chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8734, Expiration Date: Jul2021), dose 1 via intramuscular, administered in upper arm on 29Mar2021 15:45 (at the age of 19-year-old) as single dose for COVID-19 immunisation in pharmacy. The patient had no medical history and no family medical history to AE. The patient had concomitant medication taken as birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. After the first vaccination on an unknown date of 2021, the patient experienced just small cold. At the time of reporting, the outcome of event cold was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling abnormal, Head discomfort, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 34-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration on 08Jun2021 as 1st dose single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date Jun 2021, the patient stated that she feels numb, like she is not hungry, cannot sleep, didn't sleep last night, feels like she has insomnia severely. Caller stated, "I started experiencing, I was fine then sleep went away. I noticed more energy yesterday, I thought, I have a lot of energy, but by 11PM wasn't tired at all and just got worse over night. It's constant, I don't feel manic, but I do feel awake, feel awake with more energy than usual, my head feels pressured, my whole body feels like I'm being squeezed. It's like an emotional numbness, insomnia, not feeling hungry or anything". The patient had nausea as well. Side effects that patient experienced throughout the rest of her body (systemic side effects) included fever and chills, were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. The outcome of all other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 34-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration on 08Jun2021 as 1st dose single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date Jun 2021, the patient stated that she feels numb, like she is not hungry, cannot sleep, didn't sleep last night, feels like she has insomnia severely. Caller stated, "I started experiencing, I was fine then sleep went away. I noticed more energy yesterday, I thought, I have a lot of energy, but by 11PM wasn't tired at all and just got worse over night. It's constant, I don't feel manic, but I do feel awake, feel awake with more energy than usual, my head feels pressured, my whole body feels like I'm being squeezed. It's like an emotional numbness, insomnia, not feeling hungry or anything". The patient had nausea as well. Side effects that patient experienced throughout the rest of her body (systemic side effects) included fever and chills, were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. The outcome of all other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: II have received both doses of your vaccine and after the second dose, my long Covid symptoms subsided; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history included COVID-19 (several months) from Nov2020 to an unknown date and was hospitalized for 5 nights and 6 days and multiple sclerosis. The concomitant medication included Ocrevus for multiple Sclerosis. The patient past drug event included Ocrevus for multiple Sclerosis that depletes patient B cells and select T cells. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient received both doses of vaccine and after the second dose, her long COVID symptoms subsided. The patient firmly believe her Ocrevus infusion every 6 months will repeatedly wipe out COVID vaccine. The patient wanted COVID booster or the two shot series every 6 month and asked that was that possible. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: II have received both doses of your vaccine and after the second dose, my long Covid symptoms subsided; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history included COVID-19 (several months) from Nov2020 to an unknown date and was hospitalized for 5 nights and 6 days and multiple sclerosis. The concomitant medication included Ocrevus for multiple Sclerosis. The patient past drug event included Ocrevus for multiple Sclerosis that depletes patient B cells and select T cells. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient received both doses of vaccine and after the second dose, her long COVID symptoms subsided. The patient firmly believe her Ocrevus infusion every 6 months will repeatedly wipe out COVID vaccine. The patient wanted COVID booster or the two shot series every 6 month and asked that was that possible. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Gastric disorder, Gastric emptying study, Malaise, Ultrasound scan
Clinical narrative: Experiencing like stomach symptoms after the vaccine; Got very sick; This is a spontaneous report from a contactable consumer. This 19-year-old female consumer (Patient) and her Mother reported for that: A 19-years-old female patient received bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Lot number: ER8731 and Expiration date: Jul2021), dose 2 via intramuscular route in upper am on 19Apr2021 at 11:00 as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has no family medical history. The patient's concomitant medication included unspecified birth control medication. The patient received first dose of bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Lot number: ER8734 and Expiration date: Jul2021), dose 1 via intramuscular route on 29Mar2021 at 3:45 as single dose for covid-19 immunisation. Patient has not received any other vaccine in 4 weeks. On an unknown date, the patient started experiencing like stomach symptoms after the vaccine and got very sick. Her stomach problem did not go away and she was still dealing with them. The patient underwent lab tests and procedures which included blood work test, blood samples, some ultrasound and gastric emptying exam which resulted as negative. Outcome of event gastric disorder was not recovered while unknown for event malaise.