chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Dizzy; Joint pain; Weak; Shaky; Fever; Headache; This is a spontaneous report from a non-contactable other hcp. A 66-year-old female non pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, age at vaccination 66-year-old) via an unspecified route of administration on unspecified date in Jan2021 (Lot Number and expiry date was not reported) as single dose for COVID-19 immunisation. Medical history included keratitis and known allergies to Plaster, Sanitizer from an unknown date and unknown if ongoing. Concomitant medications included fish oil; probiotics; calcium; colecalciferol (VITAMIN D) taken for an unspecified indication start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration on unspecified date in Jan2021 (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. No COVID prior to vaccination. On 26Jan2021, the patient was dizzy, weak, shaky and had joint pain, fever, headache. The patient experienced dizzy symptoms a month after taking it, never got dizzy. She still had joint pain over a month after taking it. She was weak, shaky, fever, headache, and joint pain the night after taking second dose and latest three days. The patient underwent lab tests and procedures which included sars-cov-2 test via nasal swab as negative post vaccination on 26Feb2021. She did not receive treatment for adverse event. The outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Allergic sinusitis, Arthralgia, Pruritus, Rash, Seasonal allergy
Clinical narrative: Hay fever; soreness in joints; Nose is itching; Rash on right side of nose under eye/rash in face; sinuses; This is a spontaneous report from a contactable consumer or other non -health care professional (Patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 24Feb2021 14:00 (at the age of 78 years) as single for covid-19 immunization. Medical history included asthma (Asthma), seasonal allergy (Hay fever). The patient concomitant medications were not reported. On an unspecified date of 2021 the patient developed a reaction of pain in her joints. Had allergies like sinuses and hay fever for almost two days. She Had a rash in her face. Thursday started developing side effects like sinus or hay fever. Had it for two days. Then the side of her nose kept itching. she was looking in the glass and spotted a bump or a little rash on right side of her nose right under her eye. It is a round rash that is as big as her little fingernail. It is still there and plumped up and itching. There's one spot on top of her nose that is still itching. She had the allergy, sneezing, and blowing her nose. It was like sinus. It stopped because she took the Benadryl for that. Has been taking Tylenol 335mg for joint soreness. The Tylenol is slowing down the soreness in her joints. Benadryl has slowed down the allergy, itching, sneezing, and blowing her nose. Keeps drinking a lot of water. Every times she sneezes or blows her nose, she drink half a bottle of water. Itching and rash is still there now. Takes just one liqui-gel. Doesn't like taking too much of it. She was active and does exercising and doesn't want to be sleeping all of the time. May take one a day and that's it. Started Benadryl with just one, but her nose kept itching during the night so she would take another one. She takes one at night and one during the day. Now she was not taking any Benadryl because her allergy is gone. She was not blowing her nose. Nose it not itching. Still has the rash down the side of her face on top of her nose. Helped somewhat with the itching of her face. She had tried the cortisone 10 plus ultra moisturizing cream. It is good for itching and rashes. Benadryl helped somewhat with the itching on her face. Would take one Benadryl during the day, but then her nose kept itching at night so she would take another one. On an unspecified date of 2021 the outcome of the events hay fever, nose is itching, rash on right side of nose under eye/rash in face was unknown. The outcome of the event soreness was recovering. The outcome of the event sinuses was recovered on an unspecified date of 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Injection site erythema, Weight
Clinical narrative: second dose, she does not know how it is remotely possible that a 1 inch or 1.5 inch needle could have gone in to the deltoid; experienced a "lot of pain and extreme tenderness" on the shoulder, tight were her arm connects to her shoulder; injection site turned red with a raised area; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201; Expiration Date: 28Feb2021) via subcutaneous route of administration, administered in Arm on 24Feb2021 (at the age of 66 years old) as dose 2, single for COVID-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for back pain. Medical history included autoimmune disorder (She added she has an autoimmune disease, lung problem and several of other comorbidities), lung problem, heavy/50 lbs over weight/I weigh 150 something pounds, soft tissue problems, and back aches. The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269) via unspecified route of administration on 03Feb2021 09:30 (at the age of 66 years old) as single for COVID-19 immunisation and experienced as first dose, vaccine possibly left out of refrigeration. The patient experienced as, second dose, she does not know how it is remotely possible that a 1 inch or 1.5 inch needle could have gone in to the deltoid on 24Feb2021, experienced a "lot of pain and