chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Thunderclap headache
Clinical narrative: I feel like shit. I just feel bad; Thunderclap headache; My head has been hurting all day long; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Feb2022 11:30 (Lot number: FK9896) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: THUNDERCLAP HEADACHE (non-serious) with onset 03Feb2022, outcome "recovered" (03Feb2022), described as "Thunderclap headache"; HEADACHE (non-serious) with onset 03Feb2022, outcome "not recovered", described as "My head has been hurting all day long"; MALAISE (non-serious), outcome "unknown", described as "I feel like crud. I just feel bad". Therapeutic measures were not taken as a result of thunderclap headache, headache, malaise.  Additional information: Patient did not received any vaccine prior to Covid vaccine before four week. Vaccination facility type was reported as a clinic. Patient received bnt162b2 was at about 11:30 at the 2nd of February(Further clarification unknown). Patient was reporting an adverse effect for second COVID shot. Patient got first one got, patient just had second one on the 2nd. The first shot patient got patient do not get headache, patient have started getting headaches and this morning patient had a severe sharp, barely think patient can patient look it up in it a thunderclap headache well it was real quick. Patients head has been hurting all day long, quite a surprise patient has not any more of the thunderclap headaches but never experienced it ever in life until now. Patient mean, feel like, feel like crud. Patient just feel bad. Patient did not take as treatment for events. Reporter seriousness for Thunderclap headache was unspecified.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of upper extremities; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a sponsored program. The reporter is the patient. A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Thyroid disorder" (unspecified if ongoing); "Autoimmune disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness of upper extremities". Additional information: Previously administered products included for COVID-19 immunization: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included Numbness of upper extremities with PFIZER BIONTECH COVID-19 VACCINE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Developed pain; numbness; tingling in my left foot which spread to left leg; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Feb2021 (Lot number: EIV5318) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "celiac disease" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; CYMBALTA; LEXAPRO; LIVALO; OMEPRAZOLE. Past drug history included: Bactria, reaction(s): "Drug allergy", notes: known allergies: Bactria. Niacin. Lipitor. Crestor; Niacin, reaction(s): "Drug allergy", notes: known allergies: Bactria. Niacin. Lipitor. Crestor; Lipitor, reaction(s): "Drug allergy", notes: known allergies: Bactria. Niacin. Lipitor. Crestor; Crestor, reaction(s): "Drug allergy", notes: known allergies: Bactria. Niacin. Lipitor. Crestor. Vaccination history included: Bnt162b2 (Dose 1, Single, lot number: FJ1611, vaccine location: Left arm), administration date: 11Jan2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 18Feb2021, outcome "not recovered", described as "Developed pain"; HYPOAESTHESIA (non-serious) with onset 18Feb2021, outcome "not recovered", described as "numbness"; PARAESTHESIA (non-serious) with onset 18Feb2021, outcome "not recovered", described as "tingling in my left foot which spread to left leg". The events "developed pain", "numbness" and "tingling in my left foot which spread to left leg" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, hypoaesthesia, paraesthesia.  Additional information: The patient had no other vaccine in four weeks and adverse event: Developed pain, numbness, tingling in my left foot which spread to left leg. This resolved after about 4 months but recently started up again with last booster shot 27Jan2022. treatment medication included Gabapentin and prednisone. The patient had covid prior vaccination, and tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Pain in extremity
Clinical narrative: a lot of pain on my second vaccine like throughout my leg that was like a shooting pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 -old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: EN6207) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, The LOT number was EN6202, Anatomical Site: Consumer stated, "It was on the Left arm, both times), administration date: 20Feb2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "brain zaps", "brain fog", "there was a doctor that gave me some medication for vertigo which seems like it made it wors", "Dizziness", "I have ringing in my ears now", "brain dash / headache", "light headedness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "a lot of pain on my second vaccine like throughout my leg that was like a shooting pain. The patient underwent the following laboratory tests and procedures: blood cholesterol: unknown results. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Reporter stated that she received both doses of Pfizer BioNtech Covid19 Vaccine the first primary series. She said that after exactly 2 weeks after she got the first dose. So, the reason for her call to ask his if she could get a half of her dose or a dose of a Pediatric vaccine as a booster to lessen the chance or her having additional side effects. So, she said she is rather a small person that does not do well on medication. She said she heard that doses being administered into a vein could be so many people are having side effects and that is the main complaint that she has so I thought, I need to get over to Report her side effects from her first and second doses. She got lot of pain on her second vaccine like throughout her leg that was like a shooting pain that was probably just couple of night, couple of days that not went away but the brain and light headedness has not gone away. She does not feel as healthy as she used to because of this side effects unfortunately. It is good that they know the side effects. She took treatment with Meclizine (expiry date:30Nov2022).  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Electrocardiogram, Fatigue, Somnolence, Wrong technique in product usage process