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Experiencing like stomach symptoms after the vaccine; Got very sick; This is a spontaneous report from a contactable consumer. This 19-year-old female consumer (Patient) and her Mother reported for that: A 19-years-old female patient received bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Lot number: ER8731 and Expiration date: Jul2021), dose 2 via intramuscular route in upper am on 19Apr2021 at 11:00 as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has no family medical history. The patient's concomitant medication included unspecified birth control medication. The patient received first dose of bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Lot number: ER8734 and Expiration date: Jul2021), dose 1 via intramuscular route on 29Mar2021 at 3:45 as single dose for covid-19 immunisation. Patient has not received any other vaccine in 4 weeks. On an unknown date, the patient started experiencing like stomach symptoms after the vaccine and got very sick. Her stomach problem did not go away and she was still dealing with them. The patient underwent lab tests and procedures which included blood work test, blood samples, some ultrasound and gastric emptying exam which resulted as negative. Outcome of event gastric disorder was not recovered while unknown for event malaise.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling, Urticaria
Clinical narrative: experiencing a breakout of a rash; Hives; Swelling/My back is swollen, it is very itchy; Itching/My back is swollen, it is very itchy; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0217, expiration date: unknown), via an unspecified route of administration on 07Jun2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history included allergic to sea food and tomatoes and things. The patient's concomitant medications were not reported. On an unspecified date the patient experienced a breakout of a rash, hives, swelling/my back is swollen, it was very itchy. The patient wanted to know If she can take a Benadryl to relieve the itchiness for the allergy. She didn't know If she ate something or it's from the actual shot because she took this vaccine and this was her first shot. She doesn't want to take any kind of medication that might interact with it. So she called to get permission or find out if she can take the Benadryl to alleviate the hive that cause her skin is very itchy. Some kind of allergy medication to relieve the hive because her back was swollen, it was very itchy and don't want to keep scratching and make it bigger and bigger. Patient is scheduled for 2nd dose of vaccine on 02Jul2021. Outcome for the events was unknown.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Eczema, Rash
Clinical narrative: Eczema; rash/ Full body rash; This is a spontaneous report from a contactable consumer (patient's son). A 95-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in arm right on 06Mar2021 (at the age of 95-years-old) as single dose for COVID-19 immunisation. The patient's did not had any medical history including any illness at time of vaccination. The patient's concomitant medications were not reported. It was unknown whether the patient had history of any previous immunization with the Pfizer vaccine that would be considered as suspect. The patient did not administer any additional vaccines on same date of the Pfizer suspect. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE on 11Feb2021 (at the age of 95-years-old) for COVID-19 immunisation. The patient did not receive any prior vaccinations within 4 weeks. The consumer reported that post 2nd dose vaccination, the patient developed a rash that has been ongoing for 12-14 weeks now. The rash initially appeared on his torso and his entire body (full body rash). Currently, some of which has subsided in some areas but the rash was still evident all over his body. The patient went to his primary care doctor and also a skin doctor and they tried to sort out what it could be. The patient's physicians tried multiple treatment regimens to treat that but to no success. The consumer reported that it seems to coincide with the shot. The patient has had no medication changes. The consumer was not necessarily looking to report the side effects at that point as he didn't know if the vaccine was the cause, but they have not been able to explain it. The consumer was unsure of exact date of the event. However, he thought it was 12Mar2021. The consumer further stated that it was either the end of March or the middle of March. He attempted to confirm the rash broke out on rash on a Saturday with his father. The patient underwent biopsy a couple of weeks ago (May2021), the rash was tested and he thought it came back as eczema. The patient went to urgent care first and followed up a week later with his primary care doctor regarding the rash. The events required a visit to emergency room and physician office. There was no family medical history that pertained to the rash. The consumer would like to know if that has been reported side effect in relation to the administration of the vaccine and would like to seek treatment recommendation or remedy in line with the event. The outcome of all the events was not resolved.  Information on Lot/Batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash papular, Vaccination site erythema
