chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: feel lightheaded; I have a bright red, itchy, raised and warm welt at the injection site as well; Pain and itching at the injections site immediately; Pain and itching at the injections site immediately; Throat tightness across the front; Tongue began to tingle, felt a little "fat" and then went numb for approximately 3-5 minutes; Swallowing feels like a "lump" in my throat, but does feel obstructed; I have a bright red, itchy, raised and warm welt at the injection site as well; This is a spontaneous report from a contactable Nurse who reported for herself.  A 51-years-old female patient received the first dose of bnt162b2 (BNT162B2, lot number EK5730), intramuscular in the left arm at hospital on 17Dec2020 09:45 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bacitracin zinc, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced rash. The patient experienced pain and itching at the injections site on 17Dec2020 at 09:45 (reported as immediately), lasted approximately 3 hours (as reported), the final outcome was recovering (as reported). Throat tightness across the front, but not "inside." Tongue began to tingle, felt a little "fat" and then went numb for approximately 3-5 minutes. Swallowing felt like a "lump" in her throat, but did feel obstructed. Ate lunch without difficulty. Drinking without difficulty. The front of her throat, distal from jawline, to top of breast-line felt like she had a very light weight resting on it, even 8 hours post injection. Approximately 30 minutes after injection, the patient began to feel lightheaded. Lightheadedness became more intermittent for the next 4 hours and resolved. She had a bright red, itchy, raised and warm welt at the injection site as well, 8 hours later, on 17Dec2020. The patient did not receive any treatment for the events. The outcome for the event lightheaded was recovered, for the other events was recovering. Prior to vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth, Paraesthesia oral
Clinical narrative: feel lightheaded; I have a bright red, itchy, raised and warm welt at the injection site as well; Pain and itching at the injections site immediately; Pain and itching at the injections site immediately; Throat tightness across the front; Tongue began to tingle, felt a little "fat" and then went numb for approximately 3-5 minutes; Swallowing feels like a "lump" in my throat, but does feel obstructed; I have a bright red, itchy, raised and warm welt at the injection site as well; This is a spontaneous report from a contactable Nurse who reported for herself.  A 51-years-old female patient received the first dose of bnt162b2 (BNT162B2, lot number EK5730), intramuscular in the left arm at hospital on 17Dec2020 09:45 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bacitracin zinc, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced rash. The patient experienced pain and itching at the injections site on 17Dec2020 at 09:45 (reported as immediately), lasted approximately 3 hours (as reported), the final outcome was recovering (as reported). Throat tightness across the front, but not "inside." Tongue began to tingle, felt a little "fat" and then went numb for approximately 3-5 minutes. Swallowing felt like a "lump" in her throat, but did feel obstructed. Ate lunch without difficulty. Drinking without difficulty. The front of her throat, distal from jawline, to top of breast-line felt like she had a very light weight resting on it, even 8 hours post injection. Approximately 30 minutes after injection, the patient began to feel lightheaded. Lightheadedness became more intermittent for the next 4 hours and resolved. She had a bright red, itchy, raised and warm welt at the injection site as well, 8 hours later, on 17Dec2020. The patient did not receive any treatment for the events. The outcome for the event lightheaded was recovered, for the other events was recovering. Prior to vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body, Throat tightness
Clinical narrative: feel lightheaded; I have a bright red, itchy, raised and warm welt at the injection site as well; Pain and itching at the injections site immediately; Pain and itching at the injections site immediately; Throat tightness across the front; Tongue began to tingle, felt a little "fat" and then went numb for approximately 3-5 minutes; Swallowing feels like a "lump" in my throat, but does feel obstructed; I have a bright red, itchy, raised and warm welt at the injection site as well; This is a spontaneous report from a contactable Nurse who reported for herself.  A 51-years-old female patient received the first dose of bnt162b2 (BNT162B2, lot number EK5730), intramuscular in the left arm at hospital on 17Dec2020 09:45 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bacitracin zinc, neomycin sulfate, polymyxin b sulfate (NEOSPORIN) and experienced rash. The patient experienced pain and itching at the injections site on 17Dec2020 at 09:45 (reported as immediately), lasted approximately 3 hours (as reported), the final outcome was recovering (as reported). Throat tightness across the front, but not "inside." Tongue began to tingle, felt a little "fat" and then went numb for approximately 3-5 minutes. Swallowing felt like a "lump" in her throat, but did feel obstructed. Ate lunch without difficulty. Drinking without difficulty. The front of her throat, distal from jawline, to top of breast-line felt like she had a very light weight resting on it, even 8 hours post injection. Approximately 30 minutes after injection, the patient began to feel lightheaded. Lightheadedness became more intermittent for the next 4 hours and resolved. She had a bright red, itchy, raised and warm welt at the injection site as well, 8 hours later, on 17Dec2020. The patient did not receive any treatment for the events. The outcome for the event lightheaded was recovered, for the other events was recovering. Prior to vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Sudden consent of right sided facial numbness paralysis
