chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site swelling
Clinical narrative: She has some swelling, near her clavicle bone,some swelling in that area. It's on the left side. Shereceived her Covid 19 vaccine in her left arm; Swelling in the clavicle bone area on the left side of my neck; . This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021432418 (Pfizer), US-PFIZER INC-2021432671 (Pfizer).  A 68-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 09:30 (Lot number: EW0169) at the age of 68 years 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: VACCINATION SITE SWELLING (non-serious) with onset 16Apr2021 12:00, outcome "unknown", described as "She has some swelling, near her clavicle bone,some swelling in that area. It's on the left side. Shereceived her Covid 19 vaccine in her left arm"; SWELLING (non-serious) with onset 16Apr2021 12:00, outcome "not recovered", described as "Swelling in the clavicle bone area on the left side of my neck". Therapeutic measures were not taken as a result of swelling.  Additional information: She was not calling to report new events. She was asking if swelling near her clavicle bone was a common side effect. There was no product complaint to report. No other vaccine was received in four weeks. Patient had COVID prior vaccination and was not tested COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness after receiving second COVID vaccine was reported.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness after receiving second COVID vaccine was reported.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache
Clinical narrative: First dose of Covid Vaccine 3/14 had reaction chills and temp; Temperature; Sharp pains in head stll have sliight headache.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (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: CHILLS (non-serious), outcome "recovered", described as "First dose of Covid Vaccine 3/14 had reaction chills and temp"; BODY TEMPERATURE (non-serious), outcome "recovered", described as "Temperature"; HEADACHE (non-serious), outcome "unknown", described as "Sharp pains in head stll have sliight headache.".  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: Abdominal pain upper, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Fever 100 degrees; Chills; Headache; Arm injection site pain; Stomach pain; This is a spontaneous report from a non-contactable consumer, the patient.   A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 07:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included hypercoagulable blood. The patient had shellfish allergy. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Apr2021 at 12:00, the patient experienced fever 100 degrees, chills, headache, arm injection site pain and stomach pain. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events fever 100 degrees, chills, headache, arm injection site pain and stomach pain were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: vaccination facility type selected, lab data notes, batch number statement and final sentence were updated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever 100 degrees; Chills; Headache; Arm injection site pain; Stomach pain; This is a spontaneous report from a non-contactable consumer, the patient.   A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 07:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included hypercoagulable blood. The patient had shellfish allergy. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Apr2021 at 12:00, the patient experienced fever 100 degrees, chills, headache, arm injection site pain and stomach pain. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events fever 100 degrees, chills, headache, arm injection site pain and stomach pain were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: vaccination facility type selected, lab data notes, batch number statement and final sentence were updated.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his sore arm after taking the second dose of the Pfizer Covid-19 vaccine; 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 (159558). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 21Apr2021 10:20 (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 (1st dose), for Covid-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Apr2021, outcome "unknown", described as "his sore arm after taking the second dose of the Pfizer Covid-19 vaccine".  Additional Information: Patient wants to know if he can take any pain killer medication Tylenol or Advil for his sore arm. patient stated he received his second shot yesterday at 10:20am and his arm is a little sore he stated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms
Clinical narrative: after first dose of COVID vaccine she had fatigue and leg cramps; after first dose of COVID vaccine she had fatigue and leg cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Relevant medical history included: "arthropathic psoriasis, unspecified" (ongoing). Concomitant medication(s) included: ENBREL taken for psoriatic arthropathy, start date: 21Jan2021; AMLODIPINE BESILATE; ATORVASTATIN; B12 [MECOBALAMIN]; HYDROCODONE; LEVOTHYROXIN; LOSARTAN POTASSIUM; MAGNESIUM; MONTELUKAST; OMEPRAZOLE; SPIRONOLACTON; TRELEGY ELLIPTA; VALSARTAN; VENLAFAXINE; VENTOLIN HFA; MULTIVITAMIN [VITAMINS NOS].  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", MUSCLE SPASMS (non-serious) with onset 2021, outcome "recovered" (2021) and all described as "after first dose of COVID vaccine she had fatigue and leg cramps".  Additional information: No co-suspect medications were reported. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date in 2021, the patient was taking one dose of Enbrel this month due to needing to skip doses one week before and after each Covid Vaccine. On an unknown date in 2021, the patient also stated that after first dose of COVID vaccine she had fatigue and leg cramps and the patient was advised to skip doses one week before and after vaccine. No treatment information was received. The causal relationship between the events muscle spasms, fatigue and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. The patient stated that she was off medication as per MDO while taking her two doses of covid vaccine in March/2021. she unsure the dates but back on medication.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Limb discomfort, Pain in extremity
