chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: her left arm where the vaccine was administered got very bruised after the 1st dose; This is a spontaneous report from a Pfizer- sponsored program from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 05Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the 1st dose on 05Apr2021 and her left arm where the vaccine was administered got very bruised after the 1st dose. Patient called in to reschedule her 2nd dose appointment which was scheduled on 19Apr2021. She said she's unable to make it because she had another appointment on that day. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Formication, Paraesthesia
Clinical narrative: crawling sensation in his face and head; pins and needles in his hands and feet really bad; lower back pain; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER8737) at right arm on 16Apr2021 14:00 at single dose for COVID-19 immunization (reported as because everybody is saying that we should; because he is 65). Medical history included ongoing Diverticulitis, ongoing Tinnitus, Stroke (About three years ago, he woke up one morning and started seeing two of everything and when he went to hospital they stated he probably had a slight stroke and was started on aspirin), bolt and screw in his neck due to a spinal injury, the disc collapsed, Cholesterol, acid reflux and thyroid. Concomitant medication included acetylsalicylic acid (ASPIRIN LOW) from 2018 and ongoing because had a slight stroke, omeprazole from unspecified date (started taking at let 15 years ago) and ongoing for acid reflux, levothyroxine from unspecified date (started taking about 7 years ago) and ongoing for thyroid and atorvastatin from unspecified date (been taking about 10 years) and ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect Additional Administered Vaccines If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was None. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was None. Family Medical History Relevant to AE was None. Relevant Tests was None. The caller stated she and her husband, got the first dose of the vaccine on Friday 16Apr2021. On Saturday (17Apr2021) her husband started having pins and needles in his hands and feet really bad and lower back pain, and this morning (19Apr2021) is having a crawling sensation in his face and head. She asked if he should get the second dose. No Investigation Assessment. Caller states patient is currently not taking any medication for these events. Events were not required a visit to Emergency Room or Physician Office. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Rash was all over my torso, left arm, a few spots on the right, both legs near the knees and my back. The spots were small and itchy; This is a spontaneous report received from a contactable consumer (patient). A 31-year-old female patient (not pregnant at time of event onset or vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533) via an unspecified route of administration at right arm on 06Apr2021 10:00 (31-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination) and seasonal allergies. Concomitant medications that the patient received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) and ibuprofen (both were consumed days after shot). Patient previously received cefotaxime sodium (OMNICEF) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Rash appeared beginning on 11Apr2021 16:00 and continued to appear for about five days. Rash was all over her torso, left arm, a few spots on the right, both legs near the knees and her back. The spots were small and itchy. The itching is still prevalent on her knees but new spots have not appeared in the last 3 days. Adverse vents did not result in emergency room visit or physician office visit. The patient did not test COVID post vaccination. No therapeutic measures were taken as a result of the event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Nervousness
Clinical narrative: nervous; nosebleed/ nose began to bleed out of nowhere; This is a spontaneous report from a Pfizer sponsored program.    A contactable consumer (patient) reported that a 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 16Apr2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose on 16Apr2021 and she felt alright. However, on the day of reporting morning (19Apr2021) while doing the laundry she had a nosebleed and she is concerned on what she will do next and whether it is related to the vaccine. She also reported that she was sitting in her car when her nose began to bleed out of nowhere. She states that she is nervous because she doesn't normally experience nosebleeds unless she is blowing her nose really hard. She asked if she should be concerned and if this is a common reaction. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Off label use
