chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache after 2nd dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 19Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history included pain in extremity after first dose from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen, paracetamol taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, on 29Jan2021 as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced light headache after 2nd dose. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Overdose, Pain in extremity, Product preparation issue, Weight
Clinical narrative: gave a patient too much vaccine. The patient received the whole Pfizer vaccine vial with out dilution; mild sore arm for a day; gave a patient too much vaccine. The patient received the whole Pfizer vaccine vial with out dilution; This is a spontaneous report from a contactable Pharmacist reported for a female patient. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Right Arm on 24Feb2021 07:10 (Batch/Lot Number: EN6202; Expiration Date: Jun2021) as dose 1, single (age at vaccination:37-Year-old). for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On 24Feb2021 07:10 HCP states she "gave a patient too much vaccine. The patient received the whole Pfizer vaccine vial without dilution, and experienced mild sore arm for a day.. Reporter asking that When they do receive their first dose, can they wait a month if needed for the 2nd dose. The outcome of the events was recovered on unspecific date in 2021.  Follow-up (12Apr2021): This is a follow-up spontaneous report from a contactable Pharmacist. This Pharmacist reported in response to HCP letter via telephonic follow-up activity that includes: Provide clear narrative description of the sequence of event(s), diagnosis, treatment, any other relevant details. If additional space is needed, use supplemental page, and check this box:  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Gait inability, Joint swelling, Pain, Peripheral swelling
Clinical narrative: swelling in the ankle and wrist on the side of the vaccine given; her hand is still swollen/ she couldn't bend her hand and couldn't get her rings off; she could not walk; unnecessary pain on my left side/ area was painful; the pain (inside part of the bone); she touched that it was tender; This is a spontaneous report from a contactable consumer (patient). A female patient (age currently 79, unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route, administered in left arm on 30Jan2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing breast cancer now 2 years and she took a hormone. The concomitant medications included unspecified hormone for breast cancer. The patient had questions on swelling in the ankle and wrist on the side of the vaccine given. Was a normal side effect and if someone had a side effect like that (swelling) should they get the second dose. Second dose was scheduled for Monday. She stated that it started as swelling on her thumb to wrist, hand around the wrist that area was painful then. It was under her ankle on the same side, not as bad as the wrist. Then she could not walk, then it would kink out and then she was fine again. She never had this. She walked and it was like wow. Unnecessary pain on her left side. The shot was on her left side. It was swelling initially in her hands so she could not bend her hand and she could not put on her rings and as that went down, then the pain (inside part of the wrist bone) and if she touched that it was tender, and the ankle same kind of pain (it was once in a while). Her hand was still swollen. It was not stopping her from doing stuff but it was stopping her from walking and she did not want it to be worse. She was confused and did not know if she should get the second dose. The outcome of event her hand is still swollen/ she couldn't bend her hand and couldn't get her rings off was not recovered and outcome of other events was unknown.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: swelling in the ankle and wrist on the side of the vaccine given; her hand is still swollen/ she couldn't bend her hand and couldn't get her rings off; she could not walk; unnecessary pain on my left side/ area was painful; the pain (inside part of the bone); she touched that it was tender; This is a spontaneous report from a contactable consumer (patient). A female patient (age currently 79, unit: unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route, administered in left arm on 30Jan2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing breast cancer now 2 years and she took a hormone. The concomitant medications included unspecified hormone for breast cancer. The patient had questions on swelling in the ankle and wrist on the side of the vaccine given. Was a normal side effect and if someone had a side effect like that (swelling) should they get the second dose. Second dose was scheduled for Monday. She stated that it started as swelling on her thumb to wrist, hand around the wrist that area was painful then. It was under her ankle on the same side, not as bad as the wrist. Then she could not walk, then it would kink out and then she was fine again. She never had this. She walked and it was like wow. Unnecessary pain on her left side. The shot was on her left side. It was swelling initially in her hands so she could not bend her hand and she could not put on her rings and as that went down, then the pain (inside part of the wrist bone) and if she touched that it was tender, and the ankle same kind of pain (it was once in a while). Her hand was still swollen. It was not stopping her from doing stuff but it was stopping her from walking and she did not want it to be worse. She was confused and did not know if she should get the second dose. The outcome of event her hand is still swollen/ she couldn't bend her hand and couldn't get her rings off was not recovered and outcome of other events was unknown.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Influenza, Lymphadenopathy, Pain
