chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Limb discomfort, Malaise, Nausea
Clinical narrative: very unwell/Not feeling well at all; chills; diarrhea/A little diarrhea; heaviness in her legs/Legs are heavy and weak; Nausea; she did fine but had a sore arm; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Jan2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history included sensitivity to penicillin and concomitant medications were not reported. It was reported that she had the first dose of the pfizer covid 19 vaccine on Wednesday 27Jan2021 and stated she did fine but had a sore arm. She stated that Saturday suddenly, the symptoms hit her, and she was very unwell, chills, and diarrhea that continued through today. today she had nausea, heaviness in her legs and not feeling well. She wanted to know if these are side effects or is this her body having an immune response to the vaccine. She had sensitive to penicillin, and she wanted to know the reason, she had an AE to the covid 19 vaccine. It was reported that she Took vaccine a week ago on Wednesday. Had no trouble at all. Saturday, it hit her out of nowhere. Not feeling well at all. Was at daughter's house and she went down with chills and a little diarrhea. Had no fever, and no headache. Was a little better on Sunday and Monday. It was reported that Today everything is worse. Legs are heavy and weak, was nauseous. Had no fever and no headache. The outcome of event was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very unwell/Not feeling well at all; chills; diarrhea/A little diarrhea; heaviness in her legs/Legs are heavy and weak; Nausea; she did fine but had a sore arm; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Jan2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history included sensitivity to penicillin and concomitant medications were not reported. It was reported that she had the first dose of the pfizer covid 19 vaccine on Wednesday 27Jan2021 and stated she did fine but had a sore arm. She stated that Saturday suddenly, the symptoms hit her, and she was very unwell, chills, and diarrhea that continued through today. today she had nausea, heaviness in her legs and not feeling well. She wanted to know if these are side effects or is this her body having an immune response to the vaccine. She had sensitive to penicillin, and she wanted to know the reason, she had an AE to the covid 19 vaccine. It was reported that she Took vaccine a week ago on Wednesday. Had no trouble at all. Saturday, it hit her out of nowhere. Not feeling well at all. Was at daughter's house and she went down with chills and a little diarrhea. Had no fever, and no headache. Was a little better on Sunday and Monday. It was reported that Today everything is worse. Legs are heavy and weak, was nauseous. Had no fever and no headache. The outcome of event was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at her injection site; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 as Single Dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced pain at her injection site. The reporter also wanted to know what happens if she receives vaccine (unspecified) instead of the Pfizer-BioNTech Covid-19 Vaccine when she goes back to receive the 2nd dose after 4 weeks. She said that from the facility where she received the Pfizer-BioNTech Covid-19 Vaccine, they were scheduling people 4 weeks after the 1st dose, she wants to know if this is permissible. She wanted to know the efficacy of the Pfizer-BioNTech Covid-19 Vaccine after the 1st dose, if it is within the 50% range. She took a shot yesterday in (County Name) at the (Vaccination Facility Name) in the (Facility Type) District. That should be in the list there for vaccination sites. She has had no reaction to the shot what so ever. She was given a card with the date that she is in disagreement with. They were giving out dates for four weeks for the second shot instead of the three weeks. Everyone in the facility yesterday received a date for one month later. She knows it is supposed to be three. She is wondering if they were giving (Vaccine Name) the week before and didn't change the computer. Is that permissible. Caller clarified product as COVID19 Vaccine. What can she do about the facility giving out that date? She is not handy on the computer. If she were to go back to the location in four weeks and they are giving vaccine (unspecified) and not giving out Pfizer what will happen to her second shot. If she can't get it there, she will be pushed four weeks on. She really needs to know where to go to get the second shot. She needs to be able to talk to a person. She is not good on the computer. The outcome of the event was unknown. There was no product quality complaint (PQC) present.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: asthma; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced asthma. Patient stated that her doctor encouraged her to call Pfizer directly. It was reported that patient was put on a 5 day course of prednisone for her asthma issues after first dose of Pfizer COVID-19 vaccine. Patient would like to know if it will be okay to still receive the second dose of the Pfizer COVID-19 vaccine that she was scheduled for this Friday, 05Feb2021. The event was non-serious. The outcome of the event was unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Dizziness, Headache
