chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: GI uncomfortable; Diarrhea; This is a spontaneous report from a non-contactable Other HCP (Patient). A 47-year-old non-pregnant female patient received first dose BNT162B2 (COMIRNATY, Solution for injection, lot number: Unknown, Expiration date: Unknown), via unknown route of administration in the right arm on 15Jan2021 at 12:00 as single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. Other medications taken within two weeks before the event onset reported as None. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 19Jan2021 the patient experienced Diarrhea and GI uncomfortable. No treatment was taken regarding the events. Patient was not affected prior to vaccination and no covid test was taken post vaccination. The outcome of the events was recovered.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Body aches; Fever; Body is very sore; joints are sore; Headache is very strong; This is a spontaneous report from contactable consumer. A 73-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 03Feb2021 as single dose for covid-19 immunisation. Patients Medical history included High blood pressure. Patients concomitant medications were not reported. Historical vaccine included BNT162B2 (dose 1) as single dose for covid-19 immunisation. On 03Feb2021 within 10 hours of vaccination, patient got really chills, had body aches and fever all night, had Body sore and joints sore and strong headache. Patient reported she got her second vaccine yesterday (03Feb2021) morning and starting like around 11 last night, she started getting really chills and was having body aches and fever all night and my body is very sore, you know all my joints are sore and have like my headache is very strong. Patient was not received any treatment for the events hence patient wants to know if she could take acetaminophen for the events. Patient had not yet recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Fatigue
Clinical narrative: Tired; Pain in left side of her neck; Pain in left shoulder; Hurt all over; Chills; Feel like she has the flu; Fever; Pain in lower back; This is a spontaneous report from a contactable consumer. This 85-year-old female consumer reported for herself that she received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; lot number: EN3318; Expiry date: Unknown) via an unknown route of administration in the right shoulder on 01Feb2021 (Monday) as a single dose for COVID-19 immunization.  The patients past medical history includes the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine) and patient did not have any side effects at all with the first one. The concomitant medications were not reported.   The patient was okay on Monday. On 02Feb2021 (Tuesday), at 13:00 the patient developed hurt all over, chills, feel like she has the flu, fever. at 18:00, the patient experienced pain in lower back, pain in left shoulder and pain in left side of her neck. On an unknown date, the patient was reportedly  tired. The patient did not receive any treatment. On unknown dates, the body temperature was 101.5 (Tuesday), 99.7 (Wednesday) and 99.0 Degree Centigrade today. The patient has lasting effects of still feeling achy and tired. has lasting effects that she is hurting in her lower back and neck and shoulders now. Later clarified that she is hurting only in her left shoulder. The patient was recovering from the events of hurt all over, feel like she has the flu was recovering. On 02Feb2021, chills recovered. On 04Feb2021, recovered from fever and had not recovered from the events of  pain in lower back and pain in left side of her neck, pain in left shoulder and tired. The patient did not take any other products.  The patient recently had the second dose of the Pfizer vaccine on Monday and does not know how long the bad effects last or what she should do. On Tuesday that she hurt all over, had chills and felt like she had the flu and she was only sick once in her lifetime and that she only had the flu in her early 30s. The patient reported that she was up and about but has a lot of pain in her lower back and the left side of her neck and shoulders she does not feel overall real good. She is a farm girl and knows how to get around. Stated that her daughter saw online not to take Tylenol or anything like that and wanted to know if that is correct.  Occupation/specialty, consent to contact, and email address not provided. The patient did not visit Emergency Room or Physician Office. The patient did not receive any vaccines (within 4 weeks) prior to the first administration date of the suspect vaccines.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Neck pain, Pain, Pyrexia