Clinical narrative: she felt aches all over; she thinks that she shrunk some; swollen lymph nodes; flu; This is a spontaneous report from a contactable consumer (Patient). A 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318, Expiry date was not reported), via an unspecified route of administration on 06Feb2021 08:20 (at the age of 84-years-old) in Arm Right as dose 1, single for COVID-19 immunization. The patient Medical history included mastectomy from an unknown date and unknown if ongoing, lymphoma from 1989 to an unknown date and history including any illness at time of vaccination was reported as none. The Patient concomitant medications was reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE following prior vaccinations was none. Family Medical History Relevant to AE was none. Other relevant diagnostic and confirmatory test results for events was none. Caller states she received the first dose of the Pfizer COVID 19 vaccine 06Feb2021. She was due for second dose 27Feb2021, Saturday. On 24Feb2021, She woke up this morning with swollen lymph nodes right where she had a double mastectomy. Would that be from the vaccine even though it's been 2 weeks. She applied ben gay and it went down but is still a little sore. Could this be from the vaccine. Last week on Wednesday and Thursday on unspecified date she felt aches all over and on 17Feb2021 she felt like she may have a touch of the flu, but no fever. Could this be from the vaccine. States that she doesn't feel sick. Should she still get the second dose on Saturday 27Feb2021. She used to be 5' 6 3/4", but on unspecified date, she thinks that she shrunk some. Caller does not have the full contact information to provide for her primary care physician. States that she has an appointment to see the doctor on 03Mar2021. States that she has a lot of other medical conditions and medications, but declines to provide any further details. States that her doctor has all her medical history and can provide that information if necessary. Therapeutic measures were taken as a result of swollen lymph nodes. Patient was not visited to emergency room. The patient underwent lab tests and procedures which included body height: 5' 6 3/4 on an unknown date. The outcome for the events Swollen lymph nodes was recovered on 24Feb2021 and event felt like she may have a touch of the flu was recovered on 19Feb2021 and event she felt aches all over and she thinks that she shrunk some was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: When I took the 1st Vaccine I did have arm tenderness on day of injection.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration in arm left on 22Jan2021 at 09:30 (age at the time of the vaccination 61-year-old) as dose 1, single for COVID-19 immunization at Military Base. Medical history included ITP (idiopathic thrombocytopenic purpura), fibromyalgia, PBC (primary biliary cholangitis), parathyroid and GERD (gastrooesophageal reflux disease). Concomitant medications included ursodiol and colecalciferol (VITAMIN D [COLECAL-CIFEROL]) for unspecified indication, start and stop dates were not reported. The patient previously took Zircon and Wellbutrin and experienced allergies. No other vaccine was received in four weeks. The patient had no COVID prior vaccination and not tested for COVID post vaccination. It was reported that, the patient had great body pain all day long. Patient said, on 23Jan2021 at 12: 00, when I took the 1st vaccine, I did have arm tenderness on day of injection. To her surprise she was completely pain free for about a week, she hadn't felt that great in years. Gradually all the pain returned. No treatment was received for the event. On an unspecified date in 2021, the outcome of the event was resolved.  Information on lot number/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Lethargy, Limb discomfort