Clinical narrative: imbalance/balance was off; Sore arm/arm soreness; Joint pain; headache; weakness; severe allergic reactions; light headedness/lightheaded; This is a spontaneous report from a contactable consumer (patient). Follow-up received from consumer via from a Pfizer-sponsored program  on 03Feb2021 was processed together along with initial information.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced imbalance/ balance was off, headache, arm soreness (at bedtime), joint pain (at bedtime), and light headedness/ dizziness (for 9 hours). The patient reactions that she had were not typical. She also said these side effects eventually went away, but she wants to know if there have been any reports of these side effects after receiving the vaccine. It was reported that the patient was scheduled for the second dose and she was checking before getting the second dose. It was reported that she had done V-check. It was reported that on the paperwork that there was a remote chance of severe allergic reactions. Signs can include dizziness or weakness. The next day she was fine. Outcome of events was resolved on an unspecified date.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity
Clinical narrative: imbalance/balance was off; Sore arm/arm soreness; Joint pain; headache; weakness; severe allergic reactions; light headedness/lightheaded; This is a spontaneous report from a contactable consumer (patient). Follow-up received from consumer via from a Pfizer-sponsored program  on 03Feb2021 was processed together along with initial information.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced imbalance/ balance was off, headache, arm soreness (at bedtime), joint pain (at bedtime), and light headedness/ dizziness (for 9 hours). The patient reactions that she had were not typical. She also said these side effects eventually went away, but she wants to know if there have been any reports of these side effects after receiving the vaccine. It was reported that the patient was scheduled for the second dose and she was checking before getting the second dose. It was reported that she had done V-check. It was reported that on the paperwork that there was a remote chance of severe allergic reactions. Signs can include dizziness or weakness. The next day she was fine. Outcome of events was resolved on an unspecified date.    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Malaise, Pain in extremity, Pyrexia, Vaccination site swelling
Clinical narrative: swelling around left wrist and hand-same arm as vaccine injection site; swelling around left wrist and hand-same arm as vaccine injection site; "a little fever", "felt a little warm"; pain/throbbing pain at the swelling location; A little unwell, not that bad; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 01Feb2021 at 12:00 as 1st dose, single for COVID-19 immunisation. The patient's medical history included pneumonia shot taken about 3 years ago. Concomitant medications were not reported. On 01Feb2021 , around 18:00 at the evening, the patient experienced effects like swelling around left wrist and hand-same arm as vaccine injection site (LUE). The patient also experienced pain/throbbing pain at the swelling location and reported as "a little fever", "felt a little warm and "A little unwell, not that bad". Patient did not take his temperature. Treatment medications included Tylenol and iced swelling location, which helped him. there was no more throbbing pain, but swelling and sore existed. Patient experienced similar symptoms to pneumonia shot about 3 years ago. He enquired whether to receive second dose or not. The clinical outcome of the event pain/throbbing pain at the swelling location was recovered on Feb2021, clinical outcome of the event swelling around left wrist and hand-same arm as vaccine injection site was not recovered and outcome of all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: rash/hives all over her body, rash became worse; rash/hives all over her body; Itching; This is a spontaneous report from a contactable consumer for mother. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/ Lot number and Expiry date was unknown), via an unspecified route of administration, on 22Jan2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got her first Pfizer Covid vaccine on 22Jan2021 and her second dose of vaccination was due on 12Feb2021. On 22Jan2021, after 1.5 hours receiving the first dose of vaccination, patient developed a rash/hives all over her body (not much on her face, but all over the rest of her body). Patient's HCP recommended Zyrtec that day for the rash and then overnight it became worse, after then HCP prescribed prednisone and hydrocortisone for the itching and Benadryl. After receiving 4 days of steroids, it started to clear up in about a day or 2. Patient was scheduled for second dose on 12Feb2021 and inquired whether she can receive the dose. The outcome of the event was reported as recovered on unknown date in 2021.  Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort
Clinical narrative: problem in her mouth, tooth problem; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on 18Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the patient experienced problem in her mouth that was tooth problem. Further patient explained she would receive 2nd dose of the vaccine on Monday, 08Feb2021 but on Saturday 30Jan2021, Patient had a problem with her mouth, a tooth problem, went to dentist yesterday, they told her there was nothing wrong with tooth or gums, that it was likely a virus and there was nothing they could do for it that it would have to go away on its own. The patient stated that she does not think this was due to the vaccine. The patient stated that she does not want Pfizer thinking she had a side effect that this is not caused by the vaccine. The patient wanted to know if it was okay to go ahead and get the second dose with the possible virus.  The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face
