chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: 36 hours later developed what looked like shingles on the right side of body; rash; This is a spontaneous report from a contactable nurse or other health care professional report received from a Pfizer Sponsored Program Covax US Support. A contactable female (nurse) reported for herself that received bnt162b2 (Pfizer Covid-19 Vaccine, Formulation: Solution for injection) an unspecified route of administration as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving the first dose, 36 hours later developed what looked like shingles on the right side of body, rash went away with medication and patient would like to know if should still get second dose. Therapeutic measures were taken as a result of rash. The outcome of the events rash was resolved and other event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Oropharyngeal pain
Clinical narrative: barely move my arm / arm problem; really bad sore throat; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EW0185, Expiration date was not reported), via an unspecified route of administration on 13May2021 (at the age of 27-years-old) as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14May2021, the patient experienced barely move my arm / arm problem and really bad sore throat. It was reported that the patient was asking if he could take Ibuprofen or Tylenol. The patient also wanted to make sure what he could take for the events. No treatment was received for the events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: little bit tired; tenderness in her right arm; This is a spontaneous report from a contactable consumer (patient).  A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: ER8737, Expiration Date: 20Jul2021), via an unspecified route of administration, administered in right arm on 20Apr2021 at 16:00 (at the age of 73 years old) as first dose, single for COVID-19 immunisation. Medical history included being hyperallergenic from unspecified date in 1963, since when the patient was 15 years old and unknown if ongoing. However, it was also reported that the patient has no medical history (including any illness at time of vaccination) and family medical history relevant to the adverse event. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included glipizide and dulaglutide (TRULICITY), both taken for an unspecified indication, start and stop date were not reported. On 20Apr2021, after the first dose the patient had a tenderness in her right arm, where she received the vaccine. Then on 21Apr2021, the patient felt that she was a little bit tired. Events did not result to Emergency room and Physician Office visit. Outcome of all events was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dyspepsia, Dysstasia, Hyperhidrosis
Clinical narrative: Extremely sick; Vomiting; Diarrhea; Sweat; Chest hurting; Stomach burning; I need to get up which is really difficulty right now; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date were not reported), via an unspecified route of administration on an unspecified date, as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced extremely sick, vomiting, diarrhea, sweat, chest hurting, stomach burning, and I need to get up which is really difficulty right now on an unspecified date. Patient inquired whether he/she needs to go to the emergency room, because he/she have been extremely sick, all night vomiting, diarrhea, sweat, his/her chest hurting, his/her stomach burning. Patient needed to know on what needs to be done right now. Patient also stated he/she needs to get up and go to get a pen which is really difficulty right now, so he/she is going to get a hold of somebody right away. When confirmed if the patient got the side effects from Pfizer COVID Vaccine, patient stated that no, he/she just had the vaccine on Tuesday, Tuesday night. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: Extremely sick; Vomiting; Diarrhea; Sweat; Chest hurting; Stomach burning; I need to get up which is really difficulty right now; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date were not reported), via an unspecified route of administration on an unspecified date, as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced extremely sick, vomiting, diarrhea, sweat, chest hurting, stomach burning, and I need to get up which is really difficulty right now on an unspecified date. Patient inquired whether he/she needs to go to the emergency room, because he/she have been extremely sick, all night vomiting, diarrhea, sweat, his/her chest hurting, his/her stomach burning. Patient needed to know on what needs to be done right now. Patient also stated he/she needs to get up and go to get a pen which is really difficulty right now, so he/she is going to get a hold of somebody right away. When confirmed if the patient got the side effects from Pfizer COVID Vaccine, patient stated that no, he/she just had the vaccine on Tuesday, Tuesday night. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: Scheduled for her second dose today at 12 O'clock but she is not feeling well and unable to receive it; sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received 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 first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced scheduled for her second dose today at 12 o'clock but she is not feeling well and unable to receive it and sick on an unspecified date. Patient stated she had an appointment for 12:10 and she is calling to cancel it because she is sick and wants to reschedule it. Patient then inquired if she can be scheduled a new appointment and asks what hour on Saturday. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: feel cold; feel like that i have fever; Headache; Body ache; Feeling tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced feel cold, feel like that i have fever, headache, body ache and feeling tired. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Lip oedema, Lip swelling, Paraesthesia oral