extreme tenderness" on the shoulder, tight were her arm connects to her shoulder, injection site turned red with a raised area on 2021. Reported as, She explained 8-10h prior to the receipt of her first dose of the Pfizer-BioNTech COVID-19 vaccine, she took a Tylenol for the back aches. She elaborated the reasons for believing she received the second dose subcutaneously. She explained the nurse took her free hand and gather all the tissue and administered the vaccine an inch for being on the shoulder. She said she doesn't know of a needle that can be that long and has never received a vaccine that high. She reported a "small quarter sized" "local reaction where the injection was administered". She also mentioned she experienced a "lot of pain and extreme tenderness " on the shoulder, tight were her arm connects to her shoulder. The patient underwent lab tests and procedures which included weight: 50 lbs on an unspecified date (50 lbs over weight), weight: weigh 150 something pounds on an unspecified date (weigh 150 something pounds). Outcome of all the events were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Ear pain, Nasal congestion, Oropharyngeal pain
Clinical narrative: coughing terribly; stuffy nose; sore throat; painful ears; sneezing; loss of voice; This is a spontaneous report from a Pfizer-sponsored program regulatory authority Sup-port via a contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she started coughing terribly on 24Feb2021. She was asking if this was okay. The patient also had stuffy nose, sore throat, painful ears, sneezing and loss of voice 12 days after the first dose (12Feb2021). Suspects that it was caused by the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number can-not been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: coughing terribly; stuffy nose; sore throat; painful ears; sneezing; loss of voice; This is a spontaneous report from a Pfizer-sponsored program regulatory authority Sup-port via a contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 12Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she started coughing terribly on 24Feb2021. She was asking if this was okay. The patient also had stuffy nose, sore throat, painful ears, sneezing and loss of voice 12 days after the first dose (12Feb2021). Suspects that it was caused by the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number can-not been obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: swelling at injection site; pain at injection site; Warm to touch; swelling and pain at injection site and then progression to formation of tense bullae and erythema and induration; swelling and pain at injection site and then progression to formation of tense bullae and erythema and induration; swelling and pain at injection site and then progression to formation of tense bullae and erythema and induration; This is a spontaneous report from a contactable physician. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route, administered in left deltoid on 03Mar2021 (Batch/Lot Number: EN6205 6130121) as dose 1, single for COVID-19 immunisation. The patient's medical history included COVID-19 and concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks of the vaccination. The patient was not tested for COVID post vaccination. On 04Mar2021, about 6-8 hours prior to arrival in ED (Emergency department) the patient started to have swelling and pain at injection site and then it was progressed to formation of tense bullae and erythema and induration. It was warm to the touch and painful. As corrective measure clindamycin, hydrocortisone cream was taken by the patient. The outcome was unknown for the reported events.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: swelling at injection site; pain at injection site; Warm to touch; swelling and pain at injection site and then progression to formation of tense bullae and erythema and induration; swelling and pain at injection site and then progression to formation of tense bullae and erythema and induration; swelling and pain at injection site and then progression to formation of tense bullae and erythema and induration; This is a spontaneous report from a contactable physician. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route, administered in left deltoid on 03Mar2021 (Batch/Lot Number: EN6205 6130121) as dose 1, single for COVID-19 immunisation. The patient's medical history included COVID-19 and concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks of the vaccination. The patient was not tested for COVID post vaccination. On 04Mar2021, about 6-8 hours prior to arrival in ED (Emergency department) the patient started to have swelling and pain at injection site and then it was progressed to formation of tense bullae and erythema and induration. It was warm to the touch and painful. As corrective measure clindamycin, hydrocortisone cream was taken by the patient. The outcome was unknown for the reported events.