Clinical narrative: Tired; Pain in left side of her neck; Pain in left shoulder; Hurt all over; Chills; Feel like she has the flu; Fever; Pain in lower back; This is a spontaneous report from a contactable consumer. This 85-year-old female consumer reported for herself that she received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; lot number: EN3318; Expiry date: Unknown) via an unknown route of administration in the right shoulder on 01Feb2021 (Monday) as a single dose for COVID-19 immunization.  The patients past medical history includes the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine) and patient did not have any side effects at all with the first one. The concomitant medications were not reported.   The patient was okay on Monday. On 02Feb2021 (Tuesday), at 13:00 the patient developed hurt all over, chills, feel like she has the flu, fever. at 18:00, the patient experienced pain in lower back, pain in left shoulder and pain in left side of her neck. On an unknown date, the patient was reportedly  tired. The patient did not receive any treatment. On unknown dates, the body temperature was 101.5 (Tuesday), 99.7 (Wednesday) and 99.0 Degree Centigrade today. The patient has lasting effects of still feeling achy and tired. has lasting effects that she is hurting in her lower back and neck and shoulders now. Later clarified that she is hurting only in her left shoulder. The patient was recovering from the events of hurt all over, feel like she has the flu was recovering. On 02Feb2021, chills recovered. On 04Feb2021, recovered from fever and had not recovered from the events of  pain in lower back and pain in left side of her neck, pain in left shoulder and tired. The patient did not take any other products.  The patient recently had the second dose of the Pfizer vaccine on Monday and does not know how long the bad effects last or what she should do. On Tuesday that she hurt all over, had chills and felt like she had the flu and she was only sick once in her lifetime and that she only had the flu in her early 30s. The patient reported that she was up and about but has a lot of pain in her lower back and the left side of her neck and shoulders she does not feel overall real good. She is a farm girl and knows how to get around. Stated that her daughter saw online not to take Tylenol or anything like that and wanted to know if that is correct.  Occupation/specialty, consent to contact, and email address not provided. The patient did not visit Emergency Room or Physician Office. The patient did not receive any vaccines (within 4 weeks) prior to the first administration date of the suspect vaccines.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (Patient). A 88-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3248, Expiry Date: unknown) via an unspecified route of administration at left arm on 04Feb2021 10:15 as single dose and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 14Jan2021 as single dose for COVID 19 immunization. Medical history included history of migraines. Concomitant medication was not reported. Patient experienced headache on 04Feb2021. It was reported that she has had migraines in the past, so it is possible that this could be one of those, but she has not had one quite this long. She started having these about 10 years ago. She says she cannot claim that the headache or migraine has to do with the shot, since sometimes she has migraines, since this happens to her, she is not claiming that the vaccine caused it. Patient experienced terrific shooting pains in her head except for a little time. She says that she has been taking Tylenol, and she is still experiencing them all night. She says that this was her second dose of the vaccine, she had no reaction to the first, not even a sore arm. She initially provides PF12ER as LOT for her first dose she received on 14Jan2021. She says that her Tylenol is finally kicking in, she feels a lot better, she might go sleep it off. She clarifies that she has been taking Tylenol PM from a great big bottle, that she cannot read fine print, it is huge green bluish aqua colored. She says the dose is 500mg, it was very effective at 04:30AM to 08:30AM, and she took it again about 11:00AM. She says she is just now having another shooting pain in her upper right head. Tylenol PM UPC Queried but not provided. LOT: SJA051, EXP: Apr2022. Outcome of the event was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is first of 2 reports. A 67-year-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: EL9265, Expiry Date: Unknown) intramuscular in left arm on 07Feb2021 as a single dose for COVID-19 immunization. Medical history included ongoing Lupus. She stated that it was a mild form of it. She said that she was diagnosed in the 1990's, around 1996, but she knows that she has had it since she was a kid. Patient also had a cancer (from Nov2012 to Jan2013) and underwent a surgery to remove the cancer. She had a Lumpectomy. Patient was not taking other products. Caller was a consumer that was calling about Covid-19 vaccine and said that she had a question about a side effect she was having. The caller said that she noticed the tingling the day of the injection in the evening on 07Feb2021. She was having tingling in her calf down to the bottom of her foot but stated that it is mostly on the bottom of her foot and just on the left foot. Caller stated that she felt like it was going to sleep. Caller wanted to know was this a known side effect. She did not know if it was common or not. Caller reported that her husband (age 66) experienced tingling too, but not sure what area. Her daughter knew of someone who had the tingling as well, she was much older (84-year-old). Caller stated that she was transferred from another department that obtained her symptom information, Pfizer COVID-19 vaccine's lot number and her age. Offered to transfer call back but caller refused.   There was no one present. Outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021203719 same reporter/drug/AE with different patient
