chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: small hives on my left arm/I started to see them on my stomach, back, legs and my right arm as well; arm was hurting; I started to get itchy/itchy around my lips, my face, arms, belly and back/My whole body was itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 12:30 (Lot number: 331308A) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 21Dec2021 12:45, outcome "not recovered", described as "I started to get itchy/itchy around my lips, my face, arms, belly and back/My whole body was itchy"; URTICARIA (non-serious) with onset 25Dec2021, outcome "not recovered", described as "small hives on my left arm/I started to see them on my stomach, back, legs and my right arm as well"; PAIN IN EXTREMITY (non-serious) with onset 22Dec2021, outcome "not recovered", described as "arm was hurting". The events "i started to get itchy/itchy around my lips, my face, arms, belly and back/my whole body was itchy", "small hives on my left arm/i started to see them on my stomach, back, legs and my right arm as well" and "arm was hurting" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pruritus, urticaria, pain in extremity.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. After 15 minutes of getting the vaccine I started to get itchy. At home my arm was hurting and it was still very itchy. The next day, I was itchy around my lips, my face, arms, belly and back. On the forth day I noticed small hives on my left arm. I thought it was normal but then I started to see them on my stomach, back, legs and my right arm as well. My whole body was itchy, I decided to go to the urgent care (11Jan2022) and they gave me a steroid shot, cream and medicine. I went to see my doctor and he gave me medicine as well, but it work for a little bit. I still have hives on both of my arms, part of my back, stomach and legs. Ae treatment: Steroid shot, banophen, prednisone, hydroxyzine p.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: His psoriasis did flare up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US027548_NS.  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious) with onset 27Dec2021, outcome "unknown", described as "His psoriasis did flare up".  Additional information: Patient advised when he received his COVID-19 booster shot his psoriasis did flare up. It was around 27Dec2021. Until that point his skin was clear but after he received the booster he did see his progress decline.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (005570). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had a rash, with outcome of unknown. Therapeutic measures were taken as a result of rash. Additional information: His dermatologist provided him with treatment regarding the rash; however he wondered how do we cure a long-term drug rash from the Pfizer COVID-19 vaccine. The batch/lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Mass, Pain in extremity
Clinical narrative: Chills; cough; fever of 100.5; sore arm that has a bump; sore arm that has a bump; itches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Feb2022 14:45 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "chronic hives" (unspecified if ongoing); "chronic dry skin" (unspecified if ongoing); "Known allergies: Corn" (unspecified if ongoing); "Known allergies: lettuce" (unspecified if ongoing); "Known allergies: milk" (unspecified if ongoing); "Known allergies: any and all penicillins" (unspecified if ongoing); "Known allergies: cephalasporins" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; HYDROXYZINE; MELATONIN; PREDNISONE. Past drug history included: Morphine, reaction(s): "Known allergies: morphine"; Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Topamax, reaction(s): "Known allergies: Topamax"; Meloxicam, reaction(s): "Known allergies: melaxicam". Vaccination history included: Bnt162b2 (Dose number: 1, Prev dose product: COVID 19, Prev dose brand: BioNPfizer, Prev dose administration date: 11Jan2022, Prev dose administration time: 03:00 PM, Prev dose vaccine location: Left arm), administration date: 11Jan2022, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "Chills"; COUGH (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "cough"; PYREXIA (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "fever of 100.5"; PAIN IN EXTREMITY (non-serious), MASS (non-serious) all with onset 10Feb2022 02:30, outcome "recovering" and all described as "sore arm that has a bump"; PRURITUS (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "itches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, cough, pyrexia, pain in extremity, mass, pruritus.  Additional information: The Facility type vaccine was Workplace clinic. The patient had no other vaccine in four weeks. She did not had covid prior vaccination. She was not covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Chills; cough; fever of 100.5; sore arm that has a bump; sore arm that has a bump; itches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Feb2022 14:45 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "chronic hives" (unspecified if ongoing); "chronic dry skin" (unspecified if ongoing); "Known allergies: Corn" (unspecified if ongoing); "Known allergies: lettuce" (unspecified if ongoing); "Known allergies: milk" (unspecified if ongoing); "Known allergies: any and all penicillins" (unspecified if ongoing); "Known allergies: cephalasporins" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; HYDROXYZINE; MELATONIN; PREDNISONE. Past drug history included: Morphine, reaction(s): "Known allergies: morphine"; Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Topamax, reaction(s): "Known allergies: Topamax"; Meloxicam, reaction(s): "Known allergies: melaxicam". Vaccination history included: Bnt162b2 (Dose number: 1, Prev dose product: COVID 19, Prev dose brand: BioNPfizer, Prev dose administration date: 11Jan2022, Prev dose administration time: 03:00 PM, Prev dose vaccine location: Left arm), administration date: 11Jan2022, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "Chills"; COUGH (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "cough"; PYREXIA (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "fever of 100.5"; PAIN IN EXTREMITY (non-serious), MASS (non-serious) all with onset 10Feb2022 02:30, outcome "recovering" and all described as "sore arm that has a bump"; PRURITUS (non-serious) with onset 10Feb2022 02:30, outcome "recovering", described as "itches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, cough, pyrexia, pain in extremity, mass, pruritus.  