chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: rash on both sides of her body.; swollen lymph node under right arm; swollen lymph under left arm; This is a spontaneous report from a contactable consumer (patient). Via medical information team. A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 19Feb2021 (at the age of 79 years old) as dose 2, single for covid-19 immunisation. Medical history included osteopenia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of admimistration on 20Jan2021 as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced rash on both sides of her body, swollen lymph node under right arm and swollen lymph under left arm. Patient stated that she has received both of the pfizer covid 19 vaccine. She stated that it has been two weeks since her second dose. She reported swollen lymph nodes under both arms and a rash on both sides of her body. She wanted to verify that these are reported side effects because they have lasted so long. Itch rash on both sides of body was reported as worsened. Patient stated she has had two doses of the Pfizer vaccine, stated she was 2 weeks past the second dose, was having side effects, wanted to know if it was possible to have them this far out still. Stated she has swollen lymph nodes under her arms and a rash on both sides of her body that is driving her crazy. The outcome of the events rash on both sides of her body and swollen lymph under left arm was not recovered. The event outcome swollen lymph node under right arm was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Hypoaesthesia, Pain in extremity, Pain in jaw, Swelling face
Clinical narrative: Soreness around vaccine site; Upper arm soreness; Right face cheek soreness/slight swelling; Right face cheek soreness/slight swelling; Jaw soreness/pain when chewing; Shoulder blade numbness on side of vaccination; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN6203, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Right on 08Mar2021 13:00 (at the age of 34-year-old) as dose 1, single for covid-19 immunisation. The patient medical history included generalized anxiety disorder and Hashimoto's Thyroiditis. The patient concomitant medications included sertraline, lamotrigine, levothyroxine sodium (SYNTHROID), bupropion, were taken for an unspecified indication, start and stop date were not reported. The patient was allergic to Penicillin, and Sulfa. The patient did not administer other vaccine in four weeks. The patient was not diagnosed with Covid prior vaccination. The patient was not tested Covid post vaccination. On 09Mar2021 at 08:00, the patient experienced soreness around vaccine site, upper arm soreness, right face cheek soreness/slight swelling, jaw soreness/pain when chewing, shoulder blade numbness on side of vaccination. The patient did not receive any treatment. Outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness around vaccine site; Upper arm soreness; Right face cheek soreness/slight swelling; Right face cheek soreness/slight swelling; Jaw soreness/pain when chewing; Shoulder blade numbness on side of vaccination; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN6203, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Right on 08Mar2021 13:00 (at the age of 34-year-old) as dose 1, single for covid-19 immunisation. The patient medical history included generalized anxiety disorder and Hashimoto's Thyroiditis. The patient concomitant medications included sertraline, lamotrigine, levothyroxine sodium (SYNTHROID), bupropion, were taken for an unspecified indication, start and stop date were not reported. The patient was allergic to Penicillin, and Sulfa. The patient did not administer other vaccine in four weeks. The patient was not diagnosed with Covid prior vaccination. The patient was not tested Covid post vaccination. On 09Mar2021 at 08:00, the patient experienced soreness around vaccine site, upper arm soreness, right face cheek soreness/slight swelling, jaw soreness/pain when chewing, shoulder blade numbness on side of vaccination. The patient did not receive any treatment. Outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash
Clinical narrative: lightheaded; broke out in a rash; This is a spontaneous report from a contactable consumer. An 80-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the arm on 03Mar2021 (Lot Number: EN6205; Expiration Date: 30Jun2021) (at the age of 80 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included heart failure, blood pressure abnormal (reported as blood pressure), and diabetes. The patient was currently taking unspecified medications (reported as "like 50 different medicine"). On unspecified dates in Mar2021, the patient felt lightheaded and broke out in a rash. The patient has been put on antibiotics. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Limb discomfort, Malaise, Sinus congestion, Sinusitis