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: sore arm at injection point; Fever; chills; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration in left arm on 04Mar2021 10:30 (at the age of 57-years-old) as dose 2, single for COVID-19 immunization. Medical history included Rectal ulcerative colitis. The patient previously took Ceclor and experienced allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration in left arm on 11Feb2021 10:30 (at the age of 57-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced sore arm at injection point, fever, chills, body aches and headache on 04Mar2021 21:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Arm hurt just for a day; Rash; This is a spontaneous report from a contactable reporter (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation.The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient stated that his/her arm hurt just for a day on an unspecified date. Patient got vaccination on Friday around 2 O' clock and his/her arm hurt just for a day and it just went away. Patient broke out of a rash on his/her back, arm and face as well on an unspecified date. Patient did not have any respiratory difficulty or anything. Patient informed he/she did not eat anything different or drink anything, but just wanted to know if the vaccine gave the reaction. Patient had this rash appear tonight, like around 6 o clock and he/she do not know. He/she did not eat anything different or drink anything. But he/she just wanted to know if the vaccine gave the reaction. patient took 50 mg of Benadryl but it seems to disappear. Outcome of the event Arm hurt just for a day was recovered on unspecified date. Outcome of the event rash was recovering.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort
Clinical narrative: pain primarily in the joints in his hips and legs; a lot of discomfort, mainly joint pain; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 04Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient developed pain primarily in the joints in his hips and legs and stated that he was going through a lot of discomfort, mainly joint pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Malaise, Vomiting
Clinical narrative: severe vomiting; diarrhea; very very sick; Tired; pain in hip/joint pain; This is a spontaneous report from a contactable consumer (patient). A 83-year-old female received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EN6199), via an unspecified route of administration on Wednesday, 03Mar2021 at 16:00 (at the age of 83-year-old), as dose 1, single in left arm for COVID-19 immunization Pharmacy/drug store. The patient's medical history included asthma which was not ongoing, and hip surgery 5-6 years prior to the first dose. Patient had allergy, can't take aspirin and Codeine by injection. She can only take Tylenol. Concomitant medication unspecified medicine at 06:00 AM every morning, which she has taken it for years, and has taken nothing new. On 03Mar2021, after first dose of vaccine, the patient experienced pain in hip/joint pain. Patient thought it was from her Hip surgery on the left side. But she read from papers that the vaccine causes joint pain and used heat pad. On 04Mar2021, post first dose, the patient was "very very sick" and tired. At 13:00 noon, the patient experienced severe vomiting and diarrhea. Patient has not eaten anything and was only been drinking water. The clinical outcome of the event hip/joint pain was resolving and clinical outcome of the event diarrhea was resolved on an unspecified date in Mar2021. The clinical outcome of all other events was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Pain in extremity, Taste disorder
Clinical narrative: No sense of taste; no sense of taste or smell; mild pain in her arm; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: was not reported), via unspecified route, administered on 03-MAR-202115:00 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she think she was ok, but she was scared". patient asking if loss of taste and smell are side effects of the covid vaccine and was this a contraindication to getting the second dose. She received the "first Pfizer Covid shot on 03-MAR-202115:00 (Wednesday afternoon) and on 04Mar2021 (yesterday)  she had soreness in her arm, She only had some mild pain in her arm, she took Tylenol as recommended for any discomfort afterwards. But this morning on 05Mar2021 she  woke up and she have no sense of taste or smell". Her most pressing question this morning was should she go and get a COVID test; is that going to be useful because she has been administered the Pfizer COVID-19 Vaccine; what if she now has the virus which she probably had before she got the Pfizer COVID-19 Vaccine. The outcome of events was unknown.    No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Erythema, Eye pain, Pain
Clinical narrative: soreness/ aches and pains; Shivers; face is boiling, heated; Eyes hurt; Dizzy; injection site being swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 28Feb2021 15:00 (at the age of 66-year-old) as dose 2, single for covid-19 immunisation. Medical history included eye injury from 2016 to an unknown date In 2016 he was mugged in a city, they had bashed on the head, and because of it he has eye damage on the right side of forehead, as well as his eye and retina collapsed, brain injury from Mar2020 to an unknown date He fell off a roof in Mar2020, because of that he went to (center name) for 3 months, he was in a Neurological Facility, because with the fall to his head he had damage head with many bleeds, bowel movement irregularity from an unknown date and unknown if ongoing, he take Motegrity for bowel movements but he has taken it for years. Concomitant medications included prucalopride succinate (MOTEGRITY) taken for bowel movement irregularity, start and stop date were not reported. He also takes Vitamin pills to keep healthy. Patient had no other vaccine on the same day or in the 3 weeks prior. Patient had no other relevant family medical history to add. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 04Feb2021 at some point in noon (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. On 01Mar2021, the patient experienced soreness/ aches and pains, shivers, face is boiling, heated, eyes hurt, dizzy, injection site being swollen. He had not had any visit to the ER or Physician office yet. The outcome of the events was unknown.   No follow-up attempts are possible; No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: soreness/ aches and pains; Shivers; face is boiling, heated; Eyes hurt; Dizzy; injection site being swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 28Feb2021 15:00 (at the age of 66-year-old) as dose 2, single for covid-19 immunisation. Medical history included eye injury from 2016 to an unknown date In 2016 he was mugged in a city, they had bashed on the head, and because of it he has eye damage on the right side of forehead, as well as his eye and retina collapsed, brain injury from Mar2020 to an unknown date He fell off a roof in Mar2020, because of that he went to (center name) for 3 months, he was in a Neurological Facility, because with the fall to his head he had damage head with many bleeds, bowel movement irregularity from an unknown date and unknown if ongoing, he take Motegrity for bowel movements but he has taken it for years. Concomitant medications included prucalopride succinate (MOTEGRITY) taken for bowel movement irregularity, start and stop date were not reported. He also takes Vitamin pills to keep healthy. Patient had no other vaccine on the same day or in the 3 weeks prior. Patient had no other relevant family medical history to add. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 04Feb2021 at some point in noon (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. On 01Mar2021, the patient experienced soreness/ aches and pains, shivers, face is boiling, heated, eyes hurt, dizzy, injection site being swollen. He had not had any visit to the ER or Physician office yet. The outcome of the events was unknown.   No follow-up attempts are possible; No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported that, A 52-years-old- female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), dose 2 via an unspecified route of administration on 03Mar2021 16:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation (age at vaccination 52-years-old). The patient medical history and concomitant medications were not reported. Reporter (Caregiver) Consumer calling about her sister, who says that she is personally fine though she had both Pfizer COVID-19 vaccine doses herself and inflammation of her breasts. She says she is calling on behalf of her sister who is 53. She says this is her sister's second day in bed after getting her second dose of the vaccine. She says her sister took Tylenol last evening, but it did not do anything, and she would like to know if her sister could take Theraflu or something like that. She says her sister has had fevers, chills, pounding headache, pain and swelling in her underarm lymph nodes, muscle aches, and must be tired since she is staying in bed. She says her sister got her second dose on Wednesday at about 04:30PM. DSU- potential duplicate AEResponse: Stated to caller that according to the PI LAB#6.0 Revised: 25 February 2021, clinical trial participants did use antipyretic or pain medications however it does not state which ones were used. Spoke from the attached document and referred caller to the HCP. Stated that we can make recommendations of what medication her sister should take. Reporter states that here sister did not have any other recent vaccinations or started any new medications and had lab work done about a month or so ago but has had no recent blood work. Reporter says her sister is 120lbs and healthy, she says that her sister got her Pfizer COVID-19 vaccinations done at Atlantic City Convention Centre, and she did not have her sister's vaccine card to provide NDC/LOT/EXP for her sister's doses of the vaccine. She says her sister's second dose was March 3rd, her first was three weeks prior, she doesn't know if her sister has joint pain. She says her sister's side effects began yesterday at 09:00AM, and have stayed the exact same, the Tylenol is not helping. Tylenol UPC/LOT/EXP: Unknown, she doesn't have that information to provide. Product strength and count size dispensed: not provided. Additional lot numbers: not provided. Is a sample of the product available to be returned, if requested (Y/N): not provided, Packaging sealed and intact not provided. On 04MAR2021 (09:00) patient experienced lymph node pain under arms, she developed headache/pounding headache, fever, chills, muscle aches, swelling in her underarm lymph nodes, must be tired since she is staying in bed. Outcome of the events was Unknown. No follow up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported that, A 52-years-old- female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), dose 2 via an unspecified route of administration on 03Mar2021 16:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation (age at vaccination 52-years-old). The patient medical history and concomitant medications were not reported. Reporter (Caregiver) Consumer calling about her sister, who says that she is personally fine though she had both Pfizer COVID-19 vaccine doses herself and inflammation of her breasts. She says she is calling on behalf