Clinical narrative: my bottom lip has a little puffiness on it; I have a tingling on my lips/ My lip is so tingly; the bottom lips is little swollen; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0172, Expiration Date: not reported), via an unspecified route of administration on 13May2021 (at the age of 78 years old) as second dose, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EP7533), via an unspecified route of administration on 20Apr2021 (at the age of 78 years old) as single dose for COVID-19 immunisation. On 13May2021, when the patient got home after having the second shot of BNT162B2, the patient experienced that her lips was so tingly and the bottom lips was little swollen. On 14May2021, it looked like the patient's bottom lip has a little puffiness on it. Treatment was received in response with the events which included diphenhydramine (BENADRYL, 25mg) about 4 doses about over the night (as reported). Outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Lymphadenopathy
Clinical narrative: lymph node swelling; acute pain in the upper right side of my chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lymph node swelling and acute pain in the upper right side of my chest. It was reported that after the first dose the patient had some lymph node swelling which was believed the side effect and then this morning it was about 10 minutes of acute pain in the upper right side of chest and then it stopped. Abruptly as it started so the patient wanted to know if that was the vaccine side effect. The outcome of the event acute pain in the upper right side of my chest was recovered while the outcome of the event lymph node swelling was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Product administered by wrong person, Pyrexia
Clinical narrative: Fever; patient's temperature was checked and recorded to be at 101.5; pain; I gave her the shot; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown; Expiration date: unknown) as 2nd dose, single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 on an unspecified date as 1st dose, single dose for COVID-19 immunisation. On an unspecified date, the patient experienced fever and pain. The reporter stated that he/she gave the patient the shot and the patient got her 2nd shot yesterday at 4:00 pm. The reporter was asking if paracetamol (TYLENOL) can be given to the patient or if he/she should call a doctor. On an unspecified date, the patient's temperature was checked and recorded to be at 101.5. The outcome of the reported events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: first shot that I received I felt like a little hives just once/ Hives on my face and I wonder it is like alarming; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single; second dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration 12Apr2021 as second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt like a little hives just once after the first shot. The second shot, the patient have had hives on the face. It was reported that it was a hives situation that like very alarming in it. The patient was wondering if there was any information on this or did someone called and noticed about the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Got a 102 fever; This is a spontaneous report from a contactable consumer(mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on 13May2021 as second dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a 102 (unit was unspecified) fever.  It was reported that the patient's normal temperature was 97.2 (unit was unspecified). The patient underwent lab test and procedure which included Body temperature: 102 (unit was unspecified) on 14May2021. The outcome of the event was unknown. The reporter was querying what to do to get that (temperature) down and reported that she saw on the papers that it could be one of the side effects (the fever).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: some dizziness/moves her head left and right and she feels dizzy; she can't close her eyes and looks down right now the room is spinning; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 14May2021, as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced some dizziness/moves her head left and right and she feels dizzy and she can't close her eyes and looks down right now the room is spinning on 14May2021. Reporter said patient was not dizzy earlier today and was able to read online that dizziness is an allergic reaction. With this, he asked if could it be severe. Reporter also wondered if they should go to the hospital then proceeds to state that they are just going to the hospital just to be safe. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vascular pain
Clinical narrative: felt like my hamstring was pulled but it wasn't my hamstring, in my foot like my veins in my foot and they still hurt; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number unknown), via an unspecified route of administration on an unspecified date as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that he/she was at a vaccination center because he/she was due to get the 2nd shot but was also a little bit worried about getting a 2nd shot because (and told the doctor already too) after getting the 1st shot, he/she felt like a reaction. On an unspecified date, the patient reported that he/she felt like his/her hamstring was pulled but it wasn't the hamstring, in the foot like the veins in foot and they still hurt, and they were just uncomfortable and it felt like a little pinging sensation. The patient reported that he/she can walk and everything but knew that there was something that's not right and has never felt any kind of issues with the heels of his/her foot or any veins on the feet so the patient thought it was really odd and just wanted to talk to someone before getting the 2nd dose. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Infection stated 2nd day spread on 9-12th day3 to 6; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the left arm on 06May2021 15:00 (at the age of 78-years-old) as second dose, single dose for COVID-19 immunization at a Pharmacy/drug store. Medical history included allergy (not specified) from an unknown date and unknown if ongoing. The patient also has relevant medical history (reported as yes but was not specified). Concomitant medications included valsartan (DIOVAN), omeprazole (PROTONIX), loratadine (CLARITIN), oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET), montelukast sodium (SINGULAIR) and  caffeine, paracetamol, promethazine methylene disalicylate, salicylamide (PL); all taken for an unspecified indication, start and stop dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in the left arm on 15Apr2021 12:30PM (at the age of 78-years-old) as first dose, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 08May2021 12:00 AM, the patient experienced infection which started on the 2nd day, spread on 9-12th day 6 to 6 spreading towards the core (reported as today). No treatment was given as a result of the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Gait disturbance
