chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair started falling out; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (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: ALOPECIA (non-serious), outcome "unknown", described as "Hair started falling out".  Additional Information: Caller reported she received all three Pfizer BioNTech Covid19 Vaccine doses, but after the first dose she noticed her hair started falling out. After second dose, her hair started falling out more. Then it stopped and everything seemed ok. Then she got the booster and her hair started falling out again. She had questions. This report was for caller's friend. She had a dear friend at work that has also reported the same thing. They both got Pfizer and got boosters together, 10 days ago. Caller noticed the hair failing about within a month of first dose. She noticed hair everywhere. Certainly after second dose it was like woah. Her friend at work said she had the same thing and she is caller's age too.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101595915 same reporter/drug/AE, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired healing, Off label use, Psoriasis, Skin atrophy
Clinical narrative: she took the vaccine because it said it would work well for the skin; psoriasis; thinner skin; more sensitivity to tearing and with her psoriasis problem she has skin tears that would not closing and were open wounds; more sensitivity to tearing and with her psoriasis problem she has skin tears that would not closing and were open wounds; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation, psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "she took the vaccine because it said it would work well for the skin"; PSORIASIS (non-serious), outcome "unknown", described as "psoriasis"; SKIN ATROPHY (non-serious), outcome "unknown", described as "thinner skin"; SKIN LACERATION (non-serious), IMPAIRED HEALING (non-serious), outcome "unknown" and all described as "more sensitivity to tearing and with her psoriasis problem she has skin tears that would not closing and were open wounds"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: It was confirmed that Covid 19 BioNtech vaccine was a Pfizer product. She said that her skin got thinner skin and more sensitivity to tearing and with her psoriasis problem she has skin tears that would not closing and were open wounds. It was reported that patient was riding her scooter she was healthier than the average women, and reporter was surprised when she saw she had psoriasis that showed on the arm, it was because of this vaccine. It was reported that patient had thinner skin and skin tears that would not heal. Reporter was stating that it was unethical for a product to be marketed as a skin treatment because people that had skin conditions can have side effects. Reporter could not provide the website where she got some of her information about the vaccine being used to improve skin conditions. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin laceration
Clinical narrative: she took the vaccine because it said it would work well for the skin; psoriasis; thinner skin; more sensitivity to tearing and with her psoriasis problem she has skin tears that would not closing and were open wounds; more sensitivity to tearing and with her psoriasis problem she has skin tears that would not closing and were open wounds; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation, psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "she took the vaccine because it said it would work well for the skin"; PSORIASIS (non-serious), outcome "unknown", described as "psoriasis"; SKIN ATROPHY (non-serious), outcome "unknown", described as "thinner skin"; SKIN LACERATION (non-serious), IMPAIRED HEALING (non-serious), outcome "unknown" and all described as "more sensitivity to tearing and with her psoriasis problem she has skin tears that would not closing and were open wounds"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: It was confirmed that Covid 19 BioNtech vaccine was a Pfizer product. She said that her skin got thinner skin and more sensitivity to tearing and with her psoriasis problem she has skin tears that would not closing and were open wounds. It was reported that patient was riding her scooter she was healthier than the average women, and reporter was surprised when she saw she had psoriasis that showed on the arm, it was because of this vaccine. It was reported that patient had thinner skin and skin tears that would not heal. Reporter was stating that it was unethical for a product to be marketed as a skin treatment because people that had skin conditions can have side effects. Reporter could not provide the website where she got some of her information about the vaccine being used to improve skin conditions. 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 increased
Clinical narrative: When I got the first two and my temperature did go up but it didn''t go up as high as it is now and I just checked it and it''s 101; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Blood cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: LOSARTAN; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose-01), for Immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "When I got the first two and my temperature did go up but it didn''t go up as high as it is now and I just checked it and it''s 101". 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) : PFIZER INC-202101604545 same patient and drug, different event separated in time
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Crepitations, Immunisation, Off label use, Pain in extremity, Product use issue