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Dyspnoea
Clinical narrative: About 4 hours after the vaccine during dinner felt tired. Around 11, midnight I felt achy, body hurts, I  had chills, and developed cough and shortness of breath. By Thursday I felt horrible and now I can not even taste or smell anything. My body aches are gone I feel somewhat better.  No shortness of breathe and no cough, still fatigued. Took Ibuprofen and Tylenol on Thursday Friday and Saturday. Was tested for COVID on 12/18 - tested positive.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, SARS-CoV-2 test positive
Clinical narrative: About 4 hours after the vaccine during dinner felt tired. Around 11, midnight I felt achy, body hurts, I  had chills, and developed cough and shortness of breath. By Thursday I felt horrible and now I can not even taste or smell anything. My body aches are gone I feel somewhat better.  No shortness of breathe and no cough, still fatigued. Took Ibuprofen and Tylenol on Thursday Friday and Saturday. Was tested for COVID on 12/18 - tested positive.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Malaise, Pain, Pain in extremity
Clinical narrative: About 4 hours after the vaccine during dinner felt tired. Around 11, midnight I felt achy, body hurts, I  had chills, and developed cough and shortness of breath. By Thursday I felt horrible and now I can not even taste or smell anything. My body aches are gone I feel somewhat better.  No shortness of breathe and no cough, still fatigued. Took Ibuprofen and Tylenol on Thursday Friday and Saturday. Was tested for COVID on 12/18 - tested positive.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: About 4 hours after the vaccine during dinner felt tired. Around 11, midnight I felt achy, body hurts, I  had chills, and developed cough and shortness of breath. By Thursday I felt horrible and now I can not even taste or smell anything. My body aches are gone I feel somewhat better.  No shortness of breathe and no cough, still fatigued. Took Ibuprofen and Tylenol on Thursday Friday and Saturday. Was tested for COVID on 12/18 - tested positive.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Uncontrollable chills; Fever; Headache; Arm is sore a bit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration at on an unspecified date at single dose for COVID-19 immunization.  Medical history included Covid.  The patient's concomitant medications were not reported.  On 16Dec2020, Last night, about 12 o' clock, patient woke up with the same side effects that patient had Covid. Patient had uncontrollable chills and a fever. Those were better. Patient still had a headache. Of course, his/her arm was sore a bit, that was expected. Outcome of uncontrollable chills and fever were recovering, outcome of other events was unknown.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Head discomfort, Ocular hyperaemia
Clinical narrative: Swelling  and redness in my left eye. Severe pressure on the left side of head.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: I am breastfeeding my 20 month old and she developed a rash on trunk. Maculopapular.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm
Clinical narrative: Right Ear red and purple and warm.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Immunisation, No adverse event, Wrong product administered
Clinical narrative: This patient received last year's (2019-20) influenza Vaccine on 9/26/20 due to oversight in the supply management process. The patient was notified and had not experienced any adverse effects from that vaccine. The patient did return to the office and received the appropriate Fluad Quadrivalent (2020-21) Influenza Vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Migraine, Nausea
Clinical narrative: Migraine; Migraine; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable consumer reported for herself.  A 36-year-old female patient received the first dose of BNT162B2 (Pfizer product, lot number EH9899) , via an unspecified route of administration on 15Dec2020 13:30 at single dose on left arm for immunisation.  Medical history included migraine.  There were no concomitant medications. No allergies to medications, food, or other products. No other vaccines in four weeks and no other medications in two weeks. The patient experienced migraine, fatigue, nausea, diarrhea starting the following day around 10 am (16Dec2020 10:00). The patient was not pregnant. No Covid prior vaccination, and no Covid tested post vaccination. No treatment was received for the events. The outcome of the events was resolved on an unspecified date in Dec2020. The report was assessed as non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Tachycardia
Clinical narrative: Burning at injection site followed by tachycardia and lightheadedness within 2 minutes. Lasted over half an hour
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old female patient (who happened to be a pharmacist) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a sore arm following administration of Covid 19 vaccine on an unspecified date with outcome of unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Treatment noncompliance
Clinical narrative: Patient has known anxiety and diabetes.  Blood glucose 220 - patient admitted that they had not taken DM medications.  Patient did not required any medication.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Lymph node pain, Trigeminal neuralgia