of her sister who is 53. She says this is her sister's second day in bed after getting her second dose of the vaccine. She says her sister took Tylenol last evening, but it did not do anything, and she would like to know if her sister could take Theraflu or something like that. She says her sister has had fevers, chills, pounding headache, pain and swelling in her underarm lymph nodes, muscle aches, and must be tired since she is staying in bed. She says her sister got her second dose on Wednesday at about 04:30PM. DSU- potential duplicate AEResponse: Stated to caller that according to the PI LAB#6.0 Revised: 25 February 2021, clinical trial participants did use antipyretic or pain medications however it does not state which ones were used. Spoke from the attached document and referred caller to the HCP. Stated that we can make recommendations of what medication her sister should take. Reporter states that here sister did not have any other recent vaccinations or started any new medications and had lab work done about a month or so ago but has had no recent blood work. Reporter says her sister is 120lbs and healthy, she says that her sister got her Pfizer COVID-19 vaccinations done at Atlantic City Convention Centre, and she did not have her sister's vaccine card to provide NDC/LOT/EXP for her sister's doses of the vaccine. She says her sister's second dose was March 3rd, her first was three weeks prior, she doesn't know if her sister has joint pain. She says her sister's side effects began yesterday at 09:00AM, and have stayed the exact same, the Tylenol is not helping. Tylenol UPC/LOT/EXP: Unknown, she doesn't have that information to provide. Product strength and count size dispensed: not provided. Additional lot numbers: not provided. Is a sample of the product available to be returned, if requested (Y/N): not provided, Packaging sealed and intact not provided. On 04MAR2021 (09:00) patient experienced lymph node pain under arms, she developed headache/pounding headache, fever, chills, muscle aches, swelling in her underarm lymph nodes, must be tired since she is staying in bed. Outcome of the events was Unknown. No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pain in extremity, Pain in jaw, Pharyngeal swelling, Swollen tongue
Clinical narrative: tongue got swollen/his tongue that swelled up inside his mouth; It says that the "throat"; his jaw and feet were hurting; her husbands tongue swelled up and was numb; his jaw and teeth on the side of his mouth were hurting; pain in feet /arm was hurt; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 74-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 11Feb2021 (at the age of 74-years old) (Lot Number: EL9269 and Expiry date was not reported) as dose 1, single for COVID-19 immunisation.  Medical history included cataract from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included warfarin (WARFARIN) taken for an unspecified indication, start and stop date were not reported and medications for diabetes.  On an unspecified date in Feb2021, the patient experienced tongue got swollen/his tongue that swelled up inside his mouth, he says that the throat, his jaw and feet were hurting, her husband's tongue swelled up and was numb, his jaw and teeth on the side of his mouth were hurting, arm was hurting/the pain was so bad. Therapeutic measures were taken as a result of arm was hurting/the pain was so bad. The outcome of the event pain in jaw was recovered on an unspecified date in 2021 and rest all the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: tongue got swollen/his tongue that swelled up inside his mouth; It says that the "throat"; his jaw and feet were hurting; her husbands tongue swelled up and was numb; his jaw and teeth on the side of his mouth were hurting; pain in feet /arm was hurt; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A 74-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 11Feb2021 (at the age of 74-years old) (Lot Number: EL9269 and Expiry date was not reported) as dose 1, single for COVID-19 immunisation.  Medical history included cataract from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included warfarin (WARFARIN) taken for an unspecified indication, start and stop date were not reported and medications for diabetes.  On an unspecified date in Feb2021, the patient experienced tongue got swollen/his tongue that swelled up inside his mouth, he says that the throat, his jaw and feet were hurting, her husband's tongue swelled up and was numb, his jaw and teeth on the side of his mouth were hurting, arm was hurting/the pain was so bad. Therapeutic measures were taken as a result of arm was hurting/the pain was so bad. The outcome of the event pain in jaw was recovered on an unspecified date in 2021 and rest all the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Urticaria
