chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: Unable to eat; very tired; unable to get out; feeling so bad; Sleeping a lot; Aching; very weak; This is a spontaneous report from a contactable consumer or other non hcp.   A elderly female patient received bnt162b2 (BNT162B2 Solution for solution), via an unspecified route of administration on 08Mar2021 12:30 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included clindamycin taken for an unspecified indication, start and stop date were not reported; meloxicam taken for an unspecified indication, start and stop date were not reported; metformin hcl taken for an unspecified indication, start and stop date were not reported. The patient experienced unable to eat, very tired, unable to get out, feeling so bad, sleeping a lot, aching and very weak.  The not received any treatment for the events. The outcome of the events was resolved.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: nausea; vomiting; extreme fatigue; aches; fever; diarrhea; extremely painful muscle aches; malaise; This is a spontaneous report received from a contactable other healthcare professional (patient). A 56-years-old nonpregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200) intramuscular, administered in Arm Left in Feb2021 14:30 (age at vaccination 56-years-old) as single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medication(s) included levothyroxine, multivitamin [vitamins nos], famotidine (PEPCID AC), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Exactly 7 days after vaccine, in Mar2021 the patient developed nausea/vomiting, extreme fatigue, aches. Lasted 4 days then started feeling better. 3 days later got fever, nausea, some vomiting & diarrhea, extremely painful muscle aches, fatigue, malaise. The patient had these symptoms for 7 days now and still with fever 99-103.5 fahrenheit.The symptoms come in waves, different from any other flu symptoms she had ever had & feel extreme. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. Since the vaccination, the patient had been tested for COVID-19. The patient underwent covid test type post vaccination: Nasal Swab on 12Mar2021 which was negative. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: nausea; vomiting; extreme fatigue; aches; fever; diarrhea; extremely painful muscle aches; malaise; This is a spontaneous report received from a contactable other healthcare professional (patient). A 56-years-old nonpregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200) intramuscular, administered in Arm Left in Feb2021 14:30 (age at vaccination 56-years-old) as single dose for COVID-19 immunisation. Medical history included hypothyroid. Concomitant medication(s) included levothyroxine, multivitamin [vitamins nos], famotidine (PEPCID AC), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Exactly 7 days after vaccine, in Mar2021 the patient developed nausea/vomiting, extreme fatigue, aches. Lasted 4 days then started feeling better. 3 days later got fever, nausea, some vomiting & diarrhea, extremely painful muscle aches, fatigue, malaise. The patient had these symptoms for 7 days now and still with fever 99-103.5 fahrenheit.The symptoms come in waves, different from any other flu symptoms she had ever had & feel extreme. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. Since the vaccination, the patient had been tested for COVID-19. The patient underwent covid test type post vaccination: Nasal Swab on 12Mar2021 which was negative. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heart rate of 91 two hours after receiving 1st dose of vaccine.; This is a spontaneous report from a contactable consumer (Patient) or other non-healthcare professional. A 70-year-old non-pregnant female patient received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, in Right Arm on 05Mar2021 at 11:00 (at the age of 70-year-old) as DOSE1, SINGLE for covid-19 immunisation. The patient medical history included drug hypersensitivity (Known allergies: Sulfa), high blood pressure and renal cancer stage iii (Verbatim: 3rd Stage Kidney Disease). The patient concomitant medications were not reported. The patient was not diagnosed with covid-19, prior vaccination and the patient had not been tested covid-19, post vaccination. The patient did not receive other vaccines within four weeks and did not receive other medications in two weeks of vaccination. On 05Mar2021 at11:00, the patient experienced rapid heart rate of 91 two hours after receiving 1st dose of vaccine. The Patient taken 5 mg Bystolic (a beta blocker) as a treatment. Therapeutic measures were taken as a result of rapid heart rate of 91 two hours after receiving 1st dose of vaccine. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered on an unspecified date.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Arthralgia
Clinical narrative: I got a little ache and pain in my left knee area; She was very agitated; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 27Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got a little ache and pain in her left knee area and she was very agitated on an unspecified date. It was reported that, patient was due for her 2nd shot on 22Mar2021 and she did not know what to do. Reported seriousness was non-serious. She did not know which COVID vaccine she received. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: itching sporadically all over her body/it was on her foot, then shoulder, then knee, then back, then face/It was like spot itch; rash with welts on her chest; The caller arm is sore; rash with welts on her chest; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) dose 2, via an unspecified route of administration on 14Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She received the 2nd dose of the Pfizer covid vaccine 14Mar2021 (yesterday.) On 15Mar2021, she woke up in the middle of the night with itching sporadically all over her body, but not at the same time. At one point it was on her foot, then shoulder, then knee, then back, then face. She was still experiencing that. It was like spot itch. One time the itch was in-between the toes, then on her face, then on her stomach, it kept changing all over her body. She now has a rash with welts on her chest. Her arm was sore. She wanted to know if she can take Benadryl. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Malaise, Paraesthesia, Peripheral coldness
