chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07Apr2021 18:15 (Lot number: ER8729) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hair health" (unspecified if ongoing), notes: Hair health; "Eye health supplement" (unspecified if ongoing), notes: Eye health supplement; "Dietary supplement" (unspecified if ongoing), notes: Dietary supplement. Concomitant medication(s) included: NUTRAFOL taken for hair disorder, start date: Apr2021 (ongoing); PUMPKIN SEED OIL [CUCURBITA PEPO OIL] taken for malnutrition, start date: Jan2021 (ongoing); OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL] taken for eye disorder (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "slight soreness at injection site". Additional information: The first two doses: Slight soreness at injection site. 2nd dose had slight chills. No other issues. Took no conmeds or treatments for it. Booster: My reaction was quite different then 1st 2 doses, so thought I' d report Vaccination was in the morning and on empty stomach. Symptoms listed in AE section onset with fever and rigor(slight) on evening of 28Nov2021.Increaed intensity by next morning. Felt quite weak so stayed in be and slept most of day. Late night 28Nov2021-onset of body aches and increased sweating. Intensity increased by next morning. Sweated to pint that clothes were damp as  was bed. Fatigued from early AM on 29Nov2021 increasing intensity by mid day and subsiding to resolution on 30Nov2021. All subsided by early AM on 30Nov2021. Took regular meals and hydrated throughout. No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: slight chills; slight soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 28Apr2021 18:00 (Lot number: EW0175) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NUTRAFOL taken for hair disorder, start date: Apr2021 (ongoing); PUMPKIN SEED OIL [CUCURBITA PEPO SEED OIL] taken for supplementation therapy, start date: Jan2021 (ongoing); KELP [MACROCYSTIS PYRIFERA] taken for supplementation therapy, start date: Aug2021 (ongoing); OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL] taken for supplementation therapy (ongoing); NIACINAMIDE taken for supplementation therapy, start date: May2021 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, time: 18:15, Anatomical location: left Deltoid, route of administration: intramuscular, Batch/Lot No.: ER8729), administration date: 07Apr2021, when the patient was 46 years old, for Covid-19 Immunization, reaction(s): "slight soreness at injection site". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "slight chills"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "slight soreness at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, vaccination site pain.  Additional information: The first two doses had slight soreness at injection sight and 2nd dose had slight chills no other issues. Took no conmeds or treatment for it.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I believe has said pizza has upset stomach" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Additional information:  The reporter was Pfizer employee at Age group: Adult (18-64 Years).The patient had product covid-19 for dose-1 and lot no: unknown. The 40s video posted, the other cohost states that patient was not feeling well during recording of the episode and that's why not on the episode. There were some other videos that were posted before this one stating they were "taking caution" by not being in the same room. May had also stated were "doing ok" in those episodes, but cannot remember. The Could had potentially been referring to this event. The reporter did not know exact health status, but (name) had made an appearance on a lot of the earlier episodes. He was not sure if they had already re-united or not, which could be indicated in earlier episodes. It seems that the recently aired episode was pre-recorded. The reporter Believed was vaccinated, but did not know which vaccine or dosage.   The medical history was Known allergies: I believe has said pizza has upset stomach. The reporter and patient partner posted a lot of videos without him, so he did not know how long he was/is sick. They stopped recording together while it was happening at least for some time. It seems more recently that videos with him have resumed uploading on the channel. The reporter did not know what vaccine he received. The reporter was  pretty sure he was vaccinated to some extent. He was in he believe early 40s, but he was a public figure, so you can check all information regarding him. There will be no further follow up.  