Clinical narrative: hasn't felt good for about 2 days now; bronchitis; slightly congested and has a little inflammation from her sinuses; slightly congested and has a little inflammation from her sinuses; had some discomfort in her arm for a few days; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date of 2021 as dose 1, single (at the age of 78-years-old) for COVID-19 immunisation. Medical history included patient stated that that last time she had penicillin she was 16 years old and she had it for dental work because her face was swollen and she had pus in her tooth and they had to cut it open. When she took the penicillin, she laid down on the couch in the daytime and then the next thing she knew, everything went black. It was all black. Then she woke up on the couch and she doesn't know how long she was there. She had a blanket over her, and her grandmother and mother were there and when she took the blanket off, she had hives like plateaus all over her chest. Patient never took penicillin again after that. The patient's concomitant medications were not reported. On Mar2021, patient had not felt good for about 2 days now. On an unspecified date of 2021, patient suffers from bronchitis. On an unspecified date of 2021, patient was slightly congested and had a little inflammation from her sinuses. On 10Mar2021 (Yesterday), patient went to her physician for him to look and physician confirmed that patient had bronchitis. Patient cannot take penicillin, but physician gave her a different antibiotic, levofloxacin 500mg and she took that last night. Patient was scheduled to receive the second dose of the Pfizer-BioNTech Covid-19 vaccine tomorrow (12Mar2021). Patient would like to know if there was any information in taking antibiotics and receiving the vaccine and if she should take the vaccine or reschedule her second dose. Patient mentioned that she talked to her doctor and he asked her why she would take the second dose of the vaccine if at her age with the first dose she was 74% protected. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pruritus, Urticaria
Clinical narrative: hives; with itching; inflamed; This is a spontaneous report from a contactable consumer (Patient reported for herself). A female patient (age: 52, unit not reported) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 10Mar2021 03:00 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. On unspecified date of Mar2021 the patient experienced hives with itching about eight hours after receiving vaccine. The patient stated that she had itching all night and has raised bumps. Patient queried if she could take benadryl for the itching. Patient had hives and was inflamed. The outcome of the reported events was unknown.  No follow-up attempts were possible, information about lot/batch number could not been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Flushing, Lymphadenopathy, Muscle tightness, Peripheral coldness
Clinical narrative: Caller's entire arm from shoulder to hand started to swell and there were lymph node swelling.; lymph node swelling; has a pinkish-reddish color on his arm as well; He was just very quickly flushed; freezing feet; arm is tight; tight skin; his left arm started to swell. It was not just at the injection site but it was his entire arm and hand; This is a spontaneous report from a contactable consumer (Patient). This male consumer of an unspecified age reported that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC Number: not reported), via an unspecified route of administration, administered in left arm on 05Mar2021 (Friday) at 10:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. Within the first 24 hours he had a very low grade reaction. He was just very quickly flushed and he had freezing feet (on an unspecified date in Mar2021). He didn't have anything really until Sunday evening when his left arm started to swell. It was not just at the injection site but it was his entire arm and hand (on an unspecified date in Mar2021). It went from his shoulder down to his hand. The lymph nodes under his arm and against his chest also started to swell (on an unspecified date in Mar2021).. It had continued to do so and his arm was tight (on an unspecified date in Mar2021). Other than that, he had no real pain, other than tight skin. He had a pinkish-reddish color on his arm as well (on an unspecified date in Mar2021). His left arm was very swollen compared to his other arm. He asked could anybody tell him if that was a usual side effect or could they tell him what to do about it. When asked if caller had time to complete a safety report today prior to being transferred to medical information he said that he would rather get his question answered since he waited 90 minutes for someone to answer. Caller's wife mentioned that Pfizer needs to up their game, need to get medical doctors on the phones. Caller asked what he should do regarding these possible side effect. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin tightness, Vaccination site swelling
Clinical narrative: Caller's entire arm from shoulder to hand started to swell and there were lymph node swelling.; lymph node swelling; has a pinkish-reddish color on his arm as well; He was just very quickly flushed; freezing feet; arm is tight; tight skin; his left arm started to swell. It was not just at the injection site but it was his entire arm and hand; This is a spontaneous report from a contactable consumer (Patient). This male consumer of an unspecified age reported that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC Number: not reported), via an unspecified route of administration, administered in left arm on 05Mar2021 (Friday) at 10:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunisation. Within the first 24 hours he had a very low grade reaction. He was just very quickly flushed and he had freezing feet (on an unspecified date in Mar2021). He didn't have anything really until Sunday evening when his left arm started to swell. It was not just at the injection site but it was his entire arm and hand (on an unspecified date in Mar2021). It went from his shoulder down