Clinical narrative: weeping "COVID" arm; arm feels very hot and sore; arm feels very hot and sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 19:00 (Lot number: EN6202) at the age of 68 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 (Dates for Pfizer Covid Vaccine: 01Feb2021, Lot number: EL9264, Dose 1, Single.), administration date: 01Feb2021, for COVID-19 immunization; encephalitis (10 years ago.), for Immunisation, reaction(s): "very painful experience"; Rabies (rabies and all of the other vaccines she had to get were fine.), for Immunisation. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 24Feb2021, outcome "recovered" (19Apr2021), described as "weeping "COVID" arm"; FEELING HOT (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 24Feb2021, outcome "not recovered" and all described as "arm feels very hot and sore".  Additional information: reporter stated no alcohol and marijuana was taken. Clinical course reported as COVID arm started right after the second dose, clarified as the day after on 24Feb2021. Her arm was weeping up until a few days ago. Caller clarifies it's not weeping anymore, it stopped about a week ago. Caller states she has recovered completely from the weeping. However, her arm still feels hot and sore.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After my first covid vaccine my mild tinnitus doubled.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "After my first covid vaccine my mild tinnitus doubled".  Additional information: After patient's first Covid vaccine mild tinnitus had doubled. This Saturday 2nd shot is due, and patient was scared to take it since the tinnitus had never stopped.   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: Fatigue
Clinical narrative: fatigue, worsened on 15Apr2021 after receiving covid vaccine, otherwise resolved; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) at the age of 52 years 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: FATIGUE (non-serious) with onset 15Apr2021, outcome "unknown", described as "fatigue, worsened on 15Apr2021 after receiving covid vaccine, otherwise resolved".  Additional information: Patient reports after start of therapy fatigue, worsened on 15Apr2021 after receiving covid vaccine, otherwise resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Localized pain in arm for 2 days after first shot COVID-19 vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US086450_NS (Novartis Pharmaceuticals Corporation).  A 72 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years 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 "recovered", described as "Localized pain in arm for 2 days after first shot COVID-19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Caller reported that he did not feel anything when the second dose of the Covid-19 vaccine was administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 15:00 (Lot number: ER8732) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol increased" (ongoing), notes: Verbatim: High cholesterol.Cholesterol got bad 2-3 years ago and he started taking medication. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose: Date: 05Feb2021; , Lot Number: EN4204; , Anatomical Location: Left arm), administration date: 05Feb2021, for Covid-19 immunization, reaction(s): "Sore arm"; Tetanus shot (Vaccine Name: Tetanus shot, Manufacturer: Unknown, Lot Number: Unknown, Route: Injection, Anatomical Location: Arm, Caller reported that he received the tetanus shot a month or two before the first dose of the Covid-19 vaccine.).The following information was reported: FEELING ABNORMAL (non-serious) with onset 26Feb2021, outcome "unknown", described as "Caller reported that he did not feel anything when the second dose of the Covid-19 vaccine was administered".  Additional information : No Additional Vaccines Administered Vaccines.There was No Emergency Room Visit for any AE(s).Date: Caller reported that he received the tetanus shot a month or two before the first dose of the Covid-19 vaccine.No AE(s) following prior vaccinations were reported.No Family Medical History Relevant to AE(s) was reported. Report filed. Report 1 of 2. Caller was difficult to control and would speak over agent. Multiple attempts were made to redirect and to clarify information provided. Caller was provided with phone number, and reference number, Withheld, prior to transfer.Yes , there is a Product Complaint.Description of Product Complaint:Description of complaint: talcum powder caused cancer and the company was aware of it.