Clinical narrative: Feels very warm at times; Hives; Itching/itchiness in her arm pit that was on the right side/the itchiness had migrated or moved to her neck like the front of her neck; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201, Expiry date: unknown) dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 as dose 2, 0.3 ml single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262, Expiry date: unknown) dose 1 via an unspecified route of administration on 05Feb2021 as dose 1, single for COVID-19 immunisation and experienced itchiness at the shot site. The patient reported, after the second shot that evening, she had an itchiness in her arm pit that was on the right side, she used some lotion that didn't do anything. She feels very warm at times but no fever, and her itching is under her chin are primarily. She was taking a shower the next morning and the itchiness had migrated or moved to her neck like the front of her neck, not down into the chest but about 3-4 inches down and then 4-5 days later her husband said you have had that a while. She got some Cortisone cream, the anti-itch stuff that didn't seem to do much and her husband told her she has hives. She clarifies the Cortisone did help but after a while it would wear off but what helped more than anything else, she told her son she was itchy around the neck and he told her is allergy doctor said to take a tablespoon of apple cedar vinegar and that worked the best she had a hard time swallowing it. She says it is Cortisone 10, she does not have the box she just has the tube, the end of it says 20M441 and the other side says expiration Nov2023. She would like to know when should take Benadryl if needed. The outcome of the events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash papular, Vein disorder
Clinical narrative: the right palm of her hand became red and puffed/ it was red and a little bit it looks raised, not super puffy but a little bit fat; right palm of her hand became red and puffed/ it was red and a little bit it looks raised, not super puffy but a little bit fat; underneath her wrists, she said she noticed red veins; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9267; Expiry Date: Unknown), via an unspecified route of administration on 19Feb2021 (at the age of 43-years-old) as dose 1, single for covid-19 immunisation. No relevant medical history and concomitant medications were reported. The patient was calling about the Pfizer-BioNTech COVID-19 Vaccine and she said that she has a little bit of a reaction after receiving the first dose of the vaccine. The patient clarified that within the first few minutes after she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 19Feb2021, the right palm of her hand became red and puffed. Then underneath her wrists, she said she noticed red veins. She said the reactions went away after a little while, but she wants to know if these reactions have been reported before and if it would still be safe for her to receive the 2nd dose of the vaccine. The patient further clarified that the palm was red and a little bit it looks raised, not super puffy but a little bit fat after getting the vaccine. The patient was not received treatment for reactions as the reactions went away pretty quickly. She would say it went away like a couple of minutes might be. The patient stated, she know there was system to report the reactions but het point was to find out whether the reactions that she had was something that has been experienced by others and whether she should continue to get the second vaccine or not. The patient further added, "she want to know to someone who can talk to who has knowledge as to what the reaction are to the Pfizer vaccine and what was safe and what's the reaction that should not take to the second vaccine and what was the reaction was fine to take the second vaccine. The outcome of the events was recovered in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling face
Clinical narrative: Event: swelling on left side of nose between eye and nose was reported as worsened; a little painful; Swelling of the side of my nose, between my nose and my eye; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EH6203, Expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at age of 54-years-old) as dose 1, single for covid-19 immunisation. Medical history included acne from an unknown date and ongoing at times, history of this all her life. The patient's concomitant medications were not reported. On 04Mar2021, the patient experienced swelling of the side of my nose, between my nose and my eye on and swelling on left side of nose between eye and a little painful. On 05Mar2021 nose was reported as worsened. The reporter states it was a little painful and she didn't know what it was, today she woke up and the swelling was much worse, it was a little harder to open her eye, wants to know if this could be a mild allergic reaction. The patient state she has a history of acne, states it could be a bug bite, that she had one a few days prior to the vaccine but it did not swell. The patient would take EpiPen for next dose. The patient wanted to get second dose of the vaccine. The outcome of swelling of the side of my nose, nose was reported as worsened was not recovered and a little painful was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Swelling of eyelid
