chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: she had to call out from work the next day; Vomiting; Myalgia; Shivers; she was still very tired; injection site was Red; injection site was / Swelling; injection site was / hot from injection site to the elbow; This case was reported by a other health professional and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced vomiting, myalgia and shivers. On 4th December 2020, the patient experienced activities of daily living impaired. In December 2020, the patient experienced injection site erythema, injection site swelling, extremities hot feeling of and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, extremities hot feeling of, vomiting, myalgia, shivers, fatigue and activities of daily living impaired were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, extremities hot feeling of, vomiting, myalgia, shivers, fatigue and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient was a health care professional. On the night after receiving the Shingrix vaccine, the patient had shivers, myalgia and vomiting. The patient stated that she had to call out from work the next day. Patient was able to get out of bed on the third day, but she was still very tired. She also stated that the injection site was red, swollen, and hot from the injection site to the elbow. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy, Product administered to patient of inappropriate age
Clinical narrative: Pregnant; Vaccine was given to 16 years of age patient; A report was received from a nurse concerning a 16-year-old, female patient who was participating in the mRNA-1273program and the patient received the vaccine at inappropriate age and while pregnant.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 027L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The reporter called and stated that their office had given the first dose of Moderna vaccine to a 16 year old girl who was pregnant. The patient's due date is April 2021. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events, vaccine exposure to patient of inappropriate age while pregnant, were considered resolved.; Reporter's Comments: This spontaneous  case concerns a 16-year-old female who received the vaccine at inappropriate age (inappropriate age at vaccine administration) and while pregnant for mRNA-1273 (Lot number 027L20A, expiration date unknown). No medical history, obstetric or gynecological history was provided.  Estimated date of delivery is April 2010. There were no reported AEs associated with the event of inappropriate age at vaccine administration.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased, Seizure
Clinical narrative: Low count platelets; Convulsions after vaccination without lose of consciousness; A spontaneous report was received from a pharmacist concerning a 22-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced convulsions without loss of consciousness and low platelet count.  The patient's medical history was not reported.  Concomitant medications were not provided.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On 28 Dec 2020, after getting vaccinated, the patient immediately started to experience tremors and shaking all over his body which was described as convulsions without losing consciousness.    On 05 Jan 2021, the patient had a blood test that showed a low platelet count. No treatment information was provided.  Action taken for the event was not reported.  The outcome of the events, convulsions without loss of consciousness and low platelet count, was considered unknown.; Reporter's Comments: This case concerns a 22-year old male patient. The medical history is not provided. The patient experienced a medically significant and unexpected medically significant event of Convulsions without losing consciousness immediately after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Additionally, the patient experienced an unexpected non-serious event of Platelet count decreased. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site thrombosis
Clinical narrative: Blood clot; Swelling at the injection site; Redness at the injection site; A spontaneous report was received from a consumer concerning a 85-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced swelling at the injection site, redness at the injection site and blood clot.  The patient's medical history was not reported. The patient current condition included chronic obstructive pulmonary disease (COPD). No relevant concomitant medications were reported.   On 11 Jan 2021, approximately 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient's wife called his doctor as he was experiencing swelling and redness. They were referred to the emergency room (ER) by their doctor for a suspected infection. In the ER they were told it may be a blood clot and the patient was given prednisone. Treatment for the events included prednisone.