Clinical narrative: pain to left arm above elbow. Very tender to touch and area that felt crepitus; pain to left arm above elbow. Very tender to touch and area that felt crepitus; pain to left arm above elbow. Very tender to touch and area that felt crepitus; Dose 3; Other vaccine same date vaccine date 15Oct2021; Other vaccine same date vaccine date 15Oct2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 16:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "radiculopathy" (unspecified if ongoing); "gout" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing); "Sulphur drugs" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 15Oct2021. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9810, Location of injection: Arm Left), administration date: 30Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 05Mar2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Oct2021 16:00, outcome "unknown", described as "Dose 3"; PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious) all with onset 17Oct2021, outcome "not recovered" and all described as "pain to left arm above elbow. Very tender to touch and area that felt crepitus"; CREPITATIONS (non-serious) with onset 17Oct2021, outcome "recovered" (20Oct2021), PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 15Oct2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 15Oct2021". Therapeutic measures were not taken as a result of pain in extremity, crepitations, tenderness.  Additional information: No other vaccines received 4 weeks prior to covid-19 vaccination. The patient had not tested positive for covid prior to vaccination and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: pain to left arm above elbow. Very tender to touch and area that felt crepitus; pain to left arm above elbow. Very tender to touch and area that felt crepitus; pain to left arm above elbow. Very tender to touch and area that felt crepitus; Dose 3; Other vaccine same date vaccine date 15Oct2021; Other vaccine same date vaccine date 15Oct2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 16:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "radiculopathy" (unspecified if ongoing); "gout" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing); "Sulphur drugs" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 15Oct2021. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9810, Location of injection: Arm Left), administration date: 30Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 05Mar2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Oct2021 16:00, outcome "unknown", described as "Dose 3"; PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious) all with onset 17Oct2021, outcome "not recovered" and all described as "pain to left arm above elbow. Very tender to touch and area that felt crepitus"; CREPITATIONS (non-serious) with onset 17Oct2021, outcome "recovered" (20Oct2021), PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 15Oct2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 15Oct2021". Therapeutic measures were not taken as a result of pain in extremity, crepitations, tenderness.  Additional information: No other vaccines received 4 weeks prior to covid-19 vaccination. The patient had not tested positive for covid prior to vaccination and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Bronchial disorder, Lung disorder, Pain, SARS-CoV-2 test
Clinical narrative: few months after my lungs got really bad; this flare up has been a bad one in terrible pain and my bronchial tube wont heal; this flare up has been a bad one in terrible pain and my bronchial tube wont heal; Spine and legs hurt bad and left side of neck; 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): LupusMi-AE2021.11.08.02 (GSK).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG DISORDER (non-serious), outcome "unknown", described as "few months after my lungs got really bad"; PAIN (non-serious), BRONCHIAL DISORDER (non-serious), outcome "unknown" and all described as "this flare up has been a bad one in terrible pain and my bronchial tube wont heal"; ARTHRALGIA (non-serious), outcome "unknown", described as "Spine and legs hurt bad and left side of neck". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lung disorder, pain, bronchial disorder.  Additional information: Patient got Pfizer was okay for a few months few side effects but few months after their lungs got really bad had to be on Prednisone again. They kept saying no more Prednisone but couldn't seem to get better without it. They kept hoping that they will get better cause this flare-up has been a bad one in terrible pain and their bronchial tube won't heal. Had 3 rounds of antibiotics. Tested negative for Covid 3 times my spine and legs hurt bad and left side of neck. Not sure if just a flare-up or what.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: can not stop shaking/tremors; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "can not stop shaking/tremors".  Additional information: Caller stated there was a sulfa allergy involved for her son that was required to get the Pfizer covid 19 vaccine. Caller stated she was allergic to sulfa and experienced shortness of breath and had to go the the hospital. Caller stated she knows of two family members that had injuries from the Pfizer covid 19 noting that one was experiencing tremors and could not stop shaking. Caller stated a third member might be involved. Caller asked how can she feel better about this. Caller stated she knows of 58 people that died from other vaccines and the vaccines were pulled for much less noting the vaccines were studied for 10 years. Caller asked was there a threshold or level that Pfizer is looking for that would cause them to pull the vaccine. Caller had concerns about the safety of the vaccine. Caller did not want to be transferred to medical because she said it is not her place to report the AE for her family members, noting it was reported to the doctors Caller stated these AE of the family members were reported to VAERS.  The lot number for the vaccine, [Comirnaty], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, SARS-CoV-2 test, SARS-CoV-2 test false positive, SARS-CoV-2 test positive
Clinical narrative: Positive covid PCR test; the patient had 2 additional PCR tests with negative results. This has been dismissed a false positive; mild symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date Sep2021 (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 Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Sep2021, when the patient was 12 years old, for Covid-19 immunization. The following information was reported: SARS-COV-2 TEST FALSE POSITIVE (non-serious) with onset Nov2021, outcome "recovered", described as "Positive covid PCR test; the patient had 2 additional PCR tests with negative results. This has been dismissed a false positive"; COGNITIVE DISORDER (non-serious) with onset Nov2021, outcome "recovered", described as "mild symptoms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: : Positive covid PCR test with mild symptoms within a short time from vaccination - since the discovery of this information, the patient had 2 additional PCR tests with negative results. This has been dismissed as false positive (and only mild symptoms). Covid tested post vaccination: covid test date=Nov2021, covid test result=Inconclusive.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Scar
