chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Exposure to SARS-CoV-2, Heart rate, SARS-CoV-2 test
Clinical narrative: She said she found out she was exposed to the COVID-19 Virus a week ago, yesterday. She said her granddaughter was diagnosed over the weekend with the COVID-19 Virus; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 73-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9265) via an unspecified route of administration in left arm on 29Jan2021 10:30 as 1st dose, single dose (at the age of 73-years-old) for COVID-19 immunization. Patient medical history included hospitalization and blood pressure issue and extreme sickness due to flu virus. The concomitant medications were not reported. Patient received first dose on 29Jan2021, was scheduled to get second dose of vaccine on 23Feb2021 but was exposed to her granddaughter who tested positive last week. She herself has not been tested since the exposure. She asked whether she can receive the second dose. Patient reported that she had been exposed to someone who had been diagnosed with being positive to Covid-19 virus, the infected individual was not experiencing any signs when she was with the patient but then on Thursday (11Feb2021) she started feeling sick. She said she found out she was exposed to the COVID-19 virus a week ago, yesterday (15Feb2021). She said her granddaughter was diagnosed over the weekend with the COVID-19 virus. She said she was calling Pfizer to find out if she should get the second COVID-19 Vaccine dose on 23Feb2021. She was in quarantine right and did not have a COVID-19 virus test performed after her exposure to her granddaughter who tested positive for the COVID-19 virus. She said she had been tested twice for the COVID-19 virus in the past, and both times she tested negative. She said the first time she was tested for the COVID-19 virus, she was extremely sick. She said the COVID-19 virus test was performed at either the end of Aug2020 or the beginning of Sep2020. She said her COVID-19 virus test was negative, and she was told she probably had a flu virus. Her second negative COVID-19 Virus test was done on 03Dec2020 (reported as 03Dec2021) before she had a hospital procedure on that day. She said she was supposed to stay overnight on observation after her procedure, but ended up being admitted to the hospital as an inpatient on Friday (04Dec2020). She said the morning after her procedure, her AFIB had returned with a vengeance, and she had blood pressure issues, and a rapid heart rate. She said she stayed at the hospital until late Monday (07Dec2020) when she was discharged home. The outcome of the event was unknown.   Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Heart rate, Heart rate increased, Malaise, Nausea
Clinical narrative: Feeling unwell; fast heart beat; nauseous; unbalanced when walking; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9810 and Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 04Feb2021 14:35 as 1st dose single dose for COVID-19 immunisation. The patient medical history included anxiety from Unspecified to Unspecified date. The patient concomitant medication included alprazolam (XANAX) taken for anxiety from Unspecified to Unspecified date. The patient received no other vaccines in the past 4 weeks period. On 05Feb2021, morning, she noticed she is feeling unwell and had a fast heart beat. After eating it got a little better. It says on the paperwork normal side effects to expect like feeling unwell and fast heartbeat which has calm down for her, but she was wondering how long this was expected to last and have the side effect. She was not feeling good this morning. She doesn't want this to last a long time. The patient reported that after the vaccine she felt nothing, no pain, no pain even at the arm. The patient reported that, she was not completely sure how she was feeling because she was sitting now, she felt nauseous and unbalanced, she was feeling unwell. As she was sitting down, she thinks it was better, but she still feels unbalanced when walking. The patient took half a Xanax when her heartbeat was fast, that was usually the trick that slows it. It was reported that, she takes Xanax for anxiety and maybe that was it was. She took the Xanax because she had to wait on the phone for so long to speak to someone. The second dose was schedule date on 02Mar2021. The patient had so many medications, but had not taken them before this started, she took them later. The patient received list of what she could expect, on the list what she had was a common reaction, but the Fast heart rate was in the call section, but it was not that bad for her to call 911 as she knows a fast heartbeat can happen with her anxiety. She usually gets the flu vaccine and pneumonia vaccine, she does not remember when she had it last, she usually gets them when it comes out or when pharmacy announces it and asks her. The patient noticed that people who usually get the COVID virus die of Pneumonia, so she thought she would get the pneumonia vaccine. The patient had some exam 2 weeks ago, and yesterday the Physician left a message about the results and did state on the phone that she has nothing to worry about. The outcome of Feeling unwell was not resolved and fast heart beat was resolving.