chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Yesterday her doctor, she was getting some joint pain/having joint pain; This is a spontaneous report from a Regulatory Authority via a contactable consumer reported for a patient (reporter's mother). A 91-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, administered at an unspecified anatomical location on 08Feb2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st dose of COVID vaccine 08Feb2021. After 1st dose, on 25Feb2021, she was getting some joint pain and went to HCP and the doctor told her to hold of getting cortisone shot and the nurse gave cortisone shot to her. When probed for indication of cortisone, reporter stated that she guessed she got confused. The doctor said to hold off after the second shot but they were busy and the nurse came in and gave it to her. The reporter stated that her mother was scheduled to get her second Pfizer vaccine this Tuesday the 2nd. The reporter now wondered if her mom should get 2nd dose this coming Tuesday.She wanted to find out what was their recommendation as far as her getting her the vaccine 6 days after getting the cortisone shot. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Flushing, Headache, Oropharyngeal pain, Salivary gland pain
Clinical narrative: Flushed face; painful salivary glands + unusual mouth waterig; painful salivary glands + unusual mouth watering; headache; sore throat; GI distress; This is a spontaneous report from a contactable health care professional.   A 30-year-old female other HCP reported for herself that she received bnt162b2 (BNT162B2, Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 02Mar2021 13:00  (at the age of 30-years-old) as dose 1, single for covid-19 immunization.  Medical history included polycystic ovaries. Patient previously took sulfonamides and had allergy. Concomitant medications included vitex agnus-castus (VITEX [VITEX AGNUS-CASTUS]) and cetirizine hydrochloride (ZYRTEK). Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. Patient experienced flushed face, painful salivary glands  unusual mouthwatering, headache, sore throat and GI distress on 02Mar2021 13:30 PM. No treatment was taken for the events. The outcome of all the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Salivary hypersecretion
Clinical narrative: Flushed face; painful salivary glands + unusual mouth waterig; painful salivary glands + unusual mouth watering; headache; sore throat; GI distress; This is a spontaneous report from a contactable health care professional.   A 30-year-old female other HCP reported for herself that she received bnt162b2 (BNT162B2, Lot Number: EN6203), via an unspecified route of administration, administered in left arm on 02Mar2021 13:00  (at the age of 30-years-old) as dose 1, single for covid-19 immunization.  Medical history included polycystic ovaries. Patient previously took sulfonamides and had allergy. Concomitant medications included vitex agnus-castus (VITEX [VITEX AGNUS-CASTUS]) and cetirizine hydrochloride (ZYRTEK). Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. Patient experienced flushed face, painful salivary glands  unusual mouthwatering, headache, sore throat and GI distress on 02Mar2021 13:30 PM. No treatment was taken for the events. The outcome of all the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Musculoskeletal stiffness, Rash, Rash macular
Clinical narrative: skin was inflamed; facial swelling; kind of rashy area; face got red and swelled; a bit more blotchy than the other side; face felt funny, felt super tight; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:00 at the age of 43-year-old as dose 1, single for covid-19 immunisation from defense medical center. Medical history included ongoing asthma on inhaler , hypothyroidism (taken synthroid for many years) and seasonal allergy, Strange reactions to foods that does not follow a pattern; she is known to have the odd hive outbreak occasionally over the years. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not administered additional vaccines on same date of the bnt162b2. Concomitant medication included levothyroxine sodium (SYNTHROID) taken 50mg taken once daily for hypothyroidism, start and stop date were not reported. Patient family Medical History include autoimmune diseases, psoriatic arthritis and crohn's disease. On 02Mar2021 13:20. (about 20 minutes after she got the vaccine) Patient face got red and swelled, skin was inflamed. It was reported as facial swelling and like a raised up red, kind of rashy area. She had just left the vaccine site and was driving when adverse reaction started. Her face felt funny, felt super tight. She looked in the mirror and her face was all raised up and had bright red skin raised up a bit on one side, that side was a bit more blotchy than the other side. The adverse reaction lasted several hours with bright redness that gradually started to fade but the swelling overall stayed until 03Mar2021 morning when she woke up it was gone. In morning patient noticed her face was till blotchy on one side but is getting better on its own. Patient has not seen the doctor or visit emergency room about this events an. Patients second dose is scheduled for 23Mar2021 and she wanted to know if she could still get the second dose of the vaccine. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: skin was inflamed; facial swelling; kind of rashy area; face got red and swelled; a bit more blotchy than the other side; face felt funny, felt super tight; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:00 at the age of 43-year-old as dose 1, single for covid-19 immunisation from defense medical center. Medical history included ongoing asthma on inhaler , hypothyroidism (taken synthroid for many years) and seasonal allergy, Strange reactions to foods that does not follow a pattern; she is known to have the odd hive outbreak occasionally over the years. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not administered additional vaccines on same date of the bnt162b2. Concomitant medication included levothyroxine sodium (SYNTHROID) taken 50mg taken once daily for hypothyroidism, start and stop date were not reported. Patient family Medical History include autoimmune diseases, psoriatic arthritis and crohn's disease. On 02Mar2021 13:20. (about 20 minutes after she got the vaccine) Patient face got red and swelled, skin was inflamed. It was reported as facial swelling and like a raised up red, kind of rashy area. She had just left the vaccine site and was driving when adverse reaction started. Her face felt funny, felt super tight. She looked in the mirror and her face was all raised up and had bright red skin raised up a bit on one side, that side was a bit more blotchy than the other side. The adverse reaction lasted several hours with bright redness that gradually started to fade but the swelling overall stayed until 03Mar2021 morning when she woke up it was gone. In morning patient noticed her face was till blotchy on one side but is getting better on its own. Patient has not seen the doctor or visit emergency room about this events an. Patients second dose is scheduled for 23Mar2021 and she wanted to know if she could still get the second dose of the vaccine. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rash, Systemic lupus erythematosus
Clinical narrative: lupus, and has broken out since the second dose; lupus, and has broken out since the second dose; rash; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 27Feb2021, as dose 2, single, for COVID-19 immunisation. Medical history included ongoing lupus. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunisation. It was reported that, patient had lupus, and has broken out since the second dose and noticed a little bit of rash in her arm (Clarified that this was not vaccine related). She was prescribed with some steroids. The reporter asked if this would have any effectiveness on the second dose. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Rash and the suspect BNT162B2 can be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Lethargy, Musculoskeletal stiffness, Pain
Clinical narrative: Back Pain And Stiffness; Back Pain And Stiffness; Lethargy; General Aches And Joint Pain; General Aches And Joint Pain; Left Arm Soreness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 01Mar2021 07:45 (at the age of 59-year-old) (Lot Number: ENG198) as dose 1, single for COVID-19 immunization. Medical history included high blood glucose increased, overweight, and COVID-19 (prior to vaccination). The patient did not have any known allergies. Concomitant medications included red rice yeast; cetirizine hydrochloride (ZYRTEC) and zinc, all taken for an unspecified indication, start and stop dates were not reported. The patient experienced left arm soreness, back pain and stiffness, lethargy, general aches and joint pain on 02Mar2021 06:00. The patient did not receive treatment for the events. The outcome of events was recovered. Since vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Back Pain And Stiffness; Back Pain And Stiffness; Lethargy; General Aches And Joint Pain; General Aches And Joint Pain; Left Arm Soreness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 01Mar2021 07:45 (at the age of 59-year-old) (Lot Number: ENG198) as dose 1, single for COVID-19 immunization. Medical history included high blood glucose increased, overweight, and COVID-19 (prior to vaccination). The patient did not have any known allergies. Concomitant medications included red rice yeast; cetirizine hydrochloride (ZYRTEC) and zinc, all taken for an unspecified indication, start and stop dates were not reported. The patient experienced left arm soreness, back pain and stiffness, lethargy, general aches and joint pain on 02Mar2021 06:00. The patient did not receive treatment for the events. The outcome of events was recovered. Since vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Lymphadenopathy, Pain, Rash
