chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Constipation, Gastrointestinal disorder, Haematochezia
Clinical narrative: severe constipation; severe pain on lower right abdomen; vomiting/inability to hold food or liquid down; blood/mucus membrane in stool; blood/mucus membrane in stool; intestinal issue; hemorrhaging cyst on ovary; severely ill; She missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 04Aug2021 (Batch/Lot Number: CW0198) as DOSE 1, SINGLE (age at vaccination 40 years old) for covid-19 immunisation.  Medical history included paralyzed diaphragm from an unknown date and unknown if ongoing, skin cancer from an unknown date and unknown if ongoing, chronic inflammatory response syndrome from 16Dec2016 and ongoing. No known allergies. The patient's concomitant medications were none. Vaccination facility type: Pharmacy or drug store. Vaccine administered at military facility was no. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received the vaccine shot on 04Aug2021. She missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021.  She developed severe constipation on unknown date. On 22Aug2021, severely ill with vomiting/inability to hold food or liquid down. On unknown the patient experienced severe pain on lower right abdomen. She went to ER 2.5 weeks later with severe vomiting/abdominal pain, constipation. Hospitalized duration of stay was one day. Emergency room (ER) visit resulted in hemorrhaging cyst on ovary via ultrasound on 23Aug2021. Blood/mucus membrane in stool on unknown date, had CT scan on 03Sep2021. Determines severe constipation, intestinal issue.  "AE required visit to: Emergency room and Physician office". The patient underwent lab tests and procedures which included computerised tomogram (CT scan): severe constipation / intestinal issues on 03Sep2021, ultrasound abdomen: hemorrhaging cyst on ovary on 23Aug2021. No treatment was received. Outcome of the event she missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021 was not recovered. Outcome of the event hemorrhaging cyst on ovary, blood/mucus membrane in stool, severe constipation, intestinal issue,  severely ill, vomiting/inability to hold food or liquid down and severe pain on lower right abdomen were unknown.  It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient did not receive 2nd dose due to adverse reaction.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic ovarian cyst, Illness, Menstruation delayed, Mucous stools, Ultrasound scan
Clinical narrative: severe constipation; severe pain on lower right abdomen; vomiting/inability to hold food or liquid down; blood/mucus membrane in stool; blood/mucus membrane in stool; intestinal issue; hemorrhaging cyst on ovary; severely ill; She missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 04Aug2021 (Batch/Lot Number: CW0198) as DOSE 1, SINGLE (age at vaccination 40 years old) for covid-19 immunisation.  Medical history included paralyzed diaphragm from an unknown date and unknown if ongoing, skin cancer from an unknown date and unknown if ongoing, chronic inflammatory response syndrome from 16Dec2016 and ongoing. No known allergies. The patient's concomitant medications were none. Vaccination facility type: Pharmacy or drug store. Vaccine administered at military facility was no. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received the vaccine shot on 04Aug2021. She missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021.  She developed severe constipation on unknown date. On 22Aug2021, severely ill with vomiting/inability to hold food or liquid down. On unknown the patient experienced severe pain on lower right abdomen. She went to ER 2.5 weeks later with severe vomiting/abdominal pain, constipation. Hospitalized duration of stay was one day. Emergency room (ER) visit resulted in hemorrhaging cyst on ovary via ultrasound on 23Aug2021. Blood/mucus membrane in stool on unknown date, had CT scan on 03Sep2021. Determines severe constipation, intestinal issue.  "AE required visit to: Emergency room and Physician office". The patient underwent lab tests and procedures which included computerised tomogram (CT scan): severe constipation / intestinal issues on 03Sep2021, ultrasound abdomen: hemorrhaging cyst on ovary on 23Aug2021. No treatment was received. Outcome of the event she missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021 was not recovered. Outcome of the event hemorrhaging cyst on ovary, blood/mucus membrane in stool, severe constipation, intestinal issue,  severely ill, vomiting/inability to hold food or liquid down and severe pain on lower right abdomen were unknown.  It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient did not receive 2nd dose due to adverse reaction.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe constipation; severe pain on lower right abdomen; vomiting/inability to hold food or liquid down; blood/mucus membrane in stool; blood/mucus membrane in stool; intestinal issue; hemorrhaging cyst on ovary; severely ill; She missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 04Aug2021 (Batch/Lot Number: CW0198) as DOSE 1, SINGLE (age at vaccination 40 years old) for covid-19 immunisation.  Medical history included paralyzed diaphragm from an unknown date and unknown if ongoing, skin cancer from an unknown date and unknown if ongoing, chronic inflammatory response syndrome from 16Dec2016 and ongoing. No known allergies. The patient's concomitant medications were none. Vaccination facility type: Pharmacy or drug store. Vaccine administered at military facility was no. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received the vaccine shot on 04Aug2021. She missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021.  She developed severe constipation on unknown date. On 22Aug2021, severely ill with vomiting/inability to hold food or liquid down. On unknown the patient experienced severe pain on lower right abdomen. She went to ER 2.5 weeks later with severe vomiting/abdominal pain, constipation. Hospitalized duration of stay was one day. Emergency room (ER) visit resulted in hemorrhaging cyst on ovary via ultrasound on 23Aug2021. Blood/mucus membrane in stool on unknown date, had CT scan on 03Sep2021. Determines severe constipation, intestinal issue.  "AE required visit to: Emergency room and Physician office". The patient underwent lab tests and procedures which included computerised tomogram (CT scan): severe constipation / intestinal issues on 03Sep2021, ultrasound abdomen: hemorrhaging cyst on ovary on 23Aug2021. No treatment was received. Outcome of the event she missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021 was not recovered. Outcome of the event hemorrhaging cyst on ovary, blood/mucus membrane in stool, severe constipation, intestinal issue,  severely ill, vomiting/inability to hold food or liquid down and severe pain on lower right abdomen were unknown.  It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient did not receive 2nd dose due to adverse reaction.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Hypoacusis
Clinical narrative: I am hard of hearing; I am so tired; This is spontaneous report from a contactable female consumer(patient) via Pfizer Sponsored Program. A female patient of an unspecified age received both dose 1 and dose 2 bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient received tofacitinib citrate (XELJANZ), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient received the first and second dose of the the Pfizer Covid-19 vaccine and after that or in between her doses, she had been taking her Xeljanz medication. Patient had both of them taken, the first and the second and I am looking into taking the third one and before that I would like to know if I am supposed to stop taking Xeljanz for a week or so before that or I don't have to. On an unspecified date, the patient reported that she was hard of hearing and tired. The patient is enquiring whether she is supposed to stop taking Xeljanz for a week or so before taking the third one. The action taken in response to the events, for tofacitinib citrate was unknown. The clinical outcome of events was unknown.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Full scalp psoriasis; This is spontaneous report from a contactable consumer. A 60-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number: ER8733), intramuscular, administered in arm left on 29Mar2021 09:54 AM (age at the time of vaccination was 60-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history included psoriatic arthritis from 2010.The patient's concomitant medication included adalimumab (HUMIRA) via subcutaneously from 2010 indicated for psoriatic arthritis. The patient had not administered any vaccine prior vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6202), intramuscular, administered in arm left on 02Mar2021 03:07 PM (age at the time of vaccination was 59-year-old) as dose 1, single for covid-19 immunisation. The patient had minor psoriasis, about 5 days after the first Pfizer vaccine, had a full scalp psoriasis issue. Had to shampoo with coal tar shampoo to get it to go away and covid test post vaccination/covid test result: positive. Humira taken approximately 5 days after both vaccines and approximately 5 hours after Humira injection full scalp psoriasis annoying but not life threatening on 02Apr2021. The patient assumed the immune response meant that the vaccine was working. Mostly resolved but still have some residual psoriasis in ear canal. Used honey and coconut oil masks on head for 1 hour prior to shower for days to relieve and soothe. not used anything in ear canals yet. Might try warmed olive oil and honey. The outcome of event was not recovered.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes underneath her arm pits, collar bone and groin area; This is a spontaneous report from a  contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The caller is a pharmacist calling from (pharmacy name) in (State name). She was calling about a patient who received the second dose of the Pfizer Covid vaccine. A couple of days after the second dose, on an unspecified date, the patient had noticed swollen lymph nodes underneath her arm pits, collar bone and in her groin area. The pharmacist said that she was aware of the collar bone and arm pits being swollen that may come with the vaccine but never heard of groin lymph nodes getting swollen. The outcome for the event was unknown.  Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2].
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: received BNT162B2 via trans mammary by mother; This is a spontaneous report from a contactable other HCP reported for herself and baby. This is the baby report. A patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0182), via trans mammary rout of administration in left arm on 05May2021 at 13:30 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. No other vaccine in four weeks. Other medications in two weeks were prenatal vitamins (breastfeeding). No COVID prior vaccination. No COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101068267 Same reporter/vaccine, Diffferent patient/event, Mother case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Heart beat went up; Pharmacist asked her if she was nervous or having anxiety and she said yes; Pharmacist asked her if she was nervous or having anxiety and she said yes; left arm sore; extremely dizzy; extremely weak; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: FA7485, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 59-year) in left arm on 16Aug2021 as dose 1, single for COVID-19 immunization. Medical history included allergy to penicillin, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Time the vaccination was given: 1430- 1445. Prior vaccinations (within 4 weeks) were reported none. On 16Aug2021 the patient experienced extremely dizzy, extremely weak; on 17Aug2021 the patient experienced left arm sore; on an unspecified date the patient experienced heart beat went up, pharmacist asked her if she was nervous or having anxiety and she said yes. Adverse events not required to emergency room/physician office. The patient underwent lab tests and procedures on an unspecified date which included heart rate: heartbeat went up. It was reported that she was leery and nervous to get the second dose. It was reported that "she was calling about the Pfizer covid vaccine. She received it on Monday and immediately was extremely dizzy and weak. Heart beat went up and she told the pharmacist. Pharmacist asked her if she was nervous or having anxiety and she said yes. The pharmacist stated it could be since she was nervous and was told to sit as long as she needed. She felt like she could not get up and walk and got very weak. Her dizziness did not go away for almost an hour. With that kind of reaction, she was asking if she should she get the second dose. Advised to consult with hcp. The dizziness and weakness started within seconds of her receiving the vaccine, immediately. Her left arm was still a bit sore but that was expected, it was much better and sore if she pushed on her shoulder area. The soreness started yesterday. She got to the point when she was sitting in the pharmacy and then she got to where she could get up and walk to her car but did not drive right away. She sat in her car for a while since she did not feel comfortable driving since she was still dizzy. Clarified the really bad dizziness lasted for about an hour. Then about 2 to 3 hours later she was fine." The clinical outcome of the events "dizzy, extremely weak" was resolved on 16Aug2021; outcome of the event "left arm sore" was resolving; while the outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain in extremity
Clinical narrative: Heart beat went up; Pharmacist asked her if she was nervous or having anxiety and she said yes; Pharmacist asked her if she was nervous or having anxiety and she said yes; left arm sore; extremely dizzy; extremely weak; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: FA7485, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 59-year) in left arm on 16Aug2021 as dose 1, single for COVID-19 immunization. Medical history included allergy to penicillin, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Time the vaccination was given: 1430- 1445. Prior vaccinations (within 4 weeks) were reported none. On 16Aug2021 the patient experienced extremely dizzy, extremely weak; on 17Aug2021 the patient experienced left arm sore; on an unspecified date the patient experienced heart beat went up, pharmacist asked her if she was nervous or having anxiety and she said yes. Adverse events not required to emergency room/physician office. The patient underwent lab tests and procedures on an unspecified date which included heart rate: heartbeat went up. It was reported that she was leery and nervous to get the second dose. It was reported that "she was calling about the Pfizer covid vaccine. She received it on Monday and immediately was extremely dizzy and weak. Heart beat went up and she told the pharmacist. Pharmacist asked her if she was nervous or having anxiety and she said yes. The pharmacist stated it could be since she was nervous and was told to sit as long as she needed. She felt like she could not get up and walk and got very weak. Her dizziness did not go away for almost an hour. With that kind of reaction, she was asking if she should she get the second dose. Advised to consult with hcp. The dizziness and weakness started within seconds of her receiving the vaccine, immediately. Her left arm was still a bit sore but that was expected, it was much better and sore if she pushed on her shoulder area. The soreness started yesterday. She got to the point when she was sitting in the pharmacy and then she got to where she could get up and walk to her car but did not drive right away. She sat in her car for a while since she did not feel comfortable driving since she was still dizzy. Clarified the really bad dizziness lasted for about an hour. Then about 2 to 3 hours later she was fine." The clinical outcome of the events "dizzy, extremely weak" was resolved on 16Aug2021; outcome of the event "left arm sore" was resolving; while the outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache
Clinical narrative: Chest tightness after first vaccine; Headache, after first vaccine; This is a spontaneous report received from a contactable consumer (patient's mother). A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Aug2021 (at the age of 22-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that Caller was calling about the Pfizer vaccination, later reclarified as Pfizer BioNTech Covid 19 vaccine. Caller states her daughter took her first vaccine yesterday and Caller states that today, her daughter has been having chest tightness for the last hour, and a headache. Caller asks, are those side effects of the vaccine, have they been reported? Caller asks, What can she take for the tightness in her chest? This started an hour ago. Her daughter has taken a Tylenol already and are going to see if that helps. On 18Aug2021, the patient experienced chest tightness, headache after first vaccine. Patient received treatment with Tylenol for the events. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dry mouth, Dyspnoea, Eating disorder
Clinical narrative: Chest pain like thirty minutes ago/ chest started hurting; Mouth going completely dry i ran out of saliva; Have problem breathing; Feeling dizzy; Couldn't take like food; This is a spontaneous report from a contactable consumer (patient) reported for himself that:A 36-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 05Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization(Age at vaccination 36 years).  The patient medical history was not reported. The patient's concomitant medications were not reported. on 18Aug2021 After the vaccination the patient had chest pain like thirty minutes ago and he have problem breathing and started feeling dizzy wanted to faint and having children now too they are slowly going away but scary. yeah, it's all starting with his mouth going completely dry ran out of saliva then his chest started hurting and he couldn't take like food and like breath. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular, Vaginal haemorrhage
Clinical narrative: Why is this vaccine disrupting my hormones and making me bleed; spotted last month for the first time in my life in the middle, then I got it late.; Period was heavier than normal.; Now I have my period again just 2 weeks after the last time. It is bleeding in the middle of my cycle; This is scary and I am scared; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28May2021 15:00 (at the age of 49-Years) as dose 2, single for covid-19 immunisation. Medical history reported was none. There were no concomitant medications reported. Patient did not have covid prior to vaccination. Patient was not tested for covid post vaccination. No known allergies were reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. On 15Jun2021, Since receiving her second dose, her period has been all messed up. It was scary. She spotted last month for the first time in her life in the middle, then she got it late. Period was heavier than normal. Now she had her period again just 2 weeks after the last time. It was bleeding in the middle of her cycle, this had never ever happened to her. She had watched her period like a hawk the last few years as she tried to get pregnant so this was new since the vaccine. The events led her to Doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken with respect to events. At the time of this report, the outcome of events was not recovered.  The batch number was not available despite the follow-up attempts made. Follow-up attempts had been completed and no further information was expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Severe muscle aches; Fatigue; Headache; Fever; aching bones; swelling in dermal fillers at lips; sensitive/sore skin; sensitive/sore skin; sinus swelling; sinus swelling; Labored breathing; heavy and sore chest muscles; heavy and sore chest muscles; This is a spontaneous report from a contactable consumer (patient herself). A 22-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 17Aug2021 17:00 (at the age of 22-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included levonorgestrel (SKYLA) taken for an unspecified indication. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 26Jul2021 17:00 (at the age of 22-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 18Aug2021 06:00 the patient experienced severe muscle aches, fatigue, headache, fever, aching bones, swelling in dermal fillers at lips, sensitive/sore skin, sinus swelling, labored breathing, heavy and sore chest muscles. Patient was currently at 36 hours post-vaccine with no improvement. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature with unknown results on 18Aug2021. The outcome of all events was not recovered.   No follow-up attempts are needed; information about lot/batch number can not be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lip swelling, Myalgia, Pain of skin
Clinical narrative: Severe muscle aches; Fatigue; Headache; Fever; aching bones; swelling in dermal fillers at lips; sensitive/sore skin; sensitive/sore skin; sinus swelling; sinus swelling; Labored breathing; heavy and sore chest muscles; heavy and sore chest muscles; This is a spontaneous report from a contactable consumer (patient herself). A 22-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 17Aug2021 17:00 (at the age of 22-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included levonorgestrel (SKYLA) taken for an unspecified indication. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 26Jul2021 17:00 (at the age of 22-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 18Aug2021 06:00 the patient experienced severe muscle aches, fatigue, headache, fever, aching bones, swelling in dermal fillers at lips, sensitive/sore skin, sinus swelling, labored breathing, heavy and sore chest muscles. Patient was currently at 36 hours post-vaccine with no improvement. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature with unknown results on 18Aug2021. The outcome of all events was not recovered.   No follow-up attempts are needed; information about lot/batch number can not be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin, Sinus disorder, Swelling
Clinical narrative: Severe muscle aches; Fatigue; Headache; Fever; aching bones; swelling in dermal fillers at lips; sensitive/sore skin; sensitive/sore skin; sinus swelling; sinus swelling; Labored breathing; heavy and sore chest muscles; heavy and sore chest muscles; This is a spontaneous report from a contactable consumer (patient herself). A 22-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 17Aug2021 17:00 (at the age of 22-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included levonorgestrel (SKYLA) taken for an unspecified indication. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Right on 26Jul2021 17:00 (at the age of 22-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 18Aug2021 06:00 the patient experienced severe muscle aches, fatigue, headache, fever, aching bones, swelling in dermal fillers at lips, sensitive/sore skin, sinus swelling, labored breathing, heavy and sore chest muscles. Patient was currently at 36 hours post-vaccine with no improvement. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature with unknown results on 18Aug2021. The outcome of all events was not recovered.   No follow-up attempts are needed; information about lot/batch number can not be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Palpitations, SARS-CoV-2 test
Clinical narrative: Racing heartbeat; palpitations; Shortness of breath at rest; This is a spontaneous report from a contactable nurse. This 31-year-old non-pregnant female nurse reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via intramuscular route of administration on 28Apr2021 at 12: 00 PM on left arm as dose 2, single for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient had no allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via intramuscular route of administration on 07Apr2021 at 12:00 PM on left arm as dose 1, single for COVID-19 immunization. No other vaccine was received in four weeks and no other medications in two weeks. The patient did not have Covid prior vaccination and was tested for covid post vaccination. On 12Aug2021 the patient's  heartbeat was racing, palpitations and had shortness of breath at rest. On 12Aug2021 Nasal Swab rapid antigen result was negative. No treatment was received. The event outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Gait disturbance, Headache, Mental impairment
Clinical narrative: within twenty four hours after receiving the vaccine i was barely able to walk; Very sore; Headache; not able to function mentally; muscle pain was in tenth/lots of muscle ache, muscle pain was intense especially in the lower region; muscle pain was intense especially in the lower region, my leg and hip area; severe leg pain; lower back pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0181) intramuscularly on 18Aug2021 at 10:00 as a single dose in the left arm for COVID-19 immunization. Medical history included blood clots in pelvis (needing 5 stent surgery; taking warfarin blood thinners) from 26Jan2015 and ongoing and I had COVID in Jan2021 and not ongoing (needed antibodies 1-hour long infusion of Bamlavinivimad (?)). Concomitant medications included warfarin taken for blood clot in pelvis from an unspecified date and ongoing. Concomitant products were also reported as no. Prior vaccinations were reported as no. On 19Aug2021, the patient experienced within twenty-four hours after receiving the vaccine I was barely able to walk, very sore, headache, not able to function mentally, muscle pain was in tenth/lots of muscle ache, muscle pain was intense especially in the lower region, muscle pain was intense especially in the lower region, my leg and hip area, severe leg pain and lower back pain. The events were serious for persistent/significant disability/incapacity. The patient reported that both shots of the vaccine resulted in total body inabilities to barely walk, very sore, headache, was not able to function mentally. She had the same with the second shot but also had severe chest pain (captured in AER: 202101309811). The patient stated that she almost went to hospital. She reported that she had COVID-19 in January 2021 and needed antibodies, 1-hour long infusion of Bamlavinivimad (?). The patient stated that having COVID was better than these 2 shots. She would not be doing any boosters. Treatment was not received for the events. Relevant tests were reported as none. The clinical outcomes of the events within twenty-four hours after receiving the vaccine I was barely able to walk, very sore, headache, not able to function mentally, muscle pain was in tenth/lots of muscle ache, muscle pain was intense especially in the lower region, muscle pain was intense especially in the lower region, my leg and hip area, severe leg pain and lower back pain were recovered/resolved on 20Aug2021.  No follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain assessment, Pain in extremity
Clinical narrative: within twenty four hours after receiving the vaccine i was barely able to walk; Very sore; Headache; not able to function mentally; muscle pain was in tenth/lots of muscle ache, muscle pain was intense especially in the lower region; muscle pain was intense especially in the lower region, my leg and hip area; severe leg pain; lower back pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0181) intramuscularly on 18Aug2021 at 10:00 as a single dose in the left arm for COVID-19 immunization. Medical history included blood clots in pelvis (needing 5 stent surgery; taking warfarin blood thinners) from 26Jan2015 and ongoing and I had COVID in Jan2021 and not ongoing (needed antibodies 1-hour long infusion of Bamlavinivimad (?)). Concomitant medications included warfarin taken for blood clot in pelvis from an unspecified date and ongoing. Concomitant products were also reported as no. Prior vaccinations were reported as no. On 19Aug2021, the patient experienced within twenty-four hours after receiving the vaccine I was barely able to walk, very sore, headache, not able to function mentally, muscle pain was in tenth/lots of muscle ache, muscle pain was intense especially in the lower region, muscle pain was intense especially in the lower region, my leg and hip area, severe leg pain and lower back pain. The events were serious for persistent/significant disability/incapacity. The patient reported that both shots of the vaccine resulted in total body inabilities to barely walk, very sore, headache, was not able to function mentally. She had the same with the second shot but also had severe chest pain (captured in AER: 202101309811). The patient stated that she almost went to hospital. She reported that she had COVID-19 in January 2021 and needed antibodies, 1-hour long infusion of Bamlavinivimad (?). The patient stated that having COVID was better than these 2 shots. She would not be doing any boosters. Treatment was not received for the events. Relevant tests were reported as none. The clinical outcomes of the events within twenty-four hours after receiving the vaccine I was barely able to walk, very sore, headache, not able to function mentally, muscle pain was in tenth/lots of muscle ache, muscle pain was intense especially in the lower region, muscle pain was intense especially in the lower region, my leg and hip area, severe leg pain and lower back pain were recovered/resolved on 20Aug2021.  No follow-up attempts are needed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: for the first shot, my upper left harm hurt pretty bad for a day and a half but lightened up and was pretty much gone after day 3-4; also, I had some mild shortness of breath the following day, just f; also, I had some mild shortness of breath the following day, just for that day, which was one of the symptoms I had when I was sick with covid; This is a spontaneous report from a contactable consumer reported for herself. A 47-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration, administered in left arm on 25Jul2021 at 11:00 (at age of 47-years-old) as dose 1, single for COVID-19 Immunisation. Patient medical history include asthma, sleep apnea, COVID-19. Patient concomitant medications include atenolol, rosuvastatin calcium (Crestor), levothyroxine sodium (Synthroid), lithium, desvenlafaxine succinate monohydrate (Pristiq); all used for unspecified indication start and stop dates were not reported. Patient previously took sulfa drug and experienced allergy to it. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jul2021(same day of vaccination), it was reported that for the first shot, my upper left arm hurt pretty bad for a day and a half but lightened up and was pretty much gone after day 3-4; also, I had some mild shortness of breath the following day just for that day, which was one of the symptoms I had when I was sick with covid. Patient underwent lab test and procedures include sars-cov-2 test,patient diagnosed with COVID-19 prior to vaccination on unspecified date.The Patient did not receive any treatment for events. The Outcome of the events was recovered on unspecified date in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Exercise electrocardiogram
Clinical narrative: Cardiac change- new delta wave noted in EKG on 7/25/21.  No cardiac abnormalities prior to vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Blood test, Cerebrovascular accident, Cranial nerve palsies multiple, Diplopia
Clinical narrative: 10 hours after my vaccine I developed double vision. I was told it was a cranial nerve palsy the next day when i went to an optho doctor. The next day I temporarily lost vision in the left eye. I then went to the ER the following day and was diagnosed with a midbrain stroke. I am a healthy 36 YO physician. I have been on low dose birth control for >15 years. I forgot to mention I am also on a low dose of phentermine which I have been taking for a month without any issues. I have also been on it before. I have no history of strokes nor do I have any history of DVT etc.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Drug screen negative, Echocardiogram, Electrocardiogram, Magnetic resonance imaging, Scan with contrast
Clinical narrative: 10 hours after my vaccine I developed double vision. I was told it was a cranial nerve palsy the next day when i went to an optho doctor. The next day I temporarily lost vision in the left eye. I then went to the ER the following day and was diagnosed with a midbrain stroke. I am a healthy 36 YO physician. I have been on low dose birth control for >15 years. I forgot to mention I am also on a low dose of phentermine which I have been taking for a month without any issues. I have also been on it before. I have no history of strokes nor do I have any history of DVT etc.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dysmenorrhoea, Headache, Heart rate increased, Heavy menstrual bleeding
Clinical narrative: The evening of my 2nd dose of Moderna (2nd dose date was Feb. 14, 2021; this form didn't seem to allow for indicating 2 different dose dates), I became incredibly ill and feverish. It was more painful than childbirth. My fiancé had a Percocet left over from a recent kidney stone ailment and taking that didn't alleviate my pain - which included a migraine-like pounding headache at the base of my skull - at all. I was sweating and felt deathly ill like this for about 3 days. A few weeks later, I had a period that seemed like an abortion - super painful, huge clumps, it was gross and like nothing I've ever experienced. The bizarre pounding migraine-like headache I had the first few days after my 2nd dose kept popping up for about 6 months afterward. It's now been 9-10 months since my 2nd dose and those excruciating headaches have subsided. But I'm worried about getting another Moderna dose because of the long-lasting side effects I had. I also have always had perfect blood pressure and a very low, healthy resting heart rate because I'm a runner, my entire life, always - and for the first time ever in my life, my resting heart rate has gone from 64-67 up to the mid- to high-70s and my doctor showed me a graph on his computer showing my blood pressure ad increased from a flat line up to a dangerous level, with the only difference in my life being the vaccination I received. It scared me terribly. Not sure what it means, or if those numbers will improve?
