 and it made her feel crummy; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration on 01Apr2021 (at the age of 44-year-old) as DOSE 2, SINGLE for covid-19 immunisation (immunocompromised and was called by withheld institute to get the third shot); ocrelizumab (OCREVUS), route of administration, start and stop date, batch/lot number and dose were not reported for multiple sclerosis. Medical history included Immunocompromised, multiple sclerosis, rare autoimmune vasculitis; It was reported that patient was immunocompromised and had Multiple sclerosis and a rare auto immune vasculitis prior to getting any Covid shots. States 14 years ago was diagnosed with multiple sclerosis and having been on a number of medicines since then, immunosuppressant drugs by Genzyme, Sanofi, Biogem, but she has tried all the MS drugs, pysabri, Capaxone, Betaseron 1A shot, and then provides for the rare autoimmune vasculitis she takes 2 medicines at a time, Rituxan and Cytoxan. The Rituxan is every 6 months and Cytoxan was monthly, plus a truck load of IV corticosteroids, but she does not know how much, but it was a lot; Reported that she was on a new drug for her multiple sclerosis called Ocrevus, it's a form of Rituxan, but it's like 4-6 times stronger than that. One of the warnings on the bottle is for skin infections and lower respiratory infections. That you are more at risk for skin infections, so it's a perfect storm. Like maybe a critter got in there and made her life miserable and caused this skin infection. This medication certainly makes you immunocompromised and her blood work recently showed she is low on immunoglobulins. Wonders if the skin infection could have come from this new medication or shot. Mentions she is also taking 5 days a month of IVIG therapy. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6204), on 10Mar2021 (at the age of 44-year-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced first Covid shot on 10Mar2021 and it was not as bad as the second one. No other vaccines given that day and none 4 weeks prior. No problems with vaccines in past. No history of previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior Vaccinations (within 4 weeks). On an unspecified date in 2021, the patient experienced second covid shot on 01Apr2021 and it made her feel crummy. The action taken in response to the event(s) for ocrelizumab was unknown. The outcome of event was unknown.  Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills
Clinical narrative: got chills after receiving both doses of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (Solution for injection, Batch/Lot Number: EL1283, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 07Jan2021 (at the age of 65 years old) as dose 1, 0.3 ml single for covid-19 immunisation; varenicline tartrate (CHANTIX, batch/lot number was not reported) to quit smoking. There was no relevant medical history and no concomitant medications. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require a visit to Emergency Room/Physician Office. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. No relevant medical history (including any illness at time of vaccination). Relevant family medical history to adverse event was not reported. No relevant tests done. The patient experienced got chills after receiving both doses of the vaccine on Jan2021. They lasted for about a week each time. The patient also received bnt162b2 (Solution for injection, Batch/Lot number: EL9262, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 28Jan2021 (at the age of 65 years old) as dose 2, 0.3 ml single for covid-19 immunisation and experienced chills. The outcome of the event was recovered on an unspecified date in Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Pain in extremity
Clinical narrative: energy level has been way down since last COVID-19 shot a few weeks ago; pain in hands (21Jan2021); This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2020-070510), for COVID vaccine (BNT162B2).  A 74-years-old non-pregnant female received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration, on an unspecified date, as a DOSE NUMBER UNKNOWN, SINGLE dose for COVID-19 immunization. The patient also received dose of Lenvima (LENVATINIB MESILATE, Batch/Lot number was 1562116) 10 mg daily, via oral route of administration, on 24Jan2020, taken for Malignant neoplasm of endometrium. Medical history and concomitant medications were not reported. On 21Jan2021, the patient experienced pain in hands (21Jan2021). On an unspecified date, the patient experienced energy level has been way down since last COVID-19 shot a few weeks ago. The event was not considered a drug interaction. The dose of the product was not reduced due to the event. The product was not discontinued due to event. The clinical outcome of pain in hands (21Jan2021) was Recovering, while the clinical outcome of energy level has been way down since last COVID-19 shot a few weeks ago was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in left armpit; This is a spontaneous report from a contactable other health care professional (patient herself). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Sep2021 at 16:00 (at the age of 59-years-old) (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included sensitive to most medications. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 17Sep2021, at 13:00, the patient experienced swollen lymph node in left armpit. No treatment was received for the event. The outcome of the event was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder, Pharyngeal swelling, Throat irritation