to his hand. The lymph nodes under his arm and against his chest also started to swell (on an unspecified date in Mar2021).. It had continued to do so and his arm was tight (on an unspecified date in Mar2021). Other than that, he had no real pain, other than tight skin. He had a pinkish-reddish color on his arm as well (on an unspecified date in Mar2021). His left arm was very swollen compared to his other arm. He asked could anybody tell him if that was a usual side effect or could they tell him what to do about it. When asked if caller had time to complete a safety report today prior to being transferred to medical information he said that he would rather get his question answered since he waited 90 minutes for someone to answer. Caller's wife mentioned that Pfizer needs to up their game, need to get medical doctors on the phones. Caller asked what he should do regarding these possible side effect. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Gait disturbance, Pain in extremity, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6206) administered in left arm via an unspecified route of administration on 06Mar2021 (at the age of 69 years old) as dose 1, single for covid-19 immunisation. The patient's medical history included Knee replacement from May2015 to an unknown date. The patient's concomitant medications were not reported. On 06Mar2021, the patient experienced warm rosey cheeks/she also referred to it as a rash, sore arm and on 07Mar2021, the patient experienced she was unable to walk and severe joint pain and severe joint pain was reported as worsened. As a treatment, the patient received Acetaminophen for unable to walk and joint pain which didn't do anything. The patient underwent lab tests and procedures which included x-ray normal as all the knee parts are fine on 09Mar2021. The outcome for the events warm rosey cheeks/she also referred to it as a rash was recovered on 06Mar2021 and sore arm was recovered on 07Mar2021. The outcome of the events she was unable to walk, severe joint pain and severe joint pain was reported as worsened was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray normal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6206) administered in left arm via an unspecified route of administration on 06Mar2021 (at the age of 69 years old) as dose 1, single for covid-19 immunisation. The patient's medical history included Knee replacement from May2015 to an unknown date. The patient's concomitant medications were not reported. On 06Mar2021, the patient experienced warm rosey cheeks/she also referred to it as a rash, sore arm and on 07Mar2021, the patient experienced she was unable to walk and severe joint pain and severe joint pain was reported as worsened. As a treatment, the patient received Acetaminophen for unable to walk and joint pain which didn't do anything. The patient underwent lab tests and procedures which included x-ray normal as all the knee parts are fine on 09Mar2021. The outcome for the events warm rosey cheeks/she also referred to it as a rash was recovered on 06Mar2021 and sore arm was recovered on 07Mar2021. The outcome of the events she was unable to walk, severe joint pain and severe joint pain was reported as worsened was not recovered. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Arthritis, Balance disorder, Condition aggravated
Clinical narrative: Caller also clarified she has had previous arthritis, stomach issue, and joint pain but it did get worse after vaccine she stated; Joint pain; arthritis; stomach issue; her legs felt heavy, it was difficult to walk; she could not concentrate; Leg pain; hard to keep balance; This is a spontaneous report from a contactable consumer or other non health professional (patient) via Pfizer-sponsored program COVAX US Support.   A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. The patient's medical history included ongoing arthritis, abdominal pain and Joint pain. The patient's concomitant medications were not reported. It was reported that the patient received the Pfizer Covid-19 vaccine on 05Mar2021. Caller stated she has a history of arthritis and stomach issues. However, caller reported 5 days later on 10Mar2021 after receiving the vaccine her stomach pain and joint pain got worse. Caller also reported that her legs felt heavy, it was difficult to walk, and she could not concentrate. Caller asked could you experience an reaction 5 days after receiving the vaccine. Caller asked was it safer to get the second dose of the Pfizer COVID-19 vaccine. Caller asked would her side effects be worse after the second dose. Caller clarified 5 days later she started having side effects like stomach issue, leg pain, hard to keep balance and could not concentrate. Caller also clarified she has had previous arthritis, stomach issue, and joint pain but it did get worse after vaccine she stated. Caller wants to know if side effects can happen 5 days after first dose of COVID-19 vaccine. The outcome of all the events was unknown.  No follow-up attempts are possible.Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Gait disturbance, Pain in extremity