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Headache; have received a dose of the Pfizer-BioNTech COVID-19 Vaccine that has been in the fridge undiluted for 6 days; have received a dose of the Pfizer-BioNTech COVID-19 Vaccine that has been in the fridge undiluted for 6 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: EW0167) 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: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 01May2021, outcome "unknown" and all described as "have received a dose of the Pfizer-BioNTech COVID-19 Vaccine that has been in the fridge undiluted for 6 days"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information: Caller mentioned that he may have received a dose of the Pfizer-BioNTech COVID-19 Vaccine that has been in the fridge undiluted for 6 days. Upon Follow-up Transferring agent stated, "He received the first dose of the vaccine (Further clarification was unknown hence captured by Unspecified vaccine). The vaccine he received may had been in refrigerator for six days instead of five days, but he is not sure. He wants to know what it is means for him?" Consumer stated, "One of my friends is wondered and I spoke to him about getting a vaccine and they told me that they have extra doses that are lying around, and they may have given before it expires. I went to get the dose of the vaccine and my friend reached out to me after I got the dose and they said they are not sure but the dose they have given to me is in refrigerator for six days and I want to know if that's okay? "When asked for any side effect with the first dose, Consumer stated, " Just have Headache. "When Probed for the date of the first COVID-19 Shot, Consumer Stated, "May 1st."When Probed for the date of the second COVID-19 Shot, Consumer Stated, "23rd or 24th May. "Consumer stated, "My concern was the dose that I have received, my first vaccine dose. I was told that it may have been refrigerator for 6 days. I know that it is for 5 days. "When asked for any side effect with the first dose, Consumer stated, " Just have Headache. "Further information could not be done as consumer hung up the call abruptly. Hence limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypoaesthesia, Pyrexia
Clinical narrative: She has little reaction to it; today she starts to have a fever and faster heartbeat; She has little reaction to it; today she starts to have a fever and faster heartbeat; numb legs (and sometimes hands); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Lot number: EW0169) at the age of 26 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 , Lot : EW0162), administration date: Apr2021, when the patient was 26 years old, for COVID-19 Immunization.  The following information was reported: HEART RATE INCREASED (non-serious), PYREXIA (non-serious) all with onset 28Apr2021 16:00, outcome "recovered" (28Apr2021 22:00) and all described as "She has little reaction to it; today she starts to have a fever and faster heartbeat"; HYPOAESTHESIA (non-serious) with onset 28Apr2021 16:00, outcome "recovered" (28Apr2021 22:00), described as "numb legs (and sometimes hands)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased, pyrexia, hypoaesthesia.  Additional information: Any other Products that were taken together with those indicated above: No. She had the Numb legs (hands sometimes) for about 2 to 3 hours. Reporter stated question was his girlfriend got the second shot (Unspecified Vaccine) last night and she has little reaction to it. So, no problem but today she started to have a fever and faster heartbeat. Reporter wanted to know was she need to go to the emergency room. Admission of hospital due to event: No. Treatment: Yes Ibuprofen.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm after first dose of Covid Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 83 year-old female patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EN6198) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dementia" (ongoing); "Broke Hip 5 years ago" (unspecified if ongoing); "Rod placed in arm 5 years ago" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Arm after first dose of Covid Vaccine".  Additional information: She had three surgeries in 2015. Second Dose of the Covid Vaccine:  Given on 19 Mar 2021; Lot Number: EN6208. States that the patient is his wife.  She had her vaccines the same time as him and had a sore arm after the first dose.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021495104 same reporter/drug, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I received the Pzifer vaccine for covid and now like a miracle I can taste I received the Pzifer vaccine for covid and now like a miracle I can taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No taste and smell" (unspecified if ongoing); "No taste and smell" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I received the Pzifer vaccine for covid and now like a miracle I can taste I received the Pzifer vaccine for covid and now like a miracle I can taste and smell".  Additional information: The patient had no taste or smell for several years. The doctors have been unable to determine the cause. The patient received the Pzifer vaccine for covid and now like a miracle the patient can taste and smell. This has been life changing for them.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I had my Covid shot. My arm was sore; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (133943).  A 67 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMALOG; FLOMAX [MORNIFLUMATE]; CILOSTAZOL; ALBUTEROL SULFATE HFA; CLOPIDOGREL; ANASTROZOLE; TAMSULOSIN HCL; GEMFIBROZIL; WARFARIN SODIUM; LEVO-T; GABAPENTIN; CALCIUM. Past drug history included: Hydromorphone, reaction(s): "Drug allergies: HYDROMORPHONE".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had my Covid shot. My arm was sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: injury/They give me a tetanus shot seven days after my first dose of Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (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: INJURY (non-serious), outcome "unknown", described as "injury/They give me a tetanus shot seven days after my first dose of Covid vaccine". Therapeutic measures were taken as a result of injury.  