Clinical narrative: 36 hours after injection lymph node pain in back of neck, this flared my trigeminal neuralgia.  Took 800 Ibuprofen 1 hour later that pain stopped and massive headache.  Headache was followed by drunken type vertigo. I took 20mg steroid, Benadryl, Afrin, Albuterol.  Two hours later better but still had vertigo.  By 4am symptoms light enough to do light work out, legs felt fatigued. Today no symptoms.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 36 hours after injection lymph node pain in back of neck, this flared my trigeminal neuralgia.  Took 800 Ibuprofen 1 hour later that pain stopped and massive headache.  Headache was followed by drunken type vertigo. I took 20mg steroid, Benadryl, Afrin, Albuterol.  Two hours later better but still had vertigo.  By 4am symptoms light enough to do light work out, legs felt fatigued. Today no symptoms.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia, Nasal congestion
Clinical narrative: Injection site pain; myalgia; arthralgia; congestion; neck pain; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received first dose of bnt162b2 (lot number EK5730), via an unspecified route of administration in arm left on 16Dec2020 07:15 at single dose for immunization.  Medical history included hypertension and CAD (coronary artery disease). Patient had no allergy history to medications, food, or other products. Concomitant medication included ticagrelor (BRILINTA), lisinopril, acetylsalicylic acid (ASA), ergocalciferol (VIT D) and magnesium (MAGNESIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced injection site pain, myalgia, arthralgia, congestion, neck pain, fatigue all on 16Dec2020 20:00. Treatment paracetamol (TYLENOL) were taken as a result of reported events. The outcome of the events was recovering.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Injection site pain; myalgia; arthralgia; congestion; neck pain; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received first dose of bnt162b2 (lot number EK5730), via an unspecified route of administration in arm left on 16Dec2020 07:15 at single dose for immunization.  Medical history included hypertension and CAD (coronary artery disease). Patient had no allergy history to medications, food, or other products. Concomitant medication included ticagrelor (BRILINTA), lisinopril, acetylsalicylic acid (ASA), ergocalciferol (VIT D) and magnesium (MAGNESIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced injection site pain, myalgia, arthralgia, congestion, neck pain, fatigue all on 16Dec2020 20:00. Treatment paracetamol (TYLENOL) were taken as a result of reported events. The outcome of the events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Left arm feels swollen - resolved on own.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Developed numbness and tingling to face, forehead and lips about 45 minutes after administration. Everything but nose resolved in 5-10 minutes but nose remained feeling numb - had some sensation but not normal.  2 1/2 hrs later felt like it was continuing to improve, but not normal yet.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient developed hives 30 minutes after receiving injection.  Received Benadryl and seen in ER for evaluation.  No further issues reported.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red very swollen sore arm; Red very swollen sore arm; Red very swollen sore arm; This is a spontaneous report from a contactable physician via Pfizer Sales Representative.  A 63-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose on an unspecified date for immunisation.  Medical history included smoker. Concomitant medications were not reported. The patient experienced red very swollen sore arm on an unspecified date with outcome of recovering. Therapeutic measures were taken as a result of red very swollen sore arm included Benadryl. Two days later all symptoms had subsided and didn't need to be rechecked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Feeling hot, Flushing, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: About 5-7 minutes after the injection, I was sitting in the waiting area for my 15 minutes observation period. After about 5-7 minutes I noticed that it was hard for me to swallow and I became really flushed and hot and tachycardia. I was not anxious or upset about getting the shot. I am actually an ER physician and have had lots of shots in my life without any adverse reaction. The flushing and tachycardia resolved after about 20 minutes but the sensation of difficulty swallowing did not subside completely until I took  dose of Benadryl 50mg orally. Symptoms resolved after about 1 hour post Benadryl. I also had a recurrence of symptoms the next day at around 24 hours where I felt again like I couldn't swallow, so I took Benadryl 50mg again, but this time I also had some numbness of the left side of my tongue and the left side of my face.  The abnormal sensation in the left side of my face subsided over about an hour or so.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: About 5-7 minutes after the injection, I was sitting in the waiting area for my 15 minutes observation period. After about 5-7 minutes I noticed that it was hard for me to swallow and I became really flushed and hot and tachycardia. I was not anxious or upset about getting the shot. I am actually an ER physician and have had lots of shots in my life without any adverse reaction. The flushing and tachycardia resolved after about 20 minutes but the sensation of difficulty swallowing did not subside completely until I took  dose of Benadryl 50mg orally. Symptoms resolved after about 1 hour post Benadryl. I also had a recurrence of symptoms the next day at around 24 hours where I felt again like I couldn't swallow, so I took Benadryl 50mg again, but this time I also had some numbness of the left side of my tongue and the left side of my face.  The abnormal sensation in the left side of my face subsided over about an hour or so.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Swelling