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events swelling at the injection site, redness at the injection site and blood clot were unknown.; Reporter's Comments: This case concerns a 85 year-old, male patient, who experienced events of swelling at the injection site, redness at the injection site and blood clot. The events occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Looks like cellulitis; Injection site swollen; Injection site red; Arm was just sore; A spontaneous report was received from a consumer concerning a 82-year old, female, mother who received Moderna's COVID-19 vaccine and experienced sore arm, red and swollen injection site and looks like cellulitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 10 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10 Jan 2021, after receiving the vaccine the patient's arm was sore. On 19 Jan 2021, the injection site is all red and swollen, looks like cellulitis. No treatment for events.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events was unknown.; Reporter's Comments: This case concerns an 82-year-old female patient, who experienced a serious unexpected event of cellulitis, and non- serious expected event of pain in extremity, injection site swelling, and injection site erythema. The event of pain in extremity occurred 1 day (same day) after first dose of mRNA-1273, lot # 039K20A. The event of cellulitis, injection site swelling, and injection site erythema occurred 10 days after first dose of mRNA-1273, lot # 039K20A. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia oral
Clinical narrative: All of the face paralyzed immediately after getting the shot; Tongue was numb; A report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273)and experienced  the serious adverse event of whole face paralyzed and tongue numbness.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   The reporter experienced facial numbness after 30 minutes of receiving the vaccine and mentioned two other patients that suffered the same adverse event. This case was to document the event for one of those other patients. This patient had all of the face paralyzed immediately after vaccination. The tongue was also numb. No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.   The outcome of the events was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Face paralysis that lasted 2 hours; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed face paralysis that lasted 2 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, approximately 30 minutes prior to the onset of the event, the patient received their a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  30 minutes following vaccination, the patient began to experience facial numbness. They experienced facial paralysis for 2 hours. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, face paralysis that lasted 2 hours, was considered resolved on an unknown date.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of facial paralysis. The event of facial paralysis occurred 30 min (same day) after first dose of mRNA-1273, lot # unknown. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Dizziness, Feeling abnormal, Incorrect dose administered, Mucosal exfoliation
Clinical narrative: sloughing in her mucosa; immune systen going haywire/feeling pretty bad; Tachycardia; received 5cc or 33cc of Moderna COVID-19 vaccine; Dizzy; muscle aches; Injection site hard; Injection site is swollen; feet and hands were white and cold; Nasal drainage; fingers turned blue; A spontaneous report was received from a physician concerning a 60-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced tachycardia, immune system going haywire, felt pretty bad, dizziness, muscle pain, nasal drainage, feet and hands white/blue, heart rate 100 bpm and 5cc or 33cc of Moderna COVID-19 vaccine.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, approximately 6 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 16 Jan 2021, patient Patient states having tachycardia and felt "pretty bad" about 12 hours later, which she knows is normal after immunization. Continued to have tachycardia, and yesterday began to feel incredibly dizzy and like every single muscle was aching. Reports the injection site is hard and swollen but not red. States she could hardly see because of the dizziness and tachycardia. Also reports experiencing sloughing in her mucosa similar to when she was on chemotherapy for lymphoma. Reports no cough, no fever. Patient states that on Saturday which had tachycardia, her feet and hand were white and cold and temp was 95 degrees F. Her fingers turned blue and were white, but she had no shivers, no fevers. Also reports nasal drainage every time she gets an episode of the tachycardia. Physician state she was able to control tachycardia by drinking an enormous amount of fluid. Her heart rate was about 100 bpm, normal average is 65 bpm.  Treatment for the event included Tylenol 500mg x 2 and OTC Advil.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events tachycardia, immune system going haywire, felt pretty bad, dizziness, muscle pain, nasal drainage, feet and hands white/blue, heart rate 100 bpm and 5cc or 33cc of Moderna COVID-19 vaccine was not reported.; Reporter's Comments: This refers to a case of product administration error for mRNA-1273 (Lot number 025L20A), where 5cc or 3cc of the vaccine was administered to the patient. The adverse events of tachycardia, feeling abnormal, dizziness, myalgia, peripheral coldness, cyanosis, rhinorrhea, mucosal exfoliation, vaccination site swelling and vaccination site induration were reported associated with this case of incorrect dose of vaccine administered.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral coldness, Rhinorrhoea, Tachycardia, Vaccination site induration