Follow-up (03Feb2022): This is a follow up spontaneous report from a contactable consumer. This consumer reported in response to the Non-HCP letter via email activity follow up that included: Updated information included: No new information updated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: brain fog; mental confusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 29Dec2021 13:30 (Lot number: FJ1620) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 10Dec2021, stop date: 27Dec2021, notes: tested positive for covid-19 after initial vaccination.; "night sweats" (unspecified if ongoing), notes: night sweats; "weight loss" (unspecified if ongoing), notes: weight loss; "loss of appetite" (unspecified if ongoing), notes: loss of appetite; "lethargy" (unspecified if ongoing), notes: lethargy; "mental confusion" (unspecified if ongoing), notes: mental confusion. Family history included: "Multiple suicides" (unspecified if ongoing), notes: Family medical history relevant to AE: Multiple suicides from father sides. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Date/Time (24hr): 08Dec2021 14:00, Anatomical site of injection: upper arm, Route of administration: Intramuscular, Batch/Lot number: only provided (FH8030) on vaccine card.), administration date: 08Dec2021, when the patient was 15 years old, for COVID-19 Immunization, reaction(s): "fell Ill", "missed her finals, and is still sick, due to this shot", "being bedridden for 2.5 weeks", "headaches", "chest pain", "Chills". The following information was reported: FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "brain fog"; CONFUSIONAL STATE (non-serious) with onset Dec2021, outcome "unknown", described as "mental confusion". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Limb discomfort, Peripheral swelling
Clinical narrative: Third dose: her arm is red and she can barely lift it up and its swollen; Third dose: her arm is red and she can barely lift it up and its swollen; Third dose: her arm is red and she can barely lift it up and its swollen; her arm and it was hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 12:30 (Lot number: FJ6369) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Borderline diabetes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 2), administration date: 17May2021, when the patient was 59 years old, for COVID-19 Immunization, reaction(s): "arm was red", "arm was red and swollen", "arm was red and swollen really big at that spot"; Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), LIMB DISCOMFORT (non-serious) all with onset 24Jan2022, outcome "not recovered" and all described as "Third dose: her arm is red and she can barely lift it up and its swollen"; FEELING HOT (non-serious) with onset 24Jan2022, outcome "unknown", described as "her arm and it was hot". Therapeutic measures were taken as a result of erythema, feeling hot.  Additional information: Patient had this same thing with the second dose where her arm was red and swollen really big at that spot from unspecified to unspecified date. The caller had her booster yesterday and her arm is red and she can barely lift it up and its swollen. The nurse said to ice it and raise it. The caller clarifies that she received the Pfizer covid vaccine third dose. The caller did-n't have a reaction with the first dose but had this same thing with the second dose where her arm was red and swollen really big at that spot. The caller got the third dose at 12:30 and when she woke up at 9:00 she could-n't hardly move her arm and it was hot and all red like a fever may have been in it. The caller tried to move her arm and got some ice and slept in her recliner until this morning and the redness is going away but its still swollen.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: Within 4 days after (20Nov2021) taking the Pfizer vaccine I lost my sense of smell and taste which has been going on for 2 months.; Within 4 days after (20Nov2021) taking the Pfizer vaccine I lost my sense of smell and taste which has been going on for 2 months.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 (Lot number: FH8028) at the age of 59 years as dose 1, single and administered in arm right, administration date 11Dec2021 (Lot number: FH8028) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 24Nov2021 20:00, outcome "not recovered" and all described as "Within 4 days after (20Nov2021) taking the Pfizer vaccine I lost my sense of smell and taste which has been going on for 2 months.". The event "within 4 days after (20nov2021) taking the pfizer vaccine i lost my sense of smell and taste which has been going on for 2 months." and "within 4 days after (20nov2021) taking the pfizer vaccine i lost my sense of smell and taste which has been going on for 2 months." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of anosmia, ageusia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Skin disorder