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received 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 unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a little back pain in the right side, it continued to the hip, it could be just my back (as reported). The patient's back was hurting, he cannot walk too quickly. It was further reported that the patient was not feeling any fever nor anything like that. The patient was told to take only paracetamol (TYLENOL) but the patient was wondering, if it was okay to take anything else at this point since it was on Monday (as reported) that the patient had the vaccine. The patient have a back pain at the time of the report and didn't think it was really vaccine related, it could be the patient's own issue. The patient was asking if something can be taken other than paracetamol. Outcome of all events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Headache; Backache; Body ache; Nausea; Vomiting; Diarrhea; Fever; seems like every night temperature goes up at night time mostly; This is a spontaneous report from a contactable consumer(patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on 07May2021 as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, backache, body ache, nausea, vomiting, diarrhea and fever, it seems like every night the (temperature) goes up at night time mostly. Events were described as the worst side effects by the reporter. The patient was querying on how to know if was already been exposed to virus and would it be safe to get second dose out 3 weeks. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache; Backache; Body ache; Nausea; Vomiting; Diarrhea; Fever; seems like every night temperature goes up at night time mostly; This is a spontaneous report from a contactable consumer(patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on 07May2021 as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, backache, body ache, nausea, vomiting, diarrhea and fever, it seems like every night the (temperature) goes up at night time mostly. Events were described as the worst side effects by the reporter. The patient was querying on how to know if was already been exposed to virus and would it be safe to get second dose out 3 weeks. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Having cramps in legs, thigh and calf; This is a spontaneous report from a contactable consumer (parent). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date in May2021 as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, the patient experienced having cramps in legs, thigh, and calf. The reporter just wanted to see if it was just normal or something they should be concerned about. The outcome of the event was unknown.                    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Paraesthesia, Pyrexia, Rash
Clinical narrative: Fever; Rash; Numbness; Tingling; Nerve pain; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), dose 2 via an unspecified route of administration on 13May2021 (at the age of 21-years-old) (Lot Number: EW0170) as 2nd dose, single dose for covid-19 immunization.  Medical history included asthma. Concomitant medication included salbutamol (ALBUTEROL) taken for asthma. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: ER8735) on 21Apr2021 for COVID-19 immunization. On 13May2021, the patient experienced rash, fever, nerve pain, numbness, and tingling. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea
Clinical narrative: heavy dirty diarrhea; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: E00172), via an unspecified route of administration on 26Apr2021 (at the age of 74 years old) as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, and diarrhoea. Concomitant medications included pravastatin taken for blood cholesterol and hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for hypertension. The patient underwent lab tests and procedures which included blood test revealing a normal result on an unspecified date in Apr2021. The patient experienced heavy dirty diarrhea on an unspecified date in May2021 almost three weeks after receiving the first dose of BNT162B2. The patient reported that she doesn't know if it's from something that she ate or it's from the vaccine because she was due to get her second shot on 18May2021. The patient reported that she had it once before and then it's cleared up by its own, but this was ridiculous. She was on the 'pot' all day yesterday and it started again this morning, so the patient needs to know if it's a side effect or it's just something she ate that caused this. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0167, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 12May2021 at 08:30 (at the age of 31 years old) as first dose, single for COVID-19 immunisation in a hospital. Medical history included overactive bladder from an unknown date and unknown if ongoing. The patient has known allergies with beeswax. Prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medications included tolterodine, xantofyl (LUTEIN), fish oil and vitamin d, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. When the patient got his shot of BNT162B2, the patient  felt no pain when the nurse administered the shot. On 12May2021 at 21:00, the patient started to feel numbness occasionally in the thenar muscle on the radial side of the patient's left hand. The numbness was most obvious during complex hand movements such as hand washing and but it wasn't persistent. It was further described that it felt like the sudden numbness the patient gets when he accidentally hit his elbow against the wall but less intense. The patient woke up the next day with persistent numbness in his entire left hand, affecting the wrist, palm, and all 5 fingers. This persistent numbness the patient had felt was like the numbness he gets when he was sleeping on his side with his hands under his head. It extended to the patient's distal forearm