Clinical narrative: Caller also clarified she has had previous arthritis, stomach issue, and joint pain but it did get worse after vaccine she stated; Joint pain; arthritis; stomach issue; her legs felt heavy, it was difficult to walk; she could not concentrate; Leg pain; hard to keep balance; This is a spontaneous report from a contactable consumer or other non health professional (patient) via Pfizer-sponsored program COVAX US Support.   A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. The patient's medical history included ongoing arthritis, abdominal pain and Joint pain. The patient's concomitant medications were not reported. It was reported that the patient received the Pfizer Covid-19 vaccine on 05Mar2021. Caller stated she has a history of arthritis and stomach issues. However, caller reported 5 days later on 10Mar2021 after receiving the vaccine her stomach pain and joint pain got worse. Caller also reported that her legs felt heavy, it was difficult to walk, and she could not concentrate. Caller asked could you experience an reaction 5 days after receiving the vaccine. Caller asked was it safer to get the second dose of the Pfizer COVID-19 vaccine. Caller asked would her side effects be worse after the second dose. Caller clarified 5 days later she started having side effects like stomach issue, leg pain, hard to keep balance and could not concentrate. Caller also clarified she has had previous arthritis, stomach issue, and joint pain but it did get worse after vaccine she stated. Caller wants to know if side effects can happen 5 days after first dose of COVID-19 vaccine. The outcome of all the events was unknown.  No follow-up attempts are possible.Information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Circumstance or information capable of leading to medication error
Clinical narrative: She also reports taking Ajovy for her migraines/Starting Dupixent, asking if Covid Vaccine is a live virus; asthma; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other HCP (patient) reported that: A 51-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EN6207 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 10Mar2021 (Age at vaccination was 51 years) as single dose for COVID-19 immunization. The second dose was scheduled for 31Mar2021. Medical history included brain surgery a year ago. Concomitant medication(s) included fremanezumab taken for migraine, start and stop date were not reported. On an unspecified date in 2021 the patient experienced asthma and will be starting Dupixent injections for the treatment of her asthma next week. She was told to find out if the vaccine had a live virus in it because if it did, she would not be able to start the Dupixent treatments. The medication is being shipped to her Doctors office and will arrive Monday or Tuesday next week. Patient also states that she went the day before yesterday for her first vaccine. She was inquiring about a new injection that she was supposed to take, the Dupixent injection. She states the place that was going to deliver her injection said to be aware that Dupixent and live vaccines don't mix. She states that she just took the Covid vaccine the day before yesterday and she wants to make sure it was not a live vaccine. Patient was needing to speak to someone. She spoke to someone yesterday and they informed her that the virus was not live, but that she wanted them to speak because she was getting an injection of Dupixent and already got her 1st dose. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Sleep disorder
Clinical narrative: he was not able to sleep; right shoulder is very painful; had very bad pain in his right arm; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 35-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 10Mar2021 17:00 (Lot number: EN6207, Expiry date was not reported, at the age of 35 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. The reporter reported he got his first Pfizer COVID-19 Vaccine on 10Mar2021. He said he could not move his right arm. He said he had very bad pain in his right arm. He said at the time he received his COVID-19 Vaccine, he had the normal pain someone would have with a vaccination. He said at around bedtime at 9:00PM, on 10Mar2021, he was not able to sleep because if he tried resting on his right arm, his right arm was painful. He said even if he rested on his other arm, his right arm was still painful. He said he was feeling desperate with his right arm pain. He said he used his right arm to eat, and drive. He said his right arm hurts very bad, and his right arm pain was getting more and more. He said his brain automatically used his right arm because he used his right arm to do everything. As a treatment patient took a prescription strength Ibuprofen 600mg tablet because he was unable to sleep due to his right arm pain. He said the Ibuprofen 600mg did not help his right arm pain. The events do not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome for the events right shoulder is very painful, had very bad pain in his right arm was not recovered and for he was not able to sleep was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273608 Same reporter, patient/ different event, product
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Scratch