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Investigation, Pain in extremity, Skin discolouration
Clinical narrative: skin on her left hand is darker/My left hand is darker than my right hand; the skin color is darker; feeling tired; sore arm; headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 70-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Batch/Lot Number: EL3302) as SINGLE DOSE for covid-19 immunisation. There was scheduled to receive the second vaccine on the 26Feb. The patients medical history and concomitant medications were not reported.  She received the first injection in her left arm and had noticed skin on her left hand is darker than my right hand, feeling tired, sore arm, headache  on an unspecified date. Her hand did not hurt of feel different, but the color was visibly darker. The patient underwent lab tests and procedures however the results were not reported as the patient could not visit the doctor due to bad weather.  Therapeutic measures was taken in response to the event. The patient put some lotion hoping the color might come back. The outcome of the events were unknown.  No follow-up attempts possible. No information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: she felt "very bad, weak, tired; muscle pain on her back; she felt "very bad, weak, tired; she felt "very bad, weak, tired; congested like sinusitis; nausea; dizzy; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 07Feb2021 as single dose for covid-19 immunization.  Medical history included covid-19 from an unknown date. She had COVID-19 "three or four" weeks before the vaccine. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced she felt "very bad, weak, tired (fatigue), muscle pain on her back, congested like sinusitis, nausea, dizzy. The outcome of the events very bad, weak, tired, was unknown; muscle pain on her back was recovered; congested like sinusitis, nausea, dizzy was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea
Clinical narrative: she felt "very bad, weak, tired; muscle pain on her back; she felt "very bad, weak, tired; she felt "very bad, weak, tired; congested like sinusitis; nausea; dizzy; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 07Feb2021 as single dose for covid-19 immunization.  Medical history included covid-19 from an unknown date. She had COVID-19 "three or four" weeks before the vaccine. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced she felt "very bad, weak, tired (fatigue), muscle pain on her back, congested like sinusitis, nausea, dizzy. The outcome of the events very bad, weak, tired, was unknown; muscle pain on her back was recovered; congested like sinusitis, nausea, dizzy was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: my arm was very itchy for 3-4 days/Itchy on arm where she bends her elbow; Arm soreness is in left arm, which received the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 74-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9265, expiration date not reported) via an unspecified route of administration in left arm on 11Feb2021 around 11:00 am (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included patient was allergic to Ibuprofen and gets swollen eyes. Can't take any medications with Ibuprofen in it. Hasn't taken Ibuprofen in years. Has no NDC/Lot/Exp to provide. Patient had no family medical history. Patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines were administered on same date of Pfizer suspect. Reportedly, there were no other products. No investigation assessment. There were no relevant tests. On 11Feb2021, patient experienced arm soreness is in left arm, which received the COVID-19 Vaccine and on 12Feb2021, started itching where she bends her arm across her elbow about six inches. Had no rash. Was very itchy that day and then it decreased a little. Itching went on for three to four days. Patient was little better in the morning. It was very itchy. Wants to know if that is an allergic reaction. Patient was scheduled for second dose on 03Mar2021, but she doesn't want to get the second COVID-19 Vaccine. Heard all sorts of stories. Patient asked how much she is protected if she just received one shot. Patient asked if you get a reaction can you take Benadryl after getting the vaccine. Patient also asked for his son who has a Penicillin allergy. He was supposed to get his first vaccine tomorrow. He is 45, is it ok to get the vaccine. No further details provided. The case was reported as non-serious. There was no PQC present. Patient was recovered from itching on 16Feb2021 and was recovering from arm soreness.