on 15May2021. At the day of the report ,the 5th day after vaccination (as reported), the soreness of the injection site had subsided but both types of numbness in the patient's left hand remained. They're were not as bad as "pins and needles" and there was no tingling sensation but it was concerning the patient. No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. Outcome of all events was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness on Arm (though not as much as the first shot); This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0153, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on unspecified date in Apr2021 (at the age of 30 years old) as first dose, single for COVID-19 immunisation in a Pharmacy or Drug Store. Medical history included anxiety from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and  did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccine the patient was not diagnosed with COVID-19. The patient has list of other medications received within 2 weeks of vaccination. The patient experienced soreness on arm on Apr2021. The case was considered as non-serious. Since vaccination, the patient has not been tested for COVID-19. Treatment was given in response to the event which included ibuprofen. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling hot, Pruritus
Clinical narrative: My son is troubling by the stomach ache; He feel everything like hot; Body itch; This is a spontaneous report received from a contactable consumer (patient's mother). This consumer reported similar event for 2 patients. This is the second of two reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was troubling by the stomachache, he felt everything like hot, and body itch. The reporter's concern was the patient's stomachache. The outcome for the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550808 same reporter/drug, similar event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy, Muscle spasms, Muscle tightness
Clinical narrative: Swelling in the arm; hives; I started having charley horses, cramps in my back; Underarm started hurting; Lymph is swollen under my arm and my lymph node around my clavicle; muscles are all tight, all my muscles around my leg, my back, my skull, underneath my neck and back of my leg; back of my knee is paining, aching, throbbing; Vision was a little blurry; I am itchy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 10May2021 as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had swelling in the arm and hives. The patient then started having charley horses, cramps in the back, and the patient's underarm started hurting. The lymph was swollen under the patient's arm and the lymph node around the patient's clavicle. The patient's muscles were all tight, all the muscles around the leg, the back, the skull, underneath the neck. The back of the patient's knee was paining, aching and throbbing. It was also noticed that the patient's vision was a little blurry and the patient was itchy. The patient wanted to call and make sure that the patient was okay and was asking of what should be done. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Urticaria, Vision blurred
Clinical narrative: Swelling in the arm; hives; I started having charley horses, cramps in my back; Underarm started hurting; Lymph is swollen under my arm and my lymph node around my clavicle; muscles are all tight, all my muscles around my leg, my back, my skull, underneath my neck and back of my leg; back of my knee is paining, aching, throbbing; Vision was a little blurry; I am itchy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 10May2021 as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had swelling in the arm and hives. The patient then started having charley horses, cramps in the back, and the patient's underarm started hurting. The lymph was swollen under the patient's arm and the lymph node around the patient's clavicle. The patient's muscles were all tight, all the muscles around the leg, the back, the skull, underneath the neck. The back of the patient's knee was paining, aching and throbbing. It was also noticed that the patient's vision was a little blurry and the patient was itchy. The patient wanted to call and make sure that the patient was okay and was asking of what should be done. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration on 15 May 2021, as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tired, cold, stomach ache, and diarrhea on an unspecified date. Reporter stated that her husband and son got the vaccine yesterday, Pfizer vaccine. They have the side effect. Patient was tired and cold he think he got like stomach ache and diarrhea. But reporter's son is troubling by the stomach ache and he feel everything like you know hot, body itch and like the stomach ache is the my concern. Reporter stated she doesn't know what's going on. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Pain in extremity
Clinical narrative: Arm hurts; Shortness of breath; I can hardly breathe; Heart is beating like so fast; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16May2021 11:00 (Batch/Lot number was not reported) as 1st dose, single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm hurts, shortness of breath and heart was beating like so fast on 16May2021. The outcome of the events was unknown.  The patient just wanted to know if it was normal because she never had and it was her first time having the vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pyrexia, Rash
Clinical narrative: This is a spontaneous report received from COVAES. A non-contactable consumer (patient) reported a non-pregnant 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on the right arm on 13May2021 11:45AM (Lot number: EW0182)(at the age of 37 years old) as 1st dose, single dose for COVID-19 immunization. The vaccine was administered in a Workplace Clinic. Patient's medical history included hypothyroidism and prediabetes. The patient was diagnosed with COVID-19 prior to vaccination. Patient tested positive for COVID-19 prior to vaccination on an unspecified date. The patient has no known allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE, 50 mcg tablet). On 15May2021 10:00 AM, the patient experienced rash/discoloration on groin lymph nodes, chills, dizziness, fever and extreme fatigue. The patient did not receive any treatment for the reported events. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the reported events were recovering. No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin discolouration