Clinical narrative: lots of pain on the site radiating from shoulder to hands; lots of pain on the site radiating from shoulder to hands; lots of pain on the site radiating from shoulder to hands; swelling; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lots of pain on the site radiating from shoulder to hands and swelling on an unspecified date. The outcome of event was unknown. Information on the Lot/Batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pain, Tinnitus
Clinical narrative: headache; dizzy; ringing in her ears for hours -high pitched ring; sore arm where injection was administered; This is a spontaneous report from a contactable nurse (patient).  A 28-year-old female patient (not pregnant) received first dose of bnt162b2 via intramuscular in arm right on 17Dec2020 11:30 at single dose for immunization. The patient medical history was not reported. The patient had no medications, food, or other products allergy history. The patient's concomitant medications were not reported.  The patient reported 8 hours after administration of vaccine, on 17Dec2020 8:00 pm, the patient started to get a headache then dizzy then ringing in her ears for hours -high pitched ring, and sore arm where injection was administered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received in response for reported events. The outcome of the events was recovering. Information on the lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Nervousness
Clinical narrative: complained of "chest tightness" after receiving the vaccine; being nervous; This is a spontaneous report from contactable Pharmacist. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration in 2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient (healthcare worker) received the Pfizer-BioNTech COVID-19 vaccine in 2020 and complained of chest tightness after receiving the vaccine. Chest tightness resolved quickly and the patient attributed it to being nervous. No medical interventions were received and the patient left the observation area without issue. The outcome of the events was resolved in 2020.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: feeling tired; achy; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of two reports. A patient of unspecified age and gender received bnt162b2 (Covid-19 vaccine) , via an unspecified route of administration on 16Dec2020 at single dose for immunization.  The patient's medical history and concomitant medications were not reported. The consumer had two friends who are health care professionals who received the Covid-19 vaccine on 16Dec2020. They just reported feeling tired and achy in Dec2020 to the consumer. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020501305 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: feeling tired; achy; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 2nd of two reports. A patient of unspecified age and gender received bnt162b2 (Covid-19 vaccine) , via an unspecified route of administration on 16Dec2020 at single dose for immunization.  The patient's medical history and concomitant medications were not reported. The consumer had two friends who are health care professionals who received the Covid-19 vaccine on 16Dec2020. They just reported feeling tired and achy in Dec2020 to the consumer. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020501278 same reporter/drug/event, different patient
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Hypoaesthesia, Peripheral swelling, Rash
Clinical narrative: Left arm swelling; rash throughout body; left leg going numb; loss of balance; This is a spontaneous report from a contactable Other healthcare professional reported for herself. A 22-year-old non-pregnant female patient received first dose of bnt162b2 (pfizer-biontech covid 19 vaccine), intramuscularly on left arm on 17Dec2020 at 08:30 at single dose for immunization at workplace clinic. Medical history included known allergies to watermelon, cantaloupe, honey dew, kiwi.  There were no concomitant medications in two weeks nor other vaccine in four weeks. There is no prior covid vaccination nor covid tested post vaccination. The patient experienced left arm swelling, rash throughout body, left leg going numb, loss of balance on 17Dec2020 at 09:15 with outcome of unknown. No treatment was received for the events.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Physician receiving Pfizer BioNTech COViD 19 vaccine experienced sore arm; This is a spontaneous report from a contactable physician (patient) via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration in 2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician receiving pfizer biontech covid 19 vaccine experienced sore arm within 24 hours of receiving vaccination dose in 2020 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nasal congestion
