chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pain in extremity, Skin exfoliation
Clinical narrative: her hands are very dry and peeling / Her elbow is peeling. feels dry and rough; arm was sore; Peeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 17:56 (Lot number: ER8733) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing); "Foot injury" (unspecified if ongoing); "kidney damage" (unspecified if ongoing); "Foot surgery" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRY SKIN (non-serious) with onset 27Mar2021, outcome "not recovered", described as "her hands are very dry and peeling / Her elbow is peeling. feels dry and rough"; PAIN IN EXTREMITY (non-serious) with onset 27Mar2021, outcome "recovering", described as "arm was sore"; SKIN EXFOLIATION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Peeling".  Additional information: The patient stated she took the shot last Saturday and she experienced skin peeling. Patient talked to her friend who got the vaccine on the same date and her friend said she had itching. A clone report was created to document the friends experience. Reporter clarified she received the first dose of the Pfizer COVID 19 vaccine 27Mar2021 on 1756PM in the left arm. Her arm was sore for two days, she could not lay on it and it hurt until Monday; it still hurts if she pushes on it. The day of the vaccination, she noticed peeling on her thumb; then on her fingers and elbow; and her hands are very rough and dry, like someone put some glue on her. She did some cleaning the other day but it usually does not do that. Add the peeling was on both of her whole hands, back of her hands, knuckles, the palm on both hands, and the middle finger on the right at the tip has peeled a lot. The other peeling places are just patches, and on her left elbow. She was scheduled to get the second dose on 17Apr2021. Mentions she called Pfizer first but she is going to call her HCP next.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Covid", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms". Additional Information: Patient did have Covid last year. Patient was minimally exposed to the his daughter and son. They had symptoms and both tested positive to Covid, now quarantined until holiday and has to take 2nd dose tomorrow. Patient had no symptoms at the time of the call. Patient asked if it is true that people who previously had Covid may have stronger reaction to the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in ears that began after the first dose; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 66 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single and administered in arm left, administration date 22Mar2021 (Lot number: EN6202) as dose 2, 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: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "ringing in ears that began after the first dose". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient has no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that the ringing in his ears had continued and gotten worse at the time of reporting. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: arm was not functional for 7-8 days; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "lymphedema" (unspecified if ongoing), notes: left arm; "shoulder replacement" (unspecified if ongoing), notes: with a carbon fiber shoulder in her right arm. The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISORDER (non-serious), outcome "recovered", described as "arm was not functional for 7-8 days". Additional Information: Patient could not get the first dose in her left arm due to lymphedema. She had a shoulder replacement with a carbon fiber shoulder in her right arm and when she was given the vaccine there, her arm was not functional for 7-8 days. Patient asked if they give it in her thigh, will it still be effective?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Pain in extremity
Clinical narrative: Nausea; general weakness; headache; pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 02:15 (Lot number: ER8733) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "animal dander dust" (unspecified if ongoing); "Tree" (unspecified if ongoing); "Allergy to nuts" (unspecified if ongoing), notes: Allergy to almond; "grasspollen" (unspecified if ongoing). Concomitant medication(s) included: FERRUM-SR; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 & FOLIC ACID; ALPRAZOLAM. The following information was reported: NAUSEA (non-serious) with onset 27Mar2021 02:30, outcome "not recovered", described as "Nausea"; ASTHENIA (non-serious) with onset 27Mar2021 02:30, outcome "not recovered", described as "general weakness"; HEADACHE (non-serious) with onset 27Mar2021 02:30, outcome "not recovered", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 27Mar2021 02:30, outcome "not recovered", described as "pain in arm". Therapeutic measures were not taken as a result of nausea, asthenia, headache, pain in extremity.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ligament sprain
Clinical narrative: she twisted her knee in her garden; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIGAMENT SPRAIN (non-serious) with onset 28Mar2021, outcome "unknown", described as "she twisted her knee in her garden".  Additional information: Caller had the first dose of the Pfizer COVID-19 vaccine in (state) last Saturday (27Mar2021). Everything went smoothly. The next day (28Mar2021), she twisted her knee in her garden. She wanted to know if it would be safe to take Tylenol or ibuprofen after vaccination. She also wanted to know if there was a protocol or timeframe before taking these medications after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity
Clinical narrative: Soreness in her arm; Headache; Hadn't slept much the night before; 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 female patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Food allergies" (unspecified if ongoing), notes: She used to take Benadryl, Zyrtec and Hydroxyzine.; "hives" (unspecified if ongoing), notes: hives all over her body and it was relentless, it kept getting worse and worse. Concomitant medication(s) included: BENADRYL taken for food allergy; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for food allergy; HYDROXYZINE taken for food allergy. The following information was reported: HEADACHE (non-serious) with onset 15Mar2021, outcome "unknown", described as "Headache"; INSOMNIA (non-serious) with onset 15Mar2021, outcome "unknown", described as "Hadn't slept much the night before"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in her arm". Therapeutic measures were taken as a result of headache.  Additional information: Mother calling on behalf of her daughter, aged 17, who received first dose of Pfizer BioNTech Covid 19 Vaccine, 18 days later she had a headache, during her period and had not slept much the night before. She used to take Benadryl, Zyrtec and Hydroxyzine would work but once she goes off the medications her allergies come back but when she was on them, she was super tired. Other products were not provided. This past summer the daughter started breaking out in hives all over her body and it was relentless, it kept getting worse and worse. Every doctor that they saw said to take this or that and all these medicines made the patient so sleepy, and she could not function, and she was a kid and she need to be awake and do her work. Anyways her daughter got the first Pfizer COVID vaccine, and she was fine. She was fine, she just had soreness in her arm. Then, 18 days later, so a bit after the COVID vaccine she got a headache. The caller thought well there is starch in Ibuprofen so her daughter should not be taking it because of the starch.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Thirst, Vomiting
Clinical narrative: Vomit especially after eating; dizziness; hypertension; Unquenchable thirst; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the arm left on 27Mar2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, blood pressure high, cholesterol. The patient was allergic to amoxicillin. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced vomit especially after eating, dizziness, hypertension and an unquenchable thirst. It had been 4 days then and symptoms progressively got more dramatic each day. The patient did not receive any treatment for the events.  The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events vomit especially after eating, dizziness, hypertension, and unquenchable thirst were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended vaccination Facility Country.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 female patient (reported as 73, unit unknown) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache". Additional information: Patient received the first dose of the pfizer covid 19 vaccine and did fine. patient stated that she received the second dose three weeks ago and has had a headache on an off for three weeks and wanted to know is headache a reported side effect  and want to know how long will the headache last. She mentioned that her doctor told her the headache could be antibodies building up. Caller wanted to know how long does the body build up antibodies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Temporary memory loss; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: AMNESIA (non-serious), outcome "unknown", described as "Temporary memory loss".  Additional Information: The reporter classified the event as not serious. The patient was recently vaccinated with the Pfizer COVID-19 vaccine and everything went well, but he suffered from temporary memory loss due to the medication he was taking and he could not find his vaccination card. He was asking if he can have a copy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: feel tingling in feet, legs, hands, and arms; tingling like pins and needles in her feet, legs, hands and arms; arm was sore a little bit for the first day; 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 56 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 56 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: PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "feel tingling in feet, legs, hands, and arms"; PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "tingling like pins and needles in her feet, legs, hands and arms"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "arm was sore a little bit for the first day".  Additional information: The patient was due for her second dose. Patient stated that her arm was sore a little bit for the first day and day or two after the first dose, she had tingling like pins and needles in her feet, legs, hands and arms. Patient stated that was more in her feet and legs and a small amount in her hands and arms. Patient stated that the tingling has gone away in her hands and arms but was still there in her feet and legs and her legs and feet feel like they were asleep. Patient stated she experienced this everyday but not continuously.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in his mouth; 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-2021366175 (Pfizer).  A 61-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Mar2021 10:15 (Lot number: EP7533) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "He just has one kidney" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DYSGEUSIA (non-serious) with onset 31Mar2021 12:30, outcome "not recovered", described as "metallic taste in his mouth".  Additional Information: The patient received first dose about 4 hours ago. He was having a metallic taste in his mouth and did not know if that was normal. He would like to find out if there were reports of anyone else having this symptom. Patient did not see it in the literature. He did not wish to provide an email address. There was no prescriber. He just has one kidney but does not take any medication for it. This was prior to receiving the vaccine. When he went to get it, it looked like somebody else used his name and address to get his shot. (Health network name). Vaccine supplemental form. No previous additional vaccines administered on same Date of the Pfizer suspect. NO ER or physician's office required Prior Vaccinations (within 4 weeks). No adverse event following prior vaccinations.  Follow Up(31Mar2021): Updated information included: Vaccination administration site, time, vaccine facility type, event onset time, event outcome.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Nasopharyngitis
Clinical narrative: Cold like symptoms. It is more in her nostrils than chest area. It's like she has gotten a cold. She does not have a lot of mucus. She has nasal symptoms. Cold like symptoms. It is more in her nostrils than chest area. It's like she has gotten a cold. She does not have a lot of mucus. She has nasal symptoms.; 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 29Mar2021 (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), for Covid-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), NASAL DISCOMFORT (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Cold like symptoms. It is more in her nostrils than chest area. It's like she has gotten a cold. She does not have a lot of mucus. She has nasal symptoms.".  Additional information: She received her second dose of the covid vaccine at hospital. She received her second shot on Monday morning and later she had a cold like symptoms. She thought it was like allergies. She knew that the Covid vaccine was new, and Pfizer might not know that much. Beings that it was in a three day period of receiving her second dose of the Covid vaccine, she wanted to know if it is okay to take a cold decongestant/antihistamine or a cold tablet/capsule for her symptoms. She was just trying to see if it would hurt the injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Pain, Vomiting
Clinical narrative: does not rise up from the bed; weak; pain in her body; throws up; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 93-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 2021 (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: BEDRIDDEN (non-serious), outcome "unknown", described as "does not rise up from the bed"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; PAIN (non-serious), outcome "unknown", described as "pain in her body"; VOMITING (non-serious), outcome "unknown", described as "throws up".  Additional Information: The reporter classified the events as not serious. The reporter mentioned that her mother, who was the patient, got the first dose of the Pfizer COVID vaccine at the end of the last month (2021) and tomorrow (date unspecified), she was scheduled for an appointment and she would like to know if her mother should get it or not since she was worried it might be detrimental for her. She mentioned that her mother had been a little delicate of her health. She was not rising up from the bed, weak, had pain in her body, and was throwing up. She believed this was because of her age.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tongue discomfort
Clinical narrative: tongue burns; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 04Mar2021 15:00 (Lot number: EM9810) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Allergies to Many drugs, including B-12 and Gold, etc.; "Gold allergy" (unspecified if ongoing), notes: Allergies to Many drugs, including B-12 and Gold, etc.; "Food allergy" (unspecified if ongoing), notes: Allergic to Many foods (e.g.: chocolate nuts tomatoes, etc.); "Allergy to nuts" (unspecified if ongoing), notes: Allergic to Many foods (e.g.: chocolate nuts tomatoes, etc.); "tomatoes allergy" (unspecified if ongoing), notes: Allergic to Many foods (e.g.: chocolate nuts tomatoes, etc.); "Sensation of pressure in eye" (unspecified if ongoing), notes: eye pressure; "Irritable bowel syndrome" (unspecified if ongoing); "Map dot fingerprint dystrophy" (unspecified if ongoing), notes: eye: map dot fingerprint distrophy (cornea not smooth); "Emphysema" (unspecified if ongoing), notes: Mild emphysema. Concomitant medication(s) included: CLARITIN [LORATADINE] taken for hypersensitivity; GELUSIL [ALUMINIUM HYDROXIDE; MAGNESIUM HYDROXIDE;SIMETICONE] taken for abdominal discomfort. Past drug history included: Vitamin b12, reaction(s): "Allergy to vitamin B12", notes: Allergies to Many drugs, including B-12 and Gold, etc. The following information was reported: TONGUE DISCOMFORT (non-serious) with onset 04Mar2021 14:30, outcome "not recovered", described as "tongue burns". The event "tongue burns" 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 tongue discomfort. Additional Information: Since the vaccination, the patient had been tested for COVID-19. On 04Mar2021 the patient experienced tongue burns. Further explained as the tongue started to bother the patient. It was stated by doctor that it was nothing but for her it was been going on for quite a while.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366681 same patient, same drug (different dose) and different event
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased
Clinical narrative: After the second dose the temperature of my body decreased from 36.7-8 to 35.1-5/her body temperature dropped from 98.1 dropped to a fluctuating range between 96.1 and 95.3; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 10:00 (Lot number: EN6208) at the age of 63 years as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "Hipertension Arterial" (unspecified if ongoing); "Enfermedad Renal Cronica Stage III" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; OMEGA3 JACK; ROSUVASTATIN. Vaccination history included: Bnt162b2 (1st dose, Batch/lot number: EN6198 , Date of start of drug: 27Feb2021, Anatomical Location: Arm Right), administration date: 27Feb2021, when the patient was 63 years old, for COVID-19 immunization, reaction(s): "COVID-19 immunization". The following information was reported: BODY TEMPERATURE DECREASED (non-serious) with onset 21Mar2021 10:00, outcome "not recovered", described as "After the second dose the temperature of my body decreased from 36.7-8 to 35.1-5/her body temperature dropped from 98.1 dropped to a fluctuating range between 96.1 and 95.3". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature decreased.  Additional information:Additional information- event has remained this way since receiving the 2nd dose of the vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. Patient wanted to know that if it is a side effect or you have other people reported this.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: terrible headache in back of her neck; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Single, (Lot # not provided)), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "terrible headache in back of her neck". Additional Information: The patient's age was reported as 76 (units unknown).