Additional information: The Facility type vaccine was Workplace clinic. The patient had no other vaccine in four weeks. She did not had covid prior vaccination. She was not covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: heavy menstruation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "recovering", described as "heavy menstruation". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional Information: It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient reported onset of heavy menstruation shortly after receiving vaccine. Patient reported she has an IUD and does not menstruate regularly. Patient reported this occurred with the first and second doses as well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: he reported having increased soreness and stiffness to his knees, hips, knuckles, elbows,and shoulders; he reported having increased soreness and stiffness to his knees, hips, knuckles, elbows,and shoulders; swelling in his joints; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious), outcome "unknown" and all described as "he reported having increased soreness and stiffness to his knees, hips, knuckles, elbows,and shoulders"; JOINT SWELLING (non-serious), outcome "unknown", described as "swelling in his joints".  Additional Information: Patient reported in Nov being off of xeljanz for 2 weeks because he got the covid-19 booster. While off xeljanz, he reported having increased soreness and stiffness to his knees, hips, knuckles, elbows, and shoulders. He also reported once in a while having stiffness and swelling in his joints. Md is aware. Patient also reported sometimes would be late getting his medication due to previous pharmacy being late on shipping his medication. Unknown how many days he was late as well as any adverse effect. Md was aware of the delays from previous pharmacy. Dose 11mg, Once daily via oral route for Rheumatoid Arthritis. Output Form Id: 750916 and Program ID: 141003 was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hypersensitivity, Nausea, Urticaria, Vomiting
Clinical narrative: hives; nausea; diarrhea; vomiting; she felt this was an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 28 year-old male patient received bnt162b2 (COMIRNATY) (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 (Manufacturer: Unknown, Dose number: 1), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "she felt this was an allergic reaction".  Additional information: This patient received the second dose of the adult Pfizer COVID-19 Vaccine last year and experienced side effects 2 days later. The symptoms were hives, nausea, diarrhea and vomiting, then the caller added that she felt this was an allergic reaction. Caller's inquiry was if the booster dose of the Pfizer COVID Vaccine would be recommended after her patient suffered this side effects.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction, Psoriasis
Clinical narrative: Xeljanz XR is not as effective since she has taken the Pfizer Covid vaccine.; Patient advised she has Psoriasis; 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 66 year-old female 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. The patient took concomitant medications. The following information was reported: DRUG INTERACTION (non-serious), outcome "unknown", described as "Xeljanz XR is not as effective since she has taken the Pfizer Covid vaccine."; PSORIASIS (non-serious), outcome "unknown", described as "Patient advised she has Psoriasis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Vaccination site pain
Clinical narrative: swollen arm pit and its painful/swollen armpit; swollen arm pit and its painful; injection site is tender; 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), administration date 09Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization, reaction(s): "my arm was heavy and painful to lift"; Bnt162b2 (Second dose), for Covid-19 Immunization, reaction(s): "my arm was heavy and painful to lift". The following information was reported: SWELLING (non-serious) with onset 10Feb2022, outcome "unknown", described as "swollen arm pit and its painful/swollen armpit"; AXILLARY PAIN (non-serious) with onset 10Feb2022, outcome "unknown", described as "swollen arm pit and its painful"; VACCINATION SITE PAIN (non-serious) with onset 10Feb2022, outcome "unknown", described as "injection site is tender ".  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, Pain in extremity, Pyrexia
Clinical narrative: soreness in the arm; body aches; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 34 year-old female patient received bnt162b2 (COMIRNATY) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in the arm"; PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: Fever; not hungry; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2022 15:00 (Lot number: FK8618) at the age of 10 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Time: 15.00, Anatomical site of injection: Left arm, Lot Number: FK5618), administration date: 05Jan2022, when the patient was 10 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "recovering", described as "Fever"; DECREASED APPETITE (non-serious), outcome "recovering", described as "not hungry"; FATIGUE (non-serious), outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccination Facility Type was pharmacy or drug store  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: tired/ exhausted; Headache every day since taking Pfizer Covid19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A 63 year-old female patient received BNT162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 (Lot number: EP7534) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing); "sciatica" (unspecified if ongoing), notes: was getting acupuncture. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired/ exhausted"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache every day since taking Pfizer Covid19 vaccine". Additional information: She had sciatica before and was getting acupuncture. Concomitant Products included only Synthroid for her thyroid. She had been taking it for quite a few years because her thyroid was off the charts. She was gaining weight and got checked and her thyroid was off the chart. That was why she was on Synthroid as dose: 150mg early in the morning with no food. She was fine with first dose. She didn't get fever except she was tired and exhausted with both of them. She had had more headaches that she had ever had in her life. Headached every day since taking Pfizer Covid19 vaccine. Both doses were given in top of right arm because that is her stronger side. She was pretty sure that she had both in right arm.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101689528 same reporter/ pateint/ product, different dose and similar event
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain on his left hand; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single; Location: left arm), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain on his left hand". Therapeutic measures were taken as a result of pain in extremity. Additional information: Reporter says he took the first and second one and since he took that he has had pain on his left hand. He says the left-hand pain started after his second dose, about 3-4 days later. AE Treatment: He said for his hand pain he took Tylenol, or Motrin sometimes. He doesn't remember the dosage for those medications. He says for the Tylenol he took extra strength, which he took 2-3 times, each time two pills, as needed for the pain. AE Outcome: He said that the left-hand pain died down for a bit then would come back after the medicine was not working anymore, so he would try the next dose which killed the pain and then after four to five hours it would come back when it was time for the next dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inflammation, Lip pain, Nodule, Pustule, Swelling
Clinical narrative: firm nodules; slightly tender on the right upper lip and left upper lip which formed within the first day of injection; Massaging the area made the nodules inflamed and "pus" filled; Massaging the area made the nodules inflamed and "pus" filled; Prednisone taper helped the swelling resolve; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-022222-4565.  A 30 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation; hyaluronic acid (RESTYLANE KYSSE), since 03Feb2022 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), administration date: Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2), administration date: May2021, for COVID-19 immunization. The following information was reported: NODULE (non-serious), outcome "not recovered", described as "firm nodules"; LIP PAIN (non-serious), outcome "unknown", described as "slightly tender on the right upper lip and left upper lip which formed within the first day of injection"; INFLAMMATION (non-serious), PUSTULE (non-serious), outcome "unknown" and all described as "Massaging the area made the nodules inflamed and pus filled"; SWELLING (non-serious), outcome "recovered", described as "Prednisone taper helped the swelling resolve". The action taken for hyaluronic acid was unknown. Therapeutic measures were taken as a result of nodule, lip pain, inflammation, pustule, swelling. Additional information: Patient received Restylane Kysse on 03Feb2022 reported firm nodules, slightly tender on the right upper lip and left upper lip which formed within the first day of injection; Massaging the area made the nodules inflamed and pus filled. Prednisone taper helped the swelling resolve. Nodules are unresolved. COVID vaccine received Apr2021, May2021 and booster Oct2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cognitive disorder
Clinical narrative: Her cognitive seems to be a little clearer. Her friends sent her articles about two patients going through the same thing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Dec2021 (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: COGNITIVE DISORDER (non-serious), outcome "unknown", described as "Her cognitive seems to be a little clearer. Her friends sent her articles about two patients going through the same thing". Therapeutic measures were taken as a result of cognitive disorder.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; 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 right, administration date 09Sep2021 (Lot number: 30130A) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Sep2021, outcome "recovered" (11Sep2021), described as "arm pain".  Additional information: The patient stated she was very, very upset because it has been 5 months. She has had arm pain from the injection and the doctor said they can't get it out. She does not know who else to turn to. The patient stated the pain started the day they gave her the injection. With the first injection, it lasted maybe 2 days at the most. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock, Dyspnoea, Pharyngeal swelling