Clinical narrative: wasn't able to get the second dose; wasn't able to get the second dose; afterward got the shingles; This is a spontaneous report received from a contactable consumer(patient). This female patient of an unknown age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 09Mar2021 via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient got the first dose of the Pfizer BioNTech covid vaccine and afterward got the shingles.  So she wasn't able to get the second dose at 3 weeks because of the medicine she was taking for the shingles.  She saw doctor on Friday for a routine wellness check and she said to go ahead and get the second dose.  Outcome of shingles was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report from a contactable female consumer(patient) reported for herself.  A 78 years old female patient received 1st of BNT162B2 (Pfizer/BioNTech COVID-19 Vaccine) on 26Jan2021 13:00 at single dose for covid-19 immunization. Medical history was Allergy from dust. Concomitant drug was not reported. Mentioned had Pfizer covid vaccine but aware might not be protected because on immune suppressing drug. Dr had it wrong and pharmacy was right about following protocol of wearing mask since vaccine may not be effective. Also mentioned was dizzy from being outside and having allergies from dust. Thinks mask aren't working. The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On February 25, Pfizer and BioNTech announced they have begun an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine. Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described in the company Prescribing Information / authorized product monograph Outcome of the event was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Ear pain, Fatigue, Influenza, Oropharyngeal pain
Clinical narrative: sore throat; I woke up with a sore throat. I feel it in my ears to; diarrhea; fatigue; aches and pains; feels like she has the flu; strep throat; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 29Mar2021 (Batch/Lot Number: 8732) as single dose for COVID-19 immunisation.  Medical history included obese, thyroid, fibromyalgia and bell's palsy from 2016 and ongoing. The patient's concomitant medications were not reported. Patient took the first shot on 29Mar2021 and she was due today for the second shot. The caller woke up with a sore throat and it was kind of in the ears feeling on 19Apr2021. The caller almost felt like she had the flu and diarrhea really bad on 19Apr2021. The caller's throat almost feels like strep throat and she has aches and pains on 19Apr2021. Patient felt fatigue. Events onset on 19Apr2021. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pharyngitis streptococcal
Clinical narrative: sore throat; I woke up with a sore throat. I feel it in my ears to; diarrhea; fatigue; aches and pains; feels like she has the flu; strep throat; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 29Mar2021 (Batch/Lot Number: 8732) as single dose for COVID-19 immunisation.  Medical history included obese, thyroid, fibromyalgia and bell's palsy from 2016 and ongoing. The patient's concomitant medications were not reported. Patient took the first shot on 29Mar2021 and she was due today for the second shot. The caller woke up with a sore throat and it was kind of in the ears feeling on 19Apr2021. The caller almost felt like she had the flu and diarrhea really bad on 19Apr2021. The caller's throat almost feels like strep throat and she has aches and pains on 19Apr2021. Patient felt fatigue. Events onset on 19Apr2021. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: a lot of headache; Body soreness; This is a spontaneous report from a contactable consumer. This 52-year-old female consumer(patient) reported that received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EW0151, Expiry Date: 31Jul2021) on 09Apr2021 at single dose on right arm for covid-19 immunization. Medical history and concomitant drug were not reported. Patient stated that she received her second dose of the Pfizer BioNTech COVID-19 vaccine on 09Apr2021 and she started experienced symptoms on Monday 12Apr2021 that included "a lot of" headache (Headache was reported as worsened) and "body soreness (body soreness was reported as worsened)." Caller would like to know if there are any medications that she can take to relieve this pain, as she has already taken Tylenol which his not helping. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain, Therapeutic response unexpected
Clinical narrative: Caller stated she had soreness; Really bad allergies for spring and summer with the pollen have gone away; she started having an eye twitch/Eye Twitching; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 09Apr2021 12:00 (Batch/Lot Number: ER8730) as single dose for COVID-19 immunisation. Medical history included bipolar disorder from 2001 and ongoing, pancreatitis from 2003 and pollen allergy. Family medical history included Alzheimer's and heart disease. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and VITAMIN D NOS (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported.  Caller stated she had two side effects, one good thing and one bad thing, Caller stated she was usually sick this time of year but caller stated her allergies went away specifically mentioning pollen but now there was nothing. She noticed this on 12Apr2021. Caller stated she had soreness but no headache after the vaccine but two days after the vaccine she started having an eye twitch on 10Apr2021. Caller stated it did not last all day and was periodically and lasted for 3-5 minutes. Outcome of allergies went away and eye twitch was not resolved. Outcome of soreness was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills; Fever; Body aches; Sore arm; Diarrhea; This is a spontaneous report from a contactable consumer(patient). A 45-year-old female patient (not pregnant) received 2nd doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single doe on 16Apr2021 15:00 via an unknown route in left arm for Covid-19 immunization. Medical history included obesity, allergies, eczema and allergy with penicillin.  Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Mar2021 03:00 PM in left arm for Covid-19 immunization. No other vaccine received in four weeks prior to the COVID vaccine. It was unknown if other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Apr2021 01:00, patient experienced Chills, Fever, Body aches, Sore arm, and Diarrhea. No treatment received. The report was reported as not serious. Outcome of the events was resolved.       