Clinical narrative: Pain in injection site; slight nasal congestion; This is a spontaneous report from contactable Nurse (patient) via Pfizer Sales Representative. A 27-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain in injection site, and slight nasal congestion on an unspecified date with outcome of unknown. Events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Has pain around injection site of COVID vaccine; This is a spontaneous report from a non-contactable Physician. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID vaccine. The patient's medical history and concomitant medications were not reported.  The patient had pain around injection site of COVID vaccine on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: sent to the emergency room for body rashes and hives.; sent to the emergency room for body rashes and hives.; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 4 patients. This is a third of four reports. A patient of an unspecified age and gender received BNT162B2(Solution for injection) via an unspecified route of administration on an unspecified date at single dose for immunization. The medical history included allergies to bee stings. The patient's concomitant medications were not reported. The patient sent to the emergency room for body rashes and hives. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020502532 same reporter, drug, event  different patient
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I got really sick right after it; Initial information received on 26-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).   This case involves a patient of unknown demographics, who was sick right after it (Illness), when received Influenza vaccine.  The patient's past medical treatments and family history were not provided. Patient got the Flu.                                                 It was reported patient sick with flu vaccine (Influenza vaccine) in past.  On an unknown date, the patient received influenza vaccine (batch number and expiry date unknown) via an unknown dose via unknown route at unknown administration site.   On an unknown date, patient was sick (Illness) right after vaccination. The patient stated something else in it is bad because 2 times patient got flu shot, both times got really sick right after it and had not had one since. Even when patient got the flu, it wasn't as bad as those 2 times patient got the vaccine).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: end up getting the flu every time I get the shot; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a patient.  This case involves a patient of unknown age who had flu (influenza), after the patient received Influenza Vaccine.  The patient's medical treatment(s), vaccination(s), concomitant medications and family history were not provided. At the time of the event, the patient had ongoing Autoimmune disorder.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route, administration site and expiry date unknown).    On an unknown date, the patient had flu (influenza), (unknown latency) following the administration of influenza vaccine.   No relevant laboratory test was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Dyspepsia, Influenza, Pyrexia
Clinical narrative: was laid up in bunk with a 102.2 fever; had a touch of the flu; couldnt hold food down; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).   This case involved a patient of unknown demographics who was laid up in bunk with a 102.2 fever (pyrexia), couldn't hold food down (Dyspepsia) and had a touch of the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site.   On an unknown date, 2 days latency, after initiating the suspect drug, the patient was laid up in bunk with a 102.2 fever (pyrexia), could not hold food down (Dyspepsia)  and was told by a base doc that had a touch of the flu (influenza).   Other laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown.  There will be no information available on the batch number for this case.
Age: 1.5
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HEPA
Symptoms: Wrong product administered
Clinical narrative: patient was supposed to receive the DAPTACEL vaccine but was administered PENTACEL/no AE; patient was administered PENTACEL while administering HIB part of the vaccine was only administered and not the DTAP/no AE; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case received from a physician via phone via call Center.  This case involves a 18 months old male patient who was supposed to receive the DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] but was administered a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered) batch number: U6842BA, expiry date: 05-JUN-2021 via an unknown route in unknown administration site for prophylactic vaccination on 17-Nov-2020 while administering Haemophilus influenzae type B vaccine [HIB] part of the vaccine was only administered and not the DIPHTHERIA, TETANUS, AC PERTUSSIS [DTAP] (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered and inappropriate reconstitution technique (latency: same day).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: patient just received two HD Fluzone shots; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00368422) on 23-Nov-2020.     This case involves a 66-year-old male patient just received two FLUZONE HIGH-DOSE QUADRIVALENT (extra dose administered) with no adverse event.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was a potential medication error due to extra dose administered.  On 23-Nov-2020, physician reports that a medical assistant administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ549AB expiration date: 30-Jun-2020 Strength: High-Dose) at a dose of 0.7 mL via an intramuscular route in the right arm to a patient, after she left the room, another medical assistant entered and administered the second dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ549AB expiration date: 30-Jun-2020, Strength: High-Dose) at a dose of 0.7 mL via an intramuscular route in the left arm to the patient (extra dose administered). The patient did not report this until after the second injection was given.  At the time of this report, no adverse event was reported.