Clinical narrative: administered slowly over 4 hours; tired; fell asleep for 2 of the 4 hours during the special dosing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Lot number: FE3592) at the age of 46 years as dose 2 (initial pfizer dose), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna vaccine (Dose 1, anatomical location: left arm, Lot: 040B21A, NDC: Unknown, Expiration: Unknown,Dose 1, anatomical location: left arm, Lot: 040B21A, NDC: Unknown, Expiration: Unknown), administration date: 10Apr2021, when the patient was 46 years old, for Covid-19 Immunization, reaction(s): "tinging and numbness in her lower arm, hands and fingers", "tinging and numbness in her lower arm, hands and fingers", "dizziness", "bronchial asthmatic coughing", "coughing", "tiredness", "chest tightness", "tinging and numbness in her lower arm, hands and fingers and it kept getting worse and worse/bronchial asthmatic coughing was worse", "states her left arms, hands, and fingers were completely swollen", "she had no feeling", "her hands and fingers were turning blue", "Caller states two nurses came rushing out and she never got up on her own", "she woke up with full blown flu like side effects all from that Moderna shot"; Flu shot (Caller states other than the Covid Vaccines, no reactions in the past, caller she she had all her childhood vaccines in the past and she gets her flu shot every year with no issues and both pneumonia vaccines), for Immunization; Pneumonia vaccines (Caller states other than the Covid Vaccines, no reactions in the past, caller she she had all her childhood vaccines in the past and she gets her flu shot every year with no issues and both pneumonia vaccines), for Immunization. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 28Sep2021, outcome "unknown", described as "administered slowly over 4 hours"; FATIGUE (non-serious) with onset 28Sep2021, outcome "recovered" (2021), described as "tired"; SOMNOLENCE (non-serious) with onset 28Sep2021, outcome "recovered" (28Sep2021), described as "fell asleep for 2 of the 4 hours during the special dosing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states her First Dose of the Pfizer Covid 19 Vaccine was administered slowly over 4 hours in Dr. Caller states she tolerated it well, other than being super tired and she fell asleep for 2 of the 4 hours during the special dosing.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood pressure measurement, Colonoscopy, Endoscopy, Heart rate
Clinical narrative: Sore in left arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200374157 (Pfizer).  The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 11Feb2022, this case now contains all required information to be considered valid]  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: EW0182) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid condition" (unspecified if ongoing), notes: she has a thyroid condition. Concomitant medication(s) included: LEVOTHYROXINE; VITAMIN D3 1000. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21May2021, outcome "unknown", described as "Sore in left arm at injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior vaccination: None. Concurrent medication included Morning: Levothyroxine 37.5 mg (takes 1/2 of 75mg tablet) and Evening: Sodium chloride tablet 394 mg, Vitamin D3 25mg, Periactin 4mg, Zofran 4mg. Investigation Assessment: Not Provided.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Vaccination site pain
Clinical narrative: Sore in left arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200374157 (Pfizer).  The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 11Feb2022, this case now contains all required information to be considered valid]  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: EW0182) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid condition" (unspecified if ongoing), notes: she has a thyroid condition. Concomitant medication(s) included: LEVOTHYROXINE; VITAMIN D3 1000. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21May2021, outcome "unknown", described as "Sore in left arm at injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior vaccination: None. Concurrent medication included Morning: Levothyroxine 37.5 mg (takes 1/2 of 75mg tablet) and Evening: Sodium chloride tablet 394 mg, Vitamin D3 25mg, Periactin 4mg, Zofran 4mg. Investigation Assessment: Not Provided.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Biopsy salivary gland, Blood cortisol, Blood test, Electromyogram
Clinical narrative: She had a sore arm after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2, solution for injection), administered in arm, administration date 04Jan2021 (Lot number: EL1284) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: Verbatim: Arthritis. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She had a sore arm after the first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Family Medical History Relevant to AE(s): Initially states none.Then states her son was diagnosed with Lyme disease in Feb2020 right before the pandemic broke out. He recovered from the Lyme disease and was put on antibiotics. He has been suffering with symptoms like caller's every since. Her son's symptoms were not as bad all the caller's symptoms. Patient did not provide a product name for her son's antibiotics and no further details were provided.Infectious disease doctor checked for Lyme disease, which was negative.Immunologist did blood working checking antibody levels and all were normal. That was done in Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pain in extremity