Serious: No         On 17Apr2021 : 01:00 AM, patient experienced adverse events of Chills, Fever, Body aches, sore arm, Diarrhea. No treatment received.    Outcome of the events was resolved.    No covid tested post vaccination.       No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: has problems with her knees; This is a spontaneous report from Pfizer sponsored program from a contactable consumer. A 74-Year-Old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6198) at single dose on 09Apr2021 for COVID-19 immunisation.  Relevant history was unknown. The patient received Flu shot for immunization on unknown date. The patient received the first dose of BNT162B2 on 08Mar2021 for COVID-19 immunisation. During the vaccine series they told her she needed a Flu shot and she asked the people in the hospital if that was okay and they said yes but then she ended up having to get the second dose late on the 9th because she had to wait 10-14 days. The 2nd dose was delayed because she had a flu shot in between doses of the vaccine and she was hospitalized. She would have had her second dose earlier, but she ended up in the hospital for something else, details not provided.  When hospitalized, she was offered a Flu shot.  When she asked, the Doctor and Nurse told her she could receive it even though she was getting a Covid-19 shot soon.  That delayed the 2nd dose. She also said that she needs to get a cortisone shot for her knee problem and she is asking if its okay to take the cortisone shot after the 2nd dose. Outcome of the event knee problem was unknown.   No follow-up attempts are needed as no further information can be expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: flu-like symptoms; chills; fever; nausea; he was throwing up; swollen lymph nodes; urinary infection; This is a spontaneous report from a contactable consumer (patient). A 71 years old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient stated he received the first dose of the Pfizer Covid 19 vaccine on April 2nd, the following Monday he had flu-like symptoms, he had chills, fever, nausea, he was throwing up. He also had swollen lymph nodes and a urinary infection. He is scheduled to receive his second dose this Friday. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection, Vomiting
Clinical narrative: flu-like symptoms; chills; fever; nausea; he was throwing up; swollen lymph nodes; urinary infection; This is a spontaneous report from a contactable consumer (patient). A 71 years old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient stated he received the first dose of the Pfizer Covid 19 vaccine on April 2nd, the following Monday he had flu-like symptoms, he had chills, fever, nausea, he was throwing up. He also had swollen lymph nodes and a urinary infection. He is scheduled to receive his second dose this Friday. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache
Clinical narrative: she had a headache; felt dizzy; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she had a headache and felt dizzy when she got her first dose last 08Apr2021. She said symptoms became better after. She was due to have her second dose on 29Apr2021. The outcome of the events was recovering.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Eye swelling, Headache, Ocular hyperaemia
Clinical narrative: she had a headache; felt dizzy; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she had a headache and felt dizzy when she got her first dose last 08Apr2021. She said symptoms became better after. She was due to have her second dose on 29Apr2021. The outcome of the events was recovering.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Swelling
Clinical narrative: she had a headache; felt dizzy; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she had a headache and felt dizzy when she got her first dose last 08Apr2021. She said symptoms became better after. She was due to have her second dose on 29Apr2021. The outcome of the events was recovering.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage
Clinical narrative: nurse pull the syringe out and the liquid flow out.; a lot of blood came out after administration; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included autism spectrum disorder, muscle tightness. The patient's concomitant medications were not reported. The consumer called in to ask about the amount of vaccine administered for the first dose and if it is the same for the second dose. She mentioned that her son with autism and tight muscle, got the first dose of the vaccine today (15Apr2021). She was worried if all of the dose was administered because she saw the nurse pull the syringe out and the liquid flow out. She also mentioned that a lot of blood came out after administration that they had to wipe with a cotton ball and that the needle used was big unlike when they got their first dose. She wanted to know if there was an antibody test to check if the vaccine was properly administered.  The outcome of events was unknown.    No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Eating disorder, Fatigue, Hyperhidrosis