Clinical narrative: rash on my breast-opposite side of the shot, under my arm, and on my back; Rash on my breast has turned into blisters; swollen, painful lymph nodes; The entire area has dull constant ache, sometimes sharp pain; This is a spontaneous report from a contactable consumer (patient) from medical information team.  A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9266, expiration date not reported) via an unspecified route of administration, in left arm, on 26Feb2021 (at the age of 68-years-old), at dose 1, single for covid-19 immunization. Medical history included Parkinson; that was mild and not very serious, glaucoma and had a surgery for it, dry eye. Concomitant medication included carbidopa, levodopa (RYTARY). The patient experienced rash on breast- opposite side of the shot, under arm and on back, the rash on breast turned into blisters, swollen painful lymph nodes and the entire area had dull constant ache; sometimes sharp pain on Feb2021. The patient had no investigation assessment reported. Therapeutic measures were taken included Benadryl and Ibuprofen. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: chills; fever; sweating; really achy; This is a spontaneous report from  a contactable consumer (patient) .A male patient of an unspecified age (reported as 29) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as dose number unknown, single for COVID-19 immunisation.  The patient's medical historyand concomitant medications were not reported. On 26Feb2021 (Friday), night, patient got chills, fever, sweating a lot and was really achy. At the time of report, since 26Feb2021, he had been waking up soaked in sweat. He enquired whether these side effects were normal and how long do these symptoms would last and when should he need to reach out to an HCP and whether a COVID  test need to be taken. 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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site was sore, as time went on, the site became more sore and itchy; it has become progressively more sore and itchy at the injection site; also red and warm to touch at the injection site; warm to the touch, (as if fever) itch and increase in size at injection site; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198; Expiration Date: 30Jun2021), via an unspecified route of administration in left arm, on 24Feb2021 at 11:00 (at the age of 78-years-old) as dose 2, single for COVID-19 immunization in a facility reported as other. Medical history included diverticula. No allergies to medications, food, or other products. Concomitant medications/other medications received within 2 weeks of vaccination included paracetamol (TYLENOL) 1 hour prior to the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265; Expiration Date: 31May2021), via an unspecified route of administration in left arm, on 28Jan2021 at 03:15 (at the age of 78-years-old) as dose 1, single for COVID-19 immunization and experienced a little soreness in her arm at the injection site. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. After the second dose of vaccination, on 24Feb2021, the injection site was sore like the first time. The patient's injection site was sore but it had become progressively more sore and itchy as time went on, also red and warm to touch at the injection site, the redness is now the size of her palm. Injection site continued to be red, warm/hot to the touch, (as if fever) itch and increase in size about the size of my hand. She only has fever on the spot, the rest of her body (her forehead) is not feverish. She does not know when it started getting red. She said that the area feels like it has fever. She put ice packs on it occasionally. It was reported that no treatment was received by the patient for these events. The patient wanted to know if there were any recommendation on what she should do about these events and how long these symptoms supposed to last. The outcome of the events was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Cough, Dizziness, Headache
Clinical narrative: slight swelling in [his] face, more so in [his] neck; slight swelling in [his] face, more so in [his] neck; blood sugar level increased; ringing in [his] ears; headaches; dizziness; irregular heart rate which he also qualified as nothing severe; started coughing for a little while, for no reason, and he further described it as a dry cough; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 at 11:50 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing borderline diabetic managed it by eating well. The patient's concomitant medications were not reported. The reporter reported that the vaccination provider stated there were no side effects to the vaccine. On 02Mar2021, the patient had his blood sugar level increased to 250 range and dropped to 150, 9 hours later, around 9 pm. The patient stated his blood sugar levels never got that high, the reporter usually got as high as 180 even after a meal and usually dropped to 100, within an hour.  The reporter also added that on 02Mar2021, he experienced, ringing in his ears, headaches, dizziness, an irregular heart rate which he also qualified as nothing severe. On 02Mar2021, in night, the patient started coughing for a little while, for no reason, and it was further described as a dry cough. The reporter explained that he woke up in morning on 03Sep2021, with a slight swelling in his face, more so in his neck. The patient underwent lab tests and procedures which included blood glucose: 180 and mentioned as usually get as high as 180 even after a meal and usually drop to 100, within an hour on an unknown date, blood glucose increased to 250 range on 02Mar2021 and dropped to 150, 9 hours later,  around 9 pm on the same day and heart rate irregular on 02Mar2021. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Swelling, Swelling face, Tinnitus