Clinical narrative: She had a sore arm after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2, solution for injection), administered in arm, administration date 04Jan2021 (Lot number: EL1284) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: Verbatim: Arthritis. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She had a sore arm after the first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Family Medical History Relevant to AE(s): Initially states none.Then states her son was diagnosed with Lyme disease in Feb2020 right before the pandemic broke out. He recovered from the Lyme disease and was put on antibiotics. He has been suffering with symptoms like caller's every since. Her son's symptoms were not as bad all the caller's symptoms. Patient did not provide a product name for her son's antibiotics and no further details were provided.Infectious disease doctor checked for Lyme disease, which was negative.Immunologist did blood working checking antibody levels and all were normal. That was done in Aug2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: flu symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: 3306BD) as dose number unknown, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 Immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms". Additional information: Concern about adverse reaction. After I received Pfizer booster 3306BD I came down with flu symptoms. I was not sick previously.   No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Investigation, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 17:00 (Lot number: EW0182) at the age of 13 years as dose 1, single and administered in arm left, administration date 03Jun2021 16:00 (Lot number: EW0187) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Seizure disorder petit mal" (unspecified if ongoing), notes: Verbatim: seizure disorder petit mal; "Encopresis" (unspecified if ongoing), notes: Verbatim: Encopresis. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "His arm hurt"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "His arm swelled up". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Additional Information for Other Conditions: states this was diagnosed back when he was 3. Patient states he takes a laxative, Dulcolax, daily and he did have one that day and has been taking it for awhile, it's an ongoing battle. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: he can not move his left arm and when he does there is "excruciating pain; he can not move his left arm and when he does there is "excruciating pain''; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown, Route of administration: unspecified), for COVID-19 immunization, reaction(s): "normal pain and trouble using his arm because of the pain". The following information was reported: VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 09Feb2022, outcome "unknown", described as "he can not move his left arm and when he does there is "excruciating pain"; PAIN IN EXTREMITY (non-serious) with onset 09Feb2022, outcome "unknown", described as "he can not move his left arm and when he does there is "excruciating pain''".  Additional information: The reporter stated that he received his second dose of the Pfizer COIVD-19 vaccine yesterday 08Feb2022 in his left arm and this morning when he woke up, he cannot move his left arm and when he does there is "excruciating pain". The reporter further stated that when he got his first dose, he had normal pain and trouble using his arm because of the pain but this time it is so bad he cannot lift it. He would like to know if this is normal or not.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200237751 same patient/drug, different dose, similar events
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: first dose he had normal pain and trouble using his arm because of the pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "first dose he had normal pain and trouble using his arm because of the pain". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200237614 same patient/drug, different dose, similar events
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling abnormal, Illness, Pain
Clinical narrative: chills; achy; his back hurt; he felt like he got run over by a train; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 13:00 (Lot number: EW0182) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Lot ER8735, expiration is unknown. Injected in left shoulder and they are all on left shoulder.), administration date: 11Apr2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "he felt like he got run over by a train"; ILLNESS (non-serious), outcome "recovered", described as "sick"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "achy"; BACK PAIN (non-serious), outcome "unknown", described as "his back hurt".  Additional Information: Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient's had no medical history. Family medical history relevant to AE(s): Mother had CML Leukemia and not sure if that is relevant, or not. Relevant tests was none.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "headache". Additional information: The patient experienced minor side effects such as headache after receiving the Pfizer BioNTech vaccine which resolved after few days. The patient would like to know if they can get another booster dose on March. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 28Dec2021, for COVID-19 immunization, reaction(s): "soreness in arm", "contracted COVID-19", "fever", "chills", "runny nose", "cough". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: Dark brown almost black urine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: CHROMATURIA (non-serious) with onset 13Feb2022, outcome "unknown", described as "Dark brown almost black urine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Body aches; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Dec2021 (Lot number: 3707080) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "Body aches"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "Chills". No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Nasopharyngitis, Paraesthesia, Peripheral swelling