Clinical narrative: lethargic; she felt "tips" light headed and loose, She was very light-headed and woozy feeling, and when she was walking, it felt like her feet weren't touching the ground; she felt weak; Arm soreness; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer(patient) reported. A 71-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Batch/lot number: EN6200) via unknown route of administration in left arm on 11Feb2021 (age at the time of vaccination was 71-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Acid reflux (esophageal), she had the Shingles vaccine when she was 55, and she got sick with that and a big scab that formed on her arm and she gets the flu shot, she felt sick for 3-4 days, had not had a flu shot in 7-8 years. The concomitant medication included OMEPRAZOLE MAGNESIUM (PRILOSEC) for Acid reflux (esophageal) 40mg once daily from 05Feb2021 to ongoing, took it awhile back, then doctor wanted her to get off it, had been off it for about a year, but the reflux had gotten too bad, so was back on it for a month. On 19Feb2021, after 2-3 hours she stated that that she had a reaction that she hadn't heard of she started feeling like she was tipsy or high. She was very light-headed and woozy feeling, and when she was walking, it felt like her feet weren't touching the ground. This lasted all night and when she woke up the next morning, those symptoms were gone, but she was very weak and lethargic, felt like she was recovering from an illness, just not with it, on an unspecified date in Feb2021, she also had arm soreness, but none of the other symptoms that she expected to get. The patient did not visit emergency room or physician office due to events. It was stated that she didn't even think about it being from the vaccine until she read finally read the information sheet on Sunday and it listed the side effects and severe allergies, and dizziness and weakness were under severe allergies. So, now she did not know if what she experienced was a severe allergy. It was reported that she wanted to know would this be considered the severe allergy reaction to the vaccine and also wanted to know should she get the second dose. The outcome of the events was recovered on 21Feb2021 and arm soreness was unknown.  No follow-up attempts were possible. No further information was expected
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eating disorder, Illness, Nausea, Vomiting
Clinical narrative: stomach cramping; Nausea; vomiting /has been throwing up; being sick the next day; she haven't been eating much; weight is down a little bit, it is around 98 pounds; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 86-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Batch/Lot Number: CN9581) single dose via an unspecified route of administration, administered in Arm Left on 15Feb2021 for covid-19 immunisation.  Medical history included abdominal discomfort unknown if ongoing had these stomach issues before, but not for this long of a timeframe.She does have other medications, but she had not been taking them all, she had just been taking the most important ones because she does not know if they will stay down.   On 16Feb2021 the patient experienced stomach cramps, nausea, she had been throwing up, and it hurts. she haven't been eating much because she was throwing up, so her weight is down a little bit, it is around 98 pounds. she has had these stomach issues before, but not for this long of a timeframe. The patient had no other vaccines on the same day as the COVID Vaccine. The patient underwent lab tests and procedures which included weight was it is around 98 pounds lbs on down a little bit. The outcome for the events stomach cramping, Nausea and vomiting /has been throwing up were not recovered. The outcome for the events being sick the next day, she haven't been eating much and weight is down a little bit, it is around 98 pounds were unknown. No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight abnormal
Clinical narrative: stomach cramping; Nausea; vomiting /has been throwing up; being sick the next day; she haven't been eating much; weight is down a little bit, it is around 98 pounds; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 86-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Batch/Lot Number: CN9581) single dose via an unspecified route of administration, administered in Arm Left on 15Feb2021 for covid-19 immunisation.  Medical history included abdominal discomfort unknown if ongoing had these stomach issues before, but not for this long of a timeframe.She does have other medications, but she had not been taking them all, she had just been taking the most important ones because she does not know if they will stay down.   On 16Feb2021 the patient experienced stomach cramps, nausea, she had been throwing up, and it hurts. she haven't been eating much because she was throwing up, so her weight is down a little bit, it is around 98 pounds. she has had these stomach issues before, but not for this long of a timeframe. The patient had no other vaccines on the same day as the COVID Vaccine. The patient underwent lab tests and procedures which included weight was it is around 98 pounds lbs on down a little bit. The outcome for the events stomach cramping, Nausea and vomiting /has been throwing up were not recovered. The outcome for the events being sick the next day, she haven't been eating much and weight is down a little bit, it is around 98 pounds were unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: my upper arm was very sore; sore throat; I was exhausted; This is a spontaneous report from a contactable consumer (patient herself). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6200; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 19Feb2021 18:00 (at the age of 30-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levothyroxine (LEVOTHYROXINE) and elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]) taken for an unspecified indication. The patient previously took vicodin and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. The day after the vaccination on 20Feb2021, the patient's upper arm was very sore and was exhausted. Following that day, for the next four days which brought us to today, patient had post nasal drip and a sore throat. Patient did not receive any treatment for AEs. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was recovering.  Follow-up (17Jun2021): Follow-up attempts completed. No further information expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastric disorder, Investigation, Vomiting