Clinical narrative: Red Spot on Cheek; got the injection on her arm, it is red around the injection site and then went down her arm and back up; broke out in little red bumps on her chest and her arms, and it was the same kind of redness where she had the shot injection; also on her legs/rash on chest spreading down arm; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP6955, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 28Mar2021 at 11:15 hours as 2nd dose, single dose (at the age of 76-years-old) for covid-19 immunisation. Patient's had no medical history (including any illness at time of vaccination) and relevant family medical history. Concomitant medication(s) included vitamins (occasionally takes vitamins) taken for an unspecified indication, start and stop date were not reported. Patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 07Mar2021 as 1st dose, single dose (at the age of 76-years-old) for covid-19 immunisation. Patient had no prior vaccinations (within 4 weeks). Patient stated that initially after first dose, there was no redness at injection site. On 05Apr2021, patient now indicates a big red circle/red around the injection site, patient had it since it just popped up 2 weeks after the shot. Patient stated it was red around the injection site and then went down her arm and back up and it was worsened and then she broke out in little red bumps on her chest and spreading down arm/rash on chest spreading down arm, and it was the same kind of redness where she had the shot injection. Patient stated she also had a few on her legs. Patient stated she was not sure if it was an allergic reaction or how to treat it. Patient stated the redness was on her arm down to her elbow, it was pink and red and warm and then it went away, and now it was just red at the injection site. Patient was trying sensitive soap bout expensive sensitive soap to try and dry them up as treatment as it was a two month delay to see dermatologist. Patient also reports on cheek starting last week. On 26May2021, patient had red spot on cheeks. The outcome for broke out in little red bumps on her chest and her arms, and it was the same kind of redness where she had the shot injection; also on her legs/rash on chest spreading down arm in 2021 was recovered and for rest of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Brain headache; Chills; This is a spontaneous report received from a contactable consumer (Parent).   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jun2021 (Batch/Lot Number: Unknown) as 1st dose, singled dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Jun2021, the patient experienced brain headache and chills. The outcome of events was unknown.   Information about batch/lot no has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Had developed welts on her leg and a rash broke out/she has welts on the side of her thigh; Had developed welts on her leg and a rash broke out; 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, Batch/Lot Number: EW0153), dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Other Products, Patient History, and Investigation Assessment Not Provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date as single dose COVID-19 immunization. It was reported that DSU agent mentioned caller had developed welts on her leg and a rash broke out on an unspecified date. Caller had some questions regarding the side effects associated with the vaccine. It was reported that she had the Pfizer injection this past Monday, it was her second injection. It was reported that Today she had welts on the side of her thigh and a little rash broke out. She doesn't know if it would be a side effect of the injection. She wants to know if its related. Reporter seriousness for events Unspecified. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: got heavy arm pain; This is a spontaneous report from a contactable consumer (Patient) reporting himself. A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration in Left Arm on an unspecified date as single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 administered in Left Arm on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has not received any prior vaccination within 4 weeks. Patient stated he received both doses of vaccine, Second dose received on 06May2021 and had arm pain in area of arm where the vaccine was administered; when the pain started it was pretty bad, has lasted about a month now and is definitely better now but is still annoying. The seriousness of the event was reported as non-serious. Patient had no treatment for the reported event but is muscling it out and everyone in his family got the covid vaccine and he is the only one with this pain.The clinical outcome of the event was recovering.  Information on the Lot/Batch number has been requested.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hypoacusis, Illness
Clinical narrative: Very dizzy; Hearing problem; sick; This is a spontaneous report from a contactable consumer (patient). A 74-years-old patient of an unspecified gender received first dose of bnt162b2 (formulation: Solution for injection, Batch/Lot Number: EW0153) via an unspecified route of administration, administered in Arm on 24May2021 16:40 (at the age of 74- years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and thyroid disorder which was surgically removed (thyroidectomy). Family medical history related to adverse event (dizziness), the patient reported yes, but most of the family was dead but don't think that really matter. The patient's concomitant medications include one for thyroid (not clarified further) and had never taken any medicine. The patient did not receive any other vaccine 4 weeks prior to COVID 19 Vaccine probably since 1993 and never got sick. On an unspecified date, the patient was very dizzy for over a week and didn't even think to call doctor, but did today, because patient would take the second shot on Monday (14Jun 2021). The doctor would give the patient medication if got dizzy again. The patient had lab test coming up, which are yearly test that I get because I don't have a thyroid. The patient also had hearing problem on an unknown date. The patient never got sick but covid 19 vaccine made sick. The patient did not receive treatment for the events. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dehydration, Dizziness