Clinical narrative: sloughing in her mucosa; immune systen going haywire/feeling pretty bad; Tachycardia; received 5cc or 33cc of Moderna COVID-19 vaccine; Dizzy; muscle aches; Injection site hard; Injection site is swollen; feet and hands were white and cold; Nasal drainage; fingers turned blue; A spontaneous report was received from a physician concerning a 60-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced tachycardia, immune system going haywire, felt pretty bad, dizziness, muscle pain, nasal drainage, feet and hands white/blue, heart rate 100 bpm and 5cc or 33cc of Moderna COVID-19 vaccine.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, approximately 6 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 16 Jan 2021, patient Patient states having tachycardia and felt "pretty bad" about 12 hours later, which she knows is normal after immunization. Continued to have tachycardia, and yesterday began to feel incredibly dizzy and like every single muscle was aching. Reports the injection site is hard and swollen but not red. States she could hardly see because of the dizziness and tachycardia. Also reports experiencing sloughing in her mucosa similar to when she was on chemotherapy for lymphoma. Reports no cough, no fever. Patient states that on Saturday which had tachycardia, her feet and hand were white and cold and temp was 95 degrees F. Her fingers turned blue and were white, but she had no shivers, no fevers. Also reports nasal drainage every time she gets an episode of the tachycardia. Physician state she was able to control tachycardia by drinking an enormous amount of fluid. Her heart rate was about 100 bpm, normal average is 65 bpm.  Treatment for the event included Tylenol 500mg x 2 and OTC Advil.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events tachycardia, immune system going haywire, felt pretty bad, dizziness, muscle pain, nasal drainage, feet and hands white/blue, heart rate 100 bpm and 5cc or 33cc of Moderna COVID-19 vaccine was not reported.; Reporter's Comments: This refers to a case of product administration error for mRNA-1273 (Lot number 025L20A), where 5cc or 3cc of the vaccine was administered to the patient. The adverse events of tachycardia, feeling abnormal, dizziness, myalgia, peripheral coldness, cyanosis, rhinorrhea, mucosal exfoliation, vaccination site swelling and vaccination site induration were reported associated with this case of incorrect dose of vaccine administered.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: sloughing in her mucosa; immune systen going haywire/feeling pretty bad; Tachycardia; received 5cc or 33cc of Moderna COVID-19 vaccine; Dizzy; muscle aches; Injection site hard; Injection site is swollen; feet and hands were white and cold; Nasal drainage; fingers turned blue; A spontaneous report was received from a physician concerning a 60-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced tachycardia, immune system going haywire, felt pretty bad, dizziness, muscle pain, nasal drainage, feet and hands white/blue, heart rate 100 bpm and 5cc or 33cc of Moderna COVID-19 vaccine.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, approximately 6 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 16 Jan 2021, patient Patient states having tachycardia and felt "pretty bad" about 12 hours later, which she knows is normal after immunization. Continued to have tachycardia, and yesterday began to feel incredibly dizzy and like every single muscle was aching. Reports the injection site is hard and swollen but not red. States she could hardly see because of the dizziness and tachycardia. Also reports experiencing sloughing in her mucosa similar to when she was on chemotherapy for lymphoma. Reports no cough, no fever. Patient states that on Saturday which had tachycardia, her feet and hand were white and cold and temp was 95 degrees F. Her fingers turned blue and were white, but she had no shivers, no fevers. Also reports nasal drainage every time she gets an episode of the tachycardia. Physician state she was able to control tachycardia by drinking an enormous amount of fluid. Her heart rate was about 100 bpm, normal average is 65 bpm.  Treatment for the event included Tylenol 500mg x 2 and OTC Advil.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events tachycardia, immune system going haywire, felt pretty bad, dizziness, muscle pain, nasal drainage, feet and hands white/blue, heart rate 100 bpm and 5cc or 33cc of Moderna COVID-19 vaccine was not reported.; Reporter's Comments: This refers to a case of product administration error for mRNA-1273 (Lot number 025L20A), where 5cc or 3cc of the vaccine was administered to the patient. The adverse events of tachycardia, feeling abnormal, dizziness, myalgia, peripheral coldness, cyanosis, rhinorrhea, mucosal exfoliation, vaccination site swelling and vaccination site induration were reported associated with this case of incorrect dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site swelling, Wrong technique in product usage process
