chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: feverish; Achy; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received second dose BNT162B2 (Pfizer Biotech COVID-19 vaccine, Solution for injection) via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included first shot BNT162B2 (Lot/Batch number: Unknown) on 28Dec2020 for Prevention of corona virus at 57-years and had arm sore and tired. On 11Jan2021, patient was Feverish and achy. No Admission to hospital due to the evet and no treatment received. The reported issue occur after use of a Pfizer product. Outcome of events was recovered on an unspecified date in 2021.  Information about Batch/Lot number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth.  The patient's concomitant included an unspecified medication (she takes something but not relevant).  The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth.  The patient's concomitant included an unspecified medication (she takes something but not relevant).  The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID, three weeks later; Tested positive for COVID, three weeks later; This is a spontaneous report through the Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 11Jan2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, three weeks after the administration of the first dose of vaccination, the patient had tested positive for COVID-19 test. The outcome of the event was unknown. The patient wanted to know if he can safely receive the second dose.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Abdominal pain, Vaccination site pain
Clinical narrative: Noted with soreness at injection site; abdominal pain; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-089030), for BNT162B2. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 02Mar2021 (Batch/Lot number was not reported) to an unspecified date for endometrial carcinoma; macrogol 3350 (MIRALAX), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to 02Mar2021, for constipation.  Medical history included endometrial carcinoma. The patient's concomitant medications were not reported.  The patient previously received first dose of bnt162b2 for covid-19 immunisation, Keytruda infusions.  The patient noted with soreness at injection site on 03Mar2021. Noted with abdominal pain on evening of 03Mar2021. Stated she believes abdominal pain related to stopping MIRALAX on 02Mar2021 when she began LENVIMA. Prior to start of LENVIMA, patient took MIRALAX daily for constipation. Noted with "fairly loose stools" since 02Mar2021. The action taken in response to the events for lenvatinib mesilate was unknown , for macrogol 3350 was permanently withdrawn on 02Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder, Premenstrual syndrome
Clinical narrative: Altered menstrual cycle including breakthrough bleeding and early onset pms; Altered menstrual cycle including breakthrough bleeding and early onset pms; Altered menstrual cycle including breakthrough bleeding and early onset pms; This is a spontaneous report from a contactable healthcare professional (patient).  A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 17Feb2021 at a single dose for COVID-19 immunisation.  Medical history included COVID (if COVID prior vaccination: Yes).  The patient's concomitant medications were not reported. The patient has no known allergies. The patient experienced altered menstrual cycle including breakthrough bleeding and early onset PMS on 04Mar2021. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: had a sharp twinge in the upper back muscles/all over the upper back muscles; had a sharp twinge in the upper back muscles/all over the upper back muscles; This is a spontaneous report received from a non-contactable consumer (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 at single dose for COVID-19 immunization. Medical history included neuropathy. Concomitant medications were not provided. Received vaccine the day before and overnight on 09Mar2021, the patient had a sharp twinge in the upper back muscles, it was all over the upper back muscles and then went away. Patient thought that her neuropathy was affected by the vaccine. This report is non-serious. It was unknown if the patient diagnosed with COVID-19 prior vaccination, unknown if the patient had been tested for COVID-19 since the vaccination. No treatment for the events. Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Decreased appetite, Fatigue, Nausea
Clinical narrative: fatigue; loss of appetite; constipation; nausea; This is a spontaneous report from a contactable physician. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 46 years of age), dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis, primary sclerosing cholangitis, prior NAFLD (nonalcoholic fatty liver disease); and had allergies to medications, food, or other products, all from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced allergy and DILI (Drug induced liver injury) in Dec2019. Concomitant medication included mesalazine (LIALDA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19 prior vaccination and was not tested since vaccination. It was reported that the patient got first COVID vaccine (Pfizer) on 16Jan2021 with second dose on 06Feb2021. He mentioned that he works in healthcare and as testing weekly for COVID as part of his job and has been negative. On 26Jan2021, 10 days after first dose, he developed fatigue, loss of appetite, constipation and nausea, all with outcome of recovering. The events are reported non-serious. No treatment received for the events.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Presyncope, Pyrexia, Vision blurred
Clinical narrative: Blurry vision almost black out when walking.; Blurry vision almost black out when walking.; Muscle ache; fever; Fatigue; This 32- year-old female patient contactable healthcare professional received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6203), via an unspecified route of administration, on 09Mar2021 at 09:00am (at the age of 32-years-old) as a single dose for COVID-19 immunization, in left arm. Patient is not pregnant. She has had no other vaccines on the same day or in the past 4 weeks. The patient did not have COVID-19 prior to the vaccine. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization, on 16Feb2021, (Lot EN6200), in left arm. Relevant medical history included birth control use. Concomitant medications included: Junel birth control. On 09Mar2021 at 10:00 pm, the patient experienced Muscle ache, fever, fatigue, blurry vision - almost black out when walking. The patient received treatment of ibuprofen for the events. The clinical outcome of the events Muscle ache, fever, fatigue, blurry vision - almost black out when walking was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear pain, Hypoaesthesia, Paraesthesia
Clinical narrative: Bell's Palsy; her face felt numb; tingling and pain on her left ear; tingling and pain on her left ear; This is a spontaneous report from a contactable consumer.    A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 08Mar2021  as single dose for Covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient experienced bell's palsy  on 08Mar2021 with outcome of unknown. On her way home the patient  face felt numb  , tingling and pain on her left ear The reported events were considered Important Medical Events. The patient is wondering if the Company has been informed about Bell's palsy.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Got an antibody test and it's negative; Got an antibody test and it's negative; Sore at the injection site; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) first dose on 11Jan2021 and second dose on 09Feb2021; both via an unspecified route of administration as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient got an antibody test and it's negative and she experienced sore at the injection site. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective, SARS-CoV-2 test
Clinical narrative: on 13Feb test was postive/she came down with Covid; on 13Feb test was postive/she came down with Covid; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was supposed to be due for her 2nd dose on the week of 09Feb2021 but then she came down with Covid on 13Feb2021. She was starting to feel better but she still has some symptoms which was generally a bad cough. The patient tested negative on 09Feb2021 and second test 12Feb2021 negative and they sent it out and on 13Feb test was positive. She had a chest X-ray and that came back negative, but she was still coughing. She was tested again yesterday and awaiting the results. She was asking how long she needs to wait to get the second. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Influenza like illness, Neck pain, Pain, Pain in extremity
Clinical narrative: I had the normal flu like symptoms for 2-3 days; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; my neck arm and shoulder  were killing me; my neck arm and shoulder were killing me; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; This is a spontaneous report from a contactable consumer. A 62-years-old non-pregnant  female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: was not reported),  via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 18:45 (at the age of 62 years old) as SINGLE DOSE for covid-19 immunization. The facility in which the vacation was given was a Pharmacy or Drug Store.  Medical history included hypertension, blood cholesterol increased and covid-19 (prior to vaccination). The patient has no known allergies.  Concomitant medications  included lisinopril (LISINOPRIL),  atorvastatin (ATORVASTATIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient 'was' diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 04Mar2021 at 00:00, The patient experienced flu like symptoms for 2-3 days, Pain chest, Neck pain, Arm pain and Pain. No Treatment was given. The clinical course was as follows patient had the normal flu like symptoms for 2-3 days. Then noticed that her neck arm and shoulder were killing me. Now it is the whole upper left quadrant of her body. This includes the chest area around where my heart is. It is very painful and I do cry out with a pain sound if I move a certain way. No treatment was given for the events. The clinical outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received first dose on 05Feb2021 and then tested positive for covid on 26Feb2021 and was quarantined until 01Mar2021; received first dose on 05Feb2021 and then tested positive for covid on 26Feb2021 and was quarantined until 01Mar2021/Received the first Covid vaccine; Contracted Covid; This is a spontaneous report from a contactable consumer. A 22-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm on 05Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  There were no relevant medical history and concomitant medications. Mother, calling on behalf of son, who received first dose on 05Feb2021 and then tested positive for covid on 26Feb2021 and was quarantined until 01Mar2021. The earliest available date for his second vaccine was scheduled for 30May2021, the mother is asking if it's too late or does he have to restart the vaccination series. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Feb2021. The outcome of the events was unknown. The case was assessed as serious (medically significant).    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable Pharmacist.   A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2, Lot number not reported), via an unspecified route of administration as single dose on 22Feb2021 for COVID-19 immunisation.  The patient medical history and concomitant medication were not reported.   After receiving the first Covid vaccine on 22Feb2021 the patient tested positive for Covid in 2021 and received casirivimab and imdevimab infusion on 10Mar2021. The patient underwent lab tests and procedures which included covid-19: postive in 2021. The outcome of events was unknown. Reporter queried whether the patient should delay the 2nd COVID vaccine. He was due to receive in on 15Mar. 2021.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported tested positive for Covid cannot be ruled out.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Gingival ulceration, Lip ulceration, Lymphadenopathy, Mouth ulceration
Clinical narrative: lymphadenopathy; Fever; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; They are super painful.; I can't even eat and talk. As the days go by, more appear; I can't even eat and talk. As the days go by, more appear; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 07Mar2021 17:30 (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history was not reported. On 08Mar2021 10:00, the patient experienced Fever, lymphadenopathy, a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils. They are super painful. I can't even eat and talk. As the days go by, more appear. Ae resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events. Ae treatment: Acyclovir. Maalox and Benadryl mouth rinses. The outcome of the events was not recovered. Covid test post vaccination: [covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=10Mar2021, covid test result=Negative}]
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngeal ulceration, Pyrexia, SARS-CoV-2 test, Speech disorder
Clinical narrative: lymphadenopathy; Fever; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; They are super painful.; I can't even eat and talk. As the days go by, more appear; I can't even eat and talk. As the days go by, more appear; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 07Mar2021 17:30 (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history was not reported. On 08Mar2021 10:00, the patient experienced Fever, lymphadenopathy, a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils. They are super painful. I can't even eat and talk. As the days go by, more appear. Ae resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events. Ae treatment: Acyclovir. Maalox and Benadryl mouth rinses. The outcome of the events was not recovered. Covid test post vaccination: [covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=10Mar2021, covid test result=Negative}]
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillar ulcer
Clinical narrative: lymphadenopathy; Fever; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils.; They are super painful.; I can't even eat and talk. As the days go by, more appear; I can't even eat and talk. As the days go by, more appear; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 07Mar2021 17:30 (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history was not reported. On 08Mar2021 10:00, the patient experienced Fever, lymphadenopathy, a lot of ulcers in all of the the upper and lower lips, gums, inside the mouth, throat and tonsils. They are super painful. I can't even eat and talk. As the days go by, more appear. Ae resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events. Ae treatment: Acyclovir. Maalox and Benadryl mouth rinses. The outcome of the events was not recovered. Covid test post vaccination: [covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=10Mar2021, covid test result=Negative}]
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Wound haemorrhage
Clinical narrative: previous wounds that had not yet healed having extra bleeding; never get nosebleeds and had one unexpectedly; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 03Mar2021 09:00 (batch/lot number: EN9581) as single dose for covid-19 immunization in a workplace clinic. Medical history included ongoing wounds that had not yet healed. The patient's concomitant medications were not reported. The patient has no covid prior vaccination. The patient has no other medications in two weeks. The patient has no other vaccine in four weeks. On 04Mar2021, the patient noticed previous wounds that had not yet healed having extra bleeding. The patient informed that he also never got nosebleeds and had one unexpectedly 1 week after vaccine (Mar2021). The patient was not covid tested post vaccination. The patient had no treatment received due to the events. The outcome of the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Feeling abnormal, Headache, Rhinorrhoea
Clinical narrative: runny nose; headache; Stomach ache; positive COVID-19 test with symptoms; her head felt heavy/foggy; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 04Mar2021 (at the age of 52-years-old) approximately at 14:00 (maybe 14:30), at single dose for covid-19 immunisation. The patient had no relevant medical history and no concomitant medications. On 09Mar2021 the patient was tested positive for COVID-19. On the same day the patient had sore throat, body aches, headache, back ache and stomach ache. On 11Mar2021 the patient experienced arm pain and sneezing and on 12Mar2021 she had runny nose. The patient reported that she received the dose with her husband and she was a few days behind him and had the same symptoms. At the time of reporting she had a sore throat and runny nose, but the body aches and headache were gone. She stated that she was still experiencing symptoms. Body aches were not severe, she took paracetamol (TYLENOL) and then they were gone. She reported that the arm pain was for a short amount of time, maybe half of the day on Thursday, 11Mar2021. She stated that it felt like muscle aches. The body aches and back ache were not severe. She reported that she took a couple of Tylenol and they were under control. The headache was never major except for maybe one night. She stated that other than that one occurrence, her head felt heavy/foggy and that she didn't feel like herself. She has been experiencing a sore throat in the middle of the night and stated that it was pretty heavy the night before reporting. She stated that she has had a minor sore throat during the day but it was worse at night from the air being dry. She sneezed some on 11Mar2021 but that it was worse today. Mentioned during the day she was congested. She took Tylenol and that it helped with the headache and body aches, denied taking any other medications. The patient reported also that she received the covid test at a drive through testing site. Headache and stomach ache were resolved, runny nose was not resolved and the outcome of other events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: runny nose; headache; Stomach ache; positive COVID-19 test with symptoms; her head felt heavy/foggy; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 04Mar2021 (at the age of 52-years-old) approximately at 14:00 (maybe 14:30), at single dose for covid-19 immunisation. The patient had no relevant medical history and no concomitant medications. On 09Mar2021 the patient was tested positive for COVID-19. On the same day the patient had sore throat, body aches, headache, back ache and stomach ache. On 11Mar2021 the patient experienced arm pain and sneezing and on 12Mar2021 she had runny nose. The patient reported that she received the dose with her husband and she was a few days behind him and had the same symptoms. At the time of reporting she had a sore throat and runny nose, but the body aches and headache were gone. She stated that she was still experiencing symptoms. Body aches were not severe, she took paracetamol (TYLENOL) and then they were gone. She reported that the arm pain was for a short amount of time, maybe half of the day on Thursday, 11Mar2021. She stated that it felt like muscle aches. The body aches and back ache were not severe. She reported that she took a couple of Tylenol and they were under control. The headache was never major except for maybe one night. She stated that other than that one occurrence, her head felt heavy/foggy and that she didn't feel like herself. She has been experiencing a sore throat in the middle of the night and stated that it was pretty heavy the night before reporting. She stated that she has had a minor sore throat during the day but it was worse at night from the air being dry. She sneezed some on 11Mar2021 but that it was worse today. Mentioned during the day she was congested. She took Tylenol and that it helped with the headache and body aches, denied taking any other medications. The patient reported also that she received the covid test at a drive through testing site. Headache and stomach ache were resolved, runny nose was not resolved and the outcome of other events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: she tested positive for Sars-CoV-2 infection; she tested positive for Sars-CoV-2 infection; getting sick; got the chills; This is a spontaneous report from a contactable consumer (also mentioned being a Physical Therapist Assistant). A 60-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Batch/lot number: EN6203, Expiry Date: Jun2021, in Pharmacy/Drug Store, via an unspecified route of administration, in left arm on 26Feb2021 at 12:00, at 60 years of age, as single dose for COVID-19 immunization. Medical history included SARS-CoV-2 test positive in Nov2020 (COVID-19 Virus throat swab test was used), also reported as COVID-19 infection in Nov2020 with no symptoms, except a slight sore throat and gingival disorder from an unknown date. On 26Feb2021 the patient had no symptom, saying she felt great. She reported she worked out and was in great shape for her age. She said she was not the typical 60 year old. On 09Mar2021 in the evening the patient felt like she was getting sick and got the chills and she had never had that happen before, and didn't know if her symptoms were from the 2 pills of  an herbal supplement she used for periodontal issues to strengthen her gums she had ordered online (she never saw the product in a store) and that she had taken on the same day; moreover she tested positive for SARS-CoV-2 infection on 11Mar2021 with a COVID-19 Virus 24-hour nasal swab test done at her work. The events didn't require visit to Emergency Room or Physician Office. It was reported that the patient was scheduled to receive her second dose of vaccine 19Mar2021 and the patient wanted to know if this is possible with her current diagnosis and how likely it is this is a false positive test for SARS-CoV-2. No treatment was administered for the reported events. At the time of the report the outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: She felt achey; Nauseous; Headache; Low fever; Arm pain; This is a spontaneous report from a contactable other health professional (patient's parent). A 25-year-old female patient (reporter's daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 25-year-old on 09Mar2021 at 09:30 am (batch/lot number and expiration date not reported) at SINGLE DOSE for COVID-19 immunisation. The patient's medical history included borderline obese. Concomitant medications were not reported. On 09Mar2021 at 15:30 the patient experienced that she was going to take nap because she felt achey, nauseous, headache, low fever, and had arm pain. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She felt achey; Nauseous; Headache; Low fever; Arm pain; This is a spontaneous report from a contactable other health professional (patient's parent). A 25-year-old female patient (reporter's daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 25-year-old on 09Mar2021 at 09:30 am (batch/lot number and expiration date not reported) at SINGLE DOSE for COVID-19 immunisation. The patient's medical history included borderline obese. Concomitant medications were not reported. On 09Mar2021 at 15:30 the patient experienced that she was going to take nap because she felt achey, nauseous, headache, low fever, and had arm pain. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft tissue disorders.; leg bumps/or swelling; This is a spontaneous report from a contactable consumer (patient).   A 45-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:30 (Batch/Lot number was not reported),  at the age of 45-year-old at vaccination, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.   The patient is not pregnant at the time of vaccination.  There were no concomitant medications.  The patient previously took NSAIDS and experienced drug hypersensitivity. The patient did not have COVID prior vaccination. On 09Mar2021 06:00, the patient woke up with her right knee swollen and had difficulty walking. She went to the Hospital in the afternoon and was told that her lymphatic nodes were swollen, and the diagnosis is Leg pain and swelling and other specified soft tissue disorders. The still have a swollen knee and cannot walk yet, 6 days after the vaccine. The patient still have leg bumps/or swelling in her leg. The patient was hospitalized for lymphatic nodes were swollen. It was also reported that patient has physician and ER visit. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events which includes Codeine/paracetamol, RICE routine care for injury.  Information about Batch/Lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Soft tissue disorder
Clinical narrative: lymphatic nodes were swollen; right knee swollen; cannot walk yet; Leg pain; other specified soft tissue disorders.; leg bumps/or swelling; This is a spontaneous report from a contactable consumer (patient).   A 45-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:30 (Batch/Lot number was not reported),  at the age of 45-year-old at vaccination, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.   The patient is not pregnant at the time of vaccination.  There were no concomitant medications.  The patient previously took NSAIDS and experienced drug hypersensitivity. The patient did not have COVID prior vaccination. On 09Mar2021 06:00, the patient woke up with her right knee swollen and had difficulty walking. She went to the Hospital in the afternoon and was told that her lymphatic nodes were swollen, and the diagnosis is Leg pain and swelling and other specified soft tissue disorders. The still have a swollen knee and cannot walk yet, 6 days after the vaccine. The patient still have leg bumps/or swelling in her leg. The patient was hospitalized for lymphatic nodes were swollen. It was also reported that patient has physician and ER visit. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events which includes Codeine/paracetamol, RICE routine care for injury.  Information about Batch/Lot number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: to feel a tingling sensation on the outside of her arm through to her fingertips/mid-upper arm through thumb. The tingling was most noticeable, in her wrist and thumb; Her fingers felt like she had fallen asleep on her arm and the circulation had been cut off; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208), via an unspecified route of administration, administered in arm left on 12Mar2021 14:30 as a single dose (at the age of 40-years-old) for covid-19 immunisation. The patient had no known allergies or other medical history. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The day after (13Mar2021 05:00), the patient began to feel a tingling sensation on the outside of her arm through to her fingertips. Her fingers felt like she had fallen asleep on her arm and the circulation had been cut off, it went away after a few hours and taking Advil. Day 2 (14Mar2021), the tingling was back, but on the inside of her arm, mid-upper arm through thumb. The tingling was most noticeable, in her wrist and thumb. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain, Skin reaction, Skin swelling, Vaccination site erythema