Clinical narrative: numbness in one cheek; tingling in head; ill feeling; cold hands; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female non-pregnant patient received first dose bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via unspecified route of administration in right arm on 08Mar2021 at 16:00 (at age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, fibromyalgia and cervical fusion. Concomitant and other medications in two weeks included lansoprazole (PREVACID) and clonazepam. No other vaccine in four weeks. Past drug events included allergy due to sumatriptan succinate (IMITREX), paroxetine hydrochloride (PAXIL), buspirone hydrochloride (BUSPAR) and dairy. No other vaccine received in four weeks. Patient has not been tested for COVID, post vaccination. Patient has not been tested for COVID, since the vaccination. On 08Mar2021 at 17:00 (1 hour after vaccination), patient experienced tingling in head, numbness in one cheek, cold hands and ill feeling. Events resulted in visit to doctor or other healthcare professional office/clinic. Treatment received was unknown. The outcome of all events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Fatigue, Headache
Clinical narrative: chills; runny nose; bones kind of ached; tiredness; headache; muscle pain; joint pain; feeling unwell; swollen lymph nodes in my neck; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female 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 04Mar2021 (age at the time of vaccination 70-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date Mar2021, the patient experienced chills, runny nose, bones kind of ached, tiredness, headache, muscle pain, joint pain, feeling unwell, and swollen lymph nodes in my neck. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Myalgia, Rhinorrhoea
Clinical narrative: chills; runny nose; bones kind of ached; tiredness; headache; muscle pain; joint pain; feeling unwell; swollen lymph nodes in my neck; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female 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 04Mar2021 (age at the time of vaccination 70-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date Mar2021, the patient experienced chills, runny nose, bones kind of ached, tiredness, headache, muscle pain, joint pain, feeling unwell, and swollen lymph nodes in my neck. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Mobility decreased, Stomatitis
Clinical narrative: not able to mobilize; developed sores in her mouth; She can't eat; This is a spontaneous report from Pfizer. A contactable consumer reported for a female patient(mother) that. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: Not reported), via an unspecified route of administration on 17Jan2021 as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medication was not reported. she reports that her mom is not having a good quality of life, her mom is not able to mobilize on an unspecified date. she does not know what to do. she reports that the HCPs they have seen don't know how to resolve symptom or fix it. she reports she is aware of a similar situation that happened to a person. she does not know how to handle this; she is looking for some assistance on what to do for her mom. she would like me to email or get a hold to someone to get research because of the vaccine that her mom received was from Pfizer, or it will be a lawsuit. she would like to speak to someone else that could give her more information. she was not satisfied with response to question above she reports that if someone doesn't follow up within 24 hours that she will go to social media. Possible duplicate AE. Upon callback, caller clarified that 40 minutes after receiving the Pfizer vaccine, her mother developed sores in her mouth. She can't eat, it hurts to speak (that's what was meant by her mother is not able to speak) and they are getting worse. They look like blisters and it's only in her mouth on an unspecified date. Her quality of life is poor. She has been to the emergency room three times and has been given antibiotics, steroids and several different things and nothing seems to work. It has been seven weeks. She thinks it is Pfizer's responsibility to come up with a way to treat this since she makes the vaccine. The seriousness criteria are Disability for the event not able to mobilize. The event outcome was Unknown  Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information? No  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction to the first dose of the vaccine; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 72-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced allergic reaction to the first dose of the vaccine on an unspecified date and she stated she knows she cannot get the second dose. The outcome of the event was unknown.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: experienced joint pain 2 weeks after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine; This is a spontaneous report from a non-contactable physician (patient). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single both the doses for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The Physician said he experienced joint pain 2 weeks after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine. He wanted to know if that was normal and how long the side effects usually last and also wanted to know Pfizer's recommendations on how to treat these side effects. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Hypoaesthesia, Injected limb mobility decreased, SARS-CoV-2 test negative, Vaccination site pain