Clinical narrative: I had the same rash reaction but only in my chest/she had the same reaction but on her chest, neck and face; Caller states she has a lot of scars on her chest, it looks like red; 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 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: RASH (non-serious), outcome "unknown", described as "I had the same rash reaction but only in my chest/she had the same reaction but on her chest, neck and face"; SCAR (non-serious), outcome "unknown", described as "Caller states she has a lot of scars on her chest, it looks like red". Therapeutic measures were taken as a result of rash.  Additional information: Patient had the Pfizer Covid vaccine 5-6 months ago. She had no new events to report. Start date and Stop date for covid vaccine was Unspecified. Investigation assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Product administered at inappropriate site
Clinical narrative: She could not lift or rotate her arm/person to complain about this; first dose was given in the wrong part of her arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A female 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: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "not recovered", described as "She could not lift or rotate her arm/person to complain about this"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "first dose was given in the wrong part of her arm". Additional information: Caller wanted to know if she has the correct information about getting a refund for her husbandwho is taking Latanaprost. The eye drops never worked, no solution came out of the bottle, relayed information from (with held) and she did have the correct info. As we were talking she said when she got her 1st dose of the Pfizer vaccine she could not lift or rotate her arm. It still has not gone away. When she went to get her 2nd dose the HCP told her she was the 5th person to complain about this. He told her the first dose was given in the wrong part of her arm. She is now waiting to have surgery on her arm. She said she is an RN and this has affected her job as well. Caller did not want to so will fax on her behalf.  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-202101619554 ;US-PFIZER_INC-202101619555 ;US-PFIZER_INC-202101619556 ;US-PFIZER_INC-202101619557 ;US-PFIZER_INC-202101619558 ;US-PFIZER_INC-202101619559
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: could not lift or rotate her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191).  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: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "could not lift or rotate her arm".  Additional information: No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. Caller wanted to know if she has the correct information about getting a refund for her husband who is taking Latanaprost. The eye drops never worked, no solution came out of the bottle, relayed information from (withheld) and she did have the correct info. As we were talking, she said when she got her 1st dose of the Pfizer vaccine she could not lift or rotate her arm. It still has not gone away. When she went to get her 2nd dose the HCP told her she was the 5th person to complain about this. He told her the first dose was given in the wrong part of her arm. She was now waiting to have surgery on her arm. She said she was an RN and this has affected her job as well. Caller did not want to go to the college so will fax on her behalf.   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-202101619553
Sex: U
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Limb discomfort
Clinical narrative: could not lift or rotate arm/5th person to complain about this; could not lift or rotate arm/5th person to complain about this; This is a spontaneous report received from a contactable reporter(s) (Other HCP) 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: JOINT RANGE OF MOTION DECREASED (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "could not lift or rotate arm/5th person to complain about this".  Additional information: Caller wanted to know if she has the correct information about getting a refund for her husband who is taking Latanaprost. The eye drops never worked, no solution came out of the bottle, relayed information from (with held) and she did have the correct info. As we were talking she said when she got her 1st dose of the Pfizer Covax vaccine she could not lift or rotate her arm. It still has not gone away. When she went to get her 2nd dose the HCP told her she was the 5th person to complain about this. He told her the first dose was given in the wrong part of her arm. She is now waiting to have surgery on her arm. She said she is an RN and this has affected her job as well. Will fax on her behalf.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER_INC-202101619553
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tongue discomfort, Weight decreased
Clinical narrative: Extreme weight loss; Burning tongue; Nausea; 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-202101619191 (pfizer).  A 50 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Apr2021 16:00 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot: looks like BP7534, Site: left arm), administration date: 25Mar2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Tiredness". The following information was reported: WEIGHT DECREASED (non-serious) with onset Apr2021, outcome "not recovered", described as "Extreme weight loss"; TONGUE DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Burning tongue"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nausea". The events "extreme weight loss", "burning tongue" and "nausea" were evaluated at the physician office visit.  Additional information: No additional vaccines administered on same date of the Pfizer suspect. The events result in physician office visit. The patient did not receive any other vaccinations within four weeks prior to the first  administration date of the suspect vaccine. Caller stated that his "sister took the vaccine maybe 2 months ago (second dose), maybe 3-4 months ago, no actually 4 months ago". Caller said that they've "notice significant changes like extreme weight loss, burning tongue. several, different, tired all kind of crazy stuffs that we think are related." Caller is asking if we can help and what to do. Caller mentioned " can send her somewhere to lab that we can get tested out to any relation on what's going on, where do you want me to tell my sister to go so you can all test her and see what's goin on.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia, Pain in extremity