Clinical narrative: localized skin reaction; red patches on the arm/shoulder near injection site; subcutaneuos swelling; mild pain/discomfort; mild pain/discomfort; This is a spontaneous report from a contactable physician. This report was received via a sales representative. An 80-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was living in an care facility. She received her first COVID 19 shot and within a few hours experienced what was thought to be a localized skin reaction. She experienced red patches on the arm/shoulder near injection site, subcutaneous swelling, mild pain/discomfort. This did eventually subside with antihistamine and time. The HCP was concerned about her proceeding with the second shot. The outcome of the events was recovering.    Information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Headache, Pyrexia
Clinical narrative: Covid-19; mild discomfort from the injection site; tired; fever of 102F; headache; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program,. A male patient of an unspecified age (age: 55; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history included exposure to COVID-19 on 26Feb2021. Concomitant medications were not reported. On 26Feb2021, a week prior to the patient's first dose he was in contact with someone at work who tested positive for Covid-19. The patient received the first dose of the vaccine 1 week ago on Friday, 05Mar2021. He had mild discomfort from the injection site, was tired, and slight fever Sunday 07Mar2021 figured it was from the vaccination. The patient had fever of 102F on 08Mar2021, and headache (date unspecified) and was taking ibuprofen but it only helps until he has to take the next dosage. The patient tested positive on 10Mar2021. The reporter (patient's wife) asked if the patient should get the 2nd dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site discomfort
Clinical narrative: Covid-19; mild discomfort from the injection site; tired; fever of 102F; headache; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program,. A male patient of an unspecified age (age: 55; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history included exposure to COVID-19 on 26Feb2021. Concomitant medications were not reported. On 26Feb2021, a week prior to the patient's first dose he was in contact with someone at work who tested positive for Covid-19. The patient received the first dose of the vaccine 1 week ago on Friday, 05Mar2021. He had mild discomfort from the injection site, was tired, and slight fever Sunday 07Mar2021 figured it was from the vaccination. The patient had fever of 102F on 08Mar2021, and headache (date unspecified) and was taking ibuprofen but it only helps until he has to take the next dosage. The patient tested positive on 10Mar2021. The reporter (patient's wife) asked if the patient should get the 2nd dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive on their covid test, tested positive the same day as receiving the vaccine.; This is Spontaneous report from a contactable Pharmacist . This Pharmacist reported similar events for two patients. This is a 1st of 2 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient tested positive on their covid test, tested positive the same day as receiving the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021283276 Same reporter/events/ drug/diff patient
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: fatigue; Joint pain/The joint and muscle pain I experience were primarily in my neck, shoulder elbows, wrist and fingers.; sore musles/The joint and muscle pain I experience were primarily in my neck, shoulder elbows, wrist and fingers.; headache; This is a spontaneous report from a contactable consumer. A 75-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 14Jan2021 16:45 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, and had 2 surgeries 1) was a discectomy in the lower back and 2) in 2019, right rotator cuff surgery. Prior to the surgeries, the patient suffered from arthritis that subsided following the surgeries and no longer take medications for the second surgery in 2017 was a cervical fusion of C2-3. Family's medical history includes: Mother- heart disease, Father- Cancer, Sister- COPD- cancer, and Brother- Diabetes type 2. Concomitant medications included amlodipine besylate; and metoprolol tartrate; taken for hypertension from unspecified start dates and ongoing. On 14Jan2021 21:00, the patient experienced sore muscles/joint pain, and headache (extreme). The joint and muscle pain the patient experienced were primarily in the patient's neck, shoulders, elbow, wrist and fingers. On 15Jan2021, the patient experienced fatigue. The events were assessed as serious (disability). The patient did not receive treatment for the events. The outcome of the events was recovered on 16Jan2021. It was reported that the patient received second dose of bnt162b2 on 04Feb2021 12:45 (lot number: EL9265) in right arm via intramuscular.