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Fever; Flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (unknown manufacturer; Lot Number was not reported) as single dose and influenza vaccine at an unspecified dose and frequency; both via unspecified routes of administration, in Oct2020, for immunization. The patient's medical history included being allergic to penicillin with reaction including hives from 1985 (last time she had it); and high blood pressure, overweight, and fatty liver, all three were ongoing. The patient's concomitant medications were not reported. The patient had the flu and pneumonia vaccine in Oct2020 (last October) and she had fever and flu like symptoms on an unspecified date then it went away. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site is swelling and the pain; injection site is swelling and the pain; arm was stiff and that is what happened after the first shot also; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported for a female patient of unspecified age received bnt162b2 (Pfizer-Biontech covid-19 vaccine, Formulation: solution for injection) via unspecified route of administration on unspecified date as 1st dose single dose for COVID-19 immunisation. The patient's medical history included ongoing Crohn's disease (worse flare ever had in 35 years). Concomitant medication was not reported. On an unknown date, the patient experienced injection site swelling and pain. The patient also stated she experienced arm stiff after getting first dose. The patient had history of Crohns disease and having a whole problem with that at the moment. Outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected. Decision made to close the case.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Malaise, Pain
Clinical narrative: Headache; swollen lymph glands under the left armpit as well as on the left side of the neck; Same feeling of unwellness; Full body aches; This is a spontaneous report received from a contactable consumer (Patient) reported in response to HCP letter sent in Cross-Referenced case. A 29-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via intramuscular, administered in left arm on 24Jan2021 16:00 (at the age of 29 years old) as single dose for Covid-19 immunization. The patient medical history reported as none. Concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number/Expiry Date: EJ1686), via intramuscular route, administered in arm left on 03Jan2021 for covid-19 immunization and experienced body Aches and feeling of unwellness. On 24Jan2021 16:30, the day patient got 2nd dose, she experienced the same feeling of unwellness, full body aches, and had the side effects of a headache and swollen lymph glands under the left arm-pit as well as on the left side of the neck. Gradually the symptoms became more pronounced through-out the day but started within an hour of receiving vaccine. No test was performed. Therapeutic measures were taken as a result of full body aches and swollen lymph glands. Patient took Tylenol /Ibuprofen for swelling & aches. It was reported that there is reasonable possibility that the events full body aches and swollen lymph glands are related to suspect product. The outcome of events body Aches and feeling of unwellness was recovering and events headache and swollen lymph glands under the left armpit as well as on the left side of the neck was unknown.  No follow-up attempts are possible. Information on batch/lot number cannot be obtained. .
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: wasn't feeling well; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US SUPPORT. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 11Jan2021 as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. patient stated that she had first shot on 11Jan and 2nd dose on 01Feb. Patient was not feeling well on the day of her 2nd dose so she did not go. Patient was asking where to go to get the 2nd dose. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: started feeling sick; This is a spontaneous report from a contactable consumer (patient who is retired teacher). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EL9264, expiration date unknown) 2nd dose, via an unspecified route of administration on 04Feb2021, as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number EL3246, expiration date unknown), via an unspecified route of administration on 14Jan2021, as single dose for COVID-19 immunization. The worst part was she thinks she has a UTI and it makes her feel sick. She was so mixed up with days. She had the vaccine on Thursday. She started feeling sick on Sunday, 07Feb2021. She has an appointment to see the doctor in the morning. She was starting to feel sick like she has a urinary tract infection. She doesn't think the Estring was working. She doesn't have lubrication that she normally would. She think she has a defective one. She has and appointment with her doctor tomorrow morning. She had COVID19 Vaccine on Thursday. She started feeling sick on Sunday, 07Feb2021. The outcome of the events was reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: When getting pneumonia shot her arm was red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name unspecified, manufacturer: Pfizer, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date not reported) as unknown, single for immunization. Medical history and concomitant medications were not reported. The patient experienced that when getting pneumonia shot her arm was red on an unspecified date. Clinical outcome of the event was unknown.   No follow up attempts are needed. No further information is expected. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt bad the day after the vaccine; This is a spontaneous report from a non-contactable consumer (patient). This is the 2nd case of the two cases. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced felt bad the day after the vaccine. The patient did not know about the injection site though and she did not feel well, that was the day after her second inoculation. The outcome of event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt pretty lousy; This is a spontaneous report from non-contactable Physician (patient) communicated to Pfizer Sales Representative. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, expiration date: unknown), 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. Historical vaccine included Covid-19 vaccine for covid-19 immunization. The patient experienced felt pretty lousy on an unspecified date, this event took place after taking vaccine. Took Tylenol 21 hours after vaccination and began to feel better. The patient recovered from the event on an unspecified date.  Follow up attempts are not possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient herself). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: 59267-1000-02), via intramuscular route of administration on 23Feb2021 at 18:45 (at the age of 65-year-old) as 1st dose, single dose in left arm for COVID-19 immunization at pharmacy or drug store. The patient's medical history included thalassemia minor. Concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 23Feb2021 at 14:00, the patient experienced sore arm, queasiness in stomach 18 hours later, and loose stool. Patient did not received treatment for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was resolved on an unspecified date in Feb 2021. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Aphonia, Urticaria
Clinical narrative: broke out in fine and big hives; lost her voice; This is a spontaneous report from a contactable consumer.   A 73-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, solution in prefilled syringe), via an unspecified route of administration on an unspecified date on the upper left arm (Batch/Lot number was not reported) as unknown, single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient wanted to know the ingredients to the COVID vaccine. She wants to explain why she wants to know and states a few years ago she had the pneumonia vaccine at her providers office. After getting it, she broke out in fine and big hives all over her body, the product was the PREVNAR 13 vaccine. That night into the next day she lost her voice totally. She was taken to the ER the next and was kept for a half a day to monitor; the doctor gave her medication to restore her voice and it did. Now in the pandemic time with Pfizer making the vaccine and she got to thinking about this. She spoke to her doctor and was told by the doctor that the physician would look into it. It was also recommended by the doctor that she go ahead and schedule her appointment.  It was explained that the hives but they went away but she is not sure how long before they resolved. The fine hives were on arms and upper and lower extremities and the big ones were on her butt.  The loss of her voice resolved the day after once she left the ER and after getting medication; does not know the name of the medication administered for treatment. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information on the lot/batch number cannot be obtained.
Age: 80.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Influenza like illness
Clinical narrative: side effects like the flu; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (trade name unspecified), via an unspecified route of administration, in Oct2020 (batch/lot number was not reported), as single dose, at age 80 years old; and influenza vaccine (trade name unspecified), via an unspecified route of administration, in Oct2020 (batch/lot number was not reported), at unspecified dose, at age 80 years old, for immunization. Medical history included hair loss from 1960 and ongoing (it never came back). The patient's concomitant medications were not reported. In the end of Oct2020, the patient experienced side effects like the flu after his flu shot and pneumonia shot. The event lasted about a day and a half. The patient recovered from the event on an unspecified date.  Pfizer is a marketing authorization holder of Pneumococcal 13-Valent Conjugate Vaccine (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased. This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Valent Conjugate Vaccine (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  No follow up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: 4 days after first injection, I developed herpes simplex in my right nostril, 3 on my upper right lip, and one between my right nostril and right lip.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 17Feb2021 03:45 PM (at the age of 73-year-old) as, single for covid-19 immunisation at hospital. The patient Medical history included high BP, epilepsy, environmental allergies, and asthma and patient had allergy to latex. Concomitant medications included topiramate, losartan, omeprazole, levothyroxine sodium (SYNTHROID), atorvastatin calcium (ATOR) (all medications received in two weeks). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccine within four weeks of vaccination. On 21Feb2021 at 04:00 PM, after 4 days after first injection the patient developed herpes simplex on her right nostril, 3 on upper right lip, and one between right nostril and right lip. Patient never experienced an outbreak such as this in over 50 years and was remained confined to home since this pandemic began. Patient was treated with unspecified OTC medication for the event. The event was reported as non-serious. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: He states after taking covax on 2/20 and 5 hours later his eye got better; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable male consumer (patient himself) reported. A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2, Formulation: solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 20Feb2021 as 1st dose, single dose for COVID-19 immunization and viral eye infection. The patient medical history and concomitant medications were not reported. First time patient had Viral infection in eye for over 30 days. After 2 weeks of trying everything patient went to the ER this was the end of January and they sent him to an opthalmologist who confirmed he had a virus in his eye, and it would go away in 14 days. He states it never really did. They never told patient what it was or prescribe medication for it. On 20Feb2021, stated after taking covax, 5 hours later his eye got better. So, he was calling to report a positive note for the covax. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal
Clinical narrative: felt really bad; felt unwell; This is a spontaneous report from a contactable consumer (patient). An adult male patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (tradename unspecified, solution for injection in pre-filled syringe, lot number and expiry date were not reported),  via an unspecified route of administration on an unspecified date as unknown, single dose for pneumonia shot (immunization). The patient's medical history was not reported. Concomitant medication included influenza vaccine (FLU) on an unknown date for flu shot (immunization) as unknown, single dose. A few years ago, patient got 2 at the same time, he got a flu shot and a pneumonia shot on the same day. He felt really bad for part of a day. He felt unwell that was years ago. he does not have any brand name, manufacturer name or lot number expiration information to provide for these vaccines from years ago. The outcome of the events felt really bad and felt unwell was unknown.   No follow-up attempts are needed; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Mouth ulceration, Myalgia, Pyrexia
Clinical narrative: she was positive; a little chill; pretty bad cough; little muscle aches; fever of about 100; ulcers in her mouth; This is a spontaneous report from a contactable consumer. This female consumer reported that:   The 73-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection) (Batch/Lot Number: EL9264A) via an unspecified route of administration on 29-JAN-2021 as 1St DOSE, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. It was reported that patient (age 73) and her husband (age 72) both got their first dose of the Pfizer vaccine on 29Jan2021. Two days later, she developed a chill, a fever of about 100, a bad cough for 48 hours, and ulcers in her mouth, little muscle aches. Patient was supposed to get her second vaccine on 19Feb but on 07Feb, they she was tested for covid and came back positive. Patient had since had follow up tests and on 22Feb, her husband tested negative but she was still positive but on 14Mar , she finally tested negative. They are hearing a lot of different information on how long to wait before getting the second one and if they need to repeat the doses since the first and second will be so far apart. Some told them to wait 3 months before getting the second dose and they are trying to get more info. The outcome of the event covid 19 positive was not recovered and chills, cough, myalgia, pyrexia, mouth ulceration was unknown.  Follow-up (02Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: New information regarding adverse events has been received.  Follow-up (19Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: New information regarding adverse events has been received (chill, a fever of about 100, a bad cough for 48 hours, and ulcers in her mouth).  Follow-up (25Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: no new information has been received.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test, SARS-CoV-1 test positive
Clinical narrative: she was positive; a little chill; pretty bad cough; little muscle aches; fever of about 100; ulcers in her mouth; This is a spontaneous report from a contactable consumer. This female consumer reported that:   The 73-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection) (Batch/Lot Number: EL9264A) via an unspecified route of administration on 29-JAN-2021 as 1St DOSE, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. It was reported that patient (age 73) and her husband (age 72) both got their first dose of the Pfizer vaccine on 29Jan2021. Two days later, she developed a chill, a fever of about 100, a bad cough for 48 hours, and ulcers in her mouth, little muscle aches. Patient was supposed to get her second vaccine on 19Feb but on 07Feb, they she was tested for covid and came back positive. Patient had since had follow up tests and on 22Feb, her husband tested negative but she was still positive but on 14Mar , she finally tested negative. They are hearing a lot of different information on how long to wait before getting the second one and if they need to repeat the doses since the first and second will be so far apart. Some told them to wait 3 months before getting the second dose and they are trying to get more info. The outcome of the event covid 19 positive was not recovered and chills, cough, myalgia, pyrexia, mouth ulceration was unknown.  