Clinical narrative: Also he described his male part is "like a snake", referring to the skin.; After the second dose, he has rashes and aching.; After the second dose, he has rashes and aching.; itching all over; 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 (BNT162B2) (Lot number: FJ8757) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid 19 immunization. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "Also he described his male part is "like a snake", referring to the skin."; RASH (non-serious), PAIN (non-serious), outcome "unknown" and all described as "After the second dose, he has rashes and aching."; PRURITUS (non-serious), outcome "unknown", described as "itching all over".  Additional Information: The caller was calling about the two Pfizer shots. The caller clarified that it was the Pfizer covid vaccine and provides FJ8757 from his vaccination card. The caller had and a rash ever since he has had the second shot and has been itching all over. The caller's male part is like a snake, the whole skin fell off of it. Something was wrong, the caller wanted to know what he should do about it? The caller needs to know what to do about this. Is Pfizer covid vaccine a Pfizer product: Yes. Pfizer covid vaccine manufacturer: Unspecified. Dates for Pfizer covid vaccine: (Start: Unspecified Stop: Unspecified). NDC number of Pfizer covid vaccine: Not Provided. Expiry Date of Pfizer covid vaccine: Not Provided. Other Products: Not Provided. Patient History: Not Provided Investigation Assessment: Not Provided.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: she says her first shot hurt but not that bad; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: ER8732) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diverticulitis" (unspecified if ongoing), notes: Verbatim: Diverticulitis, Additional Information for Other Conditions: Caller says she has had this many years. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "she says her first shot hurt but not that bad"; PYREXIA (non-serious) with onset Apr2021, outcome "unknown", described as "fever". The event "she says her first shot hurt but not that bad" was evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). Other Case identifier(s): 4518315.  A 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "HER+" (unspecified if ongoing), notes: Past medical history included: HER+. Concomitant medication(s) included: OXALIPLATIN; HERCEPTIN. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Ear pain, Fall
Clinical narrative: Headaches; Earaches; Muscle pain; Rash; Coughing; Difficult breathing; Fall down; Swollen rash; Dizziness; tiredness; bodyaches; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 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 and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 22Jan2021, outcome "unknown", described as "Headaches"; EAR PAIN (non-serious) with onset 22Jan2021, outcome "unknown", described as "Earaches"; MYALGIA (non-serious) with onset 22Jan2021, outcome "unknown", described as "Muscle pain"; RASH (non-serious) with onset 22Jan2021, outcome "unknown", described as "Rash"; COUGH (non-serious) with onset 22Jan2021, outcome "unknown", described as "Coughing"; DYSPNOEA (non-serious) with onset 22Jan2021, outcome "unknown", described as "Difficult breathing"; FALL (non-serious) with onset 22Jan2021, outcome "unknown", described as "Fall down"; SWELLING (non-serious) with onset 22Jan2021, outcome "unknown", described as "Swollen rash"; DIZZINESS (non-serious) with onset 22Jan2021, outcome "unknown", described as "Dizziness"; FATIGUE (non-serious) with onset 22Jan2021, outcome "unknown", described as "tiredness"; PAIN (non-serious) with onset 22Jan2021, outcome "unknown", described as "bodyaches"; NAUSEA (non-serious) with onset 22Jan2021, outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain
Clinical narrative: Headaches; Earaches; Muscle pain; Rash; Coughing; Difficult breathing; Fall down; Swollen rash; Dizziness; tiredness; bodyaches; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 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 and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 22Jan2021, outcome "unknown", described as "Headaches"; EAR PAIN (non-serious) with onset 22Jan2021, outcome "unknown", described as "Earaches"; MYALGIA (non-serious) with onset 22Jan2021, outcome "unknown", described as "Muscle pain"; RASH (non-serious) with onset 22Jan2021, outcome "unknown", described as "Rash"; COUGH (non-serious) with onset 22Jan2021, outcome "unknown", described as "Coughing"; DYSPNOEA (non-serious) with onset 22Jan2021, outcome "unknown", described as "Difficult breathing"; FALL (non-serious) with onset 22Jan2021, outcome "unknown", described as "Fall down"; SWELLING (non-serious) with onset 22Jan2021, outcome "unknown", described as "Swollen rash"; DIZZINESS (non-serious) with onset 22Jan2021, outcome "unknown", described as "Dizziness"; FATIGUE (non-serious) with onset 22Jan2021, outcome "unknown", described as "tiredness"; PAIN (non-serious) with onset 