Clinical narrative: slight swelling in [his] face, more so in [his] neck; slight swelling in [his] face, more so in [his] neck; blood sugar level increased; ringing in [his] ears; headaches; dizziness; irregular heart rate which he also qualified as nothing severe; started coughing for a little while, for no reason, and he further described it as a dry cough; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 at 11:50 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing borderline diabetic managed it by eating well. The patient's concomitant medications were not reported. The reporter reported that the vaccination provider stated there were no side effects to the vaccine. On 02Mar2021, the patient had his blood sugar level increased to 250 range and dropped to 150, 9 hours later, around 9 pm. The patient stated his blood sugar levels never got that high, the reporter usually got as high as 180 even after a meal and usually dropped to 100, within an hour.  The reporter also added that on 02Mar2021, he experienced, ringing in his ears, headaches, dizziness, an irregular heart rate which he also qualified as nothing severe. On 02Mar2021, in night, the patient started coughing for a little while, for no reason, and it was further described as a dry cough. The reporter explained that he woke up in morning on 03Sep2021, with a slight swelling in his face, more so in his neck. The patient underwent lab tests and procedures which included blood glucose: 180 and mentioned as usually get as high as 180 even after a meal and usually drop to 100, within an hour on an unknown date, blood glucose increased to 250 range on 02Mar2021 and dropped to 150, 9 hours later,  around 9 pm on the same day and heart rate irregular on 02Mar2021. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dysgeusia, Fatigue, Injection site mass
Clinical narrative: very tired; low grade fever; with muscle/joint pain; with muscle/joint pain; Light headed- few min after injection and lasted about 25 min.; Metalic taste that lasted a few hours; Pain and small lump at injection site; Pain and small lump at injection site; This is a spontaneous report from a contactable consumer (patient). A non pregnant 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 20:15 (at the age of 59-years-old) at unknown dose number single for covid-19 immunization. Medical history included cancer, diabetes, hypertension, asthma, high cholesterol, emphazema, arthritis, fibromyalgia, neuropathy and penicillin allergy. The patient previously took diclofenac, celebrex and experienced drug allergy. Concomitant medications included 19 medications of which patient could list only 4. 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 and since the vaccination has not been tested for COVID-19. The most recent covid-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced light headedness few minutes after injection and lasted about 25 min. Patient had metallic taste that lasted a few hours on 02Mar2021. She had pain and small lump at injection site that increased overnight and throughout day on 02Mar2021. She was very tired, had low grade fever with muscle/joint pain on 03Mar2021 morning. No treatment was given for the events. The outcome of the events Light headed and  Metallic taste was recovered on 02Mar2021 while rest of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: very tired; low grade fever; with muscle/joint pain; with muscle/joint pain; Light headed- few min after injection and lasted about 25 min.; Metalic taste that lasted a few hours; Pain and small lump at injection site; Pain and small lump at injection site; This is a spontaneous report from a contactable consumer (patient). A non pregnant 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 20:15 (at the age of 59-years-old) at unknown dose number single for covid-19 immunization. Medical history included cancer, diabetes, hypertension, asthma, high cholesterol, emphazema, arthritis, fibromyalgia, neuropathy and penicillin allergy. The patient previously took diclofenac, celebrex and experienced drug allergy. Concomitant medications included 19 medications of which patient could list only 4. 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 and since the vaccination has not been tested for COVID-19. The most recent covid-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced light headedness few minutes after injection and lasted about 25 min. Patient had metallic taste that lasted a few hours on 02Mar2021. She had pain and small lump at injection site that increased overnight and throughout day on 02Mar2021. She was very tired, had low grade fever with muscle/joint pain on 03Mar2021 morning. No treatment was given for the events. The outcome of the events Light headed and  Metallic taste was recovered on 02Mar2021 while rest of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Pyrexia