Follow-up (02Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: New information regarding adverse events has been received.  Follow-up (19Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: New information regarding adverse events has been received (chill, a fever of about 100, a bad cough for 48 hours, and ulcers in her mouth).  Follow-up (25Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: no new information has been received.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Malaise, Nasopharyngitis, Sneezing
Clinical narrative: Allergy attack; Did not feel good, felt like they had a really bad cold; Did not feel good, felt like they had a really bad cold; sneezing and sneezing; This is a spontaneous report from a contactable Consumer (Patient).  A female of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number: not provided; Expiration date: Unknown), via unspecified route of administration on 23Feb2021 at 11:30 as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Feb2021, 23 hours after that dose was administered, patient started having like an allergy attack , she was sneezing and sneezing. She did not feel good, felt like she had a really bad cold all yesterday. She felt better today but did not know if she should or should not get the second dose of the Pfizer COVID-19 Vaccine relative to these events. The outcome of the events was resolving.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Confusional state, Depressed level of consciousness, Dizziness
Clinical narrative: Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling in the arm where she received the shot; Slight fever; Chills; Heart rhythms; Tiredness; Sudden severe headache; Imbalance; Trouble walking; Dizziness; Vertigo; Slight vision changes; Confusion; Numbness or weakness of one side of her leg; Numbness or weakness of one side of her leg; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO9269), via an unspecified route of administration in right arm, on 10Feb2021 at 14:15 (at the age of 80 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included stroke (few years ago), multiple hip transplants, and rheumatoid arthritis (for 35 years). The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol tartrate. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a clinic. On 11Feb2021 at 16:45 PM, normal side effects felt are pain and swelling in the arm where she received the shot. In addition, the patient may have a slight fever, chills, heart rhythms, tiredness, headache, and imbalance (trouble walking) on 11Feb2021 at 16:45 PM. On the patient's first two days (starting on 11Feb2021 at 16:45 PM), the patient experienced dizziness or vertigo, slight vision changes, sudden severe headache, confusion or reduced consciousness, and numbness or weakness of one side of her leg. It was unknown if treatment was given for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Sudden severe headache", "Dizziness", "Vertigo", "Slight vision changes", "Confusion", "Reduced consciousness", and "Numbness or weakness of one side of her leg" in Feb2021; and from the other events in 2021.   No follow up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Heart rate, Heart rate abnormal
Clinical narrative: Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling in the arm where she received the shot; Slight fever; Chills; Heart rhythms; Tiredness; Sudden severe headache; Imbalance; Trouble walking; Dizziness; Vertigo; Slight vision changes; Confusion; Numbness or weakness of one side of her leg; Numbness or weakness of one side of her leg; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO9269), via an unspecified route of administration in right arm, on 10Feb2021 at 14:15 (at the age of 80 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included stroke (few years ago), multiple hip transplants, and rheumatoid arthritis (for 35 years). The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol tartrate. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a clinic. On 11Feb2021 at 16:45 PM, normal side effects felt are pain and swelling in the arm where she received the shot. In addition, the patient may have a slight fever, chills, heart rhythms, tiredness, headache, and imbalance (trouble walking) on 11Feb2021 at 16:45 PM. On the patient's first two days (starting on 11Feb2021 at 16:45 PM), the patient experienced dizziness or vertigo, slight vision changes, sudden severe headache, confusion or reduced consciousness, and numbness or weakness of one side of her leg. It was unknown if treatment was given for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Sudden severe headache", "Dizziness", "Vertigo", "Slight vision changes", "Confusion", "Reduced consciousness", and "Numbness or weakness of one side of her leg" in Feb2021; and from the other events in 2021.   