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: 1st dose I had head to toe itching; This is a spontaneous report from a contactable Other HCP (herself). A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number/Expiration date: UNKNOWN) via an unspecified route of administration, in the left Arm on 17Dec2020 14:00 as single dose for covid-19 immunisation. Medical history included covid-19 (COVID prior vaccination) and concomitant medication included duloxetine (DULOXETINE)(MANUFACTURER UNKNOWN); hydroxyzine hydrochloride (HYDROXIZINE) (MANUFACTURER UNKNOWN); bupropion hydrochloride (WELLBUTRIN) )(MANUFACTURER UNKNOWN). On an unknown date the patient had head to toe itching. Patient reported that all progress she made with taste and smell, was disappeared after the vaccine.The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: redness; pain; This is a spontaneous report from a contactable nurse via Pfizer-sponsored program. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced redness and pain after getting the vaccine and asking if they can use Benadryl. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore from vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Feb2021 as single dose for COVID-19 immunization. Patient was 76 years old at the time of vaccination. Patient medical his-tory and concomitant medications were not reported. On 05Feb2021 the patient experienced arm was sore from vaccine. Outcome of the event was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Asthenia, Body temperature, Chest X-ray
Clinical narrative: difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his wheelchair; she has been taking his temperature; no energy; can't walk; very thirsty; extremities he complains are cold even though they are not and he is feeling pain in them; dry heaves; pain and bloating in his stomach; pain and bloating in his stomach; his extremities felt cold; shivering; night sweats; wasn't eating or drinking/Has not been able to eat; This is a follow-up spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer. A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), Lot number was not reported), via an unspecified route of administration on 02Feb2021 (at the age of 81-year-old) as single dose for COVID-19 immunization.Medical history included Transverse Myelitis which is a virus of the spinal cord (from age of 11 yr), wheelchair user, difficulty walking (from the transverse myelitis). Reporter and her husband both received the first Pfizer Covid vaccine on 02Feb2021.The patient's concomitant medications were not reported. On11Feb2021, patient experienced dry heaves, pain and bloating in his stomach, his extremities felt cold and he was shivering, had night sweats and wasn't eating or drinking. He has been feeling progressively worse since Feb 11th, but she stated she has been taking his temperature and he did not had a fever but had been very thirsty. He had not been able to walk the last couple of days and had to use his wheelchair. Last night on 10Feb2021, he probably drank gallons of water due to his excessive thirst. His doctor told him to take acetaminophen and ibuprofen, which he did, but it didn't help. His symptoms have progressed such that the reporter dropped her husband off at the ER today. Reporter stated that he now did have a fever and is awaiting results of a chest x-ray and lab work (performed on 16Feb2021). He was having difficulty breathing, but his oxygen levels were normal. Reporter read online about two people in (city) developed transverse myelitis after receiving a Covid vaccine, but she was not sure which vaccine they received. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The patient Is currently in the emergency Room and has not been able to eat for 5 days. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Eating disorder, Gait disturbance, Laboratory test
Clinical narrative: difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his wheelchair; she has been taking his temperature; no energy; can't walk; very thirsty; extremities he complains are cold even though they are not and he is feeling pain in them; dry heaves; pain and bloating in his stomach; pain and bloating in his stomach; his extremities felt cold; shivering; night sweats; wasn't eating or drinking/Has not been able to eat; This is a follow-up spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer. A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), Lot number was not reported), via an unspecified route of administration on 02Feb2021 (at the age of 81-year-old) as single dose for COVID-19 immunization.Medical history included Transverse Myelitis which is a virus of the spinal cord (from age of 11 yr), wheelchair user, difficulty walking (from the transverse myelitis). Reporter