Clinical narrative: left side started to feel numb dragging of her leg/Left side is toatally intereupted; Injected limb mobility decreased; sore, injection arm; She can't hold things like she wants to; This is a spontaneous report from a contactable female consumer reported for herself. A 67-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 22Feb2021 15:45 as dose 1, single at the age of 67-years-old for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, ongoing HIV positive. Concomitant medications were not reported. It was provided for the other conditions that onset date as let's just say over 20 years but reported condition is well controlled, and her being very healthy. It is a flare up thing, not all the time. She uses an inhaler every now and then for asthma but is doing well. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect: Vaccines If applicable, all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. On 14Mar2021 11:30, patient experienced left side is totally interrupted. She can't hold things like she wants to, and her left foot is dragging a little bit. Affecting her left side including shoulder, arm, leg and foot. Outcome is a little worse. She cannot work like this, unable to work today and wants to work the other day. Hypoaesthesia, Injected limb mobility Injected limb mobility decreased sore, injection arm injection site pain, left side started to feel numb, dragging of her leg, minimal use of left arm. The adverse event did not result in emergency room/physician office visit. Patient was not hospitalized. It was mentioned later in the call that she was local yesterday at time of onset of event. She has not travelled out of the area in the last 3 weeks. Dose change: she was supposed to go back on 26Mar2021 for second dose but has no plan to get second dose due to this event. The patient underwent lab tests and procedures which included sars-cov-2 test negative resulted as negative on an unknown date 2021, she can't hold things like she wants to resulted as decreased on an unknown date 2021. The clinical outcome of the event left side started to feel numb dragging of her leg/Left side is totally interrupted was not resolved and rest of the events was unknown.  No follow up attempts are needed. Information about lot/ batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Oedema peripheral
Clinical narrative: edema in my legs; swelling under my eyes; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 14Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced edema in legs, swelling under eyes on an unspecified date. Caller stated she received her 1st Pfizer vaccine dose the day before this report on 14Mar2021 (yesterday) and had developed edema in her legs and swelling under her eyes. And asked if this was normal. The events were not serious. Clinical outcome of events was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 67-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at age 67, via an unspecified route of administration, on Mar 7, 2021, at 11:15, single dose, for COVID-19 immunization. Medical history included drug hypersensitivity from an unknown date. Concomitant medication included Synthroid for an unspecified indication; start and stop date not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. No COVID-19 prior vaccination. The patient has not  tested for COVID-19 post the vaccination. On Mar 7, 2021, at 11:15, patient experienced numbness of lower left-side of lip and left-side of face. The patient did not receive treatment for the events. The outcome of the events: recovered on an unspecified date in Mar 2021. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Heart rate, Heart rate increased
Clinical narrative: Rapid Pounding Heart rate; severe stomach pain; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route on 25Jan2021 at 11:00 (at the age of 65-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included MPV, Osteoporosis and known allergic to Niacin. The patient concomitant medications included levothyroxine sodium (SYNTHROID), Atenolol, Zinc, Vitamin C, Probiotic from an unknown date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Jan2021 at 01:30, the patient experienced rapid pounding heart rate, severe stomach pain. Severe stomach pain lasted for 4 days. The patient visited to Doctor or other healthcare professional office/clinic. The patient did not received treatment for events. The patient underwent lab tests and procedures which included heart rate was rapid pounding on 26Jan2021. The outcome for the events was recovered. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in left hand, especially thumb; This is a spontaneous report from a non-contactable consumer or other non hcp (patient reported for self). A 35-years-old (non pregnant) female patient received first dose of BNT162bB (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration, administered in Left arm on 10Mar2021 16:45 (at the age of 35-years-old) as dose 1, single for COVID-19 immunisation. (Lot unknown reason: Unable to locate or read the details). Medical history included known allergies to Penicillin. There were no concomitant medications, no other medications in two weeks. No other vaccines were received in four weeks. The patient was not diagnosed with COVID-19 prior to the vaccination. On 11Mar2021 08:00, the patient experienced numbness in left hand, especially thumb. Patient has not been tested for COVID-19 since the vaccination. No treatment was received for the adverse event. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: I am breastfeeding mom; I am breastfeeding mom; sore arm; This is a spontaneous report from a contactable other HCP (Patient). This other HCP reported for two patients (mother and baby). This report is for mother. A 39-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE; Solution for injection) via an unspecified route of administration, administered in left arm on 10Mar2021 14:15 (Batch/Lot Number: EN6199) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and patient's concomitant medications were not reported. No known allergies reported. The patient stated that I am breastfeeding mom, I (myself) didn't have any other reaction other than a sore arm on 10Mar2021 17:30. There were no other vaccine in four weeks and there were no other medications in two weeks. Patient did not have COVID prior vaccination and also patient was not COVID tested post vaccination. Treatment was not received for any AE. The outcome of event was recovered.   No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : PFIZER INC-2021287948 Mother/Baby case