Clinical narrative: anaphylactic shock; difficulty breathing; throat swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: ANAPHYLACTIC SHOCK (hospitalization), outcome "unknown", described as "anaphylactic shock"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; PHARYNGEAL SWELLING (non-serious), outcome "unknown", described as "throat swelling". Therapeutic measures were taken as a result of anaphylactic shock.  Clinical course: The patient was at a health facility getting the shot and instantly afterwards he started to get anaphylaxis. So, they had to inject him, call an ambulance, treat him at the hospital and then they watched him for a few hours, and they released him. He had to take a ride in an ambulance. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site arm pain; 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), administered in arm, administration date 2021 (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: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "injection site arm pain".  Additional information: The caller mentioned that he received his Pfizer COVID vaccine over a year ago and he had injection site arm pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fear, Rash
Clinical narrative: bone pain; red spots on her hands; had taken away a fear; 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 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious), outcome "recovered", described as "bone pain"; RASH (non-serious), outcome "unknown", described as "red spots on her hands"; FEAR (non-serious), outcome "unknown", described as "had taken away a fear".  Additional information: It was reported that, patient had bone pain (all her bones hurt) in the day and night that lasted almost 3 weeks, she also developed two red spots on her hands. She did not receive the second dose of the vaccine because the bone pain lasted longer than she planned to receive the second dose, she mentions "being afraid" of receiving the second and third doses due to the reaction she experienced. She wants to know if these reactions disappear over time or if this could affect her bones.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Infectious mononucleosis, Suspected COVID-19
Clinical narrative: calling for her 17-year-old daughter who contracted covid after getting their 1st dose of Pfizer covid vaccine; calling for her 17-year-old daughter who contracted covid after getting their 1st dose of Pfizer covid 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. The reporter is the parent.  A 17 year-old 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "calling for her 17-year-old daughter who contracted covid after getting their 1st dose of Pfizer covid vaccine". The patient underwent the following laboratory tests and procedures: infectious mononucleosis: unknown result, notes: they are currently waiting for their daughter's laboratory test result to see if she will test positive for mono.  Clinical course:Caller is calling for her 17-year-old daughter who contracted covid after getting their 1st dose of Pfizer covid vaccine adult formulation. Caller said they are currently waiting for their daughter's laboratory test result to see if she will test positive for mono (mononucleosis) as well. Caller wanted to know if her daughter can still get the vaccine for 2nd dose after testing positive for covid and how long would they have to wait. Is report related to a study or programme Yes. Caller provided her telephone number. Caller clarified that her daughter had the first dose of Pfizer Covid-19 Vaccine and got Covid after that. Caller clarified that they do not know if the patient has mono yet, they are currently waiting on lab test results to see if she is positive for Mono. She verified that the patient needs to get her second dose of Pfizer Covid-19 Vaccine. Her question is if the patient does get a positive result for Mono, can she still get the second dose of Pfizer Covid-19 Vaccine. Is there a Product Complaint: Yes. Description of Product Complaint: Description of complaint: Patient had the first dose of Pfizer Covid-19 Vaccine and got Covid after that. Product strength and count size dispensed: Not provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test date=10Jan2022 / covid test result=Positive; covid test date=10Jan2022 / covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 12:00 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and administered in arm right, administration date 14May2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "covid test date=10Jan2022 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: covid test date=10Jan2022 / covid test result=Positive; covid test date=10Jan2022 / covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 12:00 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and administered in arm right, administration date 14May2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "covid test date=10Jan2022 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: covid test date=10Jan2022 / covid test result=Positive; covid test date=10Jan2022 / covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 12:00 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and administered in arm right, administration date 14May2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "covid test date=10Jan2022 / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Anxiety, Back pain, Diarrhoea, Headache
Clinical narrative: thought she was going to die; sick just under 4 days after second dose; fever/ high fever; Vomiting; Diarrhea; soaking wet; arm ache; Headache/felt like someone was hitting her in the head with a hammer; Backache; body ache; 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. Other Case identifier(s): US-PFIZER INC-202200417698 (Pfizer).  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 10:00 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 22Jan2021, when the patient was 70 years old, for COVID-19 Immunization, reaction(s): "had an extremely sore arm". The following information was reported: ANXIETY (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "thought she was going to die"; ILLNESS (non-serious) with onset 13Feb2021 03:00, outcome "recovered" (17Feb2021), described as "sick just under 4 days after second dose"; PYREXIA (non-serious) with onset 13Feb2021 03:00, outcome "recovering", described as "fever/ high fever"; VOMITING (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "Headache/felt like someone was hitting her in the head with a hammer"; BACK PAIN (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "Backache"; PAIN (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "body ache"; HYPERHIDROSIS (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "soaking wet"; PAIN IN EXTREMITY (non-serious) with onset 13Feb2021, outcome "unknown", described as "arm ache". Relevant laboratory tests and procedures are available in the appropriate section.   