and her husband both received the first Pfizer Covid vaccine on 02Feb2021.The patient's concomitant medications were not reported. On11Feb2021, patient experienced dry heaves, pain and bloating in his stomach, his extremities felt cold and he was shivering, had night sweats and wasn't eating or drinking. He has been feeling progressively worse since Feb 11th, but she stated she has been taking his temperature and he did not had a fever but had been very thirsty. He had not been able to walk the last couple of days and had to use his wheelchair. Last night on 10Feb2021, he probably drank gallons of water due to his excessive thirst. His doctor told him to take acetaminophen and ibuprofen, which he did, but it didn't help. His symptoms have progressed such that the reporter dropped her husband off at the ER today. Reporter stated that he now did have a fever and is awaiting results of a chest x-ray and lab work (performed on 16Feb2021). He was having difficulty breathing, but his oxygen levels were normal. Reporter read online about two people in (city) developed transverse myelitis after receiving a Covid vaccine, but she was not sure which vaccine they received. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The patient Is currently in the emergency Room and has not been able to eat for 5 days. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Oxygen consumption, Pain in extremity, Peripheral coldness, Retching
Clinical narrative: difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his wheelchair; she has been taking his temperature; no energy; can't walk; very thirsty; extremities he complains are cold even though they are not and he is feeling pain in them; dry heaves; pain and bloating in his stomach; pain and bloating in his stomach; his extremities felt cold; shivering; night sweats; wasn't eating or drinking/Has not been able to eat; This is a follow-up spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer. A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), Lot number was not reported), via an unspecified route of administration on 02Feb2021 (at the age of 81-year-old) as single dose for COVID-19 immunization.Medical history included Transverse Myelitis which is a virus of the spinal cord (from age of 11 yr), wheelchair user, difficulty walking (from the transverse myelitis). Reporter and her husband both received the first Pfizer Covid vaccine on 02Feb2021.The patient's concomitant medications were not reported. On11Feb2021, patient experienced dry heaves, pain and bloating in his stomach, his extremities felt cold and he was shivering, had night sweats and wasn't eating or drinking. He has been feeling progressively worse since Feb 11th, but she stated she has been taking his temperature and he did not had a fever but had been very thirsty. He had not been able to walk the last couple of days and had to use his wheelchair. Last night on 10Feb2021, he probably drank gallons of water due to his excessive thirst. His doctor told him to take acetaminophen and ibuprofen, which he did, but it didn't help. His symptoms have progressed such that the reporter dropped her husband off at the ER today. Reporter stated that he now did have a fever and is awaiting results of a chest x-ray and lab work (performed on 16Feb2021). He was having difficulty breathing, but his oxygen levels were normal. Reporter read online about two people in (city) developed transverse myelitis after receiving a Covid vaccine, but she was not sure which vaccine they received. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The patient Is currently in the emergency Room and has not been able to eat for 5 days. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst, Walking aid user
Clinical narrative: difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his wheelchair; she has been taking his temperature; no energy; can't walk; very thirsty; extremities he complains are cold even though they are not and he is feeling pain in them; dry heaves; pain and bloating in his stomach; pain and bloating in his stomach; his extremities felt cold; shivering; night sweats; wasn't eating or drinking/Has not been able to eat; This is a follow-up spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer. A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), Lot number was not reported), via an unspecified route of administration on 02Feb2021 (at the age of 81-year-old) as single dose for COVID-19 immunization.Medical history included Transverse Myelitis which is a virus of the spinal cord (from age of 11 yr), wheelchair user, difficulty walking (from the transverse myelitis). Reporter and her husband both received the first Pfizer Covid vaccine on 02Feb2021.The patient's concomitant medications were not reported. On11Feb2021, patient experienced dry heaves, pain and bloating in his stomach, his extremities felt cold and he was shivering, had night sweats and wasn't eating or drinking. He has been feeling progressively worse since Feb 11th, but she stated she has been taking his