Clinical narrative: My face is swollen; scars started to tinging.; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was unknown) via unknown route of administration on an unknown date, first dose, single for COVID-19 Immunisation. The patient's medical history included facelift on 23Nov2020. The concomitant medications were not reported. On an unknown date, it was reported that she received her first dose of the Pfizer vaccine on Saturday. She reported her face is swollen. "It's not anaphylaxis. I'm assuming it's because I had facelift on 23Nov and It is impacting her lymph nodes. She reported she afraid to take the second dose. I don't even know if the water pills are the right path. My face is drained from one ear to ear and under the jaw line. It happened 40 minutes after the injection. It's not Botox no fillers. That's not applicable to me because I haven't had fillers or Botox. I had no other reactions. 40 minutes after all the scars started to tinging. The past 3 days, it looks like it's draining below the jawline. The outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nausea, Vertigo
Clinical narrative: nauseous; couldn't sit up; spinning; This is a spontaneous report from a contactable consumer. A 79-year-old female consumer (Patient) reported that she started to receive BNT162B2 (BNT162B2, formulation: Solution for injection, vaccinated at the age of 79-year-old) via unknown route of administration from 21Jan2021 16:00 to 21Jan2021 16:00 at single dose daily for covid-19 immunization. Patient's medical history was reported that, I have allergy to penicillin and sulfur but this was 50 years. Felt like my throat and ears were closing. Concomitant medications were not reported. It was reported that caller she received the first dose of the Pfizer vaccination on 21Jan2021 at around 4 in the afternoon. She had a bad reaction. She drove 1 hour and 45 minutes away and she was fine that night. Caller stated, "The next morning, I was nauseous. I couldn't sit up. I had to call my daughter to help me sit up. When I tried to sit up. it was like it was I had to push (myself and my daughter) up a mountain in a tornado. I couldn't control my body even if you tried. It was a very severe reaction if not vertigo. It was awful. spinning widely, nauseous. I called the doctor and he prescribed some vertigo medication/nausea medication. We tried an Epley maneuver for vertigo. spinning uncontrollably. which ear it was in. did the epley maneuver itself. I couldn't bend down. The last week or so I've been cautious but ok, tried to seen ENT and I have a therapist to help me do that Epley maneuver again. I don't want to set off anything. I don't know if you had any reports of any like that? I'm due to get my next shot 11Feb2021 and I have to drive 2 hours again and will have to drive home again. I'm most concerned and my doctor feels I need to get the second dose too. I reported to VAERS. The outcome of events was "unknown".  Information on lot/ Batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Too much tiredness; lymphatic nodes were swollen (bean size, one was hard and the other one was bigger and softer) at the right lower side of the neck. They are still swelled today; This is a spontaneous report from a non-contactable Health care professional. A 46-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: was not reported) via intramuscular, administered in right arm on 26Jan2021 at 12:15 as 2ND single dose for COVID-19 immunization. The patient medical history included penicillin drug allergies. The patient concomitant medications were not reported. Historical vaccine includes patient received, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 intramuscular, administered in right arm on 05Jan2021 at 02.30 as 1st dose, single dose for COVID-19 immunization. Patient did not received any other vaccine in four weeks and no other medication in two weeks. Patient had no COVID-19 prior vaccination. Patient had not tested for COVID-19 post vaccination. The patient experienced the night of vaccination too much tiredness. on thursday (2 days after), 2 lymphatic nodes were swollen (bean size, one was hard and the other one was bigger and softer) at the right lower side of the neck. they are still swelled today at 06.00AM on 28Jan2021. The event was not treated. The outcome of events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nasal discomfort
Clinical narrative: chills; headache; joint pain; nose was burning; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 25Jan2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient took the 1st dose after a week experienced chills, headache, joint pain and nose was burning on an unspecified date in Feb2021. The outcome of the events was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: wife is having chills; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (husband) reported for a female patient. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Feb2021 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Caller said he and his wife got the Pfizer vaccine yesterday and her wife is having chills on Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Retching
Clinical narrative: Chills; Dry heaving; Low-grade fever; Diarrhea; This is a spontaneous report from contactable other health professional. This female other HCP (patient) of unspecified age reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd Dose, Single Dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving her second dose of the Pfizer-BioNTech COVID-19 vaccine-the patient experienced chills, dry heaving, low-grade fever, diarrhea for three days. The outcome of the events was unknown.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge, Taste disorder