Clinical narrative: This is a spontaneous report received from COVAES. A non-contactable consumer (patient) reported a non-pregnant 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on the right arm on 13May2021 11:45AM (Lot number: EW0182)(at the age of 37 years old) as 1st dose, single dose for COVID-19 immunization. The vaccine was administered in a Workplace Clinic. Patient's medical history included hypothyroidism and prediabetes. The patient was diagnosed with COVID-19 prior to vaccination. Patient tested positive for COVID-19 prior to vaccination on an unspecified date. The patient has no known allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE, 50 mcg tablet). On 15May2021 10:00 AM, the patient experienced rash/discoloration on groin lymph nodes, chills, dizziness, fever and extreme fatigue. The patient did not receive any treatment for the reported events. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the reported events were recovering. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Allergic reaction; Breaking out rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 13May2021 (batch/lot number was not reported) as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported had the shot on 13May2021 and the patient was breaking out rash on 14May2021. The patient wanted to know if you get an allergic reaction like breaking out and one of the symptoms is rash. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Vomiting
Clinical narrative: Upset stomach; Abdominal cramps have gotten worse/cramps still persisting after vomiting/hurts more when moving or breathing deeply; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0183), via an unspecified route of administration, administered in the left arm on 14May2021, at 14:30 (at the age of 30 years old) as second dose, single dose for COVID-19 immunization at a public health clinic/ veterans administration facility. Medical history included penicillin allergy. The patient was not pregnant by the time of vaccination. Concomitant medications included fluticasone and desogestrel, ethinylestradiol (ENSKYCE). The patient previously received the first dose of BNT162B2 (Lot number: EW0171), administered in the left arm on 23Apr2021, at 14:30 for COVID-19 immunization with no reaction on previous exposure to vaccine. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. On 14May2021 at 16:30, the patient experienced upset stomach about two hours after the second dose. Her abdominal cramps had gotten worse for eight hours until she experienced vomiting. Her cramps was still persisting after vomiting and it hurts more when moving or breathing deeply. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of the events which included famotidine (PEPCID AC), bismuth subsalicylate (PEPTO-BISMOL), and drinking plenty of liquids. The patient reported that famotidine and bismuth subsalicylate didn't help. The patient was recovering from the events.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Sore joints and muscles; Sore joints and muscles; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 at 16:00 (Batch/Lot Number: ER2613)  (at the age of 63-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included allergies: penicillin. The patient had no COVID prior to vaccination. Patient had no other vaccines in within 4 weeks prior to COVID vaccine. Concomitant medication included sertraline taken for an unspecified indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6199) on 15Mar2021 at 16:00 (at the age of 63-years-old) in the left arm for COVID-19 immunisation. In Apr2021, patient reported sore joints and muscles. The events appeared the week of second injection and then went away and reappeared on  05May2021 and is continuing. It was unknown if treatment was given to the patient. Patient had not tested for COVID post vaccination. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Cervical cyst, Ovarian cyst, Uterine cyst
Clinical narrative: cyst on my left ovary; I was informed that I had a cyst on my left ovary, two in my uterus and three on my cervix; I was informed that I had a cyst on my left ovary, two in my uterus and three on my cervix; Abdominal pain; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, high blood pressure, border line diabetes, hardening of arteries, and allergy to "most blood pressure medications," all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID-19 vaccine. Concomitant medication included semaglutide (RYBELSUS), diltiazem hydrochloride (DILT-XR), fish oil, and multivitamin, all from unknown dates for unknown indications. the patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported that on 09May2021, she started to experience abdominal pain and went to the emergency room on 12May2021. The patient was informed that she had a cyst on her left ovary, two in her uterus and three on her cervix. She believed all these had developed after the vaccine as she did not have any issues before. The patient reported she received treatment for the events and "follow-up" with an obstetrician/gynecologist (OBGYN). The clinical outcomes of abdominal pain and she had a cyst on her left ovary, two in her uterus and three on her cervix were not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: very small pockets of liquid (maybe 4); This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: ER8732, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 30Mar2021 16:00 (at the age of 45-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient has no medical history. Concomitant medications were not reported. The patient has no known allergies. The patient has no other medications in two weeks. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced very small pockets of liquid (maybe 4) on an unspecified date. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported that a female patient of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient's mother reported that the patient was having a headache after taking the 2nd dose on an unknown date and was asking if the patient can take Ibuprofen, Tylenol. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.