Additional information: Reporter stated because of an injury, they give them a tetanus shot seven days after my first dose of Covid vaccine. Reporter got the Covid-19 vaccine, the first dose last week about 7 days ago and today a weak after first dose of the Pfizer Vaccine reporter was given a tetanus shot and it was known to the reporter under CDC website, it says to wait 14 days between the Covid vaccine and any other vaccine so reporter wanted to know what should be done. Lot and expiration date of vaccine, reporter stated, the card was not with reporter right now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: She was sick with flu-like symptoms after her second dose of Covid-19 vaccine; She was sick with flu-like symptoms after her second dose of Covid-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "She was sick with flu-like symptoms after her second dose of Covid-19 vaccine".  Additional information: Reported that Voicemail left on after-hours MIR 26APR2021 at 23:54 from Merck representative reporting al AE she learned of during a lunch at HCP's office.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Lymphadenitis, Tinnitus
Clinical narrative: Squeeky ear drum; Severe eardrum pain; Lymph node inflammation; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 16Apr2021 at 17:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus. Concomitant medications included furosemide (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient had no past drug history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Apr2021 at 02:00, within 8 -12 hours after injection the patient experienced severe eardrum pain (ear pain) on the same side of body as arm injection. It was reported that, according to advice nurse, it was possibly due to lymph node inflammation. The patient experienced pain only when laying down/sleeping, for two nights. On 19Apr2021, on third night the patient had no pain, but a squeaky ear drum (ear noises) like when filled with wax, no problems on fourth night, or since. No treatment was received. The clinical outcome of events severe eardrum pain (ear pain), lymph node inflammation and squeaky ear drum (ear noises) were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Treatment updated as no.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm after first dose of the Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 14:00 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (ongoing), notes: Verbatim: Allergic to mold, mildew, dust, pollen, some trees, dander, lactose intolerant.; "Bronchitis chronic" (ongoing), notes: Verbatim: Chronic bronchitis; "Bowel intussusception" (ongoing), notes: Verbatim: Bowel Intussusception, Was causing bowel blockages, every 2 days or so.; "Nonpolyposis colon cancer" (ongoing). Concomitant medication(s) included: LINZESS taken for intestinal obstruction; EPIPEN taken for anaphylactic reaction. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "recovered" (13Mar2021), described as "Sore Arm after first dose of the Covid Vaccine".  Additional information: Concomitant Products Linzess used for Bowel Blockages. After the first dose of the vaccine she mentions she had a sore arm. States she expected that. Says it lasted for a day then it was gone. States her doctor recommended the Covid Vaccine because the caller has anaphylactic allergies. States she uses Epi-Pens as needed and gets chronic bronchitis from any sinus or allergy. Reporter states her doctor's told her that since her allergies started in her 40's they will likely just get worse as she gets older. Denies any other medical conditions or medications relevant to events. Denies any labs, testing, or treatments relevant to events. States she wants to have further testing done to see if she had a virus; or if she is immune to the virus. Wonders if that is why her lymph nodes are swollen, because they are fighting hard? Mentions again that she can't lift her arm and has weakness and fatigue. Vaccination facility type was hospital. Vaccine was not administered at military facility. No prior vaccinations (within 4 weeks). No AE(s) following prior vaccinations. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None reported. The patient not visited emergency room due to events.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First COVID-19 vaccine, she didn't have anything but a little bit of a sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Batch/Lot number: unknown) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 08Jan2021 (unspecified if ongoing); "Back injury", start date: 2020 (unspecified if ongoing); "vertebrae crushed", start date: 2020 (unspecified if ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: SKYRIZI [RISANKIZUMAB RZAA] taken for psoriasis. Vaccination history included: Flu vaccine, reaction(s): "Arm swells up". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "First COVID-19 vaccine, she didn't have anything but a little bit of a sore arm.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Getting her second dose of the COVID vaccine which caused her to be ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Malignant neoplasm of lower-outer quadrant of right female breast" (unspecified if ongoing). Concomitant medication(s) included: IBRANCE taken for breast cancer female (ongoing). Vaccination history included: Bnt162b2 (Dose number 1,single), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Getting her second dose of the COVID vaccine which caused her to be ill".  Additional information: It was reported that, the patient missed one dose of Ibrance over the last couple of weeks. She told that, this was mainly due to her getting her second dose of the COVID vaccine which caused her to be ill. Overall, she was very adherent to her medication and she told that, she has not missed any of her doses otherwise. Stated that, the date the patient started the medication (Ibrance) was unknown. Stated that, the date this pharmacy first filled the medication (Ibrance) was on 15Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches; Chills; Low grade fever; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02May2021 at 12:15 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. On 03May2021 at 02:00, the patient experienced body aches, chills and low-grade fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body aches, chills and low-grade fever was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment(30AUG2021): This follow-up report is being submitted to amend previously reported information: Vaccine Facility Information added
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Blood test, Investigation, Loss of personal independence in daily activities
Clinical narrative: Lost use of legs after first dose of the Covid Vaccine; Very weak after first dose of the Covid Vaccine; She couldn't do anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6208) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 1997, reaction(s): "Hives". The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Lost use of legs after first dose of the Covid Vaccine"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Very weak after first dose of the Covid Vaccine"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "She couldn't do anything". The events "lost use of legs after first dose of the covid vaccine", "very weak after first dose of the covid vaccine" and "she couldn't do anything" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter states that patient has received both doses of the Covid Vaccine. reporter says patient had no symptoms before the vaccines.  patient  was gardening and mowing the lawn.Towards end of call reporter mentions that her doctor got her in for an appointment quickly since the reporter could hardly walk and had so much trouble comprehending and focusing.  States patient was focusing better. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Lost use of legs after first dose of the Covid Vaccine; Very weak after first dose of the Covid Vaccine; She couldn't do anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6208) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Bactrim, start date: 1997, reaction(s): "Hives". The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Lost use of legs after first dose of the Covid Vaccine"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Very weak after first dose of the Covid Vaccine"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "She couldn't do anything". The events "lost use of legs after first dose of the covid vaccine", "very weak after first dose of the covid vaccine" and "she couldn't do anything" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter states that patient has received both doses of the Covid Vaccine. reporter says patient had no symptoms before the vaccines.  patient  was gardening and mowing the lawn.Towards end of call reporter mentions that her doctor got her in for an appointment quickly since the reporter could hardly walk and had so much trouble comprehending and focusing.  States patient was focusing better. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: Possible interaction between allergy shot and Pfizer COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: DRUG INTERACTION (non-serious) with onset 03May2021, outcome "unknown", described as "Possible interaction between allergy shot and Pfizer COVID vaccine".  Additional information: The manufacturer, start date, NDC number and expiry date of Pfizer COVID vaccine were not reported. The patient got allergy shot a half hour after his first dose of Pfizer COVID vaccine and wanted to know if it would mix with his second dose of Pfizer COVID vaccine.The stop date of the event was unspecified.Other Products and Investigation Assessment was not provided.Reporter seriousness for possible interaction between allergy shot and Pfizer COVID vaccine was unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Received her first dose of the Pfizer BioNTech COVID-19 vaccine on 13APR2021 and a week later reported persistent dizziness and vertigo.; Received her first dose of the Pfizer BioNTech COVID-19 vaccine on 13APR2021 and a week later reported persistent dizziness and vertigo.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), VERTIGO (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Received her first dose of the Pfizer BioNTech COVID-19 vaccine on 13APR2021 and a week later reported persistent dizziness and vertigo.". 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: had a sore arm after each of her 2 doses of the Pfizer-BioNTech Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administered in arm, administration date 2021 (Batch/Lot number: unknown) as dose 2, 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 "had a sore arm after each of her 2 doses of the Pfizer-BioNTech Covid-19 Vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514884 same reporter/drug, event / different patient;US-PFIZER INC-2021514882 same reporter/drug,event, different patient;US-PFIZER INC-2021514883 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Since patient's first dose of the covid vaccine, he has had sludgy stool; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old male patient received bnt162b2 (BNT162B2) (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: DIARRHOEA (non-serious), outcome "unknown", described as "Since patient's first dose of the covid vaccine, he has had sludgy stool".  Additional Information: Since patient's first dose of the covid vaccine, he has had sludgy stool. Reporter called to report her symptoms after receiving the first dose of the covid vaccine. Reporter works in health care. Reporter mentioned that one of her clients, has also been experiencing one of the same symptoms as her  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.