Clinical narrative: Also felt a mucus feeling in the back of my throat; I had a strange taste in the back of my throat; This is a spontaneous report from a contactable consumer (Patient). This consumer reported in response to Non-HCP follow-up letter sent in cross-referenced case which included Patient Age at Time of Vaccination in Months: or Years: 50. This is the second of the two cases.  A 50-year-old female patient received second dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, lot number: EK9231; Expiration Date: 30Apr2021), via an unspecified route of administration on 08Jan2021 (at the age of 50-years-old) as single dose for COVID-19 immunisation. Medical history included ongoing mild dog allergies and takes occasional Claritin, ongoing dust allergies and takes occasional Claritin. Patient had wheezing after taking intrauterine contrast dye in 2014 that lasted for about 30 min, and required Albuterol. There were no concomitant medications. The patient previously took first dose of BNT162B2 (Pfizer COVID-19 Vaccine, solution for injection, lot number: EH9899; Expiration Date: 31Mar2021), via an unspecified route of administration on 19Dec2020 (at 09:00 (24 hour clock) Approximate) as single dose for COVID-19 immunisation and at 09:05, experienced feeling of swelling of the upper lip and throat, brief tongue tingling, palms felt sweaty/felt sweaty, throat felt dry, mildly dizzy, strange taste feeling in the back of my throat and patient treated with Benadryl and Claritin. The patient visited allergist where she was informed that she does not have any allergic reaction. The patient took Claritin the night prior ans that day (Forward arrow sign) No feeling of swelling of lip or tingling. On an unspecified date, patient had a strange taste in the back of throat but none of the other symptoms. It started a few minutes after + lasted about 1 minute. On an unspecified date, patient had mucus feeling in the back of throat, but this may be due to chronic allergies to dog/dust. The patient's allergist did not feel that patient had an allergic reaction. The outcome of the event strange taste in the back of throat was recovered and for the event mucus feeling in the back of throat, it was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation
Clinical narrative: she felt the vaccine run down her arm, when the needle was pull; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported for a female patient of an unknown age received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 02Feb2021 as an Unknown, Single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient had the vaccine yesterday (02Feb2021), she felt the vaccine run down her arm, when the needle was pull. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The outcome of event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face
Clinical narrative: after 45 minutes she felt itchy; Her face swelled up; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable female consumer (patient) of an unspecified age reported that she received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Jan2021, after 45 minutes of first dose the patient felt itchy, and her face swelled up. She was put on Predisone 2 mg and Zyrtec. She wanted to know since she was on a steroid if that would cause the Covid vaccine to be less effective and she won't have any antibodies. She stated that her allergist thinks the irritant might be polyglycol and they will be testing her next week. She stated the lot number was EL9262. She wanted to know if she would be able to take (Company name), relayed that she would have to check with them to see what was in their vaccine. The outcome of the events was unknown. Therapeutic measures were taken as a result of the events (itchy, swelling of face).  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Heart rate, Heart rate increased, Influenza like illness
Clinical narrative: increased heart rate; headache; nausea; palpitations; shortness of breath; flu-like symptoms; This is a spontaneous report from a contactable Nurse (Patient) via Pfizer Sales Representative. A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date was not providded), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is being treated for hypertension and hyperlipidemia. Patient had COVID-19 in Jun and still has lost sense of taste and smell with fatigue and headaches lingering. It was reported that after the first dose of BNT162B2, she had mild flu-like symptoms, headache and swelling at injection site. Symptoms lasted 2-3 days. On an unspecified date patient took the second dose and had experienced more significant flu-like symptoms with headache and nausea as well as increased heart rate and palpitations with shortness of breath. The flu-like symptoms lasted 24+hours but the heart rate variability for one week but is decreasing. The patient underwent lab tests and procedures which included hear rate: increased on unspecified date. The outcome of events increased heart rate was recovering and outcome for all other events was unknown.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: increased heart rate; headache; nausea; palpitations; shortness of breath; flu-like symptoms; This is a spontaneous report from a contactable Nurse (Patient) via Pfizer Sales Representative. A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date was not providded), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is being treated for hypertension and hyperlipidemia. Patient had COVID-19 in Jun and still has lost sense of taste and smell with fatigue and headaches lingering. It was reported that after the first dose of BNT162B2, she had mild flu-like symptoms, headache and swelling at injection site. Symptoms lasted 2-3 days. On an unspecified date patient took the second dose and had experienced more significant flu-like symptoms with headache and nausea as well as increased heart rate and palpitations with shortness of breath. The flu-like symptoms lasted 24+hours but the heart rate variability for one week but is decreasing. The patient underwent lab tests and procedures which included hear rate: increased on unspecified date. The outcome of events increased heart rate was recovering and outcome for all other events was unknown.