Age: 1.17
Sex: M
Vaccine: FLUX, HEP, HEPA, HIBV, IPV, PNC
Symptoms: Expired product administered
Clinical narrative: 14 month old male patient received administered expired dose of IPOL vaccine, no AE; Initial information received on 04-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 month old male patient who was vaccinated with an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 04-Dec-2020, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot P1F491M and expiry date: 30-Nov-2020) via an intramuscular route in the right thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis, Erythema
Clinical narrative: after administering vaccines mom came and got me and left leg  where Pediarix given, was red and inflamed.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pharyngeal swelling
Clinical narrative: Mild throat swelling, not enough to obscure airway, went home and took Benadryl and went to sleep. Symptoms gone post nap (also had fatigue and mailase both gone after nap)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling jittery, Flushing, Palpitations
Clinical narrative: flushed face, shortness of breath, feeling like I was going to pass out, tightness in my throat but could still swallow, had heart palpitations and feeling like my heart was going to come out of my chest.  Those symptoms lasted for about 5-10 minuets and slowly the flushed feeling went away and heart stopped racing after about 10 min. I was very shaky and still had a bit of tightness in my throat.  I left the area out 40min but was still very jittery.  Currently its 1510 and I still have some localized flush feeling in my cheeks and continued jitteriness but am breathing fine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tremor
Clinical narrative: flushed face, shortness of breath, feeling like I was going to pass out, tightness in my throat but could still swallow, had heart palpitations and feeling like my heart was going to come out of my chest.  Those symptoms lasted for about 5-10 minuets and slowly the flushed feeling went away and heart stopped racing after about 10 min. I was very shaky and still had a bit of tightness in my throat.  I left the area out 40min but was still very jittery.  Currently its 1510 and I still have some localized flush feeling in my cheeks and continued jitteriness but am breathing fine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: Fatigue Headache  Pain at injection site
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Painful respiration
Clinical narrative: Approx 5 hours after receiving vaccine, developed an aching sharp pain between my shoulder blades worsening with inspiration,  intermittent mild chills,  and fatigue. Pain between my shoulder blades lasted 4 hours, until i took tylenol and  went to bed.. i woke up 5 hours later and the pain was now a dull ache.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Fibrin D dimer normal, Full blood count normal
Clinical narrative: Chest pain and diffuse, severe myalgias, as well as persistent tachycardia to 110's and hypertension resulting in ER evaluation. No abnormalities found on basic labs and studies. Symptoms started one hour after injection and worsened over the next 24 hours.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Hypertension, Metabolic function test normal, Myalgia, Tachycardia, Troponin normal
Clinical narrative: Chest pain and diffuse, severe myalgias, as well as persistent tachycardia to 110's and hypertension resulting in ER evaluation. No abnormalities found on basic labs and studies. Symptoms started one hour after injection and worsened over the next 24 hours.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pain
Clinical narrative: The evening of the shot, patient reported he had headache and nausea. Next day nausea and Headache continued and also included Body aches, chills, achy joints which lasted for 3 days.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: The evening of the shot, patient reported he had headache and nausea. Next day nausea and Headache continued and also included Body aches, chills, achy joints which lasted for 3 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspepsia, Flushing, Heart rate increased, Hot flush
Clinical narrative: Flushing Hives Nausea Heartburn Throat itching and swelling Hot flash Blood pressure and pulse spiked  All of this happened within 5 minutes of administration. Patient was given benedryl and Pepcid and sent to the Emergency Room.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pharyngeal swelling, Throat irritation, Urticaria