Clinical narrative: My throat itching and feels swollen; My throat itching and feels swollen; lungs tightened; This is a spontaneous report from a contactable other-HCP (patient herself). A 40-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in right arm on 17Sep2021 15:30 (at the age of 40-years-old) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. Patient medical history included known allergies to Kiwi tape. The concomitant medications were not reported. On 17Sep2021 15:30, the patient experienced throat itching and feels swollen, and lungs tightened. 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 tested for COVID-19 since the vaccination. Therapeutic measures were not taken with respect to adverse events. The device date was reported as 17Sep2021. At the time of this report, the outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dysgeusia
Clinical narrative: tasting this salty taste on the tip of her tongue and side of her mouth, sometimes its just really intense; This is a spontaneous report from a Pfizer sponsored Program and a contactable consumer (patient) or other non-healthcare professional.  A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (age at vaccination: 66 year-old), as dose 2, single for covid-19 immunisation and patient received co-suspect as celecoxib (CELECOXIB), formulation: Capsule, hard via an unspecified route of administration from Mar2021 (Batch/Lot Number: KA 0 or O 3685; Expiration Date: 31Oct2022) and ongoing, at 200 mg, 1x/day for psoriatic arthropathy. Medical history included ongoing psoriatic arthropathy and diagnosed a couple of years ago, 2 or so years ago. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263), via an unspecified route of administration, administered in Arm Left on 28Jan2021, (age at vaccination: 66 year-old) as dose 1, single for covid-19 immunisation. Other products reported as No. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. AE(s) following prior vaccinations reported as none. Relevant test reported as none. On Mar2021 the patient experienced tasting this salty taste on the tip of her tongue and side of her mouth, sometimes its just really intense. Patient received second dose of vaccine on 18Feb2021 and 2 weeks after the Covid 19 vaccines, patient was started a prescription of Celebrex and she said about 2 weeks after that every day since then she has been tasting this salty taste on the tip of her tongue. Patient didn't know if it's normal and It's every day, she would said it's persisting, it hasn't changed. Patient wanted to know if Pfizer had any additional information about that. The clinical outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: This is a spontaneous report based on the information received by Pfizer (Reference number: GL-080421). A contactable other hcp reported for a female patient of an unspecified age received bnt162b2 (BNT162B2 formulation; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient received hyaluronic acid (RESTYLANE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced a lot of swelling on an unspecified date. It was reported that the patient injected with Restylane Kysse after receiving the COVID vaccine. The action taken in response to the event for hyaluronic acid was unknown. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: first one made her real sleepy; A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration on 05Feb2021 (at the age of 77-year-old) as dose 1, single for COVID-19 immunization and cortisone(Lot number: not provided, Expiration date: not reported)for unknown indication on unspecified date. The patients medical history and concomitant medications were not reported. On an unspecified date, first one made patient real sleepy. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100944492 same patient/drug, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan
Clinical narrative: Swollen lymph node; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Aug2021 (Batch/Lot number was not reported) age at vaccination of 30-years-old, as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) age at vaccination of 30-years-old, as single dose for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing (Penicillin allergy). The patient was not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node above left collar bone, lymph node became swollen two days after 1st vaccine on 14Aug2021. The event resulted in doctor or other healthcare professional office/clinic visit; the event was considered as non serious.  Saw doctor and ultrasound was done around 8 days after vaccine. Ultrasound performed on 20Aug2021 confirmed it was a swollen lymph node.  After 2nd vaccine, lymph node doubled in size (within 24hrs after vaccine). Doctor advised to wait two weeks after 2nd vaccine before making another appointment. It has been two weeks since the 2nd dose and lymph node is still swollen. No treatments were given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the event.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.