No follow up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling in the arm where she received the shot; Slight fever; Chills; Heart rhythms; Tiredness; Sudden severe headache; Imbalance; Trouble walking; Dizziness; Vertigo; Slight vision changes; Confusion; Numbness or weakness of one side of her leg; Numbness or weakness of one side of her leg; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO9269), via an unspecified route of administration in right arm, on 10Feb2021 at 14:15 (at the age of 80 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included stroke (few years ago), multiple hip transplants, and rheumatoid arthritis (for 35 years). The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol tartrate. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a clinic. On 11Feb2021 at 16:45 PM, normal side effects felt are pain and swelling in the arm where she received the shot. In addition, the patient may have a slight fever, chills, heart rhythms, tiredness, headache, and imbalance (trouble walking) on 11Feb2021 at 16:45 PM. On the patient's first two days (starting on 11Feb2021 at 16:45 PM), the patient experienced dizziness or vertigo, slight vision changes, sudden severe headache, confusion or reduced consciousness, and numbness or weakness of one side of her leg. It was unknown if treatment was given for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Sudden severe headache", "Dizziness", "Vertigo", "Slight vision changes", "Confusion", "Reduced consciousness", and "Numbness or weakness of one side of her leg" in Feb2021; and from the other events in 2021.   No follow up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Visual impairment
Clinical narrative: Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling in the arm where she received the shot; Slight fever; Chills; Heart rhythms; Tiredness; Sudden severe headache; Imbalance; Trouble walking; Dizziness; Vertigo; Slight vision changes; Confusion; Numbness or weakness of one side of her leg; Numbness or weakness of one side of her leg; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO9269), via an unspecified route of administration in right arm, on 10Feb2021 at 14:15 (at the age of 80 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included stroke (few years ago), multiple hip transplants, and rheumatoid arthritis (for 35 years). The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol tartrate. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a clinic. On 11Feb2021 at 16:45 PM, normal side effects felt are pain and swelling in the arm where she received the shot. In addition, the patient may have a slight fever, chills, heart rhythms, tiredness, headache, and imbalance (trouble walking) on 11Feb2021 at 16:45 PM. On the patient's first two days (starting on 11Feb2021 at 16:45 PM), the patient experienced dizziness or vertigo, slight vision changes, sudden severe headache, confusion or reduced consciousness, and numbness or weakness of one side of her leg. It was unknown if treatment was given for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Sudden severe headache", "Dizziness", "Vertigo", "Slight vision changes", "Confusion", "Reduced consciousness", and "Numbness or weakness of one side of her leg" in Feb2021; and from the other events in 2021.   No follow up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on lower back; This is a spontaneous report from a contactable consumer (patient). A 80-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), via an unspecified route of administration administered in Arm Left 02Mar2021 14:00 pm UNKNOWN, SINGLE DOSE for covid-19 immunization. Medical history included high cholesterol. The patient had not been tested positive for COVID-19 prior and post vaccination. The patient had no known allergies. Patient had not received any medications in two weeks. Concomitant medication included Desloratadine, Rosuvastatin and Multivitamins and all were taken for an unspecified indication. It was reported that after receiving the dose of vaccine the patient experienced rash on lower back on 05Mar2021. The patient did not receive any treatment to treat the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Flat red circular rash. Each dot approximately 1cm; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EN6206, Expiration Date: Unknown), via an unspecified route of administration, administered in arm left on 04Mar2021 09:45 (at the age of 66-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included Anxiety, osteoarthritis, Graves' disease: (in remission). known allergies was TB test. The patient's concomitant medications were not reported. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810, Expiration), via an unspecified route of administration, administered in arm left on 11Feb2021 02:00 for covid-19 immunisation. The patient experienced Flat red circular rash. Each dot approximately 1cm on 04Mar2021 18:00. Not itchy. Mainly on forearms. The outcome of the event was not recovered.   