22Jan2021, outcome "unknown", described as "bodyaches"; NAUSEA (non-serious) with onset 22Jan2021, outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Headaches; Earaches; Muscle pain; Rash; Coughing; Difficult breathing; Fall down; Swollen rash; Dizziness; tiredness; bodyaches; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 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 and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 22Jan2021, outcome "unknown", described as "Headaches"; EAR PAIN (non-serious) with onset 22Jan2021, outcome "unknown", described as "Earaches"; MYALGIA (non-serious) with onset 22Jan2021, outcome "unknown", described as "Muscle pain"; RASH (non-serious) with onset 22Jan2021, outcome "unknown", described as "Rash"; COUGH (non-serious) with onset 22Jan2021, outcome "unknown", described as "Coughing"; DYSPNOEA (non-serious) with onset 22Jan2021, outcome "unknown", described as "Difficult breathing"; FALL (non-serious) with onset 22Jan2021, outcome "unknown", described as "Fall down"; SWELLING (non-serious) with onset 22Jan2021, outcome "unknown", described as "Swollen rash"; DIZZINESS (non-serious) with onset 22Jan2021, outcome "unknown", described as "Dizziness"; FATIGUE (non-serious) with onset 22Jan2021, outcome "unknown", described as "tiredness"; PAIN (non-serious) with onset 22Jan2021, outcome "unknown", described as "bodyaches"; NAUSEA (non-serious) with onset 22Jan2021, outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives like bug bites and mosquito bites all over different parts of her body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200175739 (PFIZER).  A female patient received bnt162b2 (BNT162B2), administration date 26Jan2022 16:30 (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: URTICARIA (non-serious), outcome "unknown", described as "Hives like bug bites and mosquito bites all over different parts of her body".  Additional Information: Covid-19 Vaccine was a Pfizer product. Reporter stated that his girlfriend got a Pfizer shot on Wednesday at 4:30 PM and she was visited with him and she was got hives like bug bites and mosquito bites all over different parts of her body. Trying to see if this was side effects or was part of side effects or some other thing going on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). An 18-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunisation. The patient developed illness (got very sick for 24 hours), with outcome of recovered. Additional information: The patient got very sick for 24 hours after getting the second dose of Pfizer-BioNTech COVID-19 vaccine. She was scared to get another dose. She mentioned her school mandated the third dose for their students. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Ear pain, Pain
Clinical narrative: pain in her chest; weakness in her upper back; her ears started to hurt; she felt sore in her body; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date 01Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Patient didn't even feel the needle.), for COVID-19 immunisation. The following information was reported: EAR PAIN (non-serious) with onset 02Feb2022, outcome "unknown", described as "her ears started to hurt"; PAIN (non-serious) with onset 02Feb2022, outcome "unknown", described as "she felt sore in her body"; CHEST PAIN (non-serious) with onset 03Feb2022, outcome "unknown", described as "pain in her chest"; ASTHENIA (non-serious) with onset 03Feb2022, outcome "unknown", described as "weakness in her upper back".  Additional information: It was reported that when the patient received the second dose two days ago, someone told her that she might feel some adverse reactions. Yesterday (as reported) her ears started to hurt and she felt sore in her body. Today (as reported) she felt pain in her chest and weakness in her upper back. She was wondering if these were normal symptoms and if they would pass.   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-202200204095 Same patient and drug, different event separated in time
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Mouth swelling, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Dose next day menstural cycle start; Fever; Itching; Rash; Swollen mouth, palms and legs; Swollen mouth, palms and legs; This is a spontaneous report received from a 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 left, administration date 23Jan2022 11:00 (Lot number: FJ1614) at the age of 34 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 Number: 1, Batch/Lot No: FJ1614, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Jan2022, when the patient was 34 years old, for COVID-19 Immunization. The following information was reported: MOUTH SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 23Jan2022 12:00, outcome "recovering" and all described as "Swollen mouth, palms