Clinical narrative: Pain in upper right a radiating to elbow and entire area under armpit; cold; tingling; swelling continuing down through my right hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2022 19:15 (Lot number: FJ1611) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Degenerated discs" (unspecified if ongoing); "pinched nerves" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "bi-polar disorder" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL; METHADONE. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 033821A, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 27May2021, when the patient was 29 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 045B21A, Location of injection: Arm Right, Vaccine Administration Time: 04:30 PM), administration date: 27Apr2021, when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset Feb2022, outcome "recovered" (Feb2022), described as "Pain in upper right a radiating to elbow and entire area under armpit"; NASOPHARYNGITIS (non-serious) with onset Feb2022, outcome "recovered" (Feb2022), described as "cold"; PARAESTHESIA (non-serious) with onset Feb2022, outcome "recovered" (Feb2022), described as "tingling"; PERIPHERAL SWELLING (non-serious) with onset Feb2022, outcome "not recovered", described as "swelling continuing down through my right hand". The events "pain in upper right a radiating to elbow and entire area under armpit", "cold", "tingling" and "swelling continuing down through my right hand" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of axillary pain, nasopharyngitis, paraesthesia, peripheral swelling.  Additional information: Pain in upper right a radiating to elbow and entire area under armpit with a cold tingling and swelling continuing down through her right hand. 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. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: May2021, for COVID-19 immunization, reaction(s): "arm soreness". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever".  Additional information: Reporter received the Pfizer C19 vaccine in May and June of 2021: first dose, arm soreness for a couple hours; second dose, experienced a fever, chills 25-30 hours. Patient received other medication was unknown. Past medical history and family history was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: was fatigued but usually pretty low energy; was fatigued but usually pretty low energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "was fatigued but usually pretty low energy".  Additional information: Reporter's Mother-in-law also received the Pfizer C19 vaccine: was fatigued but "usually pretty low energy"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Optic nerve disorder
Clinical narrative: Optic nerve on left eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4261624, 3070-2088861690.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: OPTIC NERVE DISORDER (non-serious), outcome "unknown", described as "Optic nerve on left eye".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: headache; severe joint pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Jan2021 10:30 (Lot number: EL3247) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA taken for crohn's disease, start date: 2010 (ongoing); LEXAPRO taken for depression, anxiety, start date: 2013 (ongoing); ALLEGRA taken for hypersensitivity, start date: 2015 (ongoing); QUESTRAN taken for crohn's disease, start date: 2009 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Date/time:, Date: 31Dec2020, Time: 11:00, Site and route of injection:, Anatomical site of injection:  Left arm, Route of administration: Intramuscular, Batch/Lot number: EL0142), administration date: 31Dec2020, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 18Jan2021 18:00, outcome "recovered" (2021), described as "fatigue"; HEADACHE (non-serious) with onset 19Jan2021, outcome "recovered" (2021), described as "headache"; ARTHRALGIA (non-serious) with onset 19Jan2021, outcome "recovered" (2021), described as "severe joint pain". Therapeutic measures were not taken as a result of fatigue, headache, arthralgia.  Additional information: It was reported that all side effects were experienced more severely with each subsequent dose. The reporter consider the Pfizer product had a causal effect to the adverse event. No prior vaccination within 4 weeks.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Food allergy, Lip swelling
Clinical narrative: developing an allergic reaction to shellfish; she was eating mollusk, and her top lip swelled up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Mar2021 (Lot number: EN6199, Expiration Date: Jun2021) at the age of 77 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, 0.3mL, SINGLE, Lot: EM9809, Expiry: Jun2021, Patient Route of Administration: Intramascular), administration date: 03Feb2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported: FOOD ALLERGY (non-serious) with onset 2021, outcome "unknown", described as "developing an allergic reaction to shellfish"; LIP SWELLING (non-serious) with onset 2021, outcome "unknown", described as "she was eating mollusk, and her top lip swelled up". Therapeutic measures were not taken as a result of food allergy, lip swelling.  Additional information: caller wife is 78 years old. He states that she was eating mollusk, and her top lip swelled up. States that her lip swelled up after eating the baby octopus and it lasted a little over a week. She was never allergic to it before. States that she just used a cold washcloth on it and toughed it out. No other treatment was provided. Caller clarifies that they ate the baby octopus and had a reaction to it between the 2nd and 3rd dose of the Covid 19 Vaccine. Caller received Booster received on 02Dec2021, Lot: FF8841, Expiry: Mar2022, 0.3mL IM; she thinks she got it in her left arm. Got the flu shot on 22Dec2021. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) reported as none.