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Exposure via breast milk, Pyrexia
Clinical narrative: Breastfeeding mom/nursed him multiple times right after I vaccinated; Had 99.6 F temperature/temperature went up/fever; Diarrhea; This is a spontaneous report form a contactable other Health Care Professional (mother). A 19-month-old male patient received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: En6199, Expiration date: was not reported) via transmammary on 10Mar2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 10Mar2021 18:15, reporter stated her son was 19 months old. He had 99.6 F temperature and diarrhea 4 hrs after she got vaccinated (I nursed him multiple times right after I vaccinated and when his temperature went up). She also stated I am breastfeeding mom. It looks like it was transitory as this morning he no longer had a fever. He was not sick from anything else as he was in good health prior to me vaccinated and he didn't present any other symptoms. I believe the vaccine made his body react (for a brief period of time). The patient mother was not diagnosed with COVID prior vaccination and was not tested post vaccination. The outcome of event fever was recovered while other events were unknown.  Follow-up (11Jun2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021287049 Mother/Baby case
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: nerve numbness on left face, abdomen, lower leg and calf numbness; This is a spontaneous report from a contactable consumer or other non hcp. This report was received via a sales representative. A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed nerve numbness on left face, abdomen, lower leg and calf numbness in 3 hours of receiving the vaccine. He was afraid to receive the second dose due to the side effects. The reporter reported that regret involving case in this inquiry. Reporter felt like it may muddy the waters. So please de-emphasize reporter's personal involvement & perspective in this matter. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chronic obstructive pulmonary disease, General physical health deterioration, Hypersensitivity, Respiratory disorder
Clinical narrative: Upper respiratory issues; COPD; Asthma; Has issues now with his health, the allergies and different things now that are kicking in on him; Has issues now with his health, the allergies and different things now that are kicking in on him; This is a spontaneous report from a contactable consumer reporting for husband. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6202; Expiration date was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single for Covid-19 immunization. Medical history included chronic obstructive pulmonary disease, asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced upper respiratory issues, COPD, asthma, had issues with his health, the allergies and different things now that were kicking in on him on Mar2021. Reporter stated patient had his first Pfizer shot was 9 days ago. At the time of this report, he was having some issues with (incomplete sentence), he had upper respiratory issues. He was due to take his next shot, reporter thought it was on 21 or 22nd. If patient wanted to take Prednisone as an antibiotic, reporter asked if he could still get the second dose. Patient had not taken it yet. He did not know if he can, and reporter asked what would happen if he did not get the second shot. When paraphrased about the concern, reporter stated patient had COPD and asthma (further not clarified if consumer had COPD and Asthma prior taking the COVID-19 Vaccine or not, hence captured as event). Reporter added patient did not have any problem with the shot. It was just he had issues then with his health, the allergies and different things now that were kicking in on him. Reporter stated that it was not with the shot, and do not think to be. Reporter was informed about Pfizer Medical Information and telephone # was shared. Reporter was unwilling to share further information, hence, product details (NDC, UPC) and other details were unknown. Limited information was available over the call. Clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Oxygen saturation, Pyrexia
Clinical narrative: tired; chill; a fever of 100.9; This is a spontaneous report from a contactable other hcp (Patient). A 47-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 18Feb2021 16:00 (Age at vaccination: 47-years-old) as single dose for covid-19 immunization. (Vaccination facility: other: High School). No medical history and no concomitant medications were reported. Historical vaccine included first dose of bnt162b2 (Lot unknown: EL1283) in Left arm on 27Jan2021 16:00 for covid-19 immunization. Patient did not receive other vaccine in four weeks and also any other medications in two weeks. Patient was not diagnosed with covid prior to vaccination. Patient did not have Known allergies and also not pregnant at the time of vaccination. It was reported that on 11Mar2021 around 4 to 5PM she began to feel really tired and developed a chill. she got into bed and felt like a fever was coming on. she ended up with a fever of 100.9 by 6PM or so for several