and legs"; MENSTRUAL DISORDER (non-serious) with onset 24Jan2022, outcome "recovering", described as "Dose next day menstural cycle start"; PYREXIA (non-serious) with onset 24Jan2022, outcome "recovering", described as "Fever"; PRURITUS (non-serious) with onset 23Jan2022 12:00, outcome "recovering", described as "Itching"; RASH (non-serious) with onset 23Jan2022 12:00, outcome "recovering", described as "Rash". The events "swollen mouth, palms and legs", "swollen mouth, palms and legs", "dose next day menstural cycle start", "fever", "itching" and "rash" were evaluated at the physician office visit. Therapeutic measures were taken as a result of mouth swelling, peripheral swelling, menstrual disorder, pyrexia, pruritus, rash.  Additional Information: No other vaccines were received within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.Since the vaccination, patient been not tested for COVID-19. No other medications were received within 2 weeks of vaccination. Patient was given Benadryl as treatment for adverse event. Device date was 03Feb2022.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Dose next day menstural cycle start; Fever; Itching; Rash; Swollen mouth, palms and legs; Swollen mouth, palms and legs; This is a spontaneous report received from a 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 left, administration date 23Jan2022 11:00 (Lot number: FJ1614) at the age of 34 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 Number: 1, Batch/Lot No: FJ1614, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Jan2022, when the patient was 34 years old, for COVID-19 Immunization. The following information was reported: MOUTH SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 23Jan2022 12:00, outcome "recovering" and all described as "Swollen mouth, palms and legs"; MENSTRUAL DISORDER (non-serious) with onset 24Jan2022, outcome "recovering", described as "Dose next day menstural cycle start"; PYREXIA (non-serious) with onset 24Jan2022, outcome "recovering", described as "Fever"; PRURITUS (non-serious) with onset 23Jan2022 12:00, outcome "recovering", described as "Itching"; RASH (non-serious) with onset 23Jan2022 12:00, outcome "recovering", described as "Rash". The events "swollen mouth, palms and legs", "swollen mouth, palms and legs", "dose next day menstural cycle start", "fever", "itching" and "rash" were evaluated at the physician office visit. Therapeutic measures were taken as a result of mouth swelling, peripheral swelling, menstrual disorder, pyrexia, pruritus, rash.  Additional Information: No other vaccines were received within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.Since the vaccination, patient been not tested for COVID-19. No other medications were received within 2 weeks of vaccination. Patient was given Benadryl as treatment for adverse event. Device date was 03Feb2022.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Started my menstrual cycle 3 weeks early. I am normally very regular in my cycle. It also lasted 4 days longer than normal.; Started my menstrual cycle 3 weeks early. I am normally very regular in my cycle. It also lasted 4 days longer than normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jan2022 11:30 (Lot number: 33025BD) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]; MELATONIN; COLLAGEN. Vaccination history included: Bnt162b2 (lot number: EP7534, time: 04:45 PM, dose number:2 vaccine location:Right arm), administration date: 30Mar2021, when the patient was 40 years old, for covid-19 immunisation; Bnt162b2 (lot number: EP7534, administration time: 04:45 PM, dose number: 1, vaccine location: Right arm), administration date: 20Apr2021, when the patient was 40 years old, for covid-19 immunisation. The following information was reported: POLYMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 20Jan2022, outcome "recovered" and all described as "Started my menstrual cycle 3 weeks early. I am normally very regular in my cycle. It also lasted 4 days longer than normal.". Therapeutic measures were not taken as a result of polymenorrhoea, heavy menstrual bleeding.  Adverse event: Facility type vaccine at facility Patient did not received other vaccine in four weeks. Started my menstrual cycle 3 weeks early. I am normally very regular in my cycle. It also lasted 4 days longer than normal. Ae resulted in: [None of the above] Patient did had covid prior to vaccination and not tested covid post vaccination. The patient had known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Inflammatory Sporadic pain-back, chest hand; Inflammatory Sporadic pain-back, chest hand; Inflammatory Sporadic pain-back, chest hand; Inflammatory Sporadic pain-back, chest hand; Brain Fog; Toe Hematoma; Fatigue; Shortness of breath; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 08:30 (Lot number: EN6204) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), BACK PAIN (non-serious), CHEST PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 30Mar2021, outcome "not recovered" and all described as "Inflammatory Sporadic pain-back, chest hand"; FEELING ABNORMAL (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Brain Fog"; HAEMATOMA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Toe Hematoma"; FATIGUE (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Fatigue"; DYSPNOEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Shortness of breath". The events "inflammatory sporadic pain-back, chest hand", "inflammatory sporadic pain-back, chest hand", "inflammatory sporadic pain-back, chest hand", "inflammatory sporadic pain-back, chest hand", "brain fog", "toe hematoma", "fatigue" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inflammation, back pain, chest pain, pain in extremity, feeling abnormal, haematoma, fatigue, dyspnoea.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient had been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Haematoma, Inflammation, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Inflammatory Sporadic pain-back, chest hand; Inflammatory Sporadic pain-back, chest hand; Inflammatory Sporadic pain-back, chest hand; Inflammatory Sporadic pain-back, chest hand; Brain Fog; Toe Hematoma; Fatigue; Shortness of breath; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Mar2021 08:30 (Lot number: EN6204) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), BACK PAIN (non-serious), CHEST PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 30Mar2021, outcome "not recovered" and all described as "Inflammatory Sporadic pain-back, chest hand"; FEELING ABNORMAL (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Brain Fog"; HAEMATOMA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Toe Hematoma"; FATIGUE (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Fatigue"; DYSPNOEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Shortness of breath". The events "inflammatory sporadic pain-back, chest hand", "inflammatory sporadic pain-back, chest hand", "inflammatory sporadic pain-back, chest hand", "inflammatory sporadic pain-back, chest hand", "brain fog", "toe hematoma", "fatigue" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inflammation, back pain, chest pain, pain in extremity, feeling abnormal, haematoma, fatigue, dyspnoea.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient had been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Cough, Hypoaesthesia, Illness
Clinical narrative: I feel like sick; I have like cough/ cough and the phlegm; I have like cough/ cough and the phlegm; I have like sore throat; Runny nose; I have this symptoms in my face, I feel that my face is numb; My body is weak; Pain in my back; Body is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Jan2022 (Lot number: FJ5682) 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 Feb2022, outcome "recovered", described as "I feel like sick"; COUGH (non-serious), PRODUCTIVE COUGH (non-serious) all with onset Feb2022, outcome "recovered" and all described as "I have like cough/ cough and the phlegm"; OROPHARYNGEAL PAIN (non-serious) with onset Feb2022, outcome "recovered", described as "I have like sore throat"; RHINORRHOEA (non-serious) with onset Feb2022, outcome "recovered", described as "Runny nose"; HYPOAESTHESIA (non-serious) with onset Feb2022, outcome "recovered", described as "I have this symptoms in my face, I feel that my face is numb"; ASTHENIA (non-serious) with onset Feb2022, outcome "recovered", described as "My body is weak"; BACK PAIN (non-serious) with onset Feb2022, outcome "recovered", described as "Pain in my back"; PAIN (non-serious) with onset Feb2022, outcome "recovered", described as "Body is sore".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Productive cough, Rhinorrhoea
Clinical narrative: I feel like sick; I have like cough/ cough and the phlegm; I have like cough/ cough and the phlegm; I have like sore throat; Runny nose; I have this symptoms in my face, I feel that my face is numb; My body is weak; Pain in my back; Body is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Jan2022 (Lot number: FJ5682) 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 Feb2022, outcome "recovered", described as "I feel like sick"; COUGH (non-serious), PRODUCTIVE COUGH (non-serious) all with onset Feb2022, outcome "recovered" and all described as "I have like cough/ cough and the phlegm"; OROPHARYNGEAL PAIN (non-serious) with onset Feb2022, outcome "recovered", described as "I have like sore throat"; RHINORRHOEA (non-serious) with onset Feb2022, outcome "recovered", described as "Runny nose"; HYPOAESTHESIA (non-serious) with onset Feb2022, outcome "recovered", described as "I have this symptoms in my face, I feel that my face is numb"; ASTHENIA (non-serious) with onset Feb2022, outcome "recovered", described as "My body is weak"; BACK PAIN (non-serious) with onset Feb2022, outcome "recovered", described as "Pain in my back"; PAIN (non-serious) with onset Feb2022, outcome "recovered", described as "Body is sore".  