Clinical narrative: scratched; may not have been given the full dose, so they gave her a second dose; This is a spontaneous report from two contactable consumer (patient father and patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2, both via an unspecified route of administration at age of 26 years on 09Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient received an inadequate 1st dose and then received another 1st dose on the same day. The caller's daughter received 2 Pfizer vaccine shots on Tuesday, 09Mar2021, at vaccination site. The daughter (patient) then joined the phone call and stated "they weren't sure I received a whole dose, so I got a 2nd injection." Patient father said that it appeared that whoever gave patient the shot scratched her arm and they person thought that she may not have been given the full dose, so they gave her a second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever; chills; headache; nausea; This is a spontaneous report from a Contactable Consumer. A non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 10Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination was unknown. Patient has known allergies was unknown. On 11Mar2021, the patient experienced fever, chills, headache, and nausea. Patient received treatment for adverse events was unknown. The outcome for all the events was unknown.  Follow-up(16Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of the awareness date for report. The response included: Aware date of the adverse events, the events occurred about 24 hours after the first shot; not the same day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Feeling hot, Rash erythematous, Rash pruritic
Clinical narrative: Red, inflamed, itchy rash around arm from shoulder down to elbow; Red, inflamed, itchy rash around arm from shoulder down to elbow; Red, inflamed, itchy rash around arm from shoulder down to elbow; her arm was very hot, her whole arm was red in that area and went around most of her arm; her arm was very hot, her whole arm was red in that area and went around most of her arm; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200), via an unspecified route on 28Feb2021 at 17:30 (at the age of 77-years) as dose 2, 0.3 ml single in the left arm for covid-19 immunisation. The patient medical history included Glaucoma from 2008, Lymphoma from 2012, Can break out in rash/contact dermatitis/eczema had skin issues her entire life. The patient concomitant medications included Pilocarpine Eye drops 4 %, 2x/day [4% one drop in right eye, twice a day], Dorzolamide 2 drop, 2x/day [one drop twice a day in both eyes], Latanoprost 2 drop, 1x/day [one drop in both eyes at bedtime] for glaucoma. Been taking these for several years, thinks she started in 2008 but doesn't remember exactly when. The patient previously received first dose of BNT162b2 (Lot Number: EL3248), via an unspecified route on 02Feb2021 (at the age of 77-years) as dose 1, single for covid-19 immunisation and experienced slightly tender at the site of injection. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Feb2021, the patient experienced red, inflamed, itchy rash around arm from shoulder down to elbow, her arm was very hot, her whole arm was red in that area and went around most of her arm. Patient was a consumer who received the second dose of the Covid-19 shot. Patient reports about five days later, she developed a rash around the injection site and went from her shoulder down to her elbow. Patient reports her arm was very hot, her whole arm was red in that area, and went around most of her arm. Patient clarified it was not a bumpy rash, just red, inflamed, and itchy. She had no side effects with the 1st dose, other than slightly tender at the site of injection, but she'd say basically no side effects. Benadryl and cream and it went away after about 5 days. Patient reports she can break out in a rash/contact dermatitis/eczema- but she hasn't had anything since 2013. It seems like the vaccine prompted the eczema/contact dermatitis to reappear, it was similar to what she's had before. Patient did not visited to emergency room/ physician office. The outcome of the events was recovered on 05Mar2021.  No follow-up attempts are Possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dizziness, Fatigue, Headache
Clinical narrative: still isn't feeling well; headache; fatigue/tired; dizzy; cough; body aches/really painful; but feels like something in her chest; This is a spontaneous report from a contactable consumer (Patient). This 46-years-old female consumer reported herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 05Mar2021 as dose 2 single for covid-19 immunisation. 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, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunisation. The caller got her second dose 05Mar2021 (Friday) and since then, she had her 7th day of not feeling well. The caller was tired/fatigued, had a headache, was dizzy sometimes, and had a little cough, not a lot, but felt like something in her chest. The caller's body aches was still there, could not get out of the bed, somehow had made it to work the past few days but she still felt very tired. The caller wanted to know how long it would last, was it normal, and what she should she regarding the AE. Also, she wanted to know whether others have had prolonged side effects. The caller mentioned that it had gotten better, her husband was fine but its just in her case that it was really painful. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: still isn't feeling well; headache; fatigue/tired; dizzy; cough; body aches/really painful; but feels like something in her chest; This is a spontaneous report from a contactable consumer (Patient). This 46-years-old female consumer reported herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 05Mar2021 as dose 2 single for covid-19 immunisation. 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, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunisation. The caller got her second dose 05Mar2021 (Friday) and since then, she had her 7th day of not feeling well. The caller was tired/fatigued, had a headache, was dizzy sometimes, and had a little cough, not a lot, but felt like something in her chest. The caller's body aches was still there, could not get out of the bed, somehow had made it to work the past few days but she still felt very tired. The caller wanted to know how long it would last, was it normal, and what she should she regarding the AE. Also, she wanted to know whether others have had prolonged side effects. The caller mentioned that it had gotten better, her husband was fine but its just in her case that it was really painful. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Myalgia, Pain