hours, it went down to 99.8 by 11PM, and her temperature was down to 96.6 then 97.1 then back to her normal of 97.7 by 7AM. she have no other symptoms so far, will continue to check for fever. she had a pulse oximeter she checked several times, and blood oxygen is constant at 97 percent. If any other symptoms show up she will go get tested and she was self-isolating. She is healthcare practitioner and have been wearing a mask and acting the same way she have for the past year even though vaccinated. she find it interesting her fever came on 3 weeks to the day and hour that received her second vaccination. She do not generally get sick or fevers often, nor did have any other symptoms. Patient did not receive treatment for the events. Patient was not tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.9, body temperature: 99.8, body temperature: 97.1, body temperature: 96.6, body temperature: 97.7, Blood oxygen: 97 percent. The outcome for the events was reported as unknown at the time of this report.   No follow-up attempts are possible. No further information is expected
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness/paresthesias to left upper arm. This then progressed to numbness that radiated down left arm and into left 4th and 5th fingers.; numbness/paresthesias to left upper arm. This then progressed to numbness that radiated down left arm and into left 4th and 5th fingers.; The left side of my face also felt numb; This is a spontaneous report from a contactable consumer (patient) or other healthcare professional.   A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 05Mar2021 16:30 (at the age of 35-year-old) as dose 2, single for COVID-19 immunisation.  Medical history included chronic allergies and environmental allergies from unknown date unknown if ongoing. Patient had no known drug allergies. Concomitant medications included drospirenone, ethinylestradiol (LORYNA); meloxicam (MOBIC); loratadine (CLARITIN); budesonide, formoterol fumarate (SYMBICORT); montelukast sodium (SINGULAIR) all taken for unspecified indication start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration, administered in left arm on 12Feb2021 13:30 (at the age of 35-year-old) as dose 1 single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. Approximately 15 minutes after receiving the second dose of Pfizer vaccine in her left arm on 05Mar2021 16:45, patient experienced numbness/paresthesias to left upper arm. This then progressed to numbness that radiated down left arm and into left 4th and 5th fingers. The left side of her face also felt numb.  patient did not received any treatment for adverse event. Not all fingers were numb, just ulnar distribution. No drooping or motor deficits. Symptoms lasted less than 10 minutes. Outcome of the events was resolved on 05Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: It was kind of hard to open and close; Numbness at the bottom of my toes and on the right side where I had the shot and under my foot; Pain in my arm;my foot and my hand had a lot of pain in it/I only took some Tylenol as I started getting pain in my arm and it got worse and worse but it (Tylenol) really didn't do anything for it; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 13Mar2021 (age at vaccination 65 years), (Batch/Lot Number: EN6199) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: High blood pressure. Concomitant medication included losartan and amlodipine taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) for covid-19 immunisation on unspecified date. Patient stated, "I had the second Covid-19 Pfizer vaccine yesterday and I wanted to know if it is one of the side effects that you had numbness in your foot. I had numbness at the bottom of my toes and on the right side where I had the shot and under my foot, was that normal" Patient stated, "No, I started to get numbness today (14Mar2021). Yesterday (13Mar2021), I only took some Tylenol as I started getting pain in my arm and it got worse and worse, but it (Tylenol) really didn't do anything for it and then I took some pain reliever. I had the shot around 2:00 yesterday(13Mar2021) and I didn't start getting a pain in my arm until 6 o'clock in the evening. It was little better today (14Mar2021); it was just this numbness was on that same side and my foot and my hand had a lot of pain in it earlier and it was kind of gone away and it was kind of hard to open and close it when I woke up this morning." Therapeutic measures were taken as a result of pain in my arm; my foot and my hand had a lot of pain in it/ I only took some Tylenol as I started getting pain in my arm and it got worse and worse, but it (Tylenol) really didn't do anything for it as Tylenol. The clinical outcome of the event Pain in my arm; my foot and my hand had a lot of pain in it/I only took some Tylenol as I started getting pain in my arm and it got worse and worse, but it (Tylenol) really didn't do anything for it was not recovered and remaining all other events was unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site urticaria
Clinical narrative: Hive near the injection site; Hive near the injection site; This is a spontaneous report received from a Pfizer Sponsored Program Covax US Support. A contactable male consumer (Patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on 06Mar2021 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date single for covid-19 immunization. On an unspecified date the patient experienced Hive near the injection site and sides of his torso after the second dose. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Hot flush