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 11:00 (Lot number: ER20013) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "SVT" (unspecified if ongoing), notes: prior history of SVT's that had resolved. There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". The following information was reported: TACHYCARDIA (non-serious) with onset 21Mar2021 07:00, outcome "recovering", described as "tachycardia". Therapeutic measures were taken as a result of tachycardia.  Additional information: No other vaccine in four weeks, No Other medications in two weeks. tachycardia after limited physical exertion within 48 hours of first dose of vaccine. Ae treatment: homeopathic and naturapathic cardiac support. No covid prior vaccination and Patient was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200238071 Same reporter patient, Different AE/dose
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: he's whole arm up to the shoulder area turn red and became warm.; he's whole arm up to the shoulder area turn red and became warm.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 13 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: ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 21Dec2021, outcome "recovered" (21Dec2021) and all described as "he's whole arm up to the shoulder area turn red and became warm." Therapeutic measures were not taken as a result of erythema, feeling hot.  Additional Information: Caller stated that a 13-year-old male (date of birth: DOB) came in before his second dose; and mentioned that during his first dose, he's whole arm up to the shoulder area turn red and became warm. This event was anticipated for about 20 minutes with no treatment. Caller wants to know if this situation is considered a contraindication for the patient to get his second dose of Pfizer COVID vaccine. Pharmacist did not administer the second vaccine/Longer than 21 days since first vaccine. Caller states that he was calling from (Pharmacy name and address withheld), about the Pfizer Comirnaty vaccine, adult, for ages 12 and over. Caller stated he had a patient come to the pharmacy today for his second dose of vaccine. During the pre vaccine interview, the patient's mother states that her son had a reaction to the first dose of vaccine, on 21Dec2021. The mother reported that after the injection, her son's whole arm felt warm and the arm turned red and after 20 minutes the warmth and redness dissipated without any treatment.  Caller agreed to file a safety report. Caller stated that he did not want to give the patient a second dose of vaccine, until he found out if it was safe to give the vaccine to the patient, after his reaction after the first dose? Caller states if it is safe to give the patient a second dose, or if there is any contraindication with the initial reaction to the first vaccine? . Seriousness was not provided for reported events. History of all previous immunization with the Pfizer vaccine considered as suspect reported as No. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as unknown. Seriousness criteria was reported as non-serious for all reported events. Any AE(s) did not require a visit to Emergency Room and Physician office.  Prior Vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) reported as  Unknown. Patient's Medical History reported as unknown and Family Medical History Relevant to AE(s) as not provided. Relevant Tests reported as unknown.  Follow-up attempts completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Furuncle, Headache, Pruritus
Clinical narrative: feels like a big boil under his left arm; his whole body is itchy; has a very bad headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Feb2022 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Pfizer BioNTech Covid vaccine), administration date: Jul2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02, Pfizer BioNTech Covid vaccine), administration date: Jul2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: FURUNCLE (non-serious) with onset 08Feb2022, outcome "unknown", described as "feels like a big boil under his left arm"; PRURITUS (non-serious) with onset 08Feb2022, outcome "unknown", described as "his whole body is itchy"; HEADACHE (non-serious) with onset 08Feb2022, outcome "unknown", described as "has a very bad headache".  Additional information: Reported as he noticed the boil yesterday evening, his whole body itching he noticed last night and the headache since yesterday morning. Patient did not administer any vaccine in last 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.