temperature and he did not had a fever but had been very thirsty. He had not been able to walk the last couple of days and had to use his wheelchair. Last night on 10Feb2021, he probably drank gallons of water due to his excessive thirst. His doctor told him to take acetaminophen and ibuprofen, which he did, but it didn't help. His symptoms have progressed such that the reporter dropped her husband off at the ER today. Reporter stated that he now did have a fever and is awaiting results of a chest x-ray and lab work (performed on 16Feb2021). He was having difficulty breathing, but his oxygen levels were normal. Reporter read online about two people in (city) developed transverse myelitis after receiving a Covid vaccine, but she was not sure which vaccine they received. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The patient Is currently in the emergency Room and has not been able to eat for 5 days. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, SARS-CoV-2 antibody test
Clinical narrative: Severe low back pain; slight headache; The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (29Mar2021), this case now contains all required information to be considered valid.  This is spontaneous report from contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EN6201) via intramuscular route at left upper arm on 06Feb2021 at 13:15 as single dose for COVID-19 immunization. Patient medical history included ongoing Osteoarthritis, Ongoing Knee surgery Back, hips, and neck on Jun2020, Stroke on Jun2017. patient family history included: Stroke and COPD (mother), Lung cancer and COPD Mezolthezmalona (Father), Stroke (Grandmother). patient concomitant medication included Tylenol arthritis orally for Joint pain, Premarin 45 mg tablet orally for Hormone replacement, AREDS 2 eye vitamin orally for Eye health, Orphenadrine orally for Muscle relaxation, Women's Multivitamin orally for Health. On 06Feb2021 18:00 the patient experienced slight headache, on 08Feb2021 Severe low back pain. No treatment received. Seriousness criteria: Persistent/significant for Severe low back pain and Not serious for slight headache. The patient underwent lab tests and procedures which included Mar2020 and Dec2020 Covid-19 Result: Negative. The outcome of event was recovered on 13Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, X-ray
Clinical narrative: if it is okay to get the first dose of Covid-19 Vaccine if her husband had an x-ray test which was used with dye for the procedure two weeks ago; This case has been considered invalid as there is no indication that the consumer experienced an event under suspect vaccine BNT162B2.  This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient(husband) that:   Is the Reporter a Healthcare Professional (HCP)? No ; Occupation/Specialty: Unknown Is the reporter's contact information available to you or a sub-contracted party? Unknown  Is the reporter the prescribing HCP? No  Suspect Product(s): Pfizer Covid 19 Vaccine  Start Date: 11Feb2021   Verbatim and Event Description:  Caller is asking if it is okay to get the first dose of Covid-19 Vaccine if her husband had an x-ray test which was used with dye for the procedure two weeks ago and she on the other hand is taking blood pressure and cholesterol medications.  Information on the lot batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nasal congestion, Pain, Rhinorrhoea
Clinical narrative: joint pain; tired; congestion; body aches; Runny nose; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old male patient received first dose of BNT162B2 (Pfizer Covid Vaccine, solution for injection, Lot# unknown), via an unspecified route of administration, administered in left arm on 02Feb2021 at 14:00 (at the age of 51 years-old) as single dose for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 03Feb2021 at 14:00, patient experienced joint pain, tired, congestion, body aches, runny nose. The patient had no known allergies. The outcome of all the events was recovering.  Information on Lot/Batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swelling of lip; This is a spontaneous report from a contactable physician (patient). A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 26Jan2021 10:00 (Batch: EJ1685; Lot Number: EL3248; expiry: not reported) as single dose for covid-19 immunisation at hospital (at the age of 40 years). Medical history was none. The patient concomitant medications were not reported. No predisposing factor and no culture performed and no antipyretic use (around the date of Vaccination). On 26Jan2021 10:00, the patient experienced swelling of lip occurred after second dose. The patient also stated that the no action was taken for adverse event (no therapeutic measures were done) and reaction recurred on re-administration of product. The outcome of event was unknown.  Pfizer product had a causal effect to the adverse event (Causal Relationship): Yes