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: got sick and developed chronic illness; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration (Batch/Lot number was not reported) on an unspecified date (reported as couple of weeks ago) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, after the vaccination, the patient experienced got sick and developed chronic illness. On an unknown date, the patient underwent sars-cov-2 test which was negative. The patient is scheduled to get 2nd dose of vaccine this coming Monday or Tuesday. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore arm after taking the first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for a female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date as an unspecified dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm after taking the first dose on an unspecified date. The caller had a sore arm after taking the first dose and wanted to know how they can schedule their 2nd dose in their local area. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Oropharyngeal pain
Clinical narrative: Experiencing a sore throat; Exposed to Covid by his girlfriend; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a patient (Son) that a male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date. The patient experienced experiencing a sore throat and exposed to covid by his girlfriend on an unspecified date. It was stated that "caller's son took his 2nd dose of the Covid vaccine and 8 days later was exposed to Covid by his girlfriend. He is going in for a test for Covid today. Clarified if he was having symptoms of Covid, she stated he was experiencing a sore throat. She had questions such as since he has gotten both vaccines will this help him from getting Covid and numerous other questions in regard to the Covid vaccine". Outcome of the events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: experienced side effects (lymph nodes); This is a spontaneous report from a Pfizer-Sponsored Program. A contactable consumer reported for a male patient (father).  The male patient of an unspecified age received the second dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on Friday (date unspecified), as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration on an unknown date, as a single dose for Covid-19 immunization. On an unknown date, the patient experienced side effects (lymph nodes). The reporter was uncertain if it was a side effect of the vaccine. The outcome of the event of side effects (lymph nodes) was unknown.  It was notified that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts had been completed and no further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Illness, Influenza like illness, Pyrexia
Clinical narrative: Felt pretty sick; 104 degree fever for 2 days felt like he had the flu; 104 degree fever for 2 days felt like he had the flu; Still pretty tired; This is a spontaneous report via a Pfizer-sponsored program, received from a contactable consumer (patient, reported for self).  A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medications includes, blood thinner taken for Atrial fibrillation from an unspecified date and unknown if ongoing.   On an unspecified date, the patient experienced 104 degree fever for two days felt like he had the flu. The patient was progressively getting better still pretty tired and felt pretty sick. Patient enquired if the blood thinner make something bad happen. The patient takes Blood thinner for AFIB. On an unknown date, the patient underwent lab tests and procedures which included body temperature: 104 degree. Patient enquired if Blood thinner for AFIB should he take it or no. The outcome of event still pretty tired was unknown and rest events were recovering.  Information about batch/lot number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Crepitations, Inflammation, Investigation, Pain in extremity
Clinical narrative: she is rickety, and as she starts moving, she is ok, not in pain; legs and arms ache; inflammation rate was a little high; it is hard to sleep; legs and arms ache; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: E10142, Expiration date: not reported), dose 1 via an unspecified route of administration on 20Jan2021 as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021 the patient experienced adverse events reported as "she is rickety, and as she starts moving, she is ok, not in pain, she had legs and arms ache, inflammation rate was a little high, it is hard to sleep." The patient wanted to know if anyone else has the same symptoms, and should she be getting the second dose. The patient underwent lab tests and procedures which included blood test normal, inflammation rate a little high on 26Jan2021.The outcome of events legs and arms ache, Crepitations was not recovered and for inflammation, hard to sleep Was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: she is rickety, and as she starts moving, she is ok, not in pain; legs and arms ache; inflammation rate was a little high; it is hard to sleep; legs and arms ache; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: E10142, Expiration date: not reported), dose 1 via an unspecified route of administration on 20Jan2021 as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jan2021 the patient experienced adverse events reported as "she is rickety, and as she starts moving, she is ok, not in pain, she had legs and arms ache, inflammation rate was a little high, it is hard to sleep." The patient wanted to know if anyone else has the same symptoms, and should she be getting the second dose. The patient underwent lab tests and procedures which included blood test normal, inflammation rate a little high on 26Jan2021.The outcome of events legs and arms ache, Crepitations was not recovered and for inflammation, hard to sleep Was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This is a spontaneous report from a contactable other health professional, the patient.   