Clinical narrative: PT said she has an immediate reaction to the vaccine and she experienced hot flashes, her chest felt heavy and her head felt light; PT said she has an immediate reaction to the vaccine and she experienced hot flashes, her chest felt heavy and her head felt light; PT said she has an immediate reaction to the vaccine and she experienced hot flashes, her chest felt heavy and her head felt light; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced an immediate reaction to the vaccine and she experienced hot flashes, her chest felt heavy and her head felt light. Patient was asking if it is advisable to take the second dose. The outcome of the events was unknown.  Information on lot/batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Oropharyngeal pain
Clinical narrative: headache; sore throat; sore arm/ arm hurts; nausea; 108 temp; chills; body ache; This is a spontaneous report from a Pfizer-sponsored report from a contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 16Mar2021 at 10:00 as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Patient had COVID one year ago). The patient previously received aspirin [ACETYLSALICYLIC ACID] and experienced drug hypersensitivity. The patient experienced headache, sore throat, sore arm/ arm hurts on 16Mar2021 and 108 temp, chills, body ache, nausea on an unspecified date in Mar2021. The clinical course was as follows: After the first dose and patient is experiencing headache, sore throat, and sore arm. Patient was seeking information if she can take Motrin 400mg for pain. Patient allergic to a lot of medication. Reporter want to know if she can continue taking her medication. Patient allergic to aspirin. Reporter want to know if she can take Motrin, allergy pills, folic acid, b12, thiamine, metoprolol, Protonix for nausea. Reporter takes an over-the-counter allergy medicine which she knows is an antihistamine. The caller takes a lot of medications and has a lot of allergies to medications, so she has a few questions about that and is concerned now. The patient underwent lab tests and procedures which included body temperature: 108 and body temperature: 100.8 Fahrenheit on an unspecified date in Mar2021 (highest temperature was 100.8F). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: headache; sore throat; sore arm/ arm hurts; nausea; 108 temp; chills; body ache; This is a spontaneous report from a Pfizer-sponsored report from a contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 16Mar2021 at 10:00 as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Patient had COVID one year ago). The patient previously received aspirin [ACETYLSALICYLIC ACID] and experienced drug hypersensitivity. The patient experienced headache, sore throat, sore arm/ arm hurts on 16Mar2021 and 108 temp, chills, body ache, nausea on an unspecified date in Mar2021. The clinical course was as follows: After the first dose and patient is experiencing headache, sore throat, and sore arm. Patient was seeking information if she can take Motrin 400mg for pain. Patient allergic to a lot of medication. Reporter want to know if she can continue taking her medication. Patient allergic to aspirin. Reporter want to know if she can take Motrin, allergy pills, folic acid, b12, thiamine, metoprolol, Protonix for nausea. Reporter takes an over-the-counter allergy medicine which she knows is an antihistamine. The caller takes a lot of medications and has a lot of allergies to medications, so she has a few questions about that and is concerned now. The patient underwent lab tests and procedures which included body temperature: 108 and body temperature: 100.8 Fahrenheit on an unspecified date in Mar2021 (highest temperature was 100.8F). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Influenza, Loss of personal independence in daily activities, Malaise
Clinical narrative: General malaise; unable to do anything, could not function; could not fix food; sort of like flu only without nausea; This is a spontaneous report from a contactable consumer (patient). A 90-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EA6255), dose 2 via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:15 (at the age of 90-year-old) as dose 2, single for COVID-19 immunization. Medical history included GERD, HBP, neuropathy, high cholesterol, sleep apnea and known allergies (known allergies: Yes) from an unknown date and unknown if ongoing. Concomitant medication(s) included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]); amlodipine; apap; hydrocodone and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). The patient was not pregnant at the time of vaccination. The patient previously received first dose of BNT162B2 (Lot number: EB-6200) via an unspecified route of administration, administered in Left arm on 13Feb2021 12:30 PM (at the age of 90-year-old) for COVID-19 immunization. Facility where COVID-19 vaccine was administered at Hospital. The patient did not receive other vaccines in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 08Mar2021, patient experienced general malaise, unable to do anything, could not function, could not fix food, sort of like flu only without nausea, for two days. There was no treatment for the events. The clinical outcome of events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: Body aches; Pain at the site of injection; Fever; Tired; just want to sleep; This is a spontaneous report from a contactable consumer (patient spouse). A 73-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) via an unspecified route of administration on an unspecified date (age at the vaccination 73-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date were not reported) on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, Caller stated, caller and her husband had a few side effects after receiving the second dose of the Pfizer COVID-19 vaccine 10 days ago. Nothing severe. The first dose was no problem and had body aches, pain at the site of injection, fever and really bad fatigue. The fatigue is getting better but still there and feel so tired we just want to sleep. Caller wants to know any data on how long the fatigue should last. Caller had heard generally within 2-3 days side effects starts to lessen. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.