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Severe chills; mild headache; Arm and pain all over; Arm and pain all over; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and expiration date: not provided) in arm left on 16Feb2021, 07:30 AM as a single dose for COVID-19 immunisation. Patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date: not provided), via an unspecified route of administration in arm left on 26Jan2021, 07:30 AM as a single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that patient had experienced arm and pain all over, severe chills and mild headache on 16Feb2021, 08:00 PM. No treatment received for the events. Outcome of the events were recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: side effects from second dose included chills, fatigue, muscle aches; fatigue; muscle aches; This is a spontaneous report from a contactable consumer. This 33-year-old female consumer reported that the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number: EL3247), via an unspecified route of administration in left arm on 16Feb2021 11:00 (Age at vaccination: 33-year-old). Patient previously received first dose of BNT162B2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT number: EL3247) via an unspecified route of administration in left arm on 26Jan2021 11:00 (Age at vaccination: 33-year-old). The patient concomitantly received parenteral vitamins in two weeks. The patient does not have any known allergies.The patient was not tested positive either before or after vaccination. After receiving the second dose the patient had chills, fatigue, and muscle aches on 16Feb2021 23.00. The outcome of these events was reported as recovered.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen supraclavicular lymph node on left side (same side as injection). Started 24 hours after the 2nd dose. Now at 2 weeks it is still swollen and one other lymph node in same region is also swollen. Going to clinic in two days to get checked out.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Hard, 3 inch round, red lump at injection site. Painful, tender., slightly itchy.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Deep vein thrombosis, Dyspnoea, Fatigue, Haemoptysis
Clinical narrative: Lt lower leg DVT and multiple b/l pulmonary emboli.  Second vaccination given 2-25-21. Shortness of breath and fatigue started about 3-15-21. Severe dyspnea and hemoptysis started 3-25-21 resulting in EMS transport, hospitalization, IVC umbrella filter and Xarelto.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Ultrasound Doppler abnormal
Clinical narrative: Lt lower leg DVT and multiple b/l pulmonary emboli.  Second vaccination given 2-25-21. Shortness of breath and fatigue started about 3-15-21. Severe dyspnea and hemoptysis started 3-25-21 resulting in EMS transport, hospitalization, IVC umbrella filter and Xarelto.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Dizziness, Dyspnoea, Dyspnoea exertional, Echocardiogram
Clinical narrative: Lt lower leg DVT and multiple b/l pulmonary emboli.  Second vaccination given 2-25-21. Shortness of breath and fatigue started about 3-15-21. Severe dyspnea and hemoptysis started 3-25-21 resulting in EMS transport, hospitalization, IVC umbrella filter and Xarelto.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Ultrasound scan
Clinical narrative: Lt lower leg DVT and multiple b/l pulmonary emboli.  Second vaccination given 2-25-21. Shortness of breath and fatigue started about 3-15-21. Severe dyspnea and hemoptysis started 3-25-21 resulting in EMS transport, hospitalization, IVC umbrella filter and Xarelto.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Fatigue, Injection site pain, Tinnitus
Clinical narrative: On April 15th all day starting around 10:00am: 1) Fatigue, continued all day 2) Ear fullness, ringing, my tinnitus was loud all day, ended before next day 3) Mild injection site pain, all day On April 16th: 1)  fatigue, which ended by next day 2) Mild injection site pain, all day, ended by next day
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Fever 101.6, extreme fatigue, nausea, lack of appetite, headache, chills. Lasted approximately 24 hours. Onset was 7 days post vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 101.6, extreme fatigue, nausea, lack of appetite, headache, chills. Lasted approximately 24 hours. Onset was 7 days post vaccine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Hot flush
Clinical narrative: Swelling at injection site Soreness at injection site Very bad headache from 9:30 - 18:30 Fever from 9:30 - 18:30 Roaming joint pain 11:00 - 18:30 Kidney pain 13:00 - 18:30 Teeth ache 15:00 - 16:30 Hot flashes intermittent  Extreme fatigue  I took Tylenol and Aleve at separate times and neither worked until I doubled the recommended dosage of Aleve.   I had to miss work in order to allow my body to recover.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Injection site pain, Injection site swelling, Pyrexia, Toothache