Clinical narrative: Muscle and joint pains; Muscle and joint pains; Hard time in opening and closing his hands/couldn't hardly carry a cup of coffee; Hurt so bad he couldn't even turn in bed; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267, Expiration date: unknown) administered in left arm on 25Feb2021 10:00 (age at time of vaccination: 65 years) as, single dose for covid-19 immunisation in a clinic. The patient medical history was not reported, and concomitant medications was none. Family medical history was none. The patient did not receive previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. On 07Mar2021, he suffers from side effects muscle, joint achiness and Hard time in opening and closing his hands/couldn't hardly carry a cup of coffee. Sunday night and Monday it was so bad, he couldn't hardly carry a cup of coffee. Since the muscle and joint achiness started it has improved, but now it has kind of stayed the same. It has levelled out. On Sunday and Monday, he hurt so bad he couldn't even turn in bed. He was not sure if he was going back for second one because of the achiness. The outcome of the events muscle and joint pains was not recovered and unknown for other events.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Feeling cold, Hot flush, Hyperhidrosis
Clinical narrative: One of her eyes were a little swollen; Eye is really swollen and puffy; Sweats off and on; Cold; Hot and cold flashes; Hot and cold flashes; She was 'tired and tired'; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: E96199; Expiration Date: 30Jun, year not reported) administered in left arm via an unspecified route of administration on 09Mar2021 13:40-13:45 as dose 1, single for covid-19 immunization. It was reported that vaccine was not administered at facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history included ongoing high blood pressure and family medical history included hot flashes (One of them had hot flashes but she was not sure if it was related to menopause, reporter clarified she was not sure if hot flashes were after a vaccine). On an unknown date, it was reported that the patient was diagnosed years ago for an unknown conditions. The patient's concomitant medications were not reported and denied for any other products. On 10Mar2021, the patient experienced hot and cold flashes, had sweats off and on began the day after she received the shot and still having them, pretty much the same, cold and she was 'tired and tired'. On 12Mar2021, she woke up and one of her eyes was swollen and puffy, right eye and she was asking is that normal. Patient denied for any visit to emergency room or physician office. Patient was told by HCP to make an appointment to come in on Monday if her symptoms persist. Patient was asking whether the 2nd dose of the covid vaccine is the same dosage as the 1st dose, how long side effects would last after receiving the covid vaccine, was asking if one gets more side effects after receiving the 2nd dose of the covid vaccine, and whether her side effects are normal after receiving the covid vaccine. The outcome of event for one of her eyes were a little swollen and sweats off and on was not recovered whereas for other remaining events it was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Periorbital swelling
Clinical narrative: One of her eyes were a little swollen; Eye is really swollen and puffy; Sweats off and on; Cold; Hot and cold flashes; Hot and cold flashes; She was 'tired and tired'; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: E96199; Expiration Date: 30Jun, year not reported) administered in left arm via an unspecified route of administration on 09Mar2021 13:40-13:45 as dose 1, single for covid-19 immunization. It was reported that vaccine was not administered at facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medical history included ongoing high blood pressure and family medical history included hot flashes (One of them had hot flashes but she was not sure if it was related to menopause, reporter clarified she was not sure if hot flashes were after a vaccine). On an unknown date, it was reported that the patient was diagnosed years ago for an unknown conditions. The patient's concomitant medications were not reported and denied for any other products. On 10Mar2021, the patient experienced hot and cold flashes, had sweats off and on began the day after she received the shot and still having them, pretty much the same, cold and she was 'tired and tired'. On 12Mar2021, she woke up and one of her eyes was swollen and puffy, right eye and she was asking is that normal. Patient denied for any visit to emergency room or physician office. Patient was told by HCP to make an appointment to come in on Monday if her symptoms persist. Patient was asking whether the 2nd dose of the covid vaccine is the same dosage as the 1st dose, how long side effects would last after receiving the covid vaccine, was asking if one gets more side effects after receiving the 2nd dose of the covid vaccine, and whether her side effects are normal after receiving the covid vaccine. The outcome of event for one of her eyes were a little swollen and sweats off and on was not recovered whereas for other remaining events it was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia, Swelling