Clinical narrative: The way in which vaccine was administered made her bleed; injection site was bleeding a lot; injection site swelling; A spontaneous report was received from a consumer concerning an unspecified patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the way in which vaccine was administered made her bleed, injection site was bleeding a lot, and injection site swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 Jan 2021, approximately 0 days prior to the onset of the events, the patient received a dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient reported the way the vaccine was administered made her bleed profusely and she stated she had never seen that much blood. She also reported the injection site was swelling because of the way the vaccine was administered. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, the way in which vaccine was administered made her bleed, was considered on 12 Jan 2021. The outcomes of the events, injection site was bleeding a lot, and injection site swelling were unknown.; Reporter's Comments: This case concerns a female patient of an unknown age. The patient's medical history and concomitant medications were not provided. The patient experienced a non serious event of the way in which vaccine was administered made her bleed, injection site was bleeding a lot, and injection site swelling.The event occurred on the same day as the first dose of the mRNA-1273. Very limited information regarding these events have been provided at this time. Based on temporal association between the use of mRNA-1273 and the events, a causal relationship cannot be excluded. Additional information is required for further assessment.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Unresponsive to stimuli
Clinical narrative: the doctor was concerned that it might be a mini stroke; couldn't think of what he wanted to say; This is a spontaneous report from a contactable consumer reporting for the father. An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:45 at single dose in right arm because of his age group /mass senior vaccination order. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medications included blood pressure medicine since recent years. The patient previously had a flu shot (INFLUENZA VACCINE) but had that in early Nov2020. He kept saying it was the shot, but that he was fine. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient got vaccinated with the Pfizer COVID vaccine on 14Jan2021. He was feeling great with no problems. He sat and waited 15 minutes, and felt fine. When they were driving home after breakfast, her mother said she was talking asking him a question, and he wouldn't respond. Her father could hear her mother asking the question, but he said he could not think of what he wanted to say. He told her he couldn't think of what he was thinking on 14Jan2021. It probably started 1 hour to 1 hour 15 minutes after vaccination, and lasted 15-20 minutes. He kept trying to think of stuff. He kept repeating this for a little bit. His wife thought he was just trying to think of something, but couldn't remember. He was 81. He was very healthy and in shape. He still rides his bike every day. He walks in the morning to play golf too. When they got home and woke up from the nap, and he felt fine. He did say it was the weirdest thing, and that it had to have come from the shot. Since then, he has felt perfectly fine. He had nothing more going on that would indicate any side effect. Her concern was that it sounded like possibly a mini stroke. Upon checking with an HCP (Healthcare professional), the doctor was concerned that it might be a mini stroke and scheduled him for a CAT (Computerised axial tomography) scan. He kept saying it had to be the shot because he has been fine ever since. He had no issues with soreness at site or anything. He didn't have a prescribing doctor. He was driving when it happened. He didn't have a slur or anything. His second appointment is on the 04Feb2021. The event did not require a visit to Emergency Room, but required a visit to Physician Office in the morning of 18Jan2021. The outcome of the event couldn't think of what he wanted to say was recovered, and of the other event was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: He tested positive for Sars-CoV-2 in the interim; He tested positive for Sars-CoV-2 in the interim; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included exposure to a patient who was positive. The patient's concomitant medications were not reported. The patient received his first Pfizer-Biontech Covid19 vaccine on 30Dec2020, and was scheduled to receive his second dose today, 18Jan2021. He tested positive for Sars-CoV-2 in the interim and is looking for guidance on receiving the second dose. He was exposed to a patient who was positive. The patient has also tested positive. He wanted to know when he should get the second vaccine. The patient should have gotten the second dose today and was told they could get him in on Thursday which was in that 4-day window. Now, he has just been informed that they can't get him in for the second dose until Monday, which is outside to of the 4 days window and he wants guidance on this since his hospital was unsure. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: The patient received only one dose of BNT162B2 injection and then tested positive SARS-COVID-2 on an unspecific date. Given the incomplete protection from single dose of vaccine BNT162B2 , the COVID infection is unlikely related to suspect BNT162B2 administration, but may be pre-existing/intercurrent condition.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: ulcerative colitis; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).  This female patient of an unspecified received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at SINGLE DOSE for COVID-19 immunization. Medical history included she was allergic to sulfa. The patient's concomitant medications were not reported. She had ulcerative colitis and asked if that would impact anything. Outcome of the event was unkonwn.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: received first dose of vaccine and slept for two days straight; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  It was reported that the patient slept for two days straight on an unspecified date. The outcome of the event was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cast application, Computerised tomogram, Echocardiogram, Electrocardiogram, Loss of consciousness
Clinical narrative: 24 hours after receiving the vaccine, I passed out while walking.  I do not have any other new medications; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 13Jan2021 at 08:00 AM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included bronchiectasis. Patient had no known allergies. Concomitant medications in two weeks prior to the vaccination included olodaterol hydrochloride, tiotropium bromide monohydrate (STIOLTO RESPIMAT), salbutamol (ALBUTEROL HFA) and multi vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 10:00 AM patient passed out while walking, 24 hours after receiving the vaccine, patient did not have any other new medications. Event resulted in emergency room/department or urgent care and hospitalization for one day. Treatments received included cast on hand, computerised tomogram (Ct) scans, electrocardiogram (EKG) and echocardiogram on unknown date with unknown results. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the event, at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Injury associated with device, Scab
Clinical narrative: Felt pricked by shoulder and has a scab there now; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age (Age: 65; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I felt pricked by shoulder and has a scab there now, could this happen due to the vaccine? The site which she received her vaccine is rescheduling people for after 21 days. The patient felt two pricks. She got a scab on her shoulder. She thinks he accidently poked her. The patient stated, "If the person that gave the vaccination pricked her shoulder before the shot could it have caused a little irritation on her shoulder? Whenever the man gave the shot, she wasn't looking at him, but he told her to hold her sleeve up. She was just trying to hold her sleeve up. He pushed his sleeve way up on her shoulder. She felt it way up on her shoulder, and thought it was strange. He squeezed her arm, and said he thought there would be good. She felt two pricks. She got a scab on her shoulder. She thinks he accidently poked her. He tried to say he thought he poked himself, but she is pretty sure he poked her. He gave the shot in her arm. He thought he had pricked himself but pricked her. Her question is, if that happens and the needle pricks the surface of the skin, can it make it blister the skin? Her main reason for calling is that she is signed up to get the second round. Now, the city she lives in is having trouble getting the vaccine. People that were supposed to get the first vaccine Monday and Tuesday had to be pushed to Wednesday because they didn't get their shipment. So now everyone will get them on Wednesday. The day she went it was very organized so she feels bad for these people. Since Pfizer is having trouble getting this shipped, then what is going to happen on 5 Feb 2021 which is the day she is supposed to get her second dose. What will happen if they don't have vaccines?". She would just like her questions answered. Her brother said he heard somewhere the vaccine doesn't have to be given at exactly 21 days like they originally said. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: headache; nausea; fatigue; sore arm; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient (not pregnant), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration, on left arm on 16Jan2021 14:15 at single dose for COVID-19 immunization. Medical history included Diverticulosis, hypothyroid, osteoarthritis, vitiligo, psoriasis, anxiety/depression, known allergies: Iodine, sulfa, bivalve shellfish, garlic, onions. Concomitant medications included first dose of pneumococcal vaccine polysacch 23v (PNEUMOVAX) on 23Dec2020 on left arm, celecoxib (CELEBREX), sertraline, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL). The patient experienced fatigue, sore arm the day after vaccine was administered on 17Jan2021. Two days after administration on 18Jan2021, patient experienced fatigue, headache, nausea. No treatment received for all events. The outcome of the events were resolving.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pain, Pyrexia, Rash