Clinical narrative: Upper right and left back pain when laying down or trying to sleep; On going muscle and joint pain; Upper right and left back pain when laying down or trying to sleep; On going muscle and joint pain; This is a spontaneous report from a Contactable Consumer. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Sep2021 11:00 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sleep apnea" (unspecified if ongoing), notes: sleep apnea; "blood pressure" (unspecified if ongoing), notes: blood pressure. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose brand=pfizer, Prev dose brand unknown=False, Prev dose lot number=301358A, Prev dose lot unknown=False, Prev dose administration date=30Sep2021, Prev dose dose number=1), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 11Oct2021 12:00, outcome "not recovered" and all described as "Upper right and left back pain when laying down or trying to sleep"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 11Oct2021 12:00, outcome "not recovered" and all described as "On going muscle and joint pain". The events "upper right and left back pain when laying down or trying to sleep", "on going muscle and joint pain", "upper right and left back pain when laying down or trying to sleep" and "on going muscle and joint pain" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of back pain, arthralgia, pain in extremity, myalgia.  Additional information: Patient did not received other vaccine within four weeks of Covid vaccine. Patient did not experience Covid prior to vaccination, patient did not test positive post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Urticaria
Clinical narrative: Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back, again around 8-9 pm; Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back, again around 8-9 pm; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Nov2021 15:30 (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: CONCERTA 27mg; Oral METHYLPHENIDATE 27 mg taken for attention deficit hyperactivity disorder (ongoing). The following information was reported: URTICARIA (non-serious), SWELLING OF EYELID (non-serious) all with onset 17Nov2021 20:00, outcome "recovered" (2021) and all described as "Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back, again around 8-9 pm". Therapeutic measures were taken as a result of urticaria, swelling of eyelid.  Additional information: adverse event; Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back,again around 8-9 pm. Both resolved with antihistamine and prednisone. Today is day 8 now with urticaria of posterior right knee. Patient received treatment as antihistamine and prednisone for event. Upon Follow-up it was reported that Day 6 Post 1st Covid vaccine shot she developed bilateral eyelid swelling, Day 7-9 She had uitcaria of her torso arms and focally on her Right leg Benadryl, zyzal and prednisone 10 mg given each day, days 6-9 spentaneously resolved. Specific Relevant Test for thromboembolic event with Thrombocytopenia:  None. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got super super sick and didn't get the second dose; 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 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) at the age of 27 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: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "got super super sick and didn't get the second dose". Therapeutic measures were not taken as a result of illness.  Additional information: The caller stated he got the first dose of the Pfizer-BionTech Covid-19 Vaccine a little before June, in May, around there. He got super sick and didn't get the second dose. He may go back and get the second dose but asked if they must restart the series if it has been this long. The caller asked if it is super dangerous to just get one dose instead of two. He stated he does not want to end up dying. The caller stated it might scare people away from getting the vaccine at all [if they don't have any data on how safe it is to get just ONE dose and it was only studied as a two-dose series]. He did not provide lot number. He stated they did not give him a card. He only got the first dose not the second dose. He stated that, he might get the second dose later, but he is not sure yet.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Lymphadenopathy
Clinical narrative: Armpit hurts - just outside of her armpit.; She was thinking maybe it was a swollen lymph node.; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 28 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious), outcome "not recovered", described as "Armpit hurts - just outside of her armpit."; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "She was thinking maybe it was a swollen lymph node.". Therapeutic measures were not taken as a result of axillary pain, lymphadenopathy.  Additional information: Patient had no COVID prior vaccination, Patient had not tested COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath; Pressure in chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Relevant past drug history , Name of Drug as Reported: No, Reaction: Allergy. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset 28Oct2021, outcome "unknown", described as "Shortness of breath"; CHEST DISCOMFORT (non-serious) with onset 28Oct2021, outcome "unknown", described as "Pressure in chest". Therapeutic measures were not taken as a result of dyspnoea, chest discomfort.  Additional Information: The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 after vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pfizer have permission to contact the reporter about this event. Pfizer do not have the permission to contact patient's healthcare provider about this report.  Follow up (24Dec2021): This follow-up is being submitted to notify that the lot/batch number for one dose is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Poor quality product administered, Product temperature excursion issue