Reporter Comment: When she got her first vaccine she had an extremely sore arm, 21 days later she got her second dose. She thought she was going to die, she was sick just under 4 days, 3 days and a quarter and it finally stopped. She got the shot at 10:00 went to bed at 22:30 at 03:00 she had a high fever, was soaking wet, then began vomiting and then she had diarrhea. Then she got back to bed where she continued with fever, headache, felt like someone was hitting her in the head with a hammer, back ache, arm ache and she laid that way for 3 days. 15:30 in the afternoon about three days later, the fever started going down, a couple hours after that symptoms, backache, body aches, and headache went away, just under 4 days later.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: thought she was going to die; sick just under 4 days after second dose; fever/ high fever; Vomiting; Diarrhea; soaking wet; arm ache; Headache/felt like someone was hitting her in the head with a hammer; Backache; body ache; 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. Other Case identifier(s): US-PFIZER INC-202200417698 (Pfizer).  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 10:00 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 22Jan2021, when the patient was 70 years old, for COVID-19 Immunization, reaction(s): "had an extremely sore arm". The following information was reported: ANXIETY (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "thought she was going to die"; ILLNESS (non-serious) with onset 13Feb2021 03:00, outcome "recovered" (17Feb2021), described as "sick just under 4 days after second dose"; PYREXIA (non-serious) with onset 13Feb2021 03:00, outcome "recovering", described as "fever/ high fever"; VOMITING (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "Headache/felt like someone was hitting her in the head with a hammer"; BACK PAIN (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "Backache"; PAIN (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "body ache"; HYPERHIDROSIS (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "soaking wet"; PAIN IN EXTREMITY (non-serious) with onset 13Feb2021, outcome "unknown", described as "arm ache". Relevant laboratory tests and procedures are available in the appropriate section.   Reporter Comment: When she got her first vaccine she had an extremely sore arm, 21 days later she got her second dose. She thought she was going to die, she was sick just under 4 days, 3 days and a quarter and it finally stopped. She got the shot at 10:00 went to bed at 22:30 at 03:00 she had a high fever, was soaking wet, then began vomiting and then she had diarrhea. Then she got back to bed where she continued with fever, headache, felt like someone was hitting her in the head with a hammer, back ache, arm ache and she laid that way for 3 days. 15:30 in the afternoon about three days later, the fever started going down, a couple hours after that symptoms, backache, body aches, and headache went away, just under 4 days later.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: thought she was going to die; sick just under 4 days after second dose; fever/ high fever; Vomiting; Diarrhea; soaking wet; arm ache; Headache/felt like someone was hitting her in the head with a hammer; Backache; body ache; 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. Other Case identifier(s): US-PFIZER INC-202200417698 (Pfizer).  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 10:00 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 22Jan2021, when the patient was 70 years old, for COVID-19 Immunization, reaction(s): "had an extremely sore arm". The following information was reported: ANXIETY (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "thought she was going to die"; ILLNESS (non-serious) with onset 13Feb2021 03:00, outcome "recovered" (17Feb2021), described as "sick just under 4 days after second dose"; PYREXIA (non-serious) with onset 13Feb2021 03:00, outcome "recovering", described as "fever/ high fever"; VOMITING (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "Headache/felt like someone was hitting her in the head with a hammer"; BACK PAIN (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "Backache"; PAIN (non-serious) with onset 13Feb2021, outcome "recovered" (17Feb2021), described as "body ache"; HYPERHIDROSIS (non-serious) with onset 13Feb2021 03:00, outcome "unknown", described as "soaking wet"; PAIN IN EXTREMITY (non-serious) with onset 13Feb2021, outcome "unknown", described as "arm ache". Relevant laboratory tests and procedures are available in the appropriate section.   Reporter Comment: When she got her first vaccine she had an extremely sore arm, 21 days later she got her second dose. She thought she was going to die, she was sick just under 4 days, 3 days and a quarter and it finally stopped. She got the shot at 10:00 went to bed at 22:30 at 03:00 she had a high fever, was soaking wet, then began vomiting and then she had diarrhea. Then she got back to bed where she continued with fever, headache, felt like someone was hitting her in the head with a hammer, back ache, arm ache and she laid that way for 3 days. 15:30 in the afternoon about three days later, the fever started going down, a couple hours after that symptoms, backache, body aches, and headache went away, just under 4 days later.   The lot number for bnt162b2 was not provided and will be requested during follow up.