Clinical narrative: rash; eye lids were a little swollen; Skin on Neck Noticable Red particularily on right side; side got vaccine on right; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in Arm Right on 24Feb2021 at 11:45 (at the age of 71-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included, she had the one you have every 10 years, ah yes, the Tetanus shot in Dec, and she had no reaction and never had other reactions other than the enhanced flu shot for immunization. The patient started reaction I had, I never had a reaction to a shot, I did take the enhanced flu shot in the fall, on a Friday and by Sunday had a rash, and felt it was form the flu shot, I had another shot with no reaction. Concomitant medications were vitamins and 2 others. On 04Mar2021 09:00 the patient experienced rash, eye lids were a little swollen and she felt some tightness around her eyes, skin on neck noticable red particularily on right side; side got vaccine on right. It was reported that, the Dermatologist at that time gave me a strong cortisone cream and within 4 days it knocked it out. I looked on the internet people who get a rash on arm related to Injection site, mine was right arm, Right side of my neck is notably worse. a few red marks, neck on my left side and where my arm attaches, the skin is red not like hives. I took one Zyrtec and also put some zinc oxide on my chest area. Also providing information on antihistamines. For the rash from this time, caller stated that it started yesterday, she got shot in her right arm and she has red marks all on the right side of her neck, and on her left side she has a little bit and around where her arm is, and it is trying to be a rash on her chest. Patient received treatment as Zyrtec antihistamine and also put zinc oxide on her chest. Cortisone cream on the rash. Patient did not any AE(s) require a visit to emergency room and physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events rash and skin on neck noticable red particularily on right side; side got vaccine on right not recovered and eye lids were a little outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: experiencing joint and muscle pain; experiencing joint and muscle pain; This is a spontaneous report from a contactable consumer (Patient).   A 86-years-old female patient  received first dose of BNT162B2 ( PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL9269), dose 1, shot in her left arm on 11Feb2021 as dose 1, single for covid-19 immunisation. Medical history included Mild heart attack from 1996 to an unspcified date Additional Information for Other Conditions: Stent placed and thyroid surgery, intestine problem with antibiotic and anxiety from an unknown date and unknown if ongoing. Concomitant medication(s) reported as ongoing included clopidogrel (CLOPIDOGREL), 75 mg, by mouth, once a day for mild heart attack and a stent put in, levothyroxine (LEVOTHYROXINE), 75 mcg, by mouth, once a day for thyroid surgery, lorazepam (LORAZEPAM), 0.5 mc, by mouth, 3 times a day for Anxiety, probiotics (PROBIOTICS), 4 mg, by mouth once a day for intestine problem with antibiotic, vitamin d3 (VITAMIN D3), 400 iu, by mouth, once a day. On 02Mar2021, patient experienced experiencing joint and muscle pain. The The outcome for the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Headache, Pain
Clinical narrative: GI upset; Low grade fever; Headache; Body aches; Tired; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 04Mar2021 09:30 (at the age of 47-year-old) (Lot Number: EJ1685) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included breast cancer and COVID-19. The patient had allergies to sulfa and morphine. The patient's concomitant medications were none. The patient did not receive any vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 04Mar2021, the patient had low grade fever, headache, body aches, tired, dizzy, GI upset. The patient was very ill on 05Mar2021 and was completely better on 06Mar2021. The patient did not receive any treatment for the events. The outcome of the events was resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: GI upset; Low grade fever; Headache; Body aches; Tired; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 04Mar2021 09:30 (at the age of 47-year-old) (Lot Number: EJ1685) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included breast cancer and COVID-19. The patient had allergies to sulfa and morphine. The patient's concomitant medications were none. The patient did not receive any vaccine within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 04Mar2021, the patient had low grade fever, headache, body aches, tired, dizzy, GI upset. The patient was very ill on 05Mar2021 and was completely better on 06Mar2021. The patient did not receive any treatment for the events. The outcome of the events was resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Headache, Illness, Overdose, Product preparation issue
Clinical narrative: sick as a dog with a fever; sick as a dog with a fever; headache; couldn't get out of bed; The patient got an equivalent of 6 doses of very concentrated mRna vaccine.; patient received 0.3 mls of undiluted vaccine; This is a spontaneous report from a contactable pharmacist via from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: En6199; Expiration Date: 30Jun2021) via an unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 0.3 ml of undiluted vaccine. Patient receiving a full undiluted vial of the covid-19 vaccine, patient received 6 doses of the vaccine, States that one of his pharmacists did not dilute the vial, and drew a dose and gave it to a patient; so the patient received 0.3mL of undiluted vaccine. The patient got an equivalent of 6 doses of very concentrated mRna vaccine. On 06Mar2021, she was sick as a dog with a fever, headache, and she couldn't get out of bed. She was not on any other medication and confirmed she had no other vaccines 4 weeks prior to receiving the Covid vaccine. The reporter also confirmed that the dose drawn was .3mL and not the full .45ml in the undiluted vial. No Prior vaccinations. The outcome of event was recovered on unspecified date 2021  No follow up attempts are possible. No further information is expected.