Clinical narrative: Vomiting/ threw up; Diarrhea; Sick to her stomach; This is a spontaneous report from a contactable consumer (patient) and other health care professional. An 82-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6201, Expiry Date: unknown), via an unspecified route of administration on 22Feb2021 (at the age of 82-year-old) as a single dose for covid-19 immunisation. The patient medical history included gallbladder disorder and gallbladder operation (She was going through a bout right then with gall bladder problems that was why she said she does not know if that was the cause or if it seemed like it was gall bladder. She had been dealing with the gall bladder problems for about a year or more. She was tested again and again, and they finally said she has gall stones, and she has to have her gall bladder removed. The patient concomitant medications were not reported. On 23Feb2021 at 01:00 the patient experienced vomiting/ threw up, sick to her stomach, diarrhea. The reporter stated that the patient had the shot on Monday (22Feb2021), and everything was fine until 23Feb2021 (yesterday) afternoon she was sick to her stomach really bad and then during that night at about 23:30 or 24:00 she threw up and had diarrhea and she did not know if that was something that could be related to the vaccine. It was not on the sheet; nausea is but not diarrhea or throwing up. She asked if there had been anyone else call with these same symptoms. Right then it was not worse, it was worse last night, she was just sick to her stomach, she had diarrhea once again today. The patient underwent lab tests and procedures which included investigation: gall stones on unspecified date. The clinical outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling really tired; This is a spontaneous report from a contactable consumer (patient) received via  Support. An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 09Feb2021 dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date dose 1, single for COVID-19 immunization. Patient reported that she received the second dose of the Covid vaccine on February 9th and was still feeling really tired (2021). Patient asked if that can still be a reaction from the vaccine, further stated that she had back aches and other problems and wasn't sure if her being this fatigued was still from the vaccine. Patient stated she had not gotten much exercise and it had her feeling sorry for herself. The clinical outcome for the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pain in extremity
Clinical narrative: Arm soreness radiating from my shoulder to elbow after the injection.; Woke up in the middle of the night with chills; sweating; feeling achy; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date were not reported), via an unspecified route of administration, in Arm Left on 23Feb2021 at 10:00 AM (age at vaccination: 32-years-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any vaccine prior to COVID-19 vaccine with in four weeks. The patient was not allergic to any medication. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date were not reported), via an unspecified route of administration, in Arm Left on 28Jan2021 at 09:00 AM (age at vaccination: 32-years-old), as DOSE 1, SINGLE for covid-19 immunisation. On 23Feb2021, at 11:00 AM the patient experienced arm soreness radiating from his shoulder to elbow after the injection. He woke up in the middle of the night with chills/sweating and felt achy. He continued to feel achy the following day. The patient did not receive any treatment for the events. Outcome of the events was recovering.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Extreme soreness at and around site of injection in left arm; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 10:30 (at the age of 41-year-old) as a single dose for COVID-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. Patient medical history reported as none. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication. Patient had no Known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 at 13:00 the patient experienced extreme soreness at and around site of injection in left arm. Patient did not receive any treatment for the event. The clinical outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia
Clinical narrative: severe muscle pain in my back; i cannot function; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 61-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 21Feb2021 13:30 (at the age of 61-year-old) as dose 1, single for covid-19 immunization. Medical history included fibromyalgia from an unknown date and unknown if ongoing. Concomitant medications within 2 weeks included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, levothyroxine sodium (SYNTHROID) taken for an unspecified indication, risedronate sodium (ACTONEL) taken for an unspecified indication, start and stop date were not reported. Patient did not received any other vaccine in four weeks. The patient was not diagnosed with covid prior to the vaccination and had been not tested for covid post the vaccination. On 22Feb2021 the patient experienced severe muscle pain in back, patient cannot function. No treatment received for the events. Outcome of the events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain in extremity
Clinical narrative: Sore arm; stomach pains; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 75-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number EM9809), via an unspecified route of administration, administered in Arm Left on 23Feb2021 11:15 (at the age of 75 years old ) as dose 2, single , Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for Covid -19 immunization. Medical history included atrial fibrillation. There were no concomitant medications. The patient did not have any known allergies. The patient did not receive any other vaccine in last 4 weeks. The patient did not have COVID prior to vaccination. The was not tested for COVID after the vaccination. The patient was not pregnant at the time of vaccination. On unspecified date the patient experienced sore arm, stomach pains, diarrhea. The patient did not receive any treatment for the adverse events. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: UNK
Symptoms: Tendonitis
Clinical narrative: tendinitis; few days later had an interaction with another product; This is a spontaneous report from a contactable consumer (patient) reporting for herself received from a Pfizer-sponsored. A female patient of age, 62 (Unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date as single dose for covid-19 immunisation. On an unspecified date in Feb2021, the patient experienced tendinitis and few days later had an interaction with another product. The clinical course was reported as follows: The patient received the second dose of the Covid vaccine 5 days ago. She received two steroid cortisone shots for tendinitis the previous day. She asked if the cortisone shots will interfere with the efficacy of the vaccine. She received 2 steroid shots in hand five days after covid vaccine and wondering if it is going to diminish efficacy of vaccine. She got her 2nd dose of the Covid vaccine and then a few days later had an interaction with another product and she wanted to report it. She got her 2nd dose and then had a reaction with another product with the vaccine. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling hot, Gait disturbance, Hyperhidrosis, Nasopharyngitis
Clinical narrative: shaking, violently shaking; chills; sweating; very hot; forehead was cold; hardly walk; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6202 and expiry date was not reported), via an unspecified route of administration, on 23Feb2021 at 11:40 PM (age at vaccination: 78 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes allergic to penicillin and bee stings. The patient's concomitant medications were not reported. The patient's previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, on 02Feb2021 as dose 1, single for COVID-19 immunisation and after the first dose the patient did not have anything, other than his arm was a little sore. On 24Feb2021, at 3 AM that day the patient was having chills, and then sweating and very hot. It was also reported that last night the patient woke up at about 3 AM and he couldn't get warm he was shaking, violently shaking. The patient also stated that he added 3 more blankets he could not keep warm. He took a sleeping pill and an hour and a half later he finally went to sleep at about 4:30 PM. It was reported that when he woke up his forehead was cold but he was sweating and the patient wants to know is that anything to be concerned about. Reportedly last night when he started with the chills and shaking, it was bad, he felt like he was going to freeze to death, he could hardly walk he was shaking so bad. It was reported that the patient also took pain pills. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: shaking, violently shaking; chills; sweating; very hot; forehead was cold; hardly walk; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6202 and expiry date was not reported), via an unspecified route of administration, on 23Feb2021 at 11:40 PM (age at vaccination: 78 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes allergic to penicillin and bee stings. The patient's concomitant medications were not reported. The patient's previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, on 02Feb2021 as dose 1, single for COVID-19 immunisation and after the first dose the patient did not have anything, other than his arm was a little sore. On 24Feb2021, at 3 AM that day the patient was having chills, and then sweating and very hot. It was also reported that last night the patient woke up at about 3 AM and he couldn't get warm he was shaking, violently shaking. The patient also stated that he added 3 more blankets he could not keep warm. He took a sleeping pill and an hour and a half later he finally went to sleep at about 4:30 PM. It was reported that when he woke up his forehead was cold but he was sweating and the patient wants to know is that anything to be concerned about. Reportedly last night when he started with the chills and shaking, it was bad, he felt like he was going to freeze to death, he could hardly walk he was shaking so bad. It was reported that the patient also took pain pills. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: shaking, violently shaking; chills; sweating; very hot; forehead was cold; hardly walk; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EN6202 and expiry date was not reported), via an unspecified route of administration, on 23Feb2021 at 11:40 PM (age at vaccination: 78 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes allergic to penicillin and bee stings. The patient's concomitant medications were not reported. The patient's previously received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EM9810 and expiry date was not reported), via an unspecified route of administration, on 02Feb2021 as dose 1, single for COVID-19 immunisation and after the first dose the patient did not have anything, other than his arm was a little sore. On 24Feb2021, at 3 AM that day the patient was having chills, and then sweating and very hot. It was also reported that last night the patient woke up at about 3 AM and he couldn't get warm he was shaking, violently shaking. The patient also stated that he added 3 more blankets he could not keep warm. He took a sleeping pill and an hour and a half later he finally went to sleep at about 4:30 PM. It was reported that when he woke up his forehead was cold but he was sweating and the patient wants to know is that anything to be concerned about. Reportedly last night when he started with the chills and shaking, it was bad, he felt like he was going to freeze to death, he could hardly walk he was shaking so bad. It was reported that the patient also took pain pills. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling hot, Gait disturbance, Hyperhidrosis, Nasopharyngitis
Clinical narrative: after the first dose he did not have anything, other than his arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810), via an unspecified route of administration on 02Feb2021 (at the age of 78 years old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. He was usually a pretty darn healthy guy. There were no concomitant medications. He was concerned about the way he reacted to it yesterday and after the first dose he did not have anything, his arm was a little sore. This time he wonders if he still has something else to look forward to. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202:) on 23Feb2021 at 11:40. The outcome of the event was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: after the first dose he did not have anything, other than his arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810), via an unspecified route of administration on 02Feb2021 (at the age of 78 years old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. He was usually a pretty darn healthy guy. There were no concomitant medications. He was concerned about the way he reacted to it yesterday and after the first dose he did not have anything, his arm was a little sore. This time he wonders if he still has something else to look forward to. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202:) on 23Feb2021 at 11:40. The outcome of the event was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: after the first dose he did not have anything, other than his arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810), via an unspecified route of administration on 02Feb2021 (at the age of 78 years old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. He was usually a pretty darn healthy guy. There were no concomitant medications. He was concerned about the way he reacted to it yesterday and after the first dose he did not have anything, his arm was a little sore. This time he wonders if he still has something else to look forward to. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202:) on 23Feb2021 at 11:40. The outcome of the event was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: underlying lung disease; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 65-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on 17Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included prednisone at 5 mg taken for an unspecified indication, start and stop date were not reported. The patient had underlying lung disease on an unknown date. The patient stated that his taking prednisone 5mg. The patient already had the first dose of the vaccine and wanted to know if this will interfere with the effect of the vaccine. The patient states his last Tylenol 16Feb2021. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood cholesterol, Blood cholesterol increased, Blood pressure measurement, Eye pain