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Malaise, Migraine, Pain, Pyrexia
Clinical narrative: The evening of my 2nd dose of Moderna (2nd dose date was Feb. 14, 2021; this form didn't seem to allow for indicating 2 different dose dates), I became incredibly ill and feverish. It was more painful than childbirth. My fiancé had a Percocet left over from a recent kidney stone ailment and taking that didn't alleviate my pain - which included a migraine-like pounding headache at the base of my skull - at all. I was sweating and felt deathly ill like this for about 3 days. A few weeks later, I had a period that seemed like an abortion - super painful, huge clumps, it was gross and like nothing I've ever experienced. The bizarre pounding migraine-like headache I had the first few days after my 2nd dose kept popping up for about 6 months afterward. It's now been 9-10 months since my 2nd dose and those excruciating headaches have subsided. But I'm worried about getting another Moderna dose because of the long-lasting side effects I had. I also have always had perfect blood pressure and a very low, healthy resting heart rate because I'm a runner, my entire life, always - and for the first time ever in my life, my resting heart rate has gone from 64-67 up to the mid- to high-70s and my doctor showed me a graph on his computer showing my blood pressure ad increased from a flat line up to a dangerous level, with the only difference in my life being the vaccination I received. It scared me terribly. Not sure what it means, or if those numbers will improve?
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Rash, Rash pruritic
Clinical narrative: Lumpy, painful/itchy, rash near the injection site
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood testosterone decreased
Clinical narrative: Moderna COVID-19 Vaccine EUA  Hello  After the  Covid Vaccine I?ve felt really low and no energy.  My doctor has diagnosed with low Testosterone count.  No one will say it?s related to the vaccine. I thought I?d just share my outcome.  It might be coincidence, but if a few other have the same coincidence.  Maybe this report is a waste of your time maybe not.   So my outcome is low testosterone. Thank you.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Gait disturbance, Hypoaesthesia, Neuralgia, Pain
Clinical narrative: I am experienced life-altering injuries after receiving the 1st shot on April29.   My hands and feet feel numb. Dr prescribed nerve pain medication Gabapentin and slightly dull my pains but hasn?t been resolved.  Every morning my feet feels swollen and like stepping on pins and needles. I can?t walk or bike for long periods like I used to and have to endure and suffer from nerve pains.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: I am experienced life-altering injuries after receiving the 1st shot on April29.   My hands and feet feel numb. Dr prescribed nerve pain medication Gabapentin and slightly dull my pains but hasn?t been resolved.  Every morning my feet feels swollen and like stepping on pins and needles. I can?t walk or bike for long periods like I used to and have to endure and suffer from nerve pains.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Sensation of foreign body
Clinical narrative: Lips began to swell and throat felt as though there was something stuck in the back of my throat for over 8hrs. Was able to breath, cough and swallow
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Antinuclear antibody negative, Nephrotic syndrome, Protein urine present, Swelling
Clinical narrative: Nephrotic Syndrome symptoms (swelling throughout body and increased protein in urine. 1 month after vaccine parents started noticing weight gain until it reach a point of concern, i.e. swelling of entire body.  At that time 9/15/21 she was taken to ER which transferred her to Hospital.  She was tested for Lupus, and other auto immune disease which were negative. Patient was treated with prednisone and lasix for 5 days and then released after symptoms subsided.  Patient is presently being treated with prednisone 60mg daily and is due next week to taper to predisone 60mg every other day.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Nephrotic Syndrome symptoms (swelling throughout body and increased protein in urine. 1 month after vaccine parents started noticing weight gain until it reach a point of concern, i.e. swelling of entire body.  At that time 9/15/21 she was taken to ER which transferred her to Hospital.  She was tested for Lupus, and other auto immune disease which were negative. Patient was treated with prednisone and lasix for 5 days and then released after symptoms subsided.  Patient is presently being treated with prednisone 60mg daily and is due next week to taper to predisone 60mg every other day.