Clinical narrative: She had a head to toe body ache 14 hours after she got the vaccine; had fever that went up to 100.8 F; had swollen lymph node on the same arm as the injection site; full body rash; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration in arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from 12Dec2020 (States that before she got the vaccine she was positive for Covid, but her positive result came back on 12Dec2020).  The patient's concomitant medications were not reported.  Caller got the COVID-19 vaccine on 11Jan2021. She had a head to toe body ache 14 hours after she got the vaccine (11Jan2021 14:00). She also had fever that went up to 100.8 Fahrenheit and had swollen lymph node on the same arm as the injection site, and a full body rash in Jan2021. She has had all these symptoms for a week now. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: She had a head to toe body ache 14 hours after she got the vaccine; had fever that went up to 100.8 F; had swollen lymph node on the same arm as the injection site; full body rash; This is a spontaneous report from a contactable pharmacist (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration in arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from 12Dec2020 (States that before she got the vaccine she was positive for Covid, but her positive result came back on 12Dec2020).  The patient's concomitant medications were not reported.  Caller got the COVID-19 vaccine on 11Jan2021. She had a head to toe body ache 14 hours after she got the vaccine (11Jan2021 14:00). She also had fever that went up to 100.8 Fahrenheit and had swollen lymph node on the same arm as the injection site, and a full body rash in Jan2021. She has had all these symptoms for a week now. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased, SARS-CoV-2 antibody test
Clinical narrative: 10 days after shot platelets have now dropped from 245000 to 94000; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) first dose on 08Jan2021 08:00 at single dose for covid-19 immunisation. The patient's medical history included thrombocytopenia. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported.  On 18Jan2021 11:00, ten days after shot platelets have now dropped from 245000 to 94000. The patient was very concerned platelets will drop below 30000 and will require hospitalization. The patient wanted guidance on what protocol to follow to avoid a further drop in platelets. No treatment was given to the event. The event resulted in emergency room visit physician office visit. The outcome of the event was not recovered. The patient underwent nasal swab on 18Jan2021, and the result was negative.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Bone pain, Dizziness, Dyspnoea
Clinical narrative: discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my legs; Within 10mins I was feeling dizzy; increase palpitation; I told the nurse she checked my blood pressure. It was 157/87; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on the right arm on 15Jan2021 15:45 at a single dose for an COVID-19 immunization at a hospital. Medical history included GERD. There were no concomitant medications. On 15Jan2021 at 15:45 (reported as within 10 mins), the patient felt dizzy and increase palpitation. The patient told the nurse and she checked her blood pressure, it was 157/87. After 15 mins of vaccine infusion (16:00), she came back home and increased weakness with shakiness in legs noted. After 2 hrs. (18:00) all symptoms were gone. The next morning (16Jan2021), the patient had discomfort in her sternum. By late afternoon, she had trouble breathing with chest congestion. The patient took 3 puffs of inhaler so she can breathe. The patient mentioned that her inhaler is expired, it was given to her 3 years ago. She didn't want to use it but used it anyway so she can sleep. The events dizzy, palpitation, blood pressure high, weakness, shakiness, and discomfort in sternum were not treated. The outcome of the events weakness and shakiness was recovered on 15Jan2021 at 18:00 while the other events were unknown.  Information about lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations, Respiratory tract congestion, Tremor
Clinical narrative: discomfort in my sternum; trouble breathing; chest congestion; increased weakness; shakiness in my legs; Within 10mins I was feeling dizzy; increase palpitation; I told the nurse she checked my blood pressure. It was 157/87; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on the right arm on 15Jan2021 15:45 at a single dose for an COVID-19 immunization at a hospital. Medical history included GERD. There were no concomitant medications. On 15Jan2021 at 15:45 (reported as within 10 mins), the patient felt dizzy and increase palpitation. The patient told the nurse and she checked her blood pressure, it was 157/87. After 15 mins of vaccine infusion (16:00), she came back home and increased weakness with shakiness in legs noted. After 2 hrs. (18:00) all symptoms were gone. The next morning (16Jan2021), the patient had discomfort in her sternum. By late afternoon, she had trouble breathing with chest congestion. The patient took 3 puffs of inhaler so she can breathe. The patient mentioned that her inhaler is expired, it was given to her 3 years ago. She didn't want to use it but used it anyway so she can sleep. The events dizzy, palpitation, blood pressure high, weakness, shakiness, and discomfort in sternum were not treated. The outcome of the events weakness and shakiness was recovered on 15Jan2021 at 18:00 while the other events were unknown.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Nausea, Sensation of foreign body
Clinical narrative: Anaphylactic reaction; This is a spontaneous report from a contactable Nurse (patient). This is the second of two cases and refers to events occurred with the second dose of the vaccine.  A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EL1283), on 11Jan2021 at 11:00 at single dose in Deltoid Left for COVID-19 immunization. Medical history included asthma, shellfish allergy, allergy lobster (used steroids). Patient was not pregnant.The patient's concomitant medications were not reported. Previously on 22Dec2020 at 12:30 PM patient took the first dose of the vaccine (Lot EJ1685) at single dose in Deltoid Left for COVID-19 immunization and couple of days after she had nausea and something stuck in her throat. On 11Jan2021, 5 minutes after the 2nd dose (at 11:05), the patient experienced anaphylactic reaction, that required Emergency room visit. Patient was not hospitalized and was treated with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLUMEDROL) and "Pepcid": she was prescribed 3-day course of oral prednisone and H2 antihistamine oral "Pepcid". After finished it, she felt it was coming back therefore she took diphenhydramine hydrochloride for 2 nights in a row. She did not experience any respiratory, cardiovascular, dermatological or gastrointestinal manifestation. She completely recovered in Jan2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of anaphylactic reaction  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: asymptomatic but positive; asymptomatic but positive; This is a spontaneous report from a contactable Other HCP (patient's parent).  A male patient (son) of unknown age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Caller states his son went back to school and initially tested negative for SARS-Cov-2 following first dose, now is asymptomatic but positive. Asking if second dose would exacerbate. Outcome is unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the limited information available, a causal relationship between event "asymptomatic but positive" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. The case will be reevaluated should additional information become available.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Coronavirus test, Fatigue, Headache, Myalgia
Clinical narrative: high platelets; fatigue; sharp muscle pains in hands and elbows; Headaches; nausea; Canker sore on my tongue; had a sizable bruise; This is a spontaneous report from a contactable other healthcare professional (patient).  A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Jan2021 11:45 AM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient is not pregnant. Patient previously took the first dose of BNT162B2 at single dose for COVID-19 immunization. Patient have had a lot of fatigue, sharp muscle pains in hands and elbows at day 9 post injection (17Jan2021). Patient was now developing a Canker sore on her tongue as a fellow coworker had the same reaction (Jan2021). Patient have high platelets and have had a sizable bruise for 9 days. Headaches and nausea were present at three hours post injection (09Jan2021). AE resulted in doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. No COVID tested post vaccination. covid test type post vaccination included Nasal Swab on 12Jan2021 with test result of Negative. No treatment received for the events. Outcome of the events was unknown.   Information on the Lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Platelet count, Platelet count increased, Tongue ulceration
Clinical narrative: high platelets; fatigue; sharp muscle pains in hands and elbows; Headaches; nausea; Canker sore on my tongue; had a sizable bruise; This is a spontaneous report from a contactable other healthcare professional (patient).  A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Jan2021 11:45 AM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient is not pregnant. Patient previously took the first dose of BNT162B2 at single dose for COVID-19 immunization. Patient have had a lot of fatigue, sharp muscle pains in hands and elbows at day 9 post injection (17Jan2021). Patient was now developing a Canker sore on her tongue as a fellow coworker had the same reaction (Jan2021). Patient have high platelets and have had a sizable bruise for 9 days. Headaches and nausea were present at three hours post injection (09Jan2021). AE resulted in doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. No COVID tested post vaccination. covid test type post vaccination included Nasal Swab on 12Jan2021 with test result of Negative. No treatment received for the events. Outcome of the events was unknown.   Information on the Lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Exhausted; sore; headache; This is a spontaneous report from a contactable consumer.  A 49-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced Exhausted, sore, headache on 18Jan2021. Outcome of events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.