Clinical narrative: Pain at injection site; Tiredness; Headache; Fever; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL 3247), via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 56-year-old), dose 1, single for COVID-19 immunisation. Medical history included COVID prior vaccination, anxiety disorder, thyroid nodules, essential hypertension, lumbar radiculopathy, cervical dystonia, allergy to casein in cow's milk, wheat intolerance, coffee and latex adhesive sensitivity. Concomitant medications included sertraline hydrochloride (ZOLOFT); losartan; lorazepam; diclofenac; thioctic acid (ALPHA-LIPON). Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 03Mar2021 at 09:45, the patient experienced pain at injection site, tiredness, headache, fever, and was feeling unwell. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021346169 same reporter/patient/product, different dose/similar event
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Migraine, Nasopharyngitis, Pain
Clinical narrative: Severe body and joint pain; Severe body and joint pain; migraine headache; cold symptoms; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 02Mar2021 (Lot number was not reported) (at the age of 58-years-old) as dose 2, single for covid-19 immunisation. Medical history included ankylosing spondylitis, chronic pain, osteoarthritis, migraine and recovery from 4 fusion surgeries. Concomitant medications included acetylsalicylic acid (ASPIRIN); gabapentine; diclofenac; topiramate (TOPAMAX); rosuvastatin calcium (ROSUVAS); all taken for an unspecified indication, start and stop date were not reported. The patient was currently going through treatment for ankylosis spondylitis, recovery from 4 fusion surgeries, and osteoarthritis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took morphine and experienced allergy. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered in left arm on 05Feb2021 (at the age of 58-years-old) as dose 2, single for covid-19 immunisation. The patient did not have covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 03Mar2021 02:30, the patient experienced severe body and joint pain, migraine headache and cold symptoms. The patient did not receive treatment for the adverse events. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Headache, Nausea, Pyrexia
Clinical narrative: fever; headache; weakness; nausea; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 14:00 (at the age of 69-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced fever, headache, weakness, and nausea on 02Mar2021. It was reported that she had a fever of 99 degrees that went up to 101 degrees on 02Mar2021. Patient wanted to know if it would be okay for her to take Ibuprofen. Patient wanted to know if these reactions are related to the vaccine and how long these side effects would last. Patient also asked if it would be safe for her to interact with her children even after receiving the vaccine. Outcome of events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Malaise
Clinical narrative: malaise; nausea; muscle pain; chills; joint pain; Headache, level of migraine; Lymph node discomfort in axially node; This is a spontaneous report from a contactable nurse. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration, administered in Deltoid Left on 24Feb2021 13:10 at the age of 73-years-old as dose 1, 0.3 ml, single for covid-19 immunization. Medical history included menopause, osteoporosis, ongoing drug hypersensitivity, arthritis, and migraine. Concomitant medications included ongoing MEDROXYPROGESTERONE and PREMARIN taken for osteoporosis, arthritis, menopause. Patient historical vaccine included small pox vaccine with which she experienced her hip swelled up like a basketball. Patient stated initially she did not have any symptoms until three days after getting the vaccine. Prior to vaccination, the patient did not receive any other vaccines within 4 weeks. She clarified she had malaise. She further explained she had a headache that continued to get worse. The headache was on the level migraine. She has migraines historically, but it was not an ordinary one. She had muscle pain, joint pain, chills, nausea, and lymph node discomfort in axillary node. The chills were mild on 26Feb2021 and increased through up to 28Feb2021, then it started going down, and started to disappear. Patient reported she has arthritic joint pain. Therefore, she can't say this was the first time she had joint pain. However, the joint pain got worse from what she normally had. Confirmed since the time it started it is better. The nausea increased as the headache increased. However, she confirmed at this time she no longer has nausea. The outcome of events malaise was unknown, headache, level of migraine, muscle pain, joint pain, and lymph node discomfort in axially node was recovering, chills, and nausea was recovered on 28Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: malaise; nausea; muscle pain; chills; joint pain; Headache, level of migraine; Lymph node discomfort in axially node; This is a spontaneous report from a contactable nurse. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration, administered in Deltoid Left on 24Feb2021 13:10 at the age of 73-years-old as dose 1, 0.3 ml, single for covid-19 immunization. Medical history included menopause, osteoporosis, ongoing drug hypersensitivity, arthritis, and migraine. Concomitant medications included ongoing MEDROXYPROGESTERONE and PREMARIN taken for osteoporosis, arthritis, menopause. Patient historical vaccine included small pox vaccine with which she experienced her hip swelled up like a basketball. Patient stated initially she did not have any symptoms until three days after getting the vaccine. Prior to vaccination, the patient did not receive any other vaccines within 4 weeks. She clarified she had malaise. She further explained she had a headache that continued to get worse. The headache was on the level migraine. She has migraines historically, but it was not an ordinary one. She had muscle pain, joint pain, chills, nausea, and lymph node discomfort in axillary node. The chills were mild on 26Feb2021 and increased through up to 28Feb2021, then it started going down, and started to disappear. Patient reported she has arthritic joint pain. Therefore, she can't say this was the first time she had joint pain. However, the joint pain got worse from what she normally had. Confirmed since the time it started it is better. The nausea increased as the headache increased. However, she confirmed at this time she no longer has nausea. The outcome of events malaise was unknown, headache, level of migraine, muscle pain, joint pain, and lymph node discomfort in axially node was recovering, chills, and nausea was recovered on 28Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: 8 days post vaccination sudden severe low abdominal pain (9/10); moving intensified, lasting 5 hours in duration then subsided to moderate pain (5/10) and mostly resolved 48 hours post initiation.  Th; arm pain; exhaustion(narcoleptic type); low grade fever; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on 21Feb2021 11:30 at the age of 52-year-old as dose 2, single for covid-19 immunisation.  Medical history included duodenal Switch With Bp/D; Low Trace Minerals (Copper, Zinc). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. Concomitant medications included hydrochlorothiazide, omeprazole, meloxicam, gabapentin all taken for an unspecified indication, start and stop date were not reported. On 01Mar2021, 8 days post vaccination patient experienced sudden severe low abdominal pain (9/10); moving intensified, lasting 5 hours in duration then subsided to moderate pain (5/10) and mostly resolved 48 hours post initiation. This is in addition to arm pain (7/10), exhaustion (narcoleptic like) and low grade fever (101.5-102) the first 24 hours. Patient rest for 6 hours before patient called in emergency because she could not move without severe pain. The patient did not receive any treatment in response to the events. The outcome of the events was recovering  No follow-up attempts are possible. No further information is expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchiness/itchiness on different parts of her body; rash; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 23Feb2021 (at the age of 95-year-old), as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itchiness on different parts of her body and sometimes there was rash and other times there wasn't. It was reported that, it started on the top of her feet and now on her arms. The patient was a nurse years ago, so she knows stuff. The patient washed all her clothes and there have been no changes in detergent and no changes in medication. If that was the case, it would have gotten better in three days. It has been everyday but in a different part of the body. It was also reported that, the patient was able to get a hold of her doctor, and the doctor told patient to go to the pharmacist and get an allergy medication over the counter. The outcome for itchiness was unknown while the outcome for rash was recovered with sequel. The patients might get second shot possibly on 08Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: Woke up freezing; Running high fever; Vomiting; Chills; Body aches; Headaches; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Mar2021 12:30 (at the age of 73-year-old) (Lot Number: Unknown) as dose number unknown, single for COVID-19 immunization. Medical history included HPB, diabetes, GERD, high cholesterol, stomach polyps. The patient had known allergies to misoprostol, spironolactone, carvedilol, ACE inhibitor, celecoxibe, pethidine (DMEEROL), furosemide (LASIX), telmisartan (MICARDIS), vioxy, hydrochlorothiazide. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); hydralazine; omeprazole; buspirone, all taken for an unspecified indication, start and stops date were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient woke up freezing, running high fever, vomiting, chills, body aches, headaches on 03Mar2021 06:00. The patient did not receive treatment for the events. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Woke up freezing; Running high fever; Vomiting; Chills; Body aches; Headaches; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 02Mar2021 12:30 (at the age of 73-year-old) (Lot Number: Unknown) as dose number unknown, single for COVID-19 immunization. Medical history included HPB, diabetes, GERD, high cholesterol, stomach polyps. The patient had known allergies to misoprostol, spironolactone, carvedilol, ACE inhibitor, celecoxibe, pethidine (DMEEROL), furosemide (LASIX), telmisartan (MICARDIS), vioxy, hydrochlorothiazide. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); hydralazine; omeprazole; buspirone, all taken for an unspecified indication, start and stops date were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient woke up freezing, running high fever, vomiting, chills, body aches, headaches on 03Mar2021 06:00. The patient did not receive treatment for the events. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: having some hip/joint pain and left knee pain/she woke up with joint pain in her hips and in her left knee; This is a spontaneous report from a contactable other healthcare professional (patient) received via medical information team. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6203, expiration date: Jun2021), via an unspecified route of administration, in left arm, on 28Feb2021 (at the age of 64-years-old), at dose 1, single for covid-19 immunization.  Medical history included high blood pressure, high cholesterol, seasonal allergy, supplementation therapy, facial hair issues, heart health (as reported). The patient had allergies to amoxicillin, erythromycin; described as vomiting, and Compazine (prochlorperazine maleate).  Concomitant medications included ongoing metoprolol taken for high blood pressure; pravastatin taken for high cholesterol; ongoing spironolactone taken for facial hair issues; ongoing colecalciferol (VITAMIN D) taken for supplementation therapy; ongoing aspirin (ACETYLSALICYLIC ACID) for heart health; loratadine and salbutamol sulfate (PROAIR) taken for seasonal allergy. On 01Mar2021, the patient woke up with joint pain especially in left hip and left knee pain; each day it has increased minimally, but it is still present at the time of report. No investigation assessment reported for the patient and no treatment was administered for the event. The outcome of the event was not recovered.    No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Panic reaction, Rash, Swelling, Vaccination site discolouration
Clinical narrative: she went into panic mode; She said that it started to swell and itch and was lower than the original place; red circle rash is larger/is further down on her arm; she did have black and blue mark; She said that she had a huge bump that was itchy and the bump looked like it had spread in height and circumference; redness/redness at the injection site; bump at the injection site; allergic reaction; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 17Feb2021 as dose 1, single for COVID-19 immunisation.  Medical history included known allergies to latex, sporins, chromium. The patient's concomitant medications were not reported.  Patient was given the shot on 17Feb2021 and she was well on that day. On the next day, 18Feb2021, she had a little redness and bump at the injection site. It got a little bit larger on 19Feb2021. She said that then it got a little flatter, but the bump did not quite go away.  Then on Wednesday, 24Feb2021, she had a huge flare up. Her huge bump was itchy and the bump looked like, it had spread in height and circumference. She had a telehealth visit with her doctor. He said that it looked like an allergic reaction and she was supposed to take Benadryl and hydrocortisone cream 1%. The following day it got better and by Sunday, on 28Feb2021 she felt as though she did not need the medication anymore, but she had a little bit of black and blue mark. On Monday, 01Mar2021 it started to itch a little bit, redness returned, and was getting bigger, and Tuesday, on 02Mar2021 it started all over again.  Also, started to swell and itch and that was lower than the original place, travelled down her arm.  On Wednesday, 03Mar2021, she went into panic mode. She returned to the doctor, he informed, that it was an allergic reaction. He said that she should not get the second dose or if she did, then it would have to be under a medical setting, or else may have another reaction and would be more difficult to handle. It was reported, at the time of report, all of this is 2 weeks old. Therapeutic measures in response to the events included benadryl and hydrocortisone cream . 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.