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 74-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Lot Number: EW0153), dose 1 via an unspecified route of administration in right arm on 24May2021 16:40 (at the age of 74-years-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included had her thyroid removed in the 90s, patient stated she has been on medication since 2002. Concomitant medication included Armour Thyroid taken from 2002 and ongoing. The patient previously took Armour thyroid as she had her thyroid removed in the 90s. On 26May2021, the patient experienced horrible dizziness which lasted for a week and a half and just ended recently. She did not understand what it was for a while and thought it could be dehydration but she drank plenty of water and that did not stop. On 24May2021, the patient experienced dehydration. On an unspecified date in May 2021, the patient had abdominal comfort. No treatment was given for the events. The outcome of the events was reported as recovered on an unspecified date in June 2021. No follow-up attempts are possible. No information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: right cheek started turning red/ spread towards the right ear, then left cheek near the nose, and turned a little bit red"; became warm to touch, felt hot inside, cheek was "warm to touch"; started itching; felt a little stingy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, 25 minutes after the first dose, the patient experienced right cheek started turning red, became warm to touch, felt hot inside, and felt a little stingy. HCPs checked and confirmed that patient cheek was "warm to touch" and that spread towards the right ear, then left cheek near the nose, and turned a little bit red. Patient received antihistamine as a treatment for the events. So, the patient started itching and she took another antihistamine, and the events went away eventually. The patient clarified that her throat didn't close up or anything like that and asked for guidance regarding her second dose. The outcome of the events was recovered.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a non-contactable consumer (wife). A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration in upper left arm on 24May2021 at 16:40 as 1st single dose for COVID-19 immunisation. The patient medical history include chickenpox. The patient concomitant medication includes apixaban (ELIQUIS) taken for unspecified indication in May probably a couple of months and supplements. Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had no adverse event prior to vaccine. On an unspecified date in May2021, the patient got shingles which was triggered by the shot. The patient was diagnosed with shingles following receiving the vaccine, confirmed as Pfizer Covid-19 Vaccine. It happened a few days later, the symptoms started about the 3rd day after the vaccine was given and patient had no idea, when he went into the Emergency facility that he had shingles. Patient thought it might be something else and was highly surprised. Patient was still experiencing it, it was about the same and he was miserable. Patient did go to the Emergency area at the hospital and they gave him prescriptions and checked him over but they did not know right away he had shingles. They found it before he left and gave patient something for pain. The patient came home, and was not admitted. The reporter informed that the patient had chicken pox and that was why it was able to be triggered in him with the shingles. People who had shingles had the chicken pox. Patient was due for second dose. The event required patient to visit emergency room. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Overdose, Wrong product administered
Clinical narrative: crying; patient came to receive meningitis vaccine and was accidentally given a third dose of Pfizer covid vaccine; patient came to receive meningitis vaccine and was accidentally given a third dose of Pfizer covid vaccine; This is spontaneous report received from contactable Pharmacist. This Pharmacist reported for 18-year-old female patient that received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0180, expiry date: Aug2021) via an unspecified route of administration on left arm on 09Jun2021, (18-year-old at the time of vaccination) 0.3ml as a single dose for COVID-19 immunization. Patient previously took first dose of covid-19 vaccine and on 13May2021 received second dose of Pfizer covid vaccine. The patient's medical history included anemic. The patient's concomitant medications were not reported. On 09Jun2021, the patient experienced patient came to receive meningitis vaccine and was accidentally given a third dose of Pfizer COVID vaccine. Caller States that the patient was only 18 years old and was now crying because she was worried about having side effects. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information was expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Needle issue, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:45 (Batch/Lot Number: EN6206) as 1st dose, single dose for COVID-19 immunization.Medical history included insomnia (will take something to help her sleep if she has trouble sleeping, but does not take any regular medications and was a healthy person).The patient concomitant medications were not reported. There was no prior vaccinations within 4 weeks. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 15 Mar 2021 (Batch/Lot Number: EN6206) as 2 nd dose, single dose for covid-19 immunization. The patient reported that she got the 2 shots of the COVID-19 vaccine. On 22Feb2021, after vaccination on same day the patient had severe pain in left arm (started the same day that she received the first dose of the COVID-19 vaccine). The pain has gotten worse, and she would like to know how long she can expect for this continue. The patient was really athletic and does a lot of sports but cannot do many things because of the pain in her left arm. The patient reported that whoever gave her the first dose of the COVID-19 vaccine said that the needle was defective and maybe this was the cause of the pain. Caller reported that she asked whoever gave her the first dose of the COVID-19 vaccine if the shot was still effective and the individual informed her that all the vaccine material was administered to the caller. It was reported that, she knew that when the nurse gave her the shot for the first dose of the COVID-19 vaccine, something happened there and when she took it out, she said the needle was defective to the person standing next to her administering vaccines. It was reported that after a couple weeks of her arm hurting, she talked with her doctor, her doctor said that the arm pain was better than COVID-19 and that it will go away, but the arm pain has continued. Her physician referred her to physical therapy, but she has not started physical therapy yet as she needs to call to make an appointment. Caller reported that she cannot sleep on her left side because her arm was so painful. She does not have any position that she can sleep on her left side and she was a side sleeper and cannot sleep on her left because her arm was too painful. Caller reported that she was vaccinated not to get the disease. The outcome of event severe pain in left arm was not resolved. The outcome of event the needle was defective was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Groin pain
Clinical narrative: Severe pain in groin area; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe pain in her groin area, and she might see a doctor. It was reported that patient was in too much pain and would have to go to an orthopedic surgeon for her groin pain. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Ear infection, Hypoacusis
Clinical narrative: Severe pain in groin area; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe pain in her groin area, and she might see a doctor. It was reported that patient was in too much pain and would have to go to an orthopedic surgeon for her groin pain. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Severe pain in groin area; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe pain in her groin area, and she might see a doctor. It was reported that patient was in too much pain and would have to go to an orthopedic surgeon for her groin pain. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Back pain, Faeces soft, Renal pain
Clinical narrative: She has soft stools; Hair thinning; Kidney pain; Sore hip and back; Sore hip and back; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history included Covid-19. The patient concomitant medications were not reported. The patient experiencing has soft stools, hair thinning and had kidney pain, sore hip and back. The outcome of events was unknown.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: She has soft stools; Hair thinning; Kidney pain; Sore hip and back; Sore hip and back; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history included Covid-19. The patient concomitant medications were not reported. The patient experiencing has soft stools, hair thinning and had kidney pain, sore hip and back. The outcome of events was unknown.  Information about lot/batch number is requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Pyrexia
Clinical narrative: He began to feel tired; Cold/acting like he had a cold; He started running a fever; This is a spontaneous report from a contactable consumer. A 12-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0167, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 01Jun2021 13:00(Age at vaccination 12 years) as 1st dose, single dose for covid-19 immunisation.  Medical history included tonsillectomy from 29Apr2021 to an unknown date, hypersensitivity. Patient family history included she and her husband had it (tonsillectomy, hypersensitivity) and it didn't bother them other relatives had the Johnson and it didn't bother them.  The patient's concomitant medications were not reported.  The patient experienced he started running a fever that has subsequently lasted every night since on 03Jun2021(2 days later), he began to feel tired on 08Jun2021, cold/acting like he had a cold on 07Jun2021. Patient stated Patient Age at time of onset of reaction was 12 years. Patient took vaccine dose as time for kids to get it for protection from COVID-19, when he comes back in from playing, he is tired. He started to drink a lot of water and lie down on the floor. That day he was at school and they have not called so he is better. reporter is asking is this normal for him a run a fever for this long, He is due for the other shot the 23Jun2021 and should he get the shot if he is still running a fever she wanted confirm. Every night when he went to bed, he would run a temperature. Therapeutic measures were taken as a result of he started running a fever Tylenol was given to break his fever, reporter sometimes gives it twice, but it did work.  The outcome of events was running a fever, cold/acting like he had a cold was not recovered and feel tired was recovering.  Follow-up(09Jun2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 12-year-old male patient (reporter's son) included: Outcome of events updated, relevant medical and family history added. Dose number confirmation to 1st dose captured, Age at vaccination added.