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: got poison ivy; 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 12Mar2021 (Lot number: EN6207) 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: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "got poison ivy". The event "got poison ivy" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of dermatitis contact.  No follow-up attempts are possible. No further information is expected.  Follow-up (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. A  female consumer (patient) reported for herself that: she was scheduled for her second shot on Friday 02Apr2021. The caller got poison ivy really bad, she went to the local clinic here and they gave her prednisone to take. The caller has not taken the prednisone yet. The caller was calling to see if she can receive the second vaccine.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: he had some arm tenderness in the upper muscle; incredibly tired; a slight headache; 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 patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (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, reaction(s): "little bit arm tenderness"; Flu shot (his symptoms are normal and nothing more than when you receive a flu shot.). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "he had some arm tenderness in the upper muscle"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "incredibly tired"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "a slight headache".  Additional Information:  Patient stated he received the second dose of the Pfizer COVID vaccine yesterday and had some arm tenderness in the upper muscle, incredibly tired and a slight headache that was tolerable. Caller stated his symptoms were normal and nothing more than when you received a flu shot. Caller states his wife says you were not suppose to take Tylenol or Advil before receiving the vaccine and his daughter says you were not suppose to take Tylenol or Advil after the vaccine. Caller would like to know who is correct and if you can take Tylenol or Advil before or after vaccination and if it will affect the efficacy of the vaccine. Patient would also wanted to know if arm soreness, tiredness, and headache are common side effects of the vaccine?. Patient and his wife had 2nd dose of Pfizer vaccine yesterday. Other family members would also get Pfizer vaccines. Said after 1st dose had little bit arm tenderness. After 2nd dose had little arm tenderness and a slight headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity, Visual impairment
Clinical narrative: Diarrheas; Headaches; Vision changes; Sore arm; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 07Feb2021 14:30 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies: Latex" (unspecified if ongoing), notes: allergies: Latex; "allergies: NSAIDS" (unspecified if ongoing), notes: allergies: NSAIDS; "allergies: Penicillin" (unspecified if ongoing), notes: allergies: Penicillin; "Slight depression" (ongoing), notes: Slight depression. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]. Past drug history included: Epinephrine, reaction(s): "allergies: Epinephrine", notes: allergies: Epinephrine. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07Feb2021 17:00, outcome "not recovered", described as "Sore arm"; DIARRHOEA (non-serious), outcome "not recovered", described as "Diarrheas"; HEADACHE (non-serious), outcome "not recovered", described as "Headaches"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "Vision changes". The events "sore arm", "diarrheas", "headaches" and "vision changes" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, diarrhoea, headache, visual impairment. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received acyclovir within 2 weeks of vaccination. The first and second days were sore arm. After each shot and until the 16th day, the patient had ongoing diarrheas, headaches, vision changes and depression. The depression was still ongoing. The events resulted in healthcare professional office visit. The patient has not been diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101389517 Same patient, same product with different dose, different event
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: slight tingling in her lips; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Single, (Lot # not provided)), for Covid-19 Vaccination, reaction(s): "slight headache". The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 31Mar2021, outcome "unknown", described as "slight tingling in her lips". Additional Information: The patient's age was reported as 48 (units unknown). The patient had her second Pfizer COVID Vaccine about one hour ago and was having slight tingling in her lips and wanted to know if it was okay to take Benadryl. She received the first COVID Vaccine and had no problems other than a slight headache.  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-2021365939 same patient, same drug(different dose), different event
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Ocular discomfort, Therapeutic response unexpected
Clinical narrative: A painless feeling of pressure inside my head, a bit like a high with the feeling of an elevated mental acuity; A painless ocular pressure that seemed to intensify the forward looking focus or sharpness of my vision; feeling of an elevated mental acuity; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 10Mar2021 08:30 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single and administered in arm left, administration date 31Mar2021 08:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. No other medications in 2 weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: HEAD DISCOMFORT (non-serious) with onset Mar2021, outcome "recovered" (31Mar2021), described as "A painless feeling of pressure inside my head, a bit like a high with the feeling of an elevated mental acuity"; OCULAR DISCOMFORT (non-serious) with onset Mar2021, outcome "recovered" (31Mar2021), described as "A painless ocular pressure that seemed to intensify the forward looking focus or sharpness of my vision"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Mar2021, outcome "recovered" (31Mar2021), described as "feeling of an elevated mental acuity". Therapeutic measures were not taken as a result of head discomfort, ocular discomfort, therapeutic response unexpected. Clinical course: A painless ocular pressure that seemed to intensify the forward looking focus or sharpness of vision when patient left the clinic 15 minutes after the second shot. A painless feeling of pressure inside the head, a bit like a high, with the feeling of an elevated mental acuity. Patient experienced the same feelings after the first dose. Patient was not complaining and do not think of it as "adverse", but wanted to report this effect. It has been 8-1/2 hours since the last injection and patient felt fine, no injection site or arm pain, no body aches or pain; felt completely normal. Additional information: Vaccine facility type was at a hospital. Since the vaccination, the patient has not been tested for COVID- 19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: leg cramping; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier: US-PFIZER INC-2021376708 (pfizer).  