Clinical narrative: fever of 100.83; left arm pain; very slight swelling; This is a spontaneous report from a contactable consumer (patient) via regulatory authority. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Mar2021 16:30 (lot number: EN6199; expiry date: unknown) at the age of 50-years-old, as dose 1, single for Covid-19 immunisation. Medical history included Covid-19 (COVID prior vaccination: Yes) and arthritis (possible rheumatoid waiting for rheumatologist appointment). The patient was taking unspecified concomitant medications. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccines four weeks prior vaccination. The patient previously took morphine and experienced allergies (known allergies: sensitive to morphine). On 12Mar2021, at 10 am, the patient experienced fever of 100.83, left arm pain, and very slight swelling. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included body temperature: 100.83 on 12Mar2021. Outcome of the events was unknown. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Pain in extremity
Clinical narrative: does not have tingling in her  tongue but loss of taste; hurting hands; Chills; Feels Weak; Feels the same as when she had Covid in Dec.; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 07Mar2021 as dose 1, single for COVID-19 immunization (age at vaccination: 50-years). Medical history included covid-19 from unspecific date in Dec2020 to Dec2020.There were no concomitant medications. On 08Mar2021 the patient reports" does not have tingling in her tongue but loss of taste, hurting hands, chills, feels weak, and feels the same as when she had covid in December. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Peripheral swelling, Ultrasound scan, Varicose vein
Clinical narrative: This is a spontaneous report from a contactable consumer other non-health professional (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6202, Expiry Date: unknown) via an unspecified route of administration, administered on left arm on 04Mar2021 11:42 (at the age of 69-Year-old) as dose 1, single for COVID-19 immunization. Medical history included varicose veins from 1 Mar2021 and was ongoing. Blood pressure and COPD both are from an unknown date and unknown it was ongoing. Patient has no relevant family history. Concomitant medications include Olmesartan HTC 40/12.5mg once daily via orally for blood pressure taking for years, Advair 250/50mg inhaler; inhale twice daily for COPD, taking for years, Ventolin HFA 90 mcg; inhaler use as needed, using a long time. No History of all previous immunization with the Pfizer vaccine considered as suspect and no other additional Vaccines Administered on Same Date of the Pfizer Suspect. No other vaccines administered within 4 weeks Prior Vaccinations covid 19 vaccines. It was reported that patient received her first dose of the Pfizer-BioNTech Covid19 vaccine last Saturday, then on Tuesday 10Mar2021 She started to feel some pain in her varicose veins on her left leg right behind the left knee and it started to swell up; it was bulging; the pain started out just dull. It kept getting worse until she called her doctor on Thursday. They called her back on Friday and told her she might want to get it checked out at the emergency room, so she went to the emergency room. Lab test and procedures included ultrasound on an unspecified date, and they did not see a blood clot. They told her the swelling was just normal. It was still swollen now but mostly it was just red and there was still some pain behind the knee. It felt a little better today. She was concerned about getting the second shot, she wanted to know if this was a reported side effect, and She was scheduled to get the second dose on 27Mar2021.Patient visited emergency room for the events. Outcome of the event varicose veins behind the left knee swelling not recovered, outcome of the event pain in her varicose veins on her left leg right behind the left knee recovering, outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Sciatica
Clinical narrative: Sciatic pain has returned and has continued to hurt everyday since that time; Intermittent pain that begins in her knee and travels down her leg; Intermittent pain that begins in her knee and travels down her leg; This is a spontaneous report from a contactable consumer (patient).   A 67-year-old female consumer reported for herself who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 23Feb2021 (at the age of 67-year-old) as dose 2, single for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history included sciatic pain has returned and ongoing. The patient's concomitant medications were not provided. After receiving the second dose of vaccination, patient reported that her sciatic pain has returned and continued to hurt everyday as intermittent pain that begins in her knee and travels down her leg on an unspecified date. The outcome of the event sciatic pain has returned and continued to hurt everyday was reported as not recovered and other events reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.