Clinical narrative: Swelling at injection site Soreness at injection site Very bad headache from 9:30 - 18:30 Fever from 9:30 - 18:30 Roaming joint pain 11:00 - 18:30 Kidney pain 13:00 - 18:30 Teeth ache 15:00 - 16:30 Hot flashes intermittent  Extreme fatigue  I took Tylenol and Aleve at separate times and neither worked until I doubled the recommended dosage of Aleve.   I had to miss work in order to allow my body to recover.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling, Rash
Clinical narrative: Bruise and bump on inner elbow of left arm (shot was upper right arm) and slight rash near bruising.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual bleeding started just next day after vaccination, which is 15th day of my cycle
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: Left eye bleeding 9:30AM 4/24/2021 Noticed blood in eye, no pain, realized it was bleeding
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Pharyngeal swelling
Clinical narrative: Within 5 minutes of receiving the vaccine the glands in my throat started to swell, which caused me to panic.  It felt like my throat was tightening and I got an overwhelming feeling a dread; My heart started beating very fast; This is a spontaneous report from a contactable consumer.   A 53-year-old (non-pregnant) female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9809, Expiration Date: 01Jun2021), via intramuscular route, administered in Arm Left on 13Feb2020 14:00 (Age at vaccination is 53-year-old) as SINGLE DOSE for covid-19 immunisation. Medical history included cystitis interstitial. Concomitant medications included pentosan polysulfate sodium (ELMIRON), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (Other medications in two weeks: Elmiron, Zyrtec). Patient received sulfamethoxazole W-Trimethoprim, Methylergonovine, Methylparaben, Propylparaben, Zoloft and Nitrofurantoin, previously and experienced allergy. Patient not received other vaccine in four weeks. Within 5 minutes of receiving the vaccine the glands in my throat started to swell, which caused me to panic. It felt like my throat was tightening and I got an overwhelming feeling a dread. Patient heart started beating very fast at which point she started practicing some relaxing breathing techniques. A doctor at the sight came over to check on her and told me to take a Benadryl. Patient drank a glass of cold water and waited around for 15 more minutes. The glands in my throat stayed swollen for a good 24-36 hours afterwards. Patient not received COVID prior vaccination. Patient not COVID tested post vaccination. At the time of this report event outcome was recovered on an unknown date in 2021.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swelling
Clinical narrative: Within 5 minutes of receiving the vaccine the glands in my throat started to swell, which caused me to panic.  It felt like my throat was tightening and I got an overwhelming feeling a dread; My heart started beating very fast; This is a spontaneous report from a contactable consumer.   A 53-year-old (non-pregnant) female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9809, Expiration Date: 01Jun2021), via intramuscular route, administered in Arm Left on 13Feb2020 14:00 (Age at vaccination is 53-year-old) as SINGLE DOSE for covid-19 immunisation. Medical history included cystitis interstitial. Concomitant medications included pentosan polysulfate sodium (ELMIRON), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (Other medications in two weeks: Elmiron, Zyrtec). Patient received sulfamethoxazole W-Trimethoprim, Methylergonovine, Methylparaben, Propylparaben, Zoloft and Nitrofurantoin, previously and experienced allergy. Patient not received other vaccine in four weeks. Within 5 minutes of receiving the vaccine the glands in my throat started to swell, which caused me to panic. It felt like my throat was tightening and I got an overwhelming feeling a dread. Patient heart started beating very fast at which point she started practicing some relaxing breathing techniques. A doctor at the sight came over to check on her and told me to take a Benadryl. Patient drank a glass of cold water and waited around for 15 more minutes. The glands in my throat stayed swollen for a good 24-36 hours afterwards. Patient not received COVID prior vaccination. Patient not COVID tested post vaccination. At the time of this report event outcome was recovered on an unknown date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Throat irritation
Clinical narrative: mild itchy sore throat; mild itchy sore throat; This is a spontaneous report from a contactable physician (patient) via medical information team. A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration on 11Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that she was fine and experienced nothing but a mild itchy sore throat. She reported that most of her symptoms were resolved. The reporter wanted to know that if it will fine for her to receive the second dose and what are the chances that she will experience the same symptoms. No one was present. She was scheduled for second dose on 04Mar2021 at the mall. The outcome of the events was unknown.