A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: MUSCLE SPASMS (non-serious), outcome "unknown", described as "leg cramping".  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Sleep apnea resolved, since the first vaccine; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 23 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "Totally disabled" (ongoing); "Sleep Apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Sleep apnea resolved, since the first vaccine".  Additional information: Caller was 74. Caregiver for 23 year totally disabled. Both received vaccines at same time. Second dose was 19Mar2021. Sleep apnea resolved, since the first vaccine. Indicated that just has to lift chin and "immediately breathing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: The patient's second dose was scheduled for 28 days and was asking if it was ok.  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-2021366660 Same reporter, drug and event; Different patient
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: have been having like constant Tinnitus on her left ear; 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 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 11Mar2021 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing), notes: she had this in the past. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "unknown", described as "have been having like constant Tinnitus on her left ear". Additional information: The patient had her first Pfizer vaccine on 11Mar2021, and since then she have been having like constant tinnitus on her left ear and she just worried about getting the second vaccine as she was reading online that some people had problem too, like 100 of people and some people have hearing loss. So, it made her worried because she haven't existing a hearing loss and she had since this (tinnitus) in past but it was not like this constant. Upon reconfirmation what happen to her left ear: consumer (reporter) stated, " Ya, Tinnitus its like ringing constant ringing on my left ear like Cricket you know."  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Oropharyngeal pain, Rhinorrhoea, Throat irritation
Clinical narrative: Sore, scratchy throat; Sore, scratchy throat; Runny nose; Diarrhea; Loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 16:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "migraine headaches" (unspecified if ongoing). Concomitant medication(s) included: AIMOVIG; HUMALOG; LOSARTAN POTASSIUM. The following information was reported: OROPHARYNGEAL PAIN (non-serious), THROAT IRRITATION (non-serious), outcome "unknown" and all described as "Sore, scratchy throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Loss of appetite". Therapeutic measures were not taken as a result of oropharyngeal pain, throat irritation, rhinorrhoea, diarrhoea, decreased appetite.  Additional information: Patient took other medications in two weeks which included Zos (as reported). The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6206), on Mar 9, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache, and myalgia/muscle pain, with outcome of unknown. Additional information: The patient asked if it was okay to have the Hepatitis B vaccine shot today (Mar 29, 2021), since she took the first dose of BNT162B2 on Mar 9, 2021. The second dose was scheduled Mar 30, 2021. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Pain, Pain in extremity, Taste disorder
Clinical narrative: She also reported a change in taste where "things tasted different" but state that as days went by, it went away; She says she had a feeling like extreme anxiety, she couldn't lie in bed and had to jump up; she was achy, nothing huge or awful, her arm was throbbing; Caller also reports that with her first dose of the vaccine she had the "throbbing" for which she took Advil and also reported "achiness" on her whole left side where she got the injection; 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-2021350929.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TASTE DISORDER (non-serious), outcome "unknown", described as "She also reported a change in taste where "things tasted different" but state that as days went by, it went away"; PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "Caller also reports that with her first dose of the vaccine she had the "throbbing" for which she took Advil and also reported "achiness" on her whole left side where she got the injection"; ANXIETY (non-serious), outcome "unknown", described as "She says she had a feeling like extreme anxiety, she couldn't lie in bed and had to jump up"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "she was achy, nothing huge or awful, her arm was throbbing". Therapeutic measures were taken as a result of pain, pain in extremity.  Additional information: Patient reports that in the middle of the night she "started out of bed" with a sensation that she equates to someone "going off drugs cold turkey" like you would see on television or movies. Patient states that she was just "jumping around but reports that "little by little it dissipated." Patient reports that when tried to go back to bed, the same thing happened. Patient also reported a change in taste where "things tasted different" but state that as days went by, it went away. Patient took couple of Advil as treatment medication. Reason for no lot number: of Pfizer COVID-19 vaccine: Complainant does not have the product with them at the time of call. Patient did not have any recent vaccine and any new medication, since Covid-19 vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.