Clinical narrative: Flushing Hives Nausea Heartburn Throat itching and swelling Hot flash Blood pressure and pulse spiked  All of this happened within 5 minutes of administration. Patient was given benedryl and Pepcid and sent to the Emergency Room.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: -Sore injection arm (left) starting at 4pm on day of injection (12/16/20) and resolved on 12/20/20. -Chills starting at 5pm on second day (12/17/20) and resolved on 12/18/20.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injected limb mobility decreased, Pain in extremity, Paraesthesia oral
Clinical narrative: PATIENT REPORTS RECEIVING VACCINATION AT APPROXIMATELY 830AM. SHE WAS BUSY THROUGHOUT THE DAY BUT ONCE SHE RETURNED TO HER OFFICE AROUND 120 PM, SHE STARTED TO NOTICE HER ARM IN WHICH SHE RECEIVED HER VACCINE WAS PAINFUL AND SHE WAS UNABLE TO "LIFT IT UP". SHE ALSO NOTICED HER TONGUE BEGAN TO FEEL "WIERD AND TINGLY". SHE THEN REALIZED HER TONGUE WAS PUSHED UP AGAINST HER TEETH AND COULD SEE A VISIBLE TOOTH MARK ON HER TONGUE. SHE ALSO REPORTS THAT HER BRAIN FELT "FOGGY" DURING THIS TIME". ADDITIONALLY, SHE REPORTS THAT ONSENT OF ALL HER SYMPTOMS PRESENTED PROGRESSIVELY. SHE RECIEVED IM BENADRYL ONSITE PRIOR TO TRANSFER TO THE EMERGENCY ROOM FOR EVALUATION. AT THE EMERGENCY ROOM SHE WAS GIVEN THREE MEDICATIONS, SHE RECALLS ONE WAS A STERIOD AND BELIEVES ATLEAST ONE WAS AN ANTIHISTAMINE. HOWEVER, SHE IS NOT COMPELTELY CERTAIN WHAT THE OTHER MEDICATIONS WERE. SHE REPORTED IMPROVEMENT OF SYMPTOMS WITH MEDICATION. SHE WAS PRESCRIBED BENADRYL AND A MEDROL DOSE PAK AT TIME OF DISCHARGE. SHE WAS NOT ADMITTED TO THE HOSPITAL.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Hypertension
Clinical narrative: headache, dizziness, hypertension,  subjective mild shortness of breath,  BP 160/100 Taken to the ER for evaluation
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: Received COVID-19 vaccine the afternoon on 12-18-2020 on 12-19-2020 developed chest pain and "heart racing" intermittently.  Lasted approximately 1 hour .  Patient did take Nitroglycerin  2 times .
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Flushing, Hypoaesthesia, Pruritus, Sensory disturbance
Clinical narrative: Per documentation of other RNs invloved, at 1009, patient began reporting sensation of numbness in right arm and "feeling funny", she also presented with visible flushing and reported itching and feeling anxious.  We monitored the patient's vital signs q5min and administered 25mg Benadryl IM.  Over the course of aproximately 1.5 hours, the patient's flushing had visibly diminished, she reported significant improvement in her anxiety and stated that the itching was "nearly resolved."  Her vital signs also improved and were WNL, including pulse, O2 saturation, temperature and blood pressure.  The patient stated that she felt well enough to return to work and verbalized understanding that if any symptoms develped or worsened she was to report immediatley to the ED.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Injection site pain
Clinical narrative: Injection site pain, malaise, fatigue decreased appetite, chills, joint pain
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Injection site pain, malaise, fatigue decreased appetite, chills, joint pain
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: transient dizziness, history of dizziness with piercings and shots
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: Staff reported numbness, tingling and heat all the way down her left arm.  She was sent to ER for further evaluation and monitoring.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, headache, body aches, arm pain for two days at site of injection. Approaching 72 hours with fever.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chest X-ray normal, Chest discomfort, Discomfort, Dizziness
Clinical narrative: Patient woke up 3 am next morning and felt like she couldn't move limbs hardly at all and "felt like a boulder sitting on my chest".  She also felt nauseous, dizzy and a headache.   By 5 am the "heaviness" of her limbs and her chest and throat felt so heavy patient was scared and was transported to ED by her husband.  ED physician didn't think it was an anaphylactic reaction, but just thought it was an extreme adverse reaction. EKG, labs including Cardiac enzymes, and chest xray were all normal.  Given IV benadryl, IV zofran, Aspirin,  tylenol and norflex.  during ED visit.  Discharged from ED 10:30 am.   Took Benadryl and Solumedrol dose pack once home.  by Saturday patient felt 95% better, but as of this report, still says arms still feel heavy and she is fatigued.  Went back to work today.