A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in left arm on 26Jan2021 12:00 pm as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness at the injection site on 26Jan2021 15:00. The patient was not pregnant. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient not had covid prior vaccination. The patient had not been tested for COVID-19 post vaccination. No treatment was received for the event. The outcome of event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash papular, Swelling
Clinical narrative: Next day it added red spots on my arms, legs and back shoulders; Next day it added red spots on my arms, legs and back shoulders; very red skin on my lower back; Had very bumpy skin and very itchy; Had very bumpy skin and very itchy; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiration date: unknown, solution for injection), via an unspecified route of administration, administered in left arm on 01Feb2021 10:30 (age at vaccination: 72 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history included cystitis interstitial and allergy to sulfa drugs. Concomitant medication(s) included calcium, fish oil, bifidobacterium lactis (PROBIOTIC), colecalciferol (VITAMIN D). On 01Feb2021 14:00, the patient experienced very red skin on my lower back, had very bumpy skin and very itchy. Next day it added red spots on my arms, legs and back shoulders. The itching comes and goes. The patient received Clobetasol Propionate and Prednisone 20 mg as treatment for the events. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: left arm was stiff this morning; injection site pain; she just realized the Arnicare Gel was expired, saying she was surprised the Arnicare Gel still worked; has a charley horse pain in her left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 02Feb2021 as 1st dose single for COVID-19 immunization. Medical history included microcytic anemia and thalassemia from an unknown date and unknown if ongoing. Restless legs syndrome from 2015 to an unknown date Verbatim. Concomitant medications included cyanocobalamin, biotin and folic acid taken for microcytic anemia from an unspecified start date and ongoing. Ethinylestradiol, norgestimate taken for hormone therapy from Oct2020 and ongoing. She said she started taking Estarylla 0.25mg/0.035mg oral birth control pill for hormone regulation in Oct2020, saying she has been taking the Estarylla for 4 months steady now. The patient previously took ropinirole for Parkinson's disease and experienced syncope from an unspecified date. Reported she tried the Parkinson medicine, Ropinirole, and that the Ropinirole knocked her out, and she didn't like that, so she stopped taking the Ropinirole 2 years ago. On 02Feb2021 patient experienced has a charley horse pain in her left arm, injection site pain and she just realized the Arnicare gel was expired, saying she was surprised the arnicare gel still worked. Left arm was stiff this morning on 03Feb2021. Stated she has a bad left shoulder, saying she thinks she has a pinched nerve, so she asked to get the vaccine in her left arm. She said her left arm pain has improved on 03Feb2021. Therapeutic measures were taken as a result of he has a charley horse pain in her left arm and left arm was stiff this morning. Treatment received with Arnica gel to help with the left arm muscle soreness. She said the Arnica gel helped. The outcome of the events was recovered, whereas injection site pain was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: noticed age spots on the back of his hand and a big one on his forehead and ever since the first shot these spots have been removed; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, lot number: EN5318, Expiration date: Unknown) via an unspecified route in the left arm (about an inch or so away from shoulder) on 27Jan2021 (21 days ago; at the age of 91-years) around at 13:30 or 14:00, as a single dose for covid-19 immunization. Medical history included pacemaker in 2015 (four years before the shot), prostate removed in Jun2020, blood pressure, age spots on the back of his hand and a big one on his forehead. Concomitant medications included metoprolol tartrate, 50 mg tablet twice a day with food for blood pressure (ongoing). The patient's cardiologist checked on 25Jan2021 and said it was okay to take the shot. Pacemaker was working. He still has 4 years before it has to be replaced. The patient received his first shot on 27Jan2021 and had no side effects or anything at all. Prior to the vaccine he noticed age spots on the back of his hand and a big one on his forehead and ever since the first shot these spots have been removed on an unspecified date in 2021. He had a few on his hand, a number of them on the back of his hand. He started to notice about a week or so ago, the age spots were disappearing. He had one that was half an inch in diameter on the front of his forehead and it has disappeared. These have all mostly disappeared. He was scheduled for the second dose on 16Feb2021 (this afternoon) at 14:45. He took his blood pressure medication this morning, has a pacemaker. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.