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Investigation, Joint swelling, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. A 42 year-old male patient received bnt162b2 (COMIRNATY), administration date 03Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Dec2021, outcome "unknown" and all described as "Chest pain on their right side together with injection site"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Pain in extremities"; JOINT SWELLING (non-serious) with onset Dec2021, outcome "not recovered", described as "Swelling on right knee both posterior and anterior/knee swelling is getting worse"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Both the patient's knees are swollen and painful". The events "chest pain on their right side together with injection site", "pain in extremities", "swelling on right knee both posterior and anterior/knee swelling is getting worse", "both the patient's knees are swollen and painful" and "chest pain on their right side together with injection site" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: It was reported that the patient had continuing side effect after getting the Pfizer Covid-19 vaccine as booster dose. The patient experienced those side effects 12 hours after the booster dose administration, and complained that the swelling was worse at that time wherein both the patient's knees were swollen and painful. The patient had lab tests, kidneys were normal, rheumatoid arthritis also normal and all tests were normal but the knee swelling was getting worse. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. A 42 year-old male patient received bnt162b2 (COMIRNATY), administration date 03Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Dec2021, outcome "unknown" and all described as "Chest pain on their right side together with injection site"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Pain in extremities"; JOINT SWELLING (non-serious) with onset Dec2021, outcome "not recovered", described as "Swelling on right knee both posterior and anterior/knee swelling is getting worse"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Both the patient's knees are swollen and painful". The events "chest pain on their right side together with injection site", "pain in extremities", "swelling on right knee both posterior and anterior/knee swelling is getting worse", "both the patient's knees are swollen and painful" and "chest pain on their right side together with injection site" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: It was reported that the patient had continuing side effect after getting the Pfizer Covid-19 vaccine as booster dose. The patient experienced those side effects 12 hours after the booster dose administration, and complained that the swelling was worse at that time wherein both the patient's knees were swollen and painful. The patient had lab tests, kidneys were normal, rheumatoid arthritis also normal and all tests were normal but the knee swelling was getting worse. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pyrexia, SARS-CoV-2 test, Urticaria
Clinical narrative: 102 temperature; hives; muscle weakness in the lower ext; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Feb2022 08:45 (Lot number: fk9896) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; PROZAC. Past drug history included: Dilaudid, reaction(s): "Known allergies: dilaudid". Vaccination history included: Bnt162b2 (lot number= el1283, Intramuscular, Left arm, administration date= 28Jan2021, 05:00 PM, dose number=2), administration date: 28Jan2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (lot number= ej1685 , administration date= 24Dec2020, 05:15 PM, dose number=1, Left arm), administration date: 24Dec2020, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 18Feb2022 12:00, outcome "not recovered", described as "102 temperature"; URTICARIA (non-serious) with onset 18Feb2022 12:00, outcome "not recovered", described as "hives"; MUSCULAR WEAKNESS (non-serious) with onset 18Feb2022 12:00, outcome "not recovered", described as "muscle weakness in the lower ext". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, urticaria, muscular weakness.  Additional information: Patient received the Benadryl as treatment of pyrexia, urticaria, muscular weakness. Patient missed day of work. Patient had Covid prior to vaccination and has been tested after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Dec2020 (Lot number: EK5730) at the age of 46 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Insulin resistance" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: Metformin; Tirosint; Cytomel. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "recovered" and all described as "On dose 1 of Pfizer Covid vaccine, saw a much smaller red warm spot about quarter to half dollar in size". Additional information: On dose 1 of Pfizer Covid vaccine, saw a much smaller red warm spot about quarter to half dollar in size but not raised and only lasted about 1 week. No Covid prior vaccination and not tested for Covid post vaccination. No known allergies. Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: my first two shots with no problems other than a sore arm; my first two shots with no problems other than a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 (Lot number: EN6207) at the age of 62 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; GABAPENTIN; LYRICA. Past drug history included: Codeine for Codeine based medication makes me nauseous., reaction(s): "Known allergies: Codeine", notes: Codeine based medication makes me nauseous. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Dose brand: Pfizer, Dose lot number: EN6202, Dose administration date: 06Feb2021), administration date: 06Feb2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Brand: Pfizer, Lot number: illegible, Administration date: 04Jan2022, Vaccine location: Left arm), administration date: 04Jan2022, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Jul2021, outcome "unknown" and all described as "my first two shots with no problems other than a sore arm".   Follow-Up: Follow-up attempts are completed. No further information is expected.