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation
Clinical narrative: Eyes burning 10 min after receiving Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. A patient received dupilumab (DUPIXENT), via an unspecified route of administration from an unspecified date (Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. On unknown date, the patient experienced eyes burning 10 min after receiving Pfizer COVID vaccine. The outcome of event was recovered on unknown date in 2021. The action taken in response to the events for dupilumab was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Patient has been having issues with her menstrual  cycle and it nor being regular; This is a spontaneous report from a Pharmacist via medical information team. A non-contactable pharmacist reported for a female patient. A female patient of an unspecified age received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number and expiration date was not reported), via an unspecified route of administration on unspecified date on Mar2021 as 2nd dose, single dose for covid-19 immunization. The patient previously received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date after the second dose, Patient has been having issues with her menstrual cycle and it nor being regular. The reporter was wondering if they had any information regarding this occurring with people.Response included that after reviewing the Prescribing Information for Pfizer COVID-19 Vaccine did not find information regarding the vaccine effecting menstrual cycle. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please have patient contact her doctor/healthcare provider about what she has been experienced/are experiencing. As Pfizer cannot assess causality with what she is experiencing is associated with the Pfizer COVID-19 Vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lethargy, Off label use, Sluggishness
Clinical narrative: Xeljanz (tofacitinib citrate) was given for Alopecia; First Dose: felt a little sluggish and lethargic; First Dose: felt a little sluggish and lethargic; This is a spontaneous report from a contactable consumer (patient's father) via a Pfizer sponsored program. A 16-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 01Jun2021 (at the age of 16-years-old) as SINGLE DOSE for covid-19 immunisation; tofacitinib citrate (XELJANZ), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for alopecia. The patient medical history was not reported. The patient concomitant medications were none. It was reported that tofacitinib citrate was given for alopecia. She had no reaction except she felt 'sluggish' and lethargic. Caller did not want to file a report. She was currently on tofacitinib citrate and she was scheduled to receive her second dose of the Pfizer BioNTech COVID-19 vaccine in 1 to 2 weeks. Since tofacitinib citrate was an immunosuppressant and people who are taking immunosuppressants may have a lower response to the vaccine and therefore not produce enough antibodies, should her daughter get an antibody test done and how long after the second dose should she get it done. The caller's daughter was taking tofacitinib citrate for Alopecia and he wanted to know the reaction between tofacitinib citrate and the Pfizer COVID Vaccine. Caller stated his daughter has been taking tofacitinib citrate for a couple of years now and he was reading how the medication would interact with the COVID vaccine. Caller stated some reports stated that after the second vaccine, it might be wise to get an antibody test to make sure the body was producing antibodies. Caller stated the patient took the first dose, but she hasn't taken the second one. Caller stated there were no adverse events, other than she felt a little sluggish and lethargic for a day or two. The outcome of all event were unknown.  Information on Lot/Batch number has been requested.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity
Clinical narrative: No other res´ponse to first shot except arm pain; This is a follow up-spontaneous report from a contactable consumer. A 34-Year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via intramuscular route of administration administered in Arm Left on 17Apr2021 18:15 (Batch/Lot Number: EW0164) as 1st dose, single dose for covid-19 immunization. Medical history included chronic sinusitis from 2004 and ongoing Adenoidectomy x2 2008+2016, Hydradenitis suppurtiva from 2010 and ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) via oral taken for seasonal allergy from 01Mar2021 and ongoing, fluticasone propionate (FLONASE ALLERGY RELIEF) via nasal taken for seasonal allergy from 01Mar2021 and ongoing, spironolactone via oral from 01Jun2019 and ongoing, famotidine via oral taken for gastrooesophageal reflux disease from 10May2021 to 17May2021. The patient previously took doxycycline and experienced Allergic reaction, sulfa g and experienced Allergic reaction. On Apr2021 the patient experienced no other response to first shot except arm pain. The patient underwent lab tests and procedures which included covid-19: negative on 08Oct2020, covid-19: negative on 15Jan2021. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: joint pain in her elbow, knees, and ankles; ankles are also now swollen; This is a spontaneous report from a contactable consumer(patient). A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/batch number: unknown), via an unspecified route of administration on 04Jun2021 as a 2ND DOSE, single dose for COVID-19 immunisation. The patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/batch number: unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date Jun2021, patient experienced joint pain in her elbow, knees, and ankles and stated her ankles are also now swollen. Patient stated that she spoke to someone who took a report including the lot number of the vaccine and then she was told to call Medical Information for more information regarding her side effects. The outcome of the events was reported as unknown.  Information about batch/ lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: extra sore after second shot; This is a spontaneous report from a contactable consumer or other non hcp (patient's Wife). A male patient of an unspecified age received BNT162B2, (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced extra sore after second shot on an unspecified date. It was also reported that Her other kids and her husband and herself all felt extra sore after the second shot. The Outcome of the event was unknown.    Information on the lot/batch number has been requested .
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: body aches; headache; fatigue; This is a spontaneous report from a non-contactable pharmacist (consumer). A 16-years-old patient of an unspecified gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 for covid-19 immunisation . On an unknown date, about 5 hours after the injection, the patient experienced body aches, headache and fatigue which lasted for about 24 hours. The patient was given Tylenol for the events. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.