Clinical narrative: couldn't eat anything/could eat cereal and maybe some ramen noodles, he couldn't eat anything; tired; sweating; This is a spontaneous report from a contactable consumer(patient). This 65-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN0158) at single dose on 13Apr2021 13:30 via an unknown route in left arm for Covid-19 immunization.  Medical history included Type 2 diabetes and high cholesterol, both ongoing. He had probably had Type 2 diabetes a lot longer than he thought. He was diagnosed with Type 2 diabetes in 2001 or 2002. He said his high cholesterol was pretty much in check because he stays on his pills. He says he has no clue how long he has had this condition, 39 years all over a year, that he probably had it while he was in Korea. His dad died of a heart attack. Concomitant drugs included metformin for cholesterol and had been taking this probably since '99 (as reported), gliclazide (GLIZIDE)(reported as "extra large (XL)") for type 2 diabetes taking this since probably about the time they discovered he had type 2 diabetes, atorvastatin calcium been taking this since the same as gliclazide for type 2 diabetes, and sitagliptin (JANUVIA) from Mar2021 for type 2 diabetes, all ongoing. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208) on 23Mar2021 10:30 AM in left arm for Covid-19 immunization and had no issues or side effects. History of all previous immunization with the Pfizer vaccine considered as suspect was reported a "NA". No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. He received his second vaccine dose on 13Apr2021 and on 15Apr2021 he began experiencing sweating. He stated he had been sweating up a storm, changing clothes 3 times a day. He said that didn't happen before the second shot. He denies fever and chills. Patient also experienced tired from 16Apr2021 and couldn't eat anything from 17Apr2021. Reporter seriousness for the events sweating, tired and couldn't eat anything was unspecified. Sweating happened 1 day right after he got the shot, which was probably "Wednesday" night, then it went away, then "Friday, Saturday, Sunday, last night" he had to change clothes 3 times. He still had to change clothes last night (as of 19Apr2021).  He was so tired he couldn't even eat, he could eat cereal and maybe some ramen noodles, he couldn't eat anything, he didn't feel like it. He was tired "Friday" afternoon. His grandkids got up and he felt like bleh. He said some days he gets up and feels fine, then he sweats, then he felt fine. On 19Apr2021 he got up and felt fairly decent. "Saturday" morning he couldn't eat anything, bacon and eggs he can't eat, he made a bowl of cream of wheat. No Emergency Room or Physician Office visit due to the events. No relevant tests performed. Outcome of tired was unknown. Outcome of the other events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: Numbness and tingling of hands/ completely numb hands; Numbness and tingling of hands; slight tingling in lips; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:30 (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient received the first dose of vaccine in Arm Left on 24Mar2021 13:30 (Batch/Lot Number: ER8733), also at age of 64 years old for covid-19 immunization and experienced migraine. Medical history included, Brown- Sequard (cervical myelopathy), Common variable immunodeficiency (CVID), migraine, fibromyalgia, Chronic interstitial cystitis (IC), Complex regional pain syndrome (CRPS), multiple orthopedic issues. Patient allergy to Sulfa, cipro, reglan, IVIG , flu vaccine , macrobid, Suprax, tetracycline. Concomitant medications included levothyroxine sodium (SYNTHROID); gabapentin (NEURONTIN DAW); liothyronine sodium (CYTOMEL); pregabalin (LYRICA), all taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On the third day after the 2nd vaccine 17Apr2021 08:00, patient  awoke with completely numb hands.  It resolved within ten minute. Tingling / partial numbness have continued. Some slight tingling in lips. The outcome of events was not recovered. Patient didn't receive treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urticaria
Clinical narrative: slight urticaria; This is a spontaneous report from a contactable physician.    A female patient of an unspecified age 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 at single dose for COVID-19 immunization, the patient also received methylprednisolone sodium succinate (SOLU-MEDROL) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported.  The patient previously took steroid antibacterials. The patient experienced slight urticaria on an unspecified date. The caller inquired whether Solu-Medrol Act-O-Vial contain polyethylene glycol. Caller stated a Covid vaccine (unknown manuf.) "might" have been administered to a patient who then had slight urticaria possibly due to the PEG component. Hypothetical patient also had allergic reactions to "steroid injections". Patient now needs an injection in her knee and caller is evaluating use of Solu-Medrol. The outcome of event was unknown.  Caller did not wish to report to safety and cited this patient as being "hypothetical". Documenting available information.  No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Extraocular muscle disorder, Muscle twitching
Clinical narrative: Experiencing involuntary muscle twitches in her leg ,calf. arm, eye, and most noticeable in her thumbs; Experiencing involuntary muscle twitches in her leg ,calf. arm, eye, and most noticeable in her thumbs; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history andconcomitant medications were not reported. The patient received her first dose of Pfizer-Biontech Covid19 vaccine back on 02Apr2021. On an unknown date in Apr2021, she has since been experiencing involuntary muscle twitches in her leg, calf, arm, eye, and most noticeable in her thumbs. She stated that the twitching has been getting worse, and was affecting her daily life, stating "its difficult to put toothpaste on my toothbrush". She wanted to know if she should get the second dose, and if it will counteract the first. She was frustrated because she's seen reports of this on social media, but no information about how long the symptoms last or if they'll go away on their own. The outcome of the events was not recovered.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Tongue discolouration, Tongue disorder
Clinical narrative: spots or discoloration on tongue; spots or discoloration on tongue; legs hurting or muscle pain; legs hurting or muscle pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 01Apr2021 at single dose for COVID-19 immunisation. The patient medical history included chemotherapy which stopped a few months ago. The patient's concomitant medications were not reported. The patient called in saying that she received the 1st dose of Pfizer COVID-19 vaccine last April 1, 2021 and she scheduled for the 2nd dose on April 22, 2021. The patient was currently experiencing spots or discoloration on tongue, legs hurting or muscle pain and other adverse events but claiming that it is not serious. The outcome of the events was not recovered.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: has issue with her back; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated that she would be getting her second dose of the Pfizer vaccine this Thursday and had issue with her back on an unspecified date that was why she was described with ibuprofene and tylenol 600 mg. The patient asked if she should stop taking this before her second dose. The outcome of the event was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush
Clinical narrative: dizzy/dizziness; hot flashes; This is spontaneous report from a contactable other healthcare professional (the patient). An 83-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 22Mar2021 (Lot Number: ER6955), dose 2 on 14Apr2021 (Lot Number: ER8735) (Time the Vaccination Was Given as "1000", it did not specify if it refers to the first/second dose), both via an unspecified route of administration in the right upper arm at age of 83-year-old at single dose for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Medical history included vertigo that happened 6-7 years ago and she was hospitalized for this. No family medical history relevant to AE. The patient's concomitant medications were not reported. The patient experienced the dizziness and hot flashes after the first dose of the vaccine (2021), the caller did not know dates of the dizziness and hot flashes she experienced after the first dose of the vaccine. The symptoms then weren't as bad as the ones she was having currently after the second dose of the vaccine. The caller stated that she had been dizzy, it was almost like vertigo that she had once before, she had been dizzy since Friday 16Apr2021 and was very dizzy on Saturday 17Apr2021 (after the second dose). She had also been having hot flashes. She has Meclizine and had taken those a couple of times. The patient had the same symptoms after the first dose of her vaccine but they were not as severe. Caller stated she did not know if her symptoms were caused by the vaccine. She thought they might be since they started after the vaccine but is not certain. No Emergency Room or Physician Office visit. The outcome of the events was recovering. The events were not serious.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Lot Number: ER8732, unknown expiration) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received his first COVID vaccine dose on 22Mar2021 and then tested positive for COVID-19 on 29Mar2021 with symptoms for 14 days. The patient supposed to get the second dose on 19Apr2021.  The patient was told to have a COVID-19 test before he can receive the second dose. He has been symptom-free for more than fourteen days and would like to know if there would be any issues with taking the second dose after developing COVID-19. The patient recovered from the event on unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Neck pain
Clinical narrative: chills; pain in elbow neck and back; pain in elbow neck and back; pain in elbow neck and back; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included patient had Covid-19 two months ago in Feb2021. The patient's concomitant medications were not reported. Patient received first dose of vaccine yesterday and had chills, pain in elbow neck and back on an unknown date in Apr2021, no fever. Wanted to know if those symptoms were normal. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension, Inappropriate schedule of product administration
Clinical narrative: heart rate elevated; hypertension; not take the second dose; not take the second dose; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL S) taken for lupus, start and stop date were not reported. The patient experienced heart rate elevated and hypertension in 2021 which she observed at the Hospital where she is working with outcome of unknown. Patient was told not to take the second dose and because she is taking Plaquenil (immunosuppressant medication) due to lupus and new medication is Methotrexate which she did not yet take because she is afraid to lower down her immune system. Patient is asking if she needs to take the 2nd dose vaccine because she was told by her Rheumatologist not to take the vaccine which is too risky and the Primary Care Physician said that it is okay to take it.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: heart rate elevated; hypertension; not take the second dose; not take the second dose; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL S) taken for lupus, start and stop date were not reported. The patient experienced heart rate elevated and hypertension in 2021 which she observed at the Hospital where she is working with outcome of unknown. Patient was told not to take the second dose and because she is taking Plaquenil (immunosuppressant medication) due to lupus and new medication is Methotrexate which she did not yet take because she is afraid to lower down her immune system. Patient is asking if she needs to take the 2nd dose vaccine because she was told by her Rheumatologist not to take the vaccine which is too risky and the Primary Care Physician said that it is okay to take it.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased, Vaccination site pain, Vision blurred