Clinical narrative: Muscles in her neck have deteriorated; High cholesterol; Headaches; Neck pain; Eye was hurting; Her back and spine have deteriorated as well; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 14Feb2021 (at the age of 73-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The second dose scheduled on 07Mar2021. On an unspecified day in 2021, the patient experienced "muscles in her neck have deteriorated", high cholesterol, headaches, neck pain, eye was hurting, her back and spine have deteriorated as well and eye was hurting. The patient eye was hurting on the second week, had headaches, neck pain, muscles in her neck deteriorated and back and spine have deteriorated as well. Patient hadn't been having problems before the vaccine. Patient also had blood pressure and high cholesterol. Patient was asking whether she get real sick after the second shot, is it safe to take the second one and what are the side effects from the second dose and what if she didn't get it. She was wondering if she could get a different vaccine as second dose. On an unspecified date, the patient underwent lab tests and procedures which included blood cholesterol which was found to be high and blood pressure with unknown results. The outcome of events was unknown.     Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle disorder, Neck pain
Clinical narrative: Muscles in her neck have deteriorated; High cholesterol; Headaches; Neck pain; Eye was hurting; Her back and spine have deteriorated as well; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 14Feb2021 (at the age of 73-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The second dose scheduled on 07Mar2021. On an unspecified day in 2021, the patient experienced "muscles in her neck have deteriorated", high cholesterol, headaches, neck pain, eye was hurting, her back and spine have deteriorated as well and eye was hurting. The patient eye was hurting on the second week, had headaches, neck pain, muscles in her neck deteriorated and back and spine have deteriorated as well. Patient hadn't been having problems before the vaccine. Patient also had blood pressure and high cholesterol. Patient was asking whether she get real sick after the second shot, is it safe to take the second one and what are the side effects from the second dose and what if she didn't get it. She was wondering if she could get a different vaccine as second dose. On an unspecified date, the patient underwent lab tests and procedures which included blood cholesterol which was found to be high and blood pressure with unknown results. The outcome of events was unknown.     Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: ill for a month and half; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.   A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was ill for a month and half. The patient reported that according to the current regime - there was no vaccination for Covid until after 20Jan2021. Patient was given 2 Pfizer shots prior to that date that he was told was the Pfizer covid vaccination. Since the current regime was saying there was no vaccination prior to 20Jan2021 what he was given and that was why he was ill for a month and half. He felt he do have a right to know what was put in his body. Outcome of the event was unknown.  No follow-up attempts are possible. information about lot/batch number cannot been obtained.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Myalgia, Pain, Pain in extremity
Clinical narrative: muscle pain; muscle cramps; chills; had terrible pain in her foot; severe pain in her heel and arch; swelling; This is a spontaneous report received from a contactable consumer or other non hcp. An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810) via an unspecified route of administration on 06Feb2021 (at the age of 87-year-old) as a single dose for COVID-19 immunization. Medical his-tory included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included allopurinol (ALLOPURINOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced had terrible pain in her foot, severe pain in her heel and arch, swelling on 10Feb2021, and muscle pain, muscle cramps, chills on an unspecified date. Additional information she received first dose on 6Feb2021 and 4 days later had terrible pain in her foot. The swelling and pain were still ongoing.  Any information if this was a side effect and how long it will last and also seeking information how much protection with just first dose. She had such a bad time with her foot. She had muscle pain, muscle cramps and chills she had all of that she had and expected all of those. She went to bed fine, but when she went to get up the next morning, my right foot was swollen and couldn't put any pressure at all. She has lost the use of her right foot. she can't make the steps to her bedroom. She has been down on the couch since the 10Feb2021, the pain isn't as severe as it was early on. It was unbearable pain, 10 out of 10 pains, you couldn't touch the foot at all, pain of a gout, even a blanket hurt. It has lessened gradually little every day hoping it goes away completely. she was wondering how long it would last and when can she get use back of my foot because she was very active person before and it's not easy. she still has pain from the arch into heel of the foot. If she doesn't put a sock on it then the toes will fall on each other. (The big toe will go over to the little toe). she doesn't want to subject myself. she can't even put a shoe on to go to the doctors. she stays in the house anyway. The clinical outcome of the event terrible pain in her foot, severe pain in her heel and arch, swelling, muscle pain, were recovering and other events was unknown.  No follow up attempts are possible. no further information is expected.