No follow-up attempts are Possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue for the day he received the first dose.; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient of unspecified age who received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue for the day he received the first dose. Outcome for the event was resolved on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: a rash "broke out" where the shot was/she thinks she is allergic to one of the Prevnar 13 ingredients; broke out in a rash up and down her arm; arm started getting hot; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jun2019 (reported as 2 years ago June) as second dose, single for immunization. Medical history included influenza immunisation from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) on an unknown date for immunization. The patient had a Prevnar 13 shot 2 years ago in the summer, a rash "broke out" where the shot was, on an unspecified date. She will receive the Johnson & Johnson COVID-19 vaccine and she wants to compare their ingredients list with the ingredients in Prevnar 13, as she thinks she is allergic to one of the Prevnar 13 ingredients but doesn't know which one. She requested the prescribing information via email during the call to check on the ingredients.The J&J ingredients she wants to compare are: ad26.cov2.s 5x1010 virus particles, sodium chloride 2.19 mg, citric acid monohydrate 0.14 mg, trisodium citrate dihydrate 2.02 mg, polysorbate 80 0.16 mg, 2 hydroxypropyl-b or 3-cyclodextran, ethanol 2.04 mg, genetically modified organisms GMOs. Mentioned there's no lactose, PEG, gelatin, egg-derived components, not derived from human animal origin, no adjuvant, no preservatives. Patient stated she has an appointment for the vaccine with Johnson and Johnson and her pharmacist told her to call us. Patient stated that she had the Prevnar 13 Pneumococcal shot 2 years ago June and she broke out a week later in a rash up and down her arm had to go to the doctor and got antibiotics. She had no problem with the flu shot or the first Prevnar 13 Pneumococcal shot, just the second one. States she talked to someone at Johnson and Johnson for the Covid vaccine to see what is in that vaccine and would like to get information about what ingredients are in the Prevnar 13 Pneumococcal shot. Patient stated that 9 days later she had a rash down her arm and her arm started getting hot on an unspecified date and she waited a few days and called her doctor and he wanted to see her. Relayed that when she went in her arm was warm, like hot and the doctor told her she needed an antibiotic, and they were horse pills and she took that for 10 days and they told her to ice it to get it calmed down. Therapeutic measures were taken as a result of the events. Clinical outcome of the events was unknown.   No follow-up attempts are needed, information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Exposure to SARS-CoV-2, Feeling abnormal, Nasal congestion
Clinical narrative: had a potential exposure to COVID-19 via her own daughter from a COVID outbreak at her school; weak for a couple of days/feeling weak; cough; congestion/feels congested; Feels bad; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age (is in her 40's) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on an unspecified in Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) on an unspecified date in Feb2021. On an unspecified date, the patient experienced a potential exposure to COVID-19 via her own daughter from a COVID outbreak at her school, weak for a couple of days/feeling weak, cough, congestion/feels congested and feels bad. The events were assessed as non-serious. The clinical outcome of the events were reported as unknown. No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Fatigue, Headache, Lethargy
Clinical narrative: joint pain on her wrist and ankles; headache; was tired; anxiety; slept okay a little bit/ couldn't sleep real well; felt very lethargic; Patient needed to walked and only lasted for 15 minutes usually she could've walked for 30 to 45 minutes a day; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 05Mar2021 at 11:30 (lot number: unknown) as first dose, single for covid-19 immunisation. Medical history included temperature and aches (got temperature and aches from shingles vaccine). The patient previously took baby aspirin and blood thinner. Also the patient previously had hepatitis vaccines. On unspecified date in Mar2021, the patient felt joint pain on her wrist and ankles and stated she can handle pain, it was okay. She had a headache, was tired, slept okay a little bit, had anxiety and couldn't sleep real well. She had a whole glass of water and it helped that was what she usually did when she got a headache. When she got backed from the grocery store, she felt very lethargic like when coming out of surgery then she slept for a bit which did helped. Patient reported that she actually tried to went walking because she had medical condition where she needed to walked and only lasted for 15 minutes usually she could've walked for 30 to 45 minutes a day. She was home and right night now, her ankles, joint pain and all over headache, for me it was hard to knew because she did had a medical condition. She stated it felt different though. Patient previously took shingles, hepatitis vaccines when she travelled and she got temperature and aches from shingles vaccine and stated this one seems to hit me harder. Patient asked that can she take Tylenol. She reported that she took baby aspirin all the time and also another blood thinner but skipped on vaccination day and medicine to increase platelets. Patient reported that her friends who took the Moderna, they told her they had to take something as well and always waited it out. Patient stated that her pain tolerance was high. Seriousness of the event was reported as non-serious. The outcome of the event headache and felt very lethargic was recovering; outcome of all other event was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.