Clinical narrative: pain radiating from the injection site to her chest; pain radiating from the injection site to her chest; rapid heart rate; blurred vision in the eye on the side of the injection; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A 7 decade female patient (reported as "approximately mid-60's") received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 07Apr2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 12Apr2021 she experienced pain radiating from the injection site to her chest, rapid heart rate, and blurred vision in the eye on the side of the injection. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a non-contactable pharmacist reported for a patient (father in law). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose via an unspecified route of administration on an unspecified date as single dose, second dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a slightly sore arm the first night after his first and second Pfizer shot. Event took place after use of product. Outcome of the event was unknown.                                No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: severe rash.; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller received her second dose of the vaccine on an unknown data (Saturday) and started to develop a severe rash on an unknown date. The outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Depression, Headache, Pain
Clinical narrative: Hands are swollen; Pain much worse; Depression 10 fold; Anxiety 10 fold; headache; pain in back; This is a spontaneous report  from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 virus last year in 2020, ongoing chronic condition of pain, depression and anxiety. The patient's concomitant medications were not reported. The patient was experiencing side effects from the first dose, the patient had chronic conditions: pain much worse, depression and anxiety were 10 fold, the patient had headache and pain in her back, patient already had in her body its making it worse. Patient was in terrible in pain, patient was in anxiety. Her hands were swollen. The nurse said it may make her conditions worse, may magnify it. She was hesitant at the moment but said to go ahead. Any time patient put medicines in her body it made it worse. Her body was not as swollen as yesterday. Its been 11 days. Patient didn't go into shock. Patient wanted to know if she should receive the second dose. The outcome of the event 'hands were swollen' was recovering, and the outcome of the other events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Hands are swollen; Pain much worse; Depression 10 fold; Anxiety 10 fold; headache; pain in back; This is a spontaneous report  from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 virus last year in 2020, ongoing chronic condition of pain, depression and anxiety. The patient's concomitant medications were not reported. The patient was experiencing side effects from the first dose, the patient had chronic conditions: pain much worse, depression and anxiety were 10 fold, the patient had headache and pain in her back, patient already had in her body its making it worse. Patient was in terrible in pain, patient was in anxiety. Her hands were swollen. The nurse said it may make her conditions worse, may magnify it. She was hesitant at the moment but said to go ahead. Any time patient put medicines in her body it made it worse. Her body was not as swollen as yesterday. Its been 11 days. Patient didn't go into shock. Patient wanted to know if she should receive the second dose. The outcome of the event 'hands were swollen' was recovering, and the outcome of the other events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Pneumonia, Pulmonary fibrosis, Respiration abnormal
Clinical narrative: Shortly after receiving this first dose,my husband's breathing went downhill, two months later he was dead. They could not find the cause. I told them I knew the cause. It was the Covid shot! I reported it to his pulmonologist and to the hospital staff. He was stable with all other conditions until he got this shot!
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thromboembolectomy
Clinical narrative: Pulmonary embolism. Had surgery to remove blood clots in lungs
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Next day had ringing in my left ear- Tinnitus  Ringing has not stopped
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Muscle spasms, Pain
Clinical narrative: Sudden onset of intense muscle spasms in back, down the legs to the knees.  Intense pain for 3 days.  Moderate pain for 5 days.  Ongoing soreness and weakness in back continues even after second shot.  The doctor recommended taking the second shot, but prescribed muscle relaxants.  Unsure of permanent damage.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: He was doing fine when I escorted him to the waiting area. Upon a few minutes later, he started to fell down. I was called and came to check on him. He told me he closed his eyes for a bit and started to fall down. I was not sure if the fall was because he lost balance or the shot made him fainted. There was no respiratory distress or any anaphylactic reaction so no Epipen was use. I applied cold pack to him and he recovered a few minutes later.