Clinical narrative: COVID19 Vaccine Administered at wrong temperature; COVID19 Vaccine Administered at wrong temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Jun2021 18:00 (Lot number: EW0178) at the age of 14 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2007 (ongoing); "Acid reflux", start date: 2020 (ongoing); "Lactose intolerant", start date: 2020 (ongoing); "Anxiety disorder" (ongoing), notes: 2016/2017. Concomitant medication(s) included: PANTOPRAZOLE taken for gastrooesophageal reflux disease, start date: 2020 (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma, start date: 2007 (ongoing). Vaccination history included: Bnt162b2 (First dose, Time: 15:00 , Anatomical site of injection: Right arm, Route of administration: Intramuscular, Lot Number: EW0179), administration date: 17May2021, when the patient was 14 years old, for COVID-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 07Jun2021, outcome "unknown" and all described as "COVID19 Vaccine Administered at wrong temperature"; ASTHMA (non-serious) with onset 2021, outcome "unknown", described as "asthma". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that his daughter was provided her second COVID-19 shot on 07Jun2021 and sent a letter to withheld which he copied Pfizer. The vaccine was given after held at the wrong temperature and also stated that it was not reported to the department of health nor CDC. He then reach out for help as he did not know what was the best course of action.  Updated information: Vaccination details lot number, time, Anatomical site, route of administration, vaccination facility address, concomitant drugs, patient medical history and relevant tests added.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Skin reaction
Clinical narrative: red spots that appeared on her face after receiving the vaccine.; red spots that appeared on her face after receiving the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (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: RASH MACULAR (non-serious), SKIN REACTION (non-serious), outcome "recovered" (2021) and all described as "red spots that appeared on her face after receiving the vaccine.".  Additional information: The patient developed red spots on her face within 5 minutes of getting the shot.  HCP stated that the patient was at her vaccination site to receive a booster dose of the Pfizer Covid-19 vaccine. The patient wants the booster shot but the pharmacist was looking for information on if this was an allergic reaction before administering the booster. The reporter confirmed that they did not give the other shot, the booster. The patient said she developed red spots on her face within 5 minutes of getting the shot. It was explained that they did not give the previous shots for the patient, so she had no information regarding those shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Received their first dose of Comirnaty on 13Nov2021 and got the 2nd dose 6 days ago, 19Nov2021; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 5 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 5 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), administration date: 13Nov2021, when the patient was 5 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Received their first dose of Comirnaty on 13Nov2021 and got the 2nd dose 6 days ago, 19Nov2021"; PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "Fever".  Additional information: Patient received the second dose from school by accident 6 days after first vaccine dose. Lot number of suspect vaccine was reported as KF5127 which was not clarified appropriately.  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-202101640262 same reporter/product/event, different patients.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "right shoulder pain" (unspecified if ongoing), notes: No other physical health related problems except right shoulder pain from an injury to my right shoulder; "injury to right shoulder" (unspecified if ongoing), notes: No other physical health related problems except right shoulder pain from an injury to my right shoulder. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "It disrupted my ability to work at my job", "My eyes were sensitive to light", "disrupting vision", "Posterior Vitreous detachment", "huge black floater on my right eye". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headaches". The event "headaches" was evaluated at the physician office visit.  Additional information: First dose, I went to my eye M.D on 4th day after the first vaccine because the problem was not going away. I still have the huge black floater on my right eye. My eye doctor called it "Posterior Vitreous detachment" on 14Nov2021, I am still dealing the big dark floaters which disrupting vision.  Follow-up attempts are completed. No further information is expected; Batch/lot number not available for BNT162B2
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Loss of personal independence in daily activities, Rhinorrhoea, Sneezing, Urticaria
Clinical narrative: chronic allergic problem; constant bouts of sneezing; runny nose; I get red balls all over my body; I can't take care of my pets anymore; 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 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: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "chronic allergic problem"; SNEEZING (non-serious), outcome "unknown", described as "constant bouts of sneezing"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; URTICARIA (non-serious), outcome "unknown", described as "I get red balls all over my body"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I can't take care of my pets anymore".  Additional information: He never had allergies in his life. Patient was much better before He put this poison in his body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm started paining me when I lay on it when I am in bed; 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 COVID-19 Vaccine - Manufacturer Unknown, administration date Feb2021 (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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "my arm started paining me when I lay on it when I am in bed".  Additional information: Consumer stated, "Here was patient question. Patient had the COVID Vaccine on February 9 months ago and couple months ago patient arm started